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(A joint stock company incorporated in the People's Republic of China with limited liability)
(Stock Code: 2157)
The Board is pleased to announce the audited consolidated annual results of the Group for the year ended December 31, 2025, together with the comparative figures of 2024.
Strong pickup in revenue: Revenue was approximately RMB934.9 million for the year ended December 31, 2025, approximately 2.5 times of the revenue in 2024 (2024: RMB367.8 million), and primarily comprised:
First year to achieve profits: The Group achieved a positive profit attributable to owners of the Company of approximately RMB261.4 million for the year ended December 31, 2025, representing a substantial increase compared with 2024.
Broadly balanced net operating cash flow: Net cash used in operating activities for the year ended December 31, 2025 was approximately RMB12.2 million. Cash and cash equivalents as of December 31, 2025 was approximately RMB853.0 million, which was more than double of the amount as of December 31, 2024 (approximately RMB401.3 million).
Decrease in R&D expenses: Research and development expenses amounted to approximately RMB400.7 million for the year ended December 31, 2025, representing a decrease of approximately 8.5% compared to approximately RMB437.7 million for the year ended December 31, 2024.
(1): We define “adjusted net loss (non-IFRS measure) for the year” as our profit or loss for the year, deducting certain item as set out in the section headed “Adjusted Net Loss (Non-IFRS Measure) for the Reporting Period”. We exclude this item because it is non-recurring income related to one of our investments that is non-operating in nature.
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FIC EGFR-TARGETED ADC MEIYOUHENG OBTAINED APPROVAL, MORE DRUGS ENTERED THE PIVOTAL STAGE, AND TREATMENT LINES ADVANCEMENT ACHIEVED BY COMBINATION THERAPY
In October 2025, MEIYOUHENG obtained marketing approval from the NMPA for R/M NPC, making it the first EGFR-targeted ADC approved in China.
In addition, we are currently conducting the Phase III clinical trial for the combination therapy of becotatug vedotin with pucotenlimab for R/M NPC. The promising clinical results from the Phase II trial for the combination therapy of becotatug vedotin with pucotenlimab were presented at the 2025 ESMO Congress. This combination therapy was granted BTD by the CDE in September 2025.
In terms of combination therapy with becotatug vedotin and pucotenlimab, we are currently conducting the Phase II clinical trial on HNSCC, which has moved to first-line treatment, and the encouraging data was presented at the ESMO Congress 2025. We are also conducting the Phase II clinical trial targeting LA-HNSCC in Europe. Furthermore, we obtained the IND approval from CDE for the combination therapy of becotatug vedotin with pucotenlimab targeting preoperative patients with LA-HNSCC in China.
In February 2023, AstraZeneca was granted the exclusive global license for the research, development, registration, production, and commercialization of CMG901 (AZD0901). AstraZeneca is actively conducting two Phase III clinical trials of CMG901: one as a monotherapy for advanced/metastatic gastric or gastroesophageal junction adenocarcinoma, and another as a combination therapy with capecitabine, with or without rilverostomig for the first-line treatment of Claudin18.2-positive and HER2-negative advanced/metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. Subject to the License Agreement, the first patient dosing in the combination trial has triggered a US$45 million milestone payment, which has been made by AstraZeneca.
We are currently conducting a Phase III clinical trial for the treatment of PDAC in China. In August 2025, MRG004A received BTD from CDE. The encouraging Phase Ib expansion data on PC was presented at the ESMO Congress 2025.
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CG0070 (oncolytic virus):
CG0070 is currently in a MRCT Phase III clinical study conducted by our U.S. partner, CG Oncology. The latest encouraging data observed have been orally presented as LBA at the 26th SUO Annual Meeting.
As of December 31, 2025, we have initiated patient enrollment for the domestic pivotal clinical trial. In addition, CG0070 was granted BTD by the CDE in 2025.
MRG001(CD20-ADC):
We are conducting a Phase II clinical study evaluating MRG001 in combination with BTK inhibitors for the treatment of DLBCL patients, with encouraging interim data from the study presented at the 67th ASH Annual Meeting.
MRG006A(GPC3-ADC):
MRG006A is a novel topoisomerase I inhibitor-based GPC-3 ADC candidate with global first-in-class potential, which has been developed based on our Hi-TOPI ADC platform. We are conducting the Phase II clinical trial for HCC in China. Moreover, we received IND clearance for MRG006A from the FDA, and the drug was granted FTD and ODD designations by the FDA. The encouraging data from the Phase I clinical study has been observed and is planned to be presented at the ASCO Congress 2026.
MRG007(CDH17-ADC):
The Company and Arrivent are concurrently conducting a Phase I MRCT for the treatment of unresectable locally advanced or metastatic solid tumors in China and the U.S.. The pre-clinical data for MRG007, presented at the 2025 AACR Annual Meeting, showed promising clinical potential for the treatment of GI cancers.
In January 2025, the Company entered into an exclusive licensing agreement with ArriVent, pursuant to which the Company has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. Under the terms of the agreement, the Company is eligible to receive up to US$1.2 billion in total in upfront payment and development, regulatory and sales milestones, together with tiered royalties on net sales.
Innovation platforms:
The Company's R&D platforms, Hi-TOPI ADC platform and T cell engager platform, are mature and validated. In addition to the products under development in the pipeline, the Company is also actively developing multi-specific antibody IO and multi-specific antibody ADC candidates through its proprietary R&D platforms. Preclinical data of one bispecific ADC candidate and one novel immune-oncology fusion protein candidate candidate are planned to be presented at the AACR Annual Meeting in April 2026.
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MRG006A: In February 2026, MRG006A obtained IND approval from the CDE for the first-line treatment of HCC in combination therapy with Pucotenlimab and Avastin, providing a new therapeutic option for HCC patients.
MRG007: In March 2026, the Company’s partner, ArriVent, completed FPI in the U.S.. From now on, we conduct the MRCT together.
MEIYOUHENG (Becotatug Vedotin Injection): In March 2026, we obtained the IND approval from CDE for the combination therapy of becotatug vedotin with pucotenlimab, which is for the Phase II clinical trial specifically targeting preoperative patients with LA-HNSCC to evaluate the efficacy and safety prior to surgery.
We are an innovation-driven biopharmaceutical company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. Since our establishment, we have been dedicated to developing innovative ADCs through our comprehensive and advanced ADC technology development platform and we aim to develop optimal and innovative drugs to better serve the unmet medical needs of cancer patients. We have an integrated end-to-end capability across drug discovery, clinical development, CMC and GMP-compliant manufacturing, encompassing all critical functions of the biopharmaceutical value chain. We are committed to continuously developing a market-differentiating pipeline by fully integrating our independent innovation capabilities and strategic collaborations. Concurrently, we are dedicated to exploring synergistic therapeutic approaches on the basis of the continuous enrichment of our product pipeline. We have established and are progressively expanding our internal manufacturing capabilities, driven by the business needs stemming from the commercialization of our ADC candidates.
We have strategically designed our pipeline with a range of oncology products. As of the date of this announcement, we have (i) two clinical/commercialization-stage drug candidates; (ii) eight clinical-stage drug candidates, including one co-developed through a joint venture; and (iii) five clinical-stage combination therapies of our candidates. Two of our drug candidates have obtained marketing approval with respect to their targeted indications, with clinical trials for other indications ongoing. Among the eight clinical-stage drug candidates, six are targeted therapeutics and two are immunotherapeutics, which are an oncolytic virus drug and T cell agonistic antibody. MEIYOUHENG (Becotatug Vedotin Injection), which obtained marketing approval from NMPA in China, was granted BTD, ODD and FTD on NPC from the FDA. The combination therapy of MEIYOUHENG (Becotatug Vedotin Injection) with pucotenlimab was granted BTD by CDE. MRG002 was granted ODD on GC/GEJ from the FDA. CMG901 was granted FTD and ODD in GC/GEJ from the FDA, and obtained BTD from CDE. MRG004A was granted ODD and FTD by the FDA for the treatment of PC, and BTD by the CDE. MRG006A was granted ODD and FTD by the FDA for the treatment of HCC. CG0070 was granted BTD from the CDE and FDA. In addition, MEIYOUHENG (Becotatug Vedotin Injection) and MRG006A have obtained IND clearance from the FDA. We continuously strive to build and advance novel technology platforms as the Company’s innovative engines, while driving the continuous advancement of a pipeline of novel and innovative molecules.
We aim to commercialize our pipeline products in China through dedicated sales and marketing forces, while attaining international market reach through strategic partnerships. As of the end of the Reporting Period, the Company has achieved significant milestones in the monetisation of our R&D capabilities through domestic commercialization and BD activities: PUYOUHENG (Pucotenlimab Injection) has completed the full commercialization process and is currently under a rapid sales growth. Building on this momentum, we aim to optimize the commercialization strategy for MEIYOUHENG (Becotatug Vedotin Injection) (FIC EGFR-ADC) to drive more efficient market penetration and growth. In addition, two other products, CMG901 and MRG007 have also been licensed out through our BD activities. Notably, CMG901's global rights have been licensed to AstraZeneca, and MRG007's rights for regions outside Greater China have been licensed to ArriVent. These accomplishments have established a solid foundation for the Company's future commercialization of drug candidates and global cooperations. The Company has established end-to-end commercialization capabilities in the domestic market, while positioning itself as a global biotech company with growing engagement in international R&D and strategic partnerships.
The following chart illustrates our pipeline and summarizes the development status of our clinical-stage:
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Notes:
BUSINESS REVIEW
Domestic commercialization & licensing transaction
During the Reporting Period, the Group recognized substantial revenue growth, recording a total revenue of approximately RMB934.9 million, which was approximately 2.5 times of its revenue in 2024 at RMB367.8 million.
For domestic commercialization, the Group recorded a revenue of approximately RMB501.0 million for the sales of PUYOUHENG (Pucotenlimab Injection) and MEIYOUHENG (Becotatug Vedotin Injection), marking a significant increase of 66.8% from the sales recorded in 2024 (2024: RMB300.3 million). Meanwhile, MEIYOUHENG, the newly launched product that obtained NMPA approval in October 2025, contributed preliminary revenue during the reporting period, further enriching the Group’s commercial product portfolio and laying a solid foundation for substantial growth.
For licensing activities, the Group has recognized approximately RMB424.2 million in revenue (2024: RMB22.0 million), primarily from the out-licensing of MRG007 and out-licensing of TCE assets. We remain committed to advancing our global licensing strategy and actively carry out out-licensing collaborations. In January 2025, the Company entered into an exclusive licensing agreement with ArriVent, pursuant to which the Company has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. Under the terms of the agreement, the Company is eligible to receive up to US$1.2 billion in total upfront payment, development, regulatory and sales milestones payments, on top of tiered royalties on net sales. In addition, on August 1, 2025, the Company entered into a licensing transaction with Excalipoint for the license-out and/or transfer of certain intellectual property rights relating to two pre-clinical assets developed by the Group’s proprietary T cell engager-TOPAbody platform. The Company is eligible to receive an aggregate upfront cash payment of US$10 million plus 10% of the enlarged issued capital of Excalipoint Cayman (to be issued to the Company’s wholly-owned subsidiary), aggregate development and commercial milestone payments of up to US$847.5 million in cash, and sales royalties at a tiered rate. These transactions demonstrate the Company’s growing expertise in global partnership strategies, as it continues to accumulate experience in seeking strategic partners worldwide to advance its pipeline assets across international markets.
In 2025, most notably, our FIC EGFR-targeted ADC MEIYOUHENG has obtained marketing approval in China. Meanwhile, more of our drug candidates have entered the pivotal clinical stage, and treatment line advancement was achieved through the development and optimization of combination therapy regimens. A description of the progress made and the latest status in respect of the Group’s drug candidates for 2025 and up to the date of this annual results announcement is as follows:
MEIYOUHENG (Becotatug Vedotin Injection) is an ADC comprised of an EGFR-targeted mAb conjugated with the potent microtubulin disrupting payload MMAE via a vc linker. It binds specifically with high affinity to human EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker, and results in tumor cell death. In October 2025, becotatug vedotin received marketing approval from the NMPA for R/M NPC, making it the first EGFR-targeted ADC approved in China.
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We are also conducting the Phase III clinical trial for combination therapy of MEIYOUHENG (Becotatug Vedotin Injection) with pucotenlimab for R/M NPC. The Phase II clinical trial of the combination therapy of becotatug vedotin with pucotenlimab, as of April 27, 2025, demonstrated significant and sustained clinical benefits in patients previously failing IO and platinum-based chemotherapy, with the cORR reaching 73.3%, cDCR reaching 93.3% and mPFS of 10.9 months; the mOS has not been reached, and the 12-month and 18-month overall survival rates were 92.8% and 82.5%, respectively. These findings were presented at the 2025 ESMO Congress. Becotatug vedotin in combination with pucotenlimab was granted BTD by CDE in September 2025 for R/M NPC patients who failed at least one prior platinum-based therapy and PD/L1 inhibitor therapy, with the potential to deliver an efficacious treatment option for this underserved patient population.
In terms of combination therapy with becotatug vedotin and pucotenlimab, we are currently conducting the Phase II clinical trial on HNSCC, which has moved to first-line treatment, and the encouraging data in phase II clinical trial were presented at the ESMO Congress 2025. As of February 28, 2025, the 2.0 mg/kg dose cohort achieved a CR rate of 4.8%, ORR of 47.6% and DCR of 95.2%. For the 2.3 mg/kg dose cohort, the ORR and DCR were 60% and 100%, respectively. The median PFS was 5.2 months for the 2.0 mg/kg dose cohort and immature for the 2.3 mg/kg dose cohort. We are also conducting the Phase II clinical trial targeting LA-HNSCC in Europe. Furthermore, we obtained IND approval from the CDE for the combination therapy of becotatug vedotin with pucotenlimab in China, which is intended to evaluate the efficacy and safety of this regimen in preoperative patients with LA-HNSCC prior to surgical intervention.
CMG901 is a CLDN18.2-targeting ADC comprising a CLDN18.2-specific antibody, a cleavable linker and a toxic payload, MMAE. It is the first CLDN18.2 targeting ADC to have received IND clearance both in China and the U.S. CLDN18.2 is selectively and widely expressed in GC, PC and other solid tumors, which makes it an ideal tumor target for therapeutic development. It is being co-developed by us and Keymed through a joint venture, KYM. In February 2023, AstraZeneca was granted the exclusive global license for the research, development, registration, production, and commercialization of CMG901 (AZD0901). As of the date of this announcement, AstraZeneca has initiated multiple clinical studies on CMG901 (AZD0901) for the treatment of advanced solid tumors, with indications including GC, PC, and biliary tract cancer.
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As of the date of this announcement, in addition to the above-mentioned clinical trials, AstraZeneca has also conducted multiple clinical studies regarding sonesitatug vedotin (CMG901/AZD0901) for the treatment of advanced solid tumors, targeting indications including gastric cancer, pancreatic cancer and biliary tract cancer (only trials at the highest clinical phase are presented for the same indications):
(1) A multi-center, open-label, sponsor-blinded, randomized Phase III clinical study to compare AZD0901 monotherapy with investigator-choice regimen in adult subjects with advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma with Claudin 18.2-expression who had previously received second or later-line treatment (CLARITY Gastric 01).
(2) A multi-center, randomized, controlled Phase III clinical trial of Sonesitatug vedotin (AZD0901) in combination with capecitabine, with or without Rilverostomig, as a first-line treatment for Claudin18.2-positive, HER2-negative advanced/metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma (CLARITY-Gastric 02). In February 2026, the first patient in this clinical trial was dosed, which triggered a milestone payment of US$45 million in total. AstraZeneca has made the corresponding milestone payment.
(3) An open-label, multi-drug, multi-center Phase II study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of a novel drug or a combination therapy as a perioperative treatment of subjects with locally advanced, resectable gastroesophageal junction adenocarcinoma (GEMINI-PeriOp GC).
(4) A Phase II, open-label, multi-center clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of AZD0901 monotherapy and in combination with anti-tumor drugs for the treatment of subjects with Claudin 18.2-expressing advanced solid tumors (including gastric cancer/gastroesophageal junction adenocarcinoma, pancreatic cancer, biliary tract cancer) (CLARITY-PanTumour01).
MRG004A is a novel TF-targeted site-specifically conjugated ADC. We have completed the Phase I clinical study on solid tumors in China. In August 2025, we initiated the pivotal Phase III clinical trial of MRG004A, with the first patient enrollment completed in January 2026; it also received BTD designation from the CDE in the same month. The encouraging Phase Ib expansion data on PC were presented at the ESMO Congress 2025. As of February 10, 2025, for patients who had previously received 1L treatment, the ORR and DCR were 40.0% and 80.0%, respectively, with corresponding mPFS and mOS of 5.8 months and 13.2 months. For those with prior ≥2L treatment, the ORR and DCR reached 18.5% and 70.4%, respectively, while the mPFS and mOS stood at 2.7 months and 5.8 months. MRG004A is expected to offer a brand-new treatment option to patients with pancreatic cancer.
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CG0070 is an oncolytic adenovirus for the treatment of BCG-unresponsive bladder cancer patients and is currently in a MRCT Phase III clinical study conducted by our U.S. partner, CG Oncology. The latest encouraging data observed have been orally presented as LBA at the 26th SUO Annual Meeting. As of September 1, 2025, 75.5% of patients achieved CR at any time after receiving treatment with CG0070 as monotherapy. CG0070 demonstrated HG-EFS at 3-, 6-, and 9-month of 95.7%, 84.6% and 80.4%, respectively, in HR BCG-unresponsive Ta/T1 Disease.
We in-licensed CG0070 from CG Oncology and were granted the rights to develop, manufacture and commercialize it in Mainland China, Hong Kong and Macau. As of December 31, 2025 we have completed the Phase I clinical trial in China and have initiated patient enrollment for the domestic pivotal clinical trial. For the combination therapy of CG0070 with PUYOUHENG (Pucotenlimab Injection), we received an IND approval from the NMPA for its Phase I trial in the treatment of patients with BCG-unresponsive NMIBC.
In addition, CG0070 was granted BTD by the CDE in 2025 for the treatment of BCG unresponsive bladder cancer patients, which have relapsed or are refractory to prior approved therapies, and this designation signified the innovativeness and the potential of CG0070 to fulfill the unmet medical needs.
MRG002 is an innovative ADC targeting HER2, a molecular target abnormally over-expressed in many cancer types including BC, UC and GC/GEJ. Our clinical development strategy for MRG002 in China aims at realizing the efficacy potential of MRG002 in various prevalent malignancies, especially for second- or later-line systemic therapy of BC. Registrational clinical trials in the aforementioned indications are ongoing. We are constantly exploring the potential of MRG002 through its combination with immuno-oncology by conducting clinical studies which aim to target more patients in early stage and provide more options to fulfill the unmet medical needs.
HER2 over-expressing BC: We have completed the pivotal Phase II clinical trial on HER2 over-expressed BC with liver metastasis in China and have observed encouraging data. As of December 31, 2025, we are conducting a Phase III clinical study on HER2-positive BC.
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MRG001 is a clinically advancing CD20-targeted ADC which addresses the medical needs of B cell NHL patients with either primary drug resistance to rituximab or acquired drug resistance to the combination therapy of rituximab and standard chemotherapies. We have completed the Phase Ib dose expansion study of MRG001 in China and have observed encouraging preliminary data on DLBCL. Meanwhile, the Phase II clinical study of MRG001 in combination with BTK inhibitors for patients with DLBCL is ongoing, with interim data presented at the 67th ASH Annual Meeting. As of August 31, 2025, the ORR and DCR among evaluable patients aged ≥18 years with ECOG PS 0-2, histologically confirmed R/R DLBCL who had received at least one prior line of therapy—80.8% of whom had received ≥2 prior lines of systemic therapy with a median of 3 lines—were 66.7% and 85.7%, respectively. The mDoR reached 10.2 months, with an mPFS of 13.1 months for this patient population, and mOS was not reached.
MRG006A is a novel topoisomerase I inhibitor-based GPC-3 ADC candidate with global first-in-class potential, which has been developed based on our Hi-TOPi ADC platform. We are conducting the Phase II clinical trial for HCC in China. Moreover, we received IND clearance for MRG006A from the FDA, and the drug was granted FTD and ODD designations by the FDA. The encouraging data from the Phase I clinical study has been observed and is planned to be presented at the ASCO Congress 2026. In pre-clinical studies, MRG006A resulted in a robust and dose-dependent tumor growth inhibition on multiple CDX models and HCC PDX models. In the meantime, MRG006A also demonstrated good tolerability in the exploratory toxicology study.
MRG007 is a potential best-in-class ADC for the treatment of GI malignancies based on preclinical and IND enabling studies. We are currently conducting a Phase Ia clinical trial for the treatment of unresectable locally advanced or metastatic solid tumors. In March 2026, ArriVent, our partner completed FPI in the U.S.. From now on, we conduct the MRCT together. The pre-clinical data for MRG007, presented at the 2025 AACR Annual Meeting, showed promising clinical potential for the treatment of GI cancers.
On January 22, 2025, the Company has entered into an exclusive license agreement with ArriVent to develop and commercialize MRG007. Under the terms of the agreement, the Company has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. The one-time upfront and near-term milestone payments amount to US$47 million and the Company is eligible to receive up to US$1.16 billion in development, regulatory and sales milestones and tiered royalties on net sales outside of Greater China. As of December 31, 2025, we have received the upfront payment.
PUYOUHENG (Pucotenlimab Injection)
PUYOUHENG (Pucotenlimab Injection) is a humanized IgG4 mAb against human PD-1, which can antagonize the PD-1 signal to restore the capability of the immune cells to kill cancer cells through blocking PD-1 binding to their ligands PD-L1 and PD-L2, and which has been commercialized for treating MSI-H/dMMR and inoperable or metastatic melanoma since the second half of 2022. In April 2023, two indications were included into the 2023 CSCO Guideline, which are pucotenlimab as ≥ second-line treatment of MSI-H/dMMR colorectal cancer and solid tumors, and pucotenlimab as second-line treatment of melanoma. Moreover, Pucotenlimab for treatment of advanced and recurrent MSI-H/dMMR gynecological cancer was included into the 2023 CSGO Guideline. Pucotenlimab demonstrated robust antitumor activity in patients (pts) with MSI-H/dMMR, based on findings from the phase II study, and we presented the long-term survival results and the updated safety profile at the ASCO Annual Meeting 2025.
MSI-H/dMMR solid tumors: We are conducting an open label, multi-center and randomized Phase III clinical trial on the first-line MSI-H/dMMR metastatic colorectal cancer as a confirmatory clinical study for the conditional marketing approval as of December 31, 2025.
Innovation Platforms
We continuously strive to build up and develop novel technology platforms as innovative engines for the Company. We have developed multiple innovative linker-payload platforms for ADC drug candidates, including the Hi-TOPi ADC platform and other early-stage platforms. During the Reporting Period, our innovative ADC platforms have achieved significant progress. Leveraging these innovative platforms, we have generated two ADC candidates, which are MRG006A with global first-in-class potential and MRG007 with global best-in-class potential. Both candidates have demonstrated robust and reproducible pre-clinical efficacy with a well-tolerated safety profile, and have successfully received IND approvals in China with rapid clinical initiation. Pre-clinical data of MRG007 was presented at the AACR Annual Meeting in April 2025. Furthermore, we plan to present preclinical data of one bispecific ADC drug candidate and one novel immune-oncology fusion protein candidate at the AACR Annual Meeting in April 2026.
Using the novel linker-payload platform, we have developed MRG006A, which is an ADC candidate with global first-in-class potential and is currently undergoing Phase II clinical trial in China.
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We have been operating a 2,000L GMP-compliant bioreactor production line at our Beijing manufacturing plant, which mainly supports the production of clinical drug supply, offers CDMO production services and enables continuous process optimization for the approved drug. During the Reporting Period, we have recognized RMB9.6 million in revenue from the provision of CDMO services.
In addition, the manufacturing facilities in the Shanghai Biotech Park have a designed total capacity of 12,000L, and has obtained the environmental impact assessment report for the production of mAb and ADC. Going forward, we will continue to build or expand our manufacturing facilities based on our business needs arising from the commercialization of our ADC candidates.
The Company has entered into a framework agreement with Lepu Medical in respect of the provision of CDMO technical services by the Company and/or its subsidiaries to Lepu Medical and/or its subsidiaries for their development of GLP-1 and related products on November 28, 2025. The annual cap with respect to the provision of CDMO services for the year ending December 31, 2026 is RMB18.2 million.
On even date, the Company also entered into another framework agreement with Lepu Medical in respect of the procurement of raw materials and supplementary materials for clinical trials, pharmaceutical products, biological sample test services for clinical trials, products for employee welfare and other services by the Group from Lepu Medical and/or its subsidiaries and/or associates. The annual cap for the year ending December 31, 2026 is RMB12.0 million.
For further details of the aforementioned continuing connected transaction with Lepu Medical, please refer to the announcement of the Company dated November 28, 2025.
Completion of the H Share Full Circulation
On July 21, 2025, the conversion of 54,268,364 unlisted shares of the Company into H shares of the Company was completed, and listing of such converted H Shares commenced at 9:00 a.m. on July 22, 2025 on the Stock Exchange. Please refer to the Company’s announcement dated July 21, 2025 for further details.
Adoption of the RSU Scheme
On December 18, 2025, the Company obtained Shareholders’ approval at the 2025 second extraordinary general meeting for the RSU Scheme. The RSU Scheme is intended to attract, motivate and retain key personnel by granting restricted share units to eligible employees and Directors (excluding independent non-executive Directors) of the Group, subject to vesting conditions, performance targets, and clawback provisions as set out in the scheme rules. The Shareholders also approved a cap limiting the total number of new Shares that may be issued under the RSU Scheme and any other share incentive plans to 5% of the Company’s total number of Shares (excluding Treasury Shares, if any).
For further details of the RSU Scheme, please refer to the Company’s announcement dated November 28, 2025, circular dated November 28, 2025 and poll results announcement dated December 18, 2025.
KEY EVENTS AFTER THE REPORTING PERIOD
CDE IND Approval of MRG006A for First-Line HCC Combination Therapy
In February 2026, MRG006A obtained IND approval from the CDE for the first-line treatment of HCC in combination therapy with Pucotenlimab and Avastin, providing a new therapeutic option for the patients with HCC.
MRG007 entered Phase Ib expansion clinical trial in the U.S.
In March 2026, the Company’s partner, ArriVent, completed FPI in the U.S. From now on, we conduct the MRCT together.
CDE IND Approval for the combination therapy of MEIYOUHENG (Becotatug Vedotin Injection) for Neoadjuvant therapy for resectable LA-HNSCC Phase II Trial
In March 2026, we obtained the IND approval from CDE for the combination therapy of becotatug vedotin with pucotenlimab, which is the Phase II clinical trial designed to evaluate the efficacy and safety of Neoadjuvant therapy in resectable LA-HNSCC patients prior to surgery.
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The Company is an innovation-driven biopharmaceutical company focusing on oncology therapeutics, dedicated to promoting the technological advancement of innovative ADCs in China to better serve the unmet medical needs of cancer patients. Looking ahead to 2026, we plan to leverage our competitive advantages through the following development strategies:
In respect of drug R&D, we strive to enrich our differentiated marketed product portfolio targeting indications with significant medical needs by combining our independent R&D capability with strategic collaborations. We will further focus on advancing strategic research and development priorities in next generation ADC drugs and IO bi/tri specific antibodies, while accelerating the commercialization of late-stage products. Moreover, our key drug candidates are entering pivotal clinical stages. MRG004A is currently enrolling patients in Phase III clinical trials. In addition, we have initiated patient enrollment for the domestic pivotal clinical trial of CG0070. We will also work expeditiously to progress our other innovative drug candidates, including MRG006A and MRG007, to the pivotal clinical stage. Concurrently, the potential efficacy of combination therapies within our pipeline is being continuously explored, with greater clinical benefits striving to be delivered to a broader patient population.
In terms of domestic commercialization, we have successfully commercialized PUYOUHENG (Pucotenlimab Injection) through our own sales channels, which further validates our sales strategy and business model. In addition, for MEIYOUHENG (Becotatug Vedotin Injection), NMPA has granted marketing approval in China. We will continue to concentrate our resources and endeavour to drive the commercialization process, focusing on enhancing market uptake and sales performance of our approved products. We will take further actions to enhance the market accessibility of these two products, accelerating market penetration at all levels to further increase market share. By leveraging the expertise and industry connections of our commercialization team, we will seek to foster our brand's image and market knowledge of our product through various methods, such as marketing and academic activities. At the same time, we will refine our commercialization strategies in light of real-world sales performance of MEIYOUHENG (Becotatug Vedotin Injection) and focus on driving top-line revenue growth, leveraging our fully scaled-up marketing and commercialization teams. We believe that the enhancement of our efforts in terms of market outreach will translate into better market access, increased market share and increases in the sales of our commercialized product and our brand in general, thereby laying a solid market and channel foundation for the future commercialization of our drug candidates.
On the international front, we will ramp up our efforts to expand into the global market. Our ADC platform has been endorsed by multinational companies, evidenced by the successful out-licensing of CMG901's global rights to AstraZeneca and MRG007's ex-Greater China rights to ArriVent. We expect our drug candidates to have more promising business development opportunities. Going forward, we will persist in expanding our international network and exploring new business development cooperation opportunities. We remain committed to seeking more strategic partners worldwide to develop our ADC products and other innovative candidates through partnerships, licensing agreements, or joint ventures.
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For the year ended December 31, 2025, we have achieved a significant growth in revenue, recording approximately RMB934.9 million (2024: RMB367.8 million), which is approximately 2.5 times of that in 2024 and consists of (i) RMB501.0 million from the sales of our commercialized products, including the sales of PUYOUHENG (Pucotenlimab Injection) and MEIYOUHENG (Becotatug Vedotin Injection), marking a significant increase of 66.8% from the sales recorded in 2024 (2024: RMB300.3 million); (ii) RMB424.2 million from BD activities, primarily including the out-licensing of MRG007 and the out-licensing of TCE assets; and (iii) RMB9.6 million (2024: RMB45.5 million) from the provision of CDMO services.
For the year ended December 31, 2025, the Group has recorded cost of sales of RMB89.6 million (2024: RMB74.8 million), representing an increase of 19.7%, which was in line with the growth in revenue.
For the year ended December 31, 2025, the Group has recorded selling and marketing expenses of RMB240.3 million (2024: RMB146.0 million), which was in line with the growth in domestic commercialization during the Reporting Period.
Our administrative expenses primarily consist of (i) employee benefit expenses relating to our administrative staff; (ii) depreciation and amortization expenses, primarily representing depreciation expenses for right-of-use assets and property, plant and equipment; and (iii) others, mainly representing utilities as well as traveling and transportation expenses.
Our administrative expenses increased from RMB91.9 million for the year ended December 31, 2024 to RMB114.1 million for the year ended December 31, 2025, primarily due to (i) an increase in depreciation and property taxes following the completion and operation of Shanghai Biotech Park in 2024 and (ii) an increase in professional fees and service fees.
Our research and development expenses primarily consist of (i) clinical study related expenses; (ii) pre-clinical study costs; (iii) raw materials and consumables used in pre-clinical and clinical studies; (iv) employee benefit expenses (mainly including wages, salaries and bonuses and share-based payment expenses) relating to our research and development staff; (v) depreciation and amortization expenses for property, plant and equipment as well as amortization expenses for intangible assets such as intellectual properties; and (vi) other expenses. Our research and development expenses for the year ended December 31, 2025 were RMB400.7 million (2024: RMB437.7 million).
The following table sets forth the components of our research and development expenses for the years indicated.
| Year ended 31 December | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| RMB'000 | % | RMB'000 | % | |
| Clinical study related expenses | 181,149 | 45.2 | 184,604 | 42.2 |
| Pre-clinical study costs | 34,391 | 8.6 | 41,688 | 9.5 |
| Raw material and consumables used | 41,265 | 10.3 | 34,689 | 7.9 |
| Employee benefit expenses | 76,945 | 19.2 | 95,698 | 21.9 |
| Depreciation and amortization | 56,224 | 14.0 | 67,475 | 15.4 |
| Others | 10,734 | 2.7 | 13,543 | 3.1 |
| Total | 400,708 | 100 | 437,697 | 100 |
(i). Clinical study related expenses decreased by RMB3.5 million as compared to the year ended December 31, 2024;
(ii). Pre-clinical study costs decreased by approximately RMB7.3 million, primarily because certain of the Group's drug candidates progressed from the pre-clinical stage to the clinical stage, while newly initiated drug candidates remained at early stages with relatively lower associated costs;
(iii). Raw material and consumables expenses increased by approximately RMB6.6 million, mainly due to the increase in the consumption of raw materials for the CMC research of the Group's core ADC drug candidates at the NDA stage;
(iv). Employee benefit expense decreased by approximately RMB18.8 million, primarily because of the continuous process optimization for the approved drug, which led to the capitalization of related expense;
(v) Depreciation and amortization costs decreased by approximately RMB11.3 million, primarily due to the reason explained in (iv);
(vi). Other expenses for the year ended December 31, 2025 decreased by approximately RMB2.8 million as compared to the year ended December 31, 2024.
17
18
We had fair value loss on financial liabilities at fair value through profit or loss of RMB31.4 million and fair value gains on financial assets at fair value through profit or loss of RMB0.1 million for the year ended December 31, 2025. Our financial liabilities at fair value through profit or loss represent the variable part of the consideration arising from the acquisition of 40% equity interests of Taizhou Hanzhong from non-controlling interest, being a certain portion of future annual net sales revenue of relevant PD-1 products.
The following table sets forth a breakdown of our fair value changes on financial assets and financial liabilities at fair value through profit or loss for the periods indicated.
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Financial liabilities at fair value through profit or loss | (31,361) | 5,077 |
| Financial assets at fair value through profit or loss | 112 | - |
| Total | (31,249) | 5,077 |
Our finance income primarily represents our bank interest income and foreign exchange gain. Our finance costs primarily consist of interest costs on lease liabilities and borrowings.
Our finance income increased from RMB6.0 million for the year ended December 31, 2024 to RMB12.3 million for the year ended December 31, 2025, mainly due to an increase in foreign currency exchange gain. Our finance costs increased from RMB23.0 million for the year ended December 31, 2024 to RMB29.3 million for the year ended December 31, 2025, due to the completion and operation of Shanghai Biotech Park in 2024, which resulted in its loan interest no longer being capitalized.
For the year ended December 31, 2025, the Group's income tax expenses were RMB1.8 million (for the year ended December 31, 2024: nil).
19
Based on the factors described above, the Group recorded a profit of RMB258.9 million in 2025, representing a turnaround from a loss of RMB424.2 million in 2024, primarily attributable to the significant growth in revenue generated from domestic commercialization and expansion of licensing activities.
To supplement our consolidated financial statements which are presented in accordance with International Financial Reporting Standards ("IFRS"), we also use adjusted net loss (non-IFRS measure) for the year (defined below) as an additional financial measure, which is not required by, or presented in accordance with IFRS. We believe that the presentation of this non-IFRS measure facilitates comparisons of operating performance from period to period and company to company by eliminating potential impact of non-recurring income related to our investment that is non-operating in nature. However, the use of non-IFRS measure has limitations as an analytical tool, and should not be considered in isolation from, or as a substitute for analysis of, our results of operations or financial conditions as reported under IFRS. In addition, the non-IFRS financial measure may be defined differently from similar terms used by other companies.
For the Reporting Period, we define "adjusted net loss (non-IFRS measures) for the year" as profit or loss for the year after deducting net gains on reclassification of investment in an associate using equity method to financial asset at fair value which is item that is not in the financial results for the previous financial year. For the year ended December 31, 2025, our adjusted net loss (non-IFRS measure) for the year was approximately RMB30.6 million (for the year ended December 31, 2024: approximately RMB424.2 million).
The following table sets forth the reconciliations of our non-IFRS financial measure for the years ended December 31, 2025 and 2024 to the nearest measure prepared in accordance with IFRS:
| Year ended December 31 | ||
|---|---|---|
| 2025 | ||
| RMB'000 | 2024 | |
| RMB'000 | ||
| Profit/(Loss for the year) | 258,886 | (424,193) |
| Deduct: | ||
| Net gains on reclassification of investment in an associate using equity method to financial asset at fair value | 289,442 | – |
| Adjusted net loss (non-IFRS measure) for the year | (30,556) | (424,193) |
20
Our primary use of cash is to fund our research and development activities and support our commercialization activities. For the year ended December 31, 2025, our net cash in operating cash flow was broadly balanced and our net cash used in operating activities was RMB12.2 million, a decrease of RMB184.2 million from RMB196.4 million as of December 31, 2024. As of December 31, 2025, our cash and cash equivalents was approximately RMB853.0 million, which was more than double of the amount as of December 31, 2024 (approximately RMB401.3 million) as a result of our rapid growth in revenue.
The main sources of the Group's liquidity are: (i) our operating activities, including domestic commercialization by our sales team, and licensing collaboration with strategic partners worldwide; (ii) equity financing; and (iii) bank borrowings.
Our bank borrowings are divided into secured loans and unsecured loans. As of December 31, 2025, the Group's bank borrowings amounted to RMB1,031.9 million (December 31, 2024: RMB794.4 million), among which unsecured and unguaranteed bank borrowings amounted to RMB831.7 million (December 31, 2024: RMB534.1 million) in total with interest at fixed and floating interest rates, among which RMB676.2 million of such borrowing will be repayable within one year.
As of December 31, 2025, the Group's secured and unguaranteed bank borrowings amounted to RMB200.1 million (December 31, 2024: RMB260.3 million) in total which bear interest at floating interest rates. Such bank borrowings are repayable by instalments and will mature in September 2027 and are secured by the Group's land use rights, buildings and facilities.
As of December 31, 2025, we had utilized RMB1,181.1 million from our banking facilities and RMB568.9 million remained unutilized under our banking facilities.
References are made to the announcements of the Company dated May 17, 2024 and May 24, 2024. The Company placed 51,170,000 H Shares to certain places through placing agents at the placing price of HK$4.58 per H Share under its general mandate. After deducting all applicable costs and expenses, including placing commission, legal fees and levies, the net proceeds raised amounted to approximately HK$229.75 million (equivalent to approximately RMB209.2 million). The net proceeds from the 2024 Placing will be used as to (i) approximately 70% (being HK$160.83 million or RMB146.4 million) for the research and development, clinical trials, registration filings and other workstreams of the Company's ADC product candidates; (ii) approximately 20% (being HK$45.95 million or RMB41.8 million) for the clinical trials and other workstreams of the Company's oncolytic virus product candidate CG0070; and (iii) approximately 10% (being HK$22.98 million or RMB20.9 million) to replenish the Company's working capital and for general corporate purposes.
As of December 31, 2025, approximately RMB146.4 million of the proceeds has been used for the research and development, clinical trials, registration filings and other workstreams of the Company's ADC product candidates, RMB5.3 million has been used for the clinical trials and other workstreams of CG0070 and RMB19.9 million of the proceeds has been used to replenish the Company's working capital and for general corporate purposes.
References are made to the announcements of the Company dated July 4, 2025, and July 11, 2025, respectively. The Company placed 93,825,000 Shares to certain places through placing agents at the placing price of HK$5.02 per Share. Completion of the 2025 Placing took place on July 11, 2025.
After deducting all applicable costs and expenses, including placing commission, legal fees and levies, the net proceeds raise amounted to approximately HK$462.94 million (equivalent to approximately RMB421.5 million). The net proceeds from the 2025 Placing will be used as to (i) approximately 20% (being HK$92.59 million or RMB84.3 million) for the commercialization and marketing of the Company's core product MEIYOUHENG (Becotatug Vedotin Injection); (ii) approximately 60% (being HK$277.76 million or RMB252.9 million) for advancing clinical trials of core products of the Company; and (iii) approximately 20% (being HK$92.59 million or RMB84.3 million) for the research and development of new product pipelines.
As of December 31, 2025, approximately RMB16.9 million of the proceeds has been used for advancing clinical trials of core products of the Company and RMB10.7 million of the proceeds has been used for the research and development of new product pipelines.
The gearing ratio is calculated using the Group's liabilities divided by its assets. As of December 31, 2025, the Group's gearing ratio was 56.0% (December 31, 2024: 70.1%).
The Group did not have any other significant investments or material acquisitions or disposals of subsidiaries, associates and joint ventures for the year ended December 31, 2025.
As of December 31, 2025, the Group had capital commitments for property, plant and equipment of RMB439.0 million (December 31, 2024: RMB456.8 million), reflecting the capital expenditure of our Group contracted at the end of the year but not yet incurred.
As of December 31, 2025, the Group did not have any contingent liabilities.
21
22
Save as disclosed in this announcement, as of December 31, 2025, the Group did not have any charges over its assets.
Our financial statements are expressed in RMB, but certain of our Group’s subsidiaries in PRC are exposed to foreign exchange risks arising from recognized financial liabilities denominated in foreign currencies. We currently do not have a foreign currency hedging policy. However, our management manages foreign exchange risks by performing regular reviews and will consider hedging significant foreign currency exposure should the need arise.
As of December 31, 2025, the Group had a total of 710 employees (As of December 31, 2024: 498). The total remuneration cost for 2025 was RMB242.0 million, as compared to RMB211.9 million for 2024, primarily due to an increase in the expansion of the sales team.
To maintain the quality, knowledge and skill levels of our workforce, the Group provides regular and specialized trainings tailored to the needs of our employees in different departments, including regular training sessions conducted by senior employees or third-party consultants covering various aspects of our business operations, for our employees to stay up to date with both industry developments and skills and technologies. The Group also organizes workshops from time to time to discuss specific topics.
We provide various incentives and benefits to our employees. We offer competitive remuneration packages to our employees to effectively motivate our business development team. We participate in various social security plans (including housing provident fund, pension insurance, medical insurance, maternity insurance and work-related injury insurance and unemployment insurance) for our employees in accordance with applicable PRC laws.
On December 18, 2025, we have adopted the RSU Scheme. The RSU Scheme is intended to attract, motivate and retain key personnel by granting restricted share units to eligible employees and Directors (excluding independent non-executive directors) of the Group, subject to vesting conditions, performance targets, and clawback provisions as set out in the scheme rules.
For further details of the RSU Scheme, please refer to the Company’s announcement dated November 28, 2025, circular dated November 28, 2025 and poll results announcement dated December 18, 2025.
23
The Company has adopted the principles and code provisions as set out in the Corporate Governance Code and has complied with all applicable code provisions for the year ended December 31, 2025.
The Company has adopted the Model Code as its own code of conduct regarding securities transactions by the Directors and Supervisors. Having made specific enquiries with all Directors and Supervisors, each of them has confirmed that he/she has complied with the Model Code for the year ended December 31, 2025. No incident of non-compliance with the Model Code by the employees who are likely to be in possession of inside information of the Company was noted by the Company.
Neither the Company nor any of its subsidiaries purchased, sold or redeemed any of the Company's listed securities (including sale of treasury shares) during the year ended December 31, 2025. As of December 31, 2025, the Company did not hold any of treasury shares.
The Board does not recommend the payment of a final dividend for the year ended December 31, 2025 (for the year ended December 31, 2024: nil).
24
The Board has established the Audit Committee which comprises Mr. Fengmao Hua (chairman) and Mr. Yang Haifeng as independent non-executive Directors, and Ms. Pu Jue as non-executive Director. The primary duties of the Audit Committee are to review and supervise the Company’s financial reporting process and internal controls.
The Audit Committee, together with the management of the Company, has reviewed the consolidated financial statements and this annual results announcement of the Group for the year ended December 31, 2025, reviewed the accounting principles and practices adopted by the Group and discussed auditing, internal controls and financial reporting matters.
The figures in respect of the Group’s consolidated balance sheet and consolidated statement of comprehensive loss and the related notes thereto for the year ended December 31, 2025 as set out in this annual results announcement have been agreed by the Group’s auditor, Ernst & Young, to the amounts set out in the Group’s audited consolidated financial statements for the year. The work performed by Ernst & Young in this respect did not constitute an assurance engagement and consequently no assurance has been expressed by Ernst & Young on this annual results announcement.
This annual results announcement is published on the respective websites of the Stock Exchange (www.hkexnews.hk) and the Company (www.lepubiopharma.com).
The annual report of the Company for the year ended December 31, 2025 containing all the information required by the Listing Rules will be published on the respective websites of the Stock Exchange and the Company in due course.
25
Year ended 31 December 2025
| | Notes | 2025
RMB'000 | 2024
RMB'000 |
| --- | --- | --- | --- |
| Revenue | 4 | 934,869 | 367,794 |
| Cost of sales | | (89,591) | (74,824) |
| Gross profit | | 845,278 | 292,970 |
| Other income | | 7,196 | 8,499 |
| Other expenses | | (375) | (69) |
| Selling and marketing expenses | | (240,332) | (145,951) |
| Administrative expenses | | (114,129) | (91,943) |
| Research and development expenses | | (400,708) | (437,697) |
| Fair value changes on financial instruments at fair value through profit or loss (“FVTPL”) | 6 | (31,249) | 5,077 |
| Other gains/(losses), net | 7 | 219,449 | (21,651) |
| Operating profit/(loss) | | 285,130 | (390,765) |
| Finance income | | 12,328 | 5,996 |
| Finance costs | | (29,309) | (22,985) |
| Finance costs, net | | (16,981) | (16,989) |
| Share of loss of investments accounted for using the equity method | | (7,513) | (16,439) |
| Profit/(loss) before income tax | | 260,636 | (424,193) |
| Income tax expense | 8 | (1,750) | – |
| Profit/(loss) for the year | | 258,886 | (424,193) |
| Profit/(loss) attributable to: | | | |
| Owners of the Company | | 261,364 | (411,376) |
| Non-controlling interests | | (2,478) | (12,817) |
| | | 258,886 | (424,193) |
26
| Notes | 2025
RMB’000 | 2024
RMB’000 |
| --- | --- | --- |
| Other comprehensive income/(loss) | | |
| Items that may be subsequently reclassified to profit or loss | | |
| Currency translation differences | 423 | 76 |
| Share of other comprehensive income of associate | – | 901 |
| Items that will not be subsequently reclassified to profit or loss | | |
| Change in fair value of equity investments at fair value through other comprehensive income (“FVTOCI”) | 5,921 | – |
| Share of other comprehensive income/(loss) of associate | (1,652) | – |
| Total comprehensive income/(loss) | 263,578 | (423,216) |
| Total comprehensive income/(loss) attributable to: | | |
| Owners of the Company | 266,056 | (410,399) |
| Non-controlling interests | (2,478) | (12,817) |
| | 263,578 | (423,216) |
| Earnings/(losses) per share attributable to owners of the Company for the year (expressed in RMB per share) | | |
| – Basic earnings/(loss) per share | 9 | 0.15 |
| – Diluted earnings/(loss) per share | 9 | 0.15 |
31 December 2025
| Notes | 31 December 2025 RMB'000 | 31 December 2024 RMB'000 | |
|---|---|---|---|
| Assets | |||
| Non-current assets | |||
| Property, plant and equipment | 927,130 | 930,106 | |
| Right-of-use assets | 100,285 | 120,932 | |
| Intangible assets | 501,070 | 435,250 | |
| Investments accounted for using the equity method | 669 | 114,073 | |
| Financial assets at FVTOCI | 396,677 | - | |
| Other receivables, prepayments and deposits | 31,562 | 34,816 | |
| Total non-current assets | 1,957,393 | 1,635,177 | |
| Current assets | |||
| Inventories | 51,827 | 22,787 | |
| Trade receivables | 10 | 66,883 | 45,821 |
| Other receivables, prepayments and deposits | 64,825 | 111,986 | |
| Financial assets at FVTPL | 105,726 | 63,628 | |
| Cash and cash equivalents | 853,030 | 401,286 | |
| Total current assets | 1,142,291 | 645,508 | |
| Total assets | 3,099,684 | 2,280,685 |
27
| Notes | 31 December 2025 RMB'000 | 31 December 2024 RMB'000 | |
|---|---|---|---|
| Equity | |||
| Equity attributable to owners of the Company | |||
| Share capital | 11 | 1,804,440 | 1,710,615 |
| Reserves | 2,086,213 | 1,757,172 | |
| Accumulated losses | (2,504,349) | (2,764,962) | |
| 1,386,304 | 702,825 | ||
| Non-controlling interests | (23,500) | (21,022) | |
| Total equity | 1,362,804 | 681,803 | |
| Liabilities | |||
| Non-current liabilities | |||
| Borrowings | 275,551 | 255,940 | |
| Lease liabilities | - | 11,455 | |
| Deferred government grants | 17,660 | 18,020 | |
| Deferred tax liabilities | 37,687 | 37,687 | |
| Financial liabilities at FVTPL | 12 | 243,923 | 232,267 |
| Total non-current liabilities | 574,821 | 555,369 | |
| Current liabilities | |||
| Borrowings | 756,320 | 538,411 | |
| Trade payables | 13 | 183,827 | 236,135 |
| Other payables and accruals | 195,292 | 233,684 | |
| Lease liabilities | 26,206 | 34,378 | |
| Contract liabilities | 414 | 905 | |
| Total current liabilities | 1,162,059 | 1,043,513 | |
| Total liabilities | 1,736,880 | 1,598,882 | |
| Total equity and liabilities | 3,099,684 | 2,280,685 |
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
31 December 2025
Lepu Biopharma Co., Ltd. (the “Company”) was established in Shanghai, the People’s Republic of China (the “PRC”) on 19 January 2018 as a limited liability company. Upon approval by the shareholders’ general meeting held on 10 December 2020, the Company was converted into a joint stock company with limited liability under the Company Law of the PRC.
The Company, together with its subsidiaries (collectively referred to as the “Group”), are principally focused on the discovery, development and commercialisation of drugs for cancer – targeted therapy and immunotherapy globally.
The consolidated financial statements are presented in Renminbi (“RMB”) and all values are rounded to the nearest thousand except when otherwise indicated.
2.1 Basis of preparation
(a) Compliance with IFRS Accounting Standards and the disclosure requirements of the Hong Kong Companies Ordinance
The consolidated financial statements of the Group have been prepared in accordance with IFRS Accounting Standards and the disclosure requirements of the Hong Kong Companies Ordinance Cap. 622.
IFRS Accounting Standards comprise the following authoritative literature:
For the year ended 31 December 2025, the Group has incurred net profits of approximately RMB258.9 million, while net cash used in operating activities was approximately RMB12.2 million. As at 31 December 2025, the Group had cash and cash equivalents of approximately RMB853.0 million and net current liabilities of approximately RMB19.8 million. Historically, the Group has relied principally on non-operational sources of financing from investors and banks as well as cash generated from sales activities to fund its operations and business development. The Group’s ability to continue as a going concern is dependent on management’s ability to successfully execute its business plan. The directors of the Company believes that the cash and cash equivalents, unutilised bank facilities and cash generated from operating activities are sufficient to meet the cash requirements to fund planned operations and other commitments for at least the next twelve months from 31 December 2025. The Group therefore continues to prepare consolidated financial statement on a going concern basis.
(b) Historical cost convention
The financial statements have been prepared on a historical cost basis, except for financial assets and liabilities at FVTPL or FVTOCI, which are measured at fair value.
29
30
The Group has adopted amendments to IAS 21 Lack of Exchangeability for the first time for the current year’s financial statements. The Group has not early adopted any other standard or amendment that has been issued but is not yet effective.
Amendments to IAS 21 specify how an entity shall assess whether a currency is exchangeable into another currency and how it shall estimate a spot exchange rate at a measurement date when exchangeability is lacking. The amendments require disclosures of information that enable users of financial statements to understand the impact of a currency not being exchangeable. As the currencies that the Group had transacted in and the functional currencies of overseas subsidiaries and associates for translation into the Group’s presentation currency were exchangeable, the amendments did not have any impact on the Group’s financial statements.
In addition, the Amendments to Illustrative Examples on IFRS 7, IFRS 18, IAS 1, IAS 8, IAS 36 and IAS 37 Disclosures about Uncertainties in the Financial Statements, added illustrative examples in the corresponding IFRS Accounting Standards. These examples reflect existing requirements in the corresponding IFRS Accounting Standards to report the effects of uncertainties in the financial statements using climate-related examples. Therefore, the amendments do not have an effective date or transitional provisions. The Group has assessed and concluded that the amendments did not have any impact on the Group’s financial statements.
The Group has not applied the following new and amended IFRS Accounting Standards, that have been issued but are not yet effective, in these financial statements. The Group intends to apply these new and amended IFRS Accounting Standards, if applicable, when they become effective.
¹ Effective for annual periods beginning on or after 1 January 2026
² Effective for annual/reporting periods beginning on or after 1 January 2027
³ No mandatory effective date yet determined but available for adoption
Further information about those IFRS Accounting Standards that are expected to be applicable to the Group is described below.
IFRS 18 replaces IAS 1 Presentation of Financial Statements. While a number of sections have been brought forward from IAS 1 with limited changes, IFRS 18 introduces new requirements for presentation within the statement of profit or loss, including specified totals and subtotals. Entities are required to classify all income and expenses within the statement of profit or loss into one of the five categories: operating, investing, financing, income taxes and discontinued operations and to present two new defined subtotals. It also requires disclosures about management-defined performance measures in a single note and introduces enhanced requirements on the grouping (aggregation and disaggregation) and the location of information in both the primary financial statements and the notes. Some requirements previously included in IAS 1 are moved to IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors, which is renamed as IAS 8 Basis of Preparation of Financial Statements. As a consequence of the issuance of IFRS 18, limited, but widely applicable, amendments are made to IAS 7 Statement of Cash Flows, IAS 33 Earnings per Share and IAS 34 Interim Financial Reporting. In addition, there are minor consequential amendments to other IFRS Accounting Standards. IFRS 18 and the consequential amendments to other IFRS Accounting Standards are effective for annual periods beginning on or after 1 January 2027 with earlier application permitted. Retrospective application is required. The Group is currently analysing the new requirements and assessing the impact of IFRS 18 on the presentation and disclosure of the Group's financial statements.
Except for IFRS 18, the directors of the Company anticipate that the application of these new and revised IFRSs will have no material impact on the Group's financial performance and financial position in the foreseeable future.
Management has determined the operating segments based on the reports reviewed by the chief operating decision maker ("CODM"). The CODM, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the executive directors of the Group.
During the year ended 31 December 2025, the Group has been principally engaged in the sale of pharmaceutical products and research and development of new drugs. Management reviews the operating results of the business as one operating segment to make decisions about the allocation of resources. Therefore, the CODM of the Company regards that there is only one segment which is used to make strategic decisions.
The major operating entity of the Group is domiciled in Chinese mainland. Accordingly, the Group's results were primarily derived in Chinese mainland during the reporting period, and its non-current assets were also primarily located in Chinese mainland.
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Revenue recognised at a point in time | ||
| - Sale of pharmaceutical products | 501,021 | 300,333 |
| - Licensing related income | 424,249 | 21,964 |
| 925,270 | 322,297 | |
| Revenue recognised over time | ||
| - CDMO services | 9,599 | 45,497 |
| Total | 934,869 | 367,794 |
Information about the geographical markets of the Group's revenue is presented based on the locations of the customers.
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| Geographical markets | ||
| - Chinese mainland | 571,080 | 345,830 |
| - Overseas | 363,789 | 21,964 |
| Total | 934,869 | 367,794 |
For the year ended 31 December 2025, revenue of approximately RMB307,186,000 was derived from Customer A, RMB167,433,000 from Customer B, RMB141,570,000 from Customer C and RMB102,882,000 from Customer D. Other than the aforementioned customer, the revenue derived from each of the remaining external customers was less than 10% of the Group's total revenue.
The corresponding revenue of these customers for the prior year is not disclosed as the amount attributable to each customer did not individually account for 10% or more of the Group's revenue for the relevant periods.
The Group produces and sells pharmaceutical products to customers. The Group transports the products to the agreed location in accordance with the sales contract, and the sales are recognised after the customer has accepted the products and both parties have signed the goods delivery notes. The Group adopts advance collection or a credit term of 7 days, 10 days or 30 days with its customers, and the transaction price does not have a significant financing component.
The Group generates revenue from licensing of intellectual property ("IP") to customers. As the customers are able to direct the use of, and obtain substantially all of the benefits from, the licence at the time control of the licence is transferred to the licensee, the licences that provide a right to use an entity's IP are performance obligations satisfied at a point in time. Revenue is recognised when or as control of the licences is transferred to the licensee.
The Group recognises revenue for a sales-based or usage-based royalty promised in exchange for a licence of IP only when (or as) the later of the following events occurs:
32
(iii) Revenue from CDMO services
The CDMO services are integrated services including project management, drug manufacturing, development, optimisation, trial production, and other relevant services. The duration of the contracts ranges from months to year. The contracts contain multiple deliverable units, which are generally in the form of technical laboratory reports, samples and/or products for manufacturing, and each deliverable unit has an individual selling price specified within the contract. The Group has assessed whether each deliverable is distinct to determine the performance obligation within the contract. Any deliverable in the contract is identified as a performance obligation if the deliverable is distinct. If the deliverables are highly interdependent or highly interrelated, those deliverables are not separately identifiable, and are combined into a single performance obligation.
The Group satisfies a performance obligation and recognises revenue over time, if one of the following criteria is met:
If none of the above criteria is met, the Group recognises revenue at the point in time when the customer obtains control of the distinct good or service.
If control of the service transfers over time, revenue is recognised over the period of the contract by reference to the progress towards complete satisfaction of that performance obligation using output method. Otherwise, revenue is recognised at the point in time when the customer obtains control of the service.
The transaction price allocated to the remaining performance obligations, all of which pertain to CDMO services, amounted to RMB3,858,000 and is expected to be recognized as revenue over the next five years.
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| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| Cost of sales | 89,591 | 74,824 |
| Depreciation of property, plant and equipment | 48,559 | 51,997 |
| Depreciation of right-of-use assets | 14,109 | 17,864 |
| Amortisation of other intangible assets | 31,058 | 30,318 |
| Research and development costs (excluding depreciation, amortisation and employee benefit expense) | 267,539 | 274,524 |
| Lease payments not included in the measurement of lease liabilities | 827 | 616 |
| Auditors’ remuneration | 2,642 | 2,650 |
| Employee benefit expense: | ||
| Wages, salaries and welfare | 193,155 | 158,012 |
| Share-based payment expenses | - | 4,402 |
| Pension scheme contributions* | 21,606 | 18,399 |
| Other social security costs, housing benefits and other employee benefits | 27,251 | 31,067 |
| Less: amount capitalised | (17,698) | (3,129) |
| Foreign exchange difference, net | (7,051) | (1,329) |
| Bank interest income | (5,277) | (4,667) |
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| Financial assets at FVTPL | 112 | - |
| Financial liabilities at FVTPL | (31,361) | 5,077 |
| Total | (31,249) | 5,077 |
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB’000 | RMB’000 | |
| Net gains on reclassification of investment in an associate using equity method to FVTOCI | 289,442 | - |
| Net gains on disposal of right-of-use assets | - | 11 |
| Net gains/(losses) on disposal of property, plant and equipment | 913 | (18) |
| Expected credit losses | (356) | 221 |
| Donation | (70,394) | (19,852) |
| Others | (156) | (2,013) |
| Total | 219,449 | (21,651) |
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| Year ended 31 December | ||
|---|---|---|
| 2025 RMB’000 | 2024 RMB’000 | |
| Current income tax expense | 1,750 | – |
| Deferred income tax expense | – | – |
| Income tax expense | 1,750 | – |
The Group’s principal applicable taxes and tax rates are as follows:
Pursuant to the Corporate Income Tax Law of the PRC and the respective regulators, the entities which operate in Chinese mainland are subject to corporate income tax at a rate of 25% on the taxable income except for those entities which were subject to tax concession set out below.
The Company was qualified as a High and New Technology Enterprise (“HNTE”) under the relevant PRC laws and regulations in 2025. Accordingly, it was entitled to a preferential corporate income tax rate of 15% on its taxable income. The qualification as a HNTE is subject to renew by tax authority in the PRC every three years.
Shanghai Miracogen Inc. (“Shanghai Miracogen”) renewed its qualification as a HNTE under the relevant PRC laws and regulations in 2023. Accordingly, it was entitled to a preferential corporate income tax rate of 15% on its taxable income for a three-year period since 2023.
Lepu (Beijing) Biopharma Co., Ltd. (“Lepu Beijing”) renewed its qualification as a HNTE under the relevant PRC laws and regulations in 2024. Accordingly, it was entitled to a preferential corporate income tax rate of 15% on its taxable income for a three-year period since 2024.
CtM Bio Co., Ltd. (“CtM Bio”) was qualified as a HNTE under the relevant PRC laws and regulations on 12 December 2023. Accordingly, it was entitled to a preferential corporate income tax rate of 15% on its taxable income for a three-year period since 2023.
The subsidiary incorporated in Texas, the United States of America was subject to statutory United States federal corporate income tax at a rate of 21%.
The Company’s other subsidiaries established and operated in Chinese mainland are subject to the PRC corporate income tax at the rate of 25%.
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Basic earnings/(loss) per share is calculated by dividing:
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| Earnings/(loss) for the year attributable to owners of the Company (in RMB'000) | 261,364 | (411,376) |
| Weighted average number of ordinary shares in issue (in thousands) | 1,755,085 | 1,690,482 |
| Basic earnings/(loss) per share (in RMB) | 0.15 | (0.24) |
Diluted earnings/(loss) per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential shares into ordinary shares. For the years ended 31 December 2025 and 2024, the Company had no dilutive potential shares. Accordingly, diluted earnings/(loss) per share for the years ended 31 December 2025 and 2024 is the same as the basic earnings/(loss) per share for the respective years.
| As at 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Trade receivables | 67,646 | 46,232 |
| Less: Loss allowance | (763) | (411) |
| Total | 66,883 | 45,821 |
The Group allows a credit period within 30 days to its customers. As at 31 December 2025 and 2024, the ageing analysis of the trade receivables (net of loss allowance) based on the invoice date is as follows:
| As at 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| 0 to 30 days | 66,868 | 44,007 |
| Over 30 days | 15 | 1,814 |
| Total | 66,883 | 45,821 |
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| Number of shares | Nominal value of shares RMB'000 | |
|---|---|---|
| Authorised, issued and fully paid | ||
| At 1 January 2024 | 1,659,444,838 | 1,659,445 |
| Issuance of shares | 51,170,000 | 51,170 |
| At 31 December 2024 | 1,710,614,838 | 1,710,615 |
| Issuance of shares | 93,825,000 | 93,825 |
| At 31 December 2025 | 1,804,439,838 | 1,804,440 |
On 24 May 2024, the Company completed a placing of 51,170,000 H Shares with a par value of RMB1.00 each at the price of HK$4.58 per H Share (the “2024 Placing”). The gross proceeds from the 2024 Placing amounted to approximately HK$234 million (equivalent to RMB213,379,000), of which, RMB51,170,000 were credited to the Company’s share capital and the remaining proceeds deducting the share issue costs of RMB4,388,000 were credited to the share premium.
On 11 July 2025, the Company completed a placing of 93,825,000 H Shares with a par value of RMB1.00 each at the price of HK$5.02 per H Share (the “2025 Placing”). The gross proceeds from the 2025 Placing amounted to approximately HK$471 million (equivalent to RMB428,865,000), of which, RMB93,825,000 were credited to the Company’s share capital and the remaining proceeds deducting the share issue costs of RMB326,523,000 were credited to the share premium.
| As at 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Variable consideration payable arising from the acquisition of 40% equity interests in Taizhou Hanzhong from the then non-controlling interests | 281,335 | 263,112 |
| Less: Current portion | (37,412) | (30,845) |
| Non-current portion | 243,923 | 232,267 |
The movements of financial liabilities at FVTPL for the years ended 31 December 2025 and 2024 are set out below:
| Year ended 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Opening balance | 263,112 | 272,625 |
| Change in fair value (Note 6) | 31,361 | (5,077) |
| Variable consideration paid to Hangzhou Han.X Biomedical Co., Ltd. | (13,138) | (4,436) |
| Closing balance | 281,335 | 263,112 |
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The ageing analysis of the trade payables based on their respective invoice dates is as follows:
| As at 31 December | ||
|---|---|---|
| 2025 | 2024 | |
| RMB'000 | RMB'000 | |
| Less than 1 year | 176,671 | 211,469 |
| Over 1 year | 7,156 | 24,666 |
| Total | 183,827 | 236,135 |
Trade payables are unsecured and are usually paid within 30 days from the date of initial recognition.
The carrying amounts of trade payables are considered to be the same as their fair values, due to their short-term nature.
The trade payables are primarily denominated in RMB.
No dividend has been paid or declared by the Company or companies comprising the Group during the years ended 31 December 2025 and 2024.
There is no significant event occurred after the balance sheet date which has material impact to the consolidated financial statements of the Group.
"2024 Placing" the placing of 51,170,000 H Shares of the Company at the price of HK$4.58 per H Share under a general mandate approved at the 2022 annual general meeting, completed on May 24, 2024
"2025 Placing" the placing of 93,825,000 new H Shares of the Company at the price of HK$5.02 per H Share under a general mandate approved at the 2022 annual general meeting, completed on July 11, 2025
"AACR" American Association for Cancer Research
"ADC" antibody drug conjugate, a class of biopharmaceutical drugs that combine monoclonal antibodies specific to surface antigens present on particular tumor cells with highly potent antitumor small molecule agents linked via a chemical linker
"ASCO" American Society of Clinical Oncology
"ASH" American Society of Hematology
"AstraZeneca" AstraZeneca AB, a global pharmaceutical company which, to the best knowledge and belief of the Company, is independent of and not connected with the Company and its connected persons (as defined under the Listing Rules)
"ArriVent" ArriVent BioPharma, Inc., a clinical-stage biopharmaceutical company listed on the Nasdaq Global Market (ticker symbol: AVBP) which, to the best knowledge and belief of the Company, is independent of and not connected with the Company and its connected persons (as defined under the Listing Rules)
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"Audit Committee" the audit committee of the Board
"B cell" a type of white blood cell that differs from other types of lymphocytes by expressing B-cell receptors on its surface, and responsible for producing antibodies
"Bacillus Calmette-Guerin" or "BCG" a type of bacteria that causes a reaction in a patient's immune system that can destroy cancer cells located in the lining of the bladder. It is also widely used as a vaccine against tuberculosis
"BC" breast cancer
"BD" business development
"Board" the board of Directors of the Company
"BTD" Breakthrough Therapy Designation
"BTK" Bruton's tyrosine kinase
"CC" cervical cancer
"CD20" a B-lymphocyte antigen that is expressed on the surface of B cells, starting at the pre-B cell stage and also on mature B cells in the bone marrow and in the periphery
"cDCR" confirmed DCR
"CDE" Center for Drug Evaluation* (藥品審評中心) of the NMPA
"CDMO" Contract development and manufacturing organization, a pharmaceutical company that develops and manufactures drugs for other pharmaceutical companies on a contractual basis
"CDX" Cell derived xenograft
"CG Oncology" CG Oncology, Inc. (previously known as Cold Genesys, Inc.), a clinical-stage immuno-oncology company headquartered in the US, of which Lepu Medical holds approximately 7.73% equity interest through Lepu Holdings Limited, a company wholly-owned by Lepu Medical, and Ms. Pu Jue (蒲珏) serves as a director
"chemotherapy" a category of cancer treatment that uses one or more anti-cancer small molecule chemical agents as part of its standardized regimen
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“China”, “Mainland China” or the “PRC”
the People’s Republic of China, excluding, for the purpose of this announcement, Hong Kong, Macau Special Administrative Region and Taiwan
“CLDN18.2”
Claudin 18.2, a highly specific tissue junction protein for gastric tissue
“CMC”
chemistry, manufacturing, and controls processes in the development, licensure, manufacturing, and ongoing marketing of pharmaceutical products
“combination therapy”
a treatment modality that combines two or more therapeutic agents
“Company” or “our Company”
Lepu Biopharma Co., Ltd. (樂普生物科技股份有限公司), a joint stock company incorporated in the PRC with limited liability, the H Shares of which are listed on the Stock Exchange (Stock code: 2157)
“Core Product(s)”
has the meaning ascribed to it in Chapter 18A of the Listing Rules; for purposes of this announcement, our core products include MEIYOUHENG (Becotatug Vedotin Injection), MRG002 and PUYOUHENG (Pucotenlimab Injection)
“Corporate Governance Code”
the Corporate Governance Code as set out in Appendix C1 to the Listing Rules
“cORR”
confirmed ORR
“CR”
complete response, the disappearance of all signs of cancer in response to treatment
“CSCO”
Chinese Society of Clinical Oncology
“CSGO”
Chinese Society of Gynecological Oncology
“DCR”
disease control rate, the total proportion of patients who demonstrate a response to treatment, equal to the sum of complete responses (CR), partial responses (PR) and stable disease (SD)
“Director(s)”
the director(s) of the Company
“DLBCL”
diffuse large B cell lymphoma
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“Domestic Share(s)” ordinary Share(s) in the share capital of the Company, with a nominal value of RMB1.00 each, which are subscribed for and paid up in RMB and are unlisted shares which are currently not listed or traded on any stock exchange
“EBITDA” earnings before interest, taxes, depreciation and amortization
“ECOG PS 0-2” Eastern Cooperative Oncology Group Performance Status of 0 to 2, indicating fully active to ambulatory patients capable of self-care but unable to carry out daylight work
“EGFR” epidermal growth factor receptor
“ESMO” European Society for Medical Oncology
“Excalipoint” Excalipoint Cayman and Excalipoint Biotechnology (Shanghai) Co., Limited (艾科聯生物科技(上海)有限公司), an indirect whollyowned subsidiary of Excalipoint Cayman
“Excalipoint Cayman” Excalipoint Therapeutics Inc., a company incorporated in the Cayman Islands
“FDA” Food and Drug Administration of the United States
“FIC” first-in-class
“first-line” with respect to any disease, the first line therapy, which is the treatment regimen or regimens that are generally accepted by the medical establishment for initial treatment. It is also called primary treatment or therapy
“FISH” fluorescence in situ hybridization, a test that maps the genetic material in human cells, including specific genes or portions of genes
“FTD” Fast Track Designation
“GC” gastric cancer
“GEJ” gastroesophageal junction
“GI cancer” gastrointestinal cancer
“GLP-1” glucagon-like peptide-1
| “GMP” | a system for ensuring that products are consistently produced and controlled according to quality standards, which is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. It is also the practice required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of pharmaceutical products |
|---|---|
| “GPC-3” | Glypican-3 |
| “Group”, “we”, “us” or “our” | the Company and its subsidiaries |
| “H Share(s)” | overseas listed foreign invested ordinary Share(s) in the ordinary Share capital of the Company, with a nominal value of RMB1.00 each, listed on the Main Board of the Stock Exchange |
| “HCC” | hepatocellular carcinoma |
| “HER2” | human epidermal growth factor receptor 2 |
| “HER2-expressing” | HER2 status of tumor cells identified with a test score of IHC 1+ or above |
| “HER2-positive” or “HER2 over-expressing” | HER2 status of tumor cells identified with a test score of either IHC 3+ or IHC 2+/FISH (or ISH) + (IHC 2+ plus FISH (or ISH)+) |
| “HG-EFS” | High-Grade Event-Free Survival |
| “HK$” | Hong Kong dollars, the lawful currency of Hong Kong |
| “HNSCC” | head and neck squamous cell carcinoma |
| “Hong Kong” | the Hong Kong Special Administrative Region of the PRC |
| “HR” | high-risk |
| “IgG” | human immunoglobulin G, the most common antibody type found in blood circulation that plays an important role in antibody-based immunity against invading pathogens |
| “IgG4” | immunoglobulin G subclass 4 |
| “IHC” | immunohistochemistry, the most common application of immunostaining. It involves the process of selectively identifying antigens in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues |
|---|---|
| “IND” | investigational new drug or investigational new drug application, also known as clinical trial application in China or the United States |
| “Independent Shareholder(s)” | the Shareholders other than Lepu Medical and Ningbo Houde Yimin |
| “Intellectual Property Assignment and License Agreement” | the framework agreement in respect of the transfer or grant certain rights and interests over the Target Products to, among other things, allow Excalipoint to conduct R&D, register, manufacture, and commercialize the Target Products. entered into between the Company and Excalipoint on August 1, 2025 |
| “IO” | immuno-oncology |
| “Keymed” | Keymed Bioscience (Chengdu) Co., Ltd. (康諾亞生物醫藥科技(成都)有限公司), a limited liability company incorporated in the PRC on September 1, 2016, which is a third-party biotechnology company focusing on the in-house discovery and development of innovative biological therapies in the autoimmune and oncology therapeutic areas |
| “KOL” | key opinion leader, who are professionals that influence their peers' medical practice, including but not limited to prescribing behavior |
| “KYM” | KYM Biosciences Inc., a Delaware corporation and a joint venture formed in the United States by Keymed and the Group |
| “LA” | locally advanced |
| “LBA” | Late-Breaking Abstracts |
| “Lepu Medical” | Lepu Medical Technology (Beijing) Co., Ltd. (樂普(北京)醫療器械股份有限公司), a joint stock company incorporated in the PRC on June 11, 1999 and listed on the Shenzhen Stock Exchange (stock code: 300003) |
| “License Agreement for CMG901” | a global exclusive out-license agreement entered into by KYM and AstraZeneca on February 23, 2023 |
“License Agreement for MRG0007” an exclusive out-license agreement entered into by the Company and ArriVent on January 22, 2025
“Listing Committee” the listing committee of the Stock Exchange
“Listing Rules” the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, as amended, supplemented or otherwise modified from time to time
“M1c” a classification that indicates distant metastasis in multiple organs
“mAb” monoclonal antibody, an antibody generated by identical cells that are all clones of the same parent cell
“Macau” the Macau Special Administrative Region of the PRC
“Main Board” the Main Board of the Stock Exchange
“mDoR” median duration of response
“metastatic” in reference to any disease, including cancer, disease producing organisms or of malignant or cancerous cells transferred to other parts of the body by way of the blood or lymphatic vessels or membranous surfaces
“MMAE” monomethyl auristatin E, a potent tubulin binder with a half maximal inhibitory concentration (IC50) in the subnanomolar range
“Model Code” the Model Code for Securities Transactions by Directors of Listed Issuers as set out in Appendix C3 to the Listing Rules
“mOS” median OS
“mPFS” median progression free survival
“MRCT” multi-regional clinical trial
“MSI-H/dMMR” high levels of microsatellite instability/deficient mismatch repair
“NDA” new drug application
“NHL” non-Hodgkin’s lymphoma
“Ningbo Houde Yimin” 寧波厚德義民信息科技有限公司(Ningbo Houde Yimin Information Technology Co., Ltd.*), a limited liability company incorporated in the PRC on March 29, 2017
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"NK cell" natural killer cell, a kind of cells that play important roles in immunity against viruses and in the immune surveillance of tumors
"NMIBC" non-muscle invasive bladder cancer
"NMPA" 中國國家藥品監督管理局(National Medical Products Administration of the PRC*)
"NPC" nasopharyngeal cancer
"ODD" Orphan-drug Designation
"ORR" overall response rate
"OS" overall survival
"PC" pancreatic cancer
"PD-1" programmed cell death protein 1, an immune checkpoint receptor expressed on T cells, B cells and macrophages
"PDAC" pancreatic ductal adenocarcinoma
"PD-L1" PD-1 ligand 1, which is a protein on the surface of a normal cell or a cancer cell that binds to its receptor, PD-1, on the surface of the T cell that causes the T cell to turn off its ability to kill the cancer cell
"PD-L2" PD-1 ligand 2, which is a protein on the surface of a normal cell or a cancer cell that attaches to certain proteins on the surface of the T cell that causes the T cell to turn off its ability to kill the cancer cell
"PDX" patient derived xenografts, models of cancer where the tissue or cells from a patient's tumor are implanted into an immunodeficient mouse
"PFS" progression-free-survival
"Pgp" a drug transporter which plays important roles in multidrug resistance and drug pharmacokinetics
"pre-clinical studies" studies or programs testing a drug on non-human subjects, to gather efficacy, toxicity, pharmacokinetic and safety information and to decide whether the drug is ready for clinical trials
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| "Phase I clinical trials" or "Phase I clinical study(ies)" | study in which a drug is introduced into healthy human subjects or patients with the target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion, and if possible, to gain an early indication of its effectiveness |
|---|---|
| "Phase II clinical trials" or "Phase II clinical study(ies)" | study in which a drug is administered to a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases, and to determine dosage tolerance and optimal dosage |
| "Phase III clinical trials" or "Phase III clinical study(ies)" | study in which a drug is administered to an expanded patient population generally at geographically dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and safety of the product for approval, to provide adequate information for the labeling of the product |
| "placebo" | any dummy medical treatment administered to the control group in a controlled clinical trial in order that the specific and non-specific effects of the experimental treatment can be distinguished |
| "registrational trial" | a clinical trial or study intended to provide evidence for a drug marketing approval |
| "Reporting Period" | the year ended December 31, 2025 |
| "R/M" | recurrent/metastatic |
| "RMB" | Renminbi, the lawful currency of China |
| "R/R" | relapsed/refractory |
| "RSU Scheme" | the restricted share unit scheme adopted by the Company in accordance with the RSU Scheme Rules |
| "RSU Scheme Rules" | the rules relating to the RSU Scheme as amended from time to time |
| "R&D" | research and development |
| "second-line" | with respect to any disease, the therapy or therapies that are tried when the first-line treatments do not work adequately |
"Share(s)"
shares in the share capital of the Company, with a nominal value of RMB1.00 each, comprising the Domestic Shares, Unlisted Foreign Shares and H Shares
"Share Purchase Agreement"
the agreement in respect of issuance and subscription of the shares of Excalipoint Cayman, entered into by, among others, Innocube, Dr. Fang and the Excalipoint Companies on August 1, 2025
"Shareholder(s)"
holder(s) of the Shares
"Shenzhen Stock Exchange"
深圳證券交易所(Shenzhen Stock Exchange*)
"SUO"
Society of Urologic Oncology
"solid tumors"
an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer), or malignant (cancer). Different types of solid tumors are named for the type of cells that form them
"Stock Exchange"
The Stock Exchange of Hong Kong Limited
"subsidiaries"
has the meaning ascribed to it in section 15 of the Companies Ordinance (Cap. 622)
"Supervisor(s)"
the supervisor(s) of the Company
"T cell"
a lymphocyte of a type produced or processed by the thymus gland and actively participating in the immune response, which plays a central role in cell-mediated immunity. T cells can be distinguished from other lymphocytes, such as B cells and NK cells, by the presence of a T cell receptor on the cell surface
"Ta/T1 Disease"
non-muscle-invasive bladder cancer that has not progressed to muscle-invasive disease
"Taizhou Hanzhong"
Taizhou Hanzhong Biotechnology Co., Ltd.
"Target Products"
the pharmaceutical preparation or products under the Intellectual Property Assignment and License Agreement:
(1) CTM012 and its candidate molecules, together with other antibody products with the same target as CTM012 and any optimized, modified, improved, altered, substituted or derivative products of the aforementioned in the form of a T-cell engager;
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(2) CTM013 and its candidate molecules, together with other antibody products with the same target as CTM013 and any optimized, modified, improved, altered, substituted or derivative products of the aforementioned in the form of a T-cell engager; and
(3) all T cell engager products developed by Excalipoint (independently or through third parties) based on the transferred patents and/or the licensed patents, including any subsequent, optimized, modified, improved, altered, substituted or derivative T cell engager products,
but does not include any ADC product candidates and the follow on pipelines optimized, modified, improved, altered, substituted or derived from any of such ADC product candidates as defined under the Intellectual Property Assignment and License Agreement.
"TCE assets" CTM012 and CTM013
"TCR" a protein complex found on the surface of T cells that is responsible for recognizing fragments of antigen as peptides bound to major histocompatibility complex molecules
"tissue factor" or "TF" a protein encoded by the F3 gene, present in subendothelial tissue and leukocytes. Many cancer cells express high level of TF
"TNBC" triple-negative breast cancer
"topoisomerase I inhibitor" a chemical compound that blocks the action of type I topoisomerases
"Treasury Shares" has the meaning ascribed to it under the Listing Rules
"UC" urothelial cancer
"United States" or "U.S." the United States of America, its territories and possessions, any State of the United States, and the District of Columbia
"Unlisted Foreign Shares" ordinary shares issued by the Company with a nominal value of RMB1.00 each and are held by foreign investors and are not listed on any stock exchange
"US$"
United States dollars, the lawful currency of the United States of America
"vc linker"
valine-citrulline linker, which is adequately stable in blood circulation and cleaved effectively by the lysosomal cathepsin enzyme after the ADC is internalized and enters lysosome
"%"
per cent
By order of the Board
Lepu Biopharma Co., Ltd.
Dr. Pu Zhongjie
Chairman and Executive Director
Shanghai, the PRC
March 25, 2026
As at the date of this announcement, the Board comprises Dr. Pu Zhongjie (chairman) and Dr. Sui Ziye (chief executive officer) as executive Directors; Ms. Pu Jue and Ms. Qin Yiran as non-executive Directors; and Mr. Zhou Demin, Mr. Yang Haifeng and Mr. Fengmao Hua as independent non-executive Directors.
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