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United States securities and exchange commission logo





                              January 23, 2024

       Michael Lau
       Chief Executive Officer
       Anbio Biotechnology
       Friedrich-Ebert-Anlage 49, 60308
       Frankfurt am Main
       Germany

                                                        Re: Anbio Biotechnology
                                                            Draft Registration
Statement on Form F-1
                                                            Submitted December
27, 2023
                                                            CIK No. 0001982708

       Dear Michael Lau:

                                                        We have reviewed your
draft registration statement and have the following comments.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your
response.

               After reviewing the information you provide in response to this
letter and your amended
       draft registration statement or filed registration statement, we may
have additional comments.

       Draft Registration Statement on Form F-1 Submitted December 27, 2023

       Cover Page

   1.                                                   With respect to CVC
Investment and Northwestern Investment, please provide us with
                                                        your analysis as to
whether these shareholders are acting as a "group" as determined by
                                                        Exchange Act Rule
13d-5(b)(1). We note in this regard your disclosure under the risk
                                                        factor entitled "Our
corporate actions will be substantially controlled by our shareholders,
                                                        CVC Investment and
Northwestern Investment, which will have the ability to control or
                                                        exert significant
influence over important corporate matters that require approval of
                                                        shareholders." If these
shareholders will be acting as a group or otherwise controlling the
                                                        Company, please tell us
whether you will be a controlled company under the Nasdaq rules
                                                        upon the completion of
your offering. If you will be a controlled company, please include
                                                        appropriate disclosure
on the prospectus cover page and in the prospectus summary and
                                                        provide risk factor
disclosure of this status and disclose the corporate governance
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024      Biotechnology
January
Page 2 23, 2024 Page 2
FirstName LastName
         exemptions available to a controlled company. To the extent you will
be a controlled
         company, the cover page and prospectus summary disclosure should
include the identity
         of your controlling shareholders, the amount of voting power the
controlling shareholders
         will own following the completion of the offering, and whether you
intend to rely on any
         exemptions from the corporate governance requirements that are
available to controlled
         companies.
2.       Please revise the prospectus cover page to include a cross reference
to the risk factors
         section, including the page number where it appears in the prospectus.
Refer to Item 1 of
         Form F-1 and Item 501(b)(5) of Regulation S-K.
Table of Contents, page i

3.       We note your statement below the Table of Contents that you have not
independently
         verified the statistical data, industry data, forecasts, and market
research used in the
         prospectus. This statement may imply an inappropriate disclaimer of
responsibility with
         respect to such information. Please either delete this statement or
specifically state that
         you are liable for such information.
Prospectus Summary
Our Competitive Strengths, page 1

4.       We note from your disclosure on pages F-10 and F-24 that a significant
amount of your
         revenues has been derived from the European Union and from your
disclosure on page 64
         that you have significant customer concentration. Please balance your
disclosure regarding
         a diversified global customer portfolio in this regard. Also revise
your disclosure under
         "Diversified Global Customer Portfolio" on page 50 as appropriate.
Implications of Being an "Emerging Growth Company", page 5

5.       We note your disclosure in the last bullet point of the first
paragraph that you will not be
         required to conduct an evaluation of your internal control over
financial reporting. Please
         revise this so that it is consistent with your disclosure on page 18
that Section 404 of the
         Sarbanes-Oxley Act will require you to include a report from
management on the
         effectiveness of your internal control over financial reporting in
your annual report on
         Form 20-F beginning with your annual report for the fiscal year ending
December 31,
         2023.
Risk Factors
There can be no assurance that we will not be a passive foreign investment
company, or PFIC...,
page 24

6.       We note your disclosure on page 99 that you do not intend to provide
information
         necessary for U.S. holders to make qualified electing fund elections
which, if available,
         you disclose would result in tax treatment different from (and
generally less adverse than)
         the general tax treatment for PFICs that you describe. In this risk
factor, disclose that you
 Michael Lau
Anbio Biotechnology
January 23, 2024
Page 3
         do not intend to provide the information that would enable investors
to make a qualified
         electing fund election that could mitigate the adverse U.S. federal
income tax
         consequences should you be classified as a PFIC.
Use of Proceeds, page 29

7.       Please revise your disclosure in this section to address the
following:

                Clarify what is meant by    global market.    For example, it
is unclear whether you
              intend to use the proceeds from this offering to expand into
every market or markets
              in specific countries, regions, etc.
                Clarify how far into the development process you estimate the
proceeds from the
              offering will enable you to reach. For example, you disclose that
you will use
              proceeds to seek regulatory approval in the global market,
including relevant clinical
              studies and trial testing, and to research and develop new
products, commercialize
              existing products, and validate quality assurance, but it is
unclear whether you expect
              the proceeds will be sufficient to move from research and
development all the way
              through the approval process and commercialization.
                Identify each program, product, or product candidate you plan
to fund with the
              proceeds from the offering and the dollar amount you intend to
allocate to each
              program, product, or product candidate in each of the uses
described in the first three
              line items of the table. For example, disclose the clinical
studies and trial testing that
              will be funded with proceeds from the offering, as well as which
existing products
              you intend to commercialize with proceeds from the offering.
                Disclose whether the allocated proceeds will be sufficient to
complete the actions
              described in the table or whether you will require additional
funds to accomplish the
              specified purposes for which the proceeds are intended to be
used.
                Ensure consistency between the disclosures in this section and
the disclosures on
              page 7 referring to the expansion of your research and
development pipeline,
              advancing customer service, and strengthening sales operations.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Factors Affecting Our Operating Results
Increases in the Price of Life Sciences Reagents and Consumables May Harm Our
Profitability,
page 35

8.     We note your disclosure that you ask your suppliers not to increase
prices unilaterally
       without giving you a 12-month advance notice due to the fluctuation in
foreign exchange.
       Please revise your disclosure to clarify whether your suppliers
generally honor such
FirstName LastNameMichael Lau
       request to the extent material and whether you enter into contractual
agreements with your
Comapany   NameAnbio
       suppliers         Biotechnology
                 regarding  the same. In addition, if your suppliers are not
obligated to provide the
Januaryrequested
        23, 2024 advance
                  Page 3 notice to you, please revise your disclosure to state
that fact.
FirstName LastName
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024      Biotechnology
January
Page 4 23, 2024 Page 4
FirstName LastName
Impact of COVID-19, page 35

9.       We note your disclosure in the first sentence that you are a
fast-growing biomedical
         diagnostic company and that you are confident you will offer your
mature non-COVID-19
         IVD products to the global market as soon as possible. Please disclose
the measure by
         which you characterize the Company as    fast-growing.    In this
regard, we note the
         significant decrease in revenue during the first six months of 2023.
In addition, please
         clarify which mature non-COVID-19 IVD products you intend to offer to
the global
         market, what is meant by    global market,    and your anticipated
timeline for introducing
         these products to the global market. In this regard, the breadth of
your intended reach into
         the    global market    is unclear and your reference to offering
certain products    as soon as
         possible    is ambiguous as to how soon the products could actually be
offered into the
         market.
10.      We note your disclosure in the second paragraph that, when the
transition period for the
         IVDR 2017/746 Directive ends, your CE marked products may need to be
recertified
         under the IVDR 2017/746 Directive before they can legally be sold in
the EU. Please
         disclose when the transition period is expected to end, which of your
products may, or
         will, require certification, the status and anticipated timeline for
recertification of your
         products, and the potential impact on the Company resulting from any
delay in, or failure
         to receive, recertification.
Results of Operations
Other Income, net, page 38

11.      Please disclose what sample income, noted here, and customized package
design service,
         noted on page 39, relates to, and disclose if you will continue with
these lines of business
         and provide your accounting policy for recognizing such revenue in
your notes to the
         financial statements.
Research and Development Expenses, page 39

12.      Refer to your disclosure beginning on page 61 relating to your
research and development
         activities. Please revise your disclosure here to describe the types
of research and
         development costs incurred. In addition, revise your disclosure on
page F-25 to include
         your research and development accounting policy which is noted within
your discussion
         of Operating Expenses in Note 2, Summary of Significant Accounting
Policies. Refer to
         Item 5.C of Form 20-F.
Critical Accounting Estimates, page 41

13.      Please explain why you appear to include separate discussions of
Critical Accounting
         Estimates and Critical Accounting Policies or revise. Refer to Item
5.E of Form 20-F.
14.      Critical accounting estimates are those estimates made in accordance
with generally
         accepted accounting principles that involve a significant level of
estimation uncertainty
 Michael Lau
Anbio Biotechnology
January 23, 2024
Page 5
         and have had or are reasonably likely to have a material impact on
your financial
         condition or results of operations. Your disclosure should provide
qualitative and
         quantitative information necessary to understand the estimation
uncertainty and the impact
         the critical accounting estimate has had or is reasonably likely to
have on your financial
         condition or results of operations and should include why each
critical accounting
         estimate is subject to uncertainty and how much each estimate and/or
assumption has
         changed over a relevant period, and the sensitivity of the reported
amount to the methods,
         assumptions and estimates underlying its calculation. Refer to Item
5.E of Form 20-F.

         Specifically, please revise to explain why each critical accounting
estimate (Revenue
         Recognition, Leases, Fair Value Measurement, Income Taxes and
Estimated Allowance
         for Accounts Receivable) is subject to uncertainty and how much each
estimate and/or
         assumption has changed over a relevant period, and the sensitivity of
the reported amounts
         to the material methods, assumptions and estimates underlying its
calculation. For
         example, you state that there was no provision for doubtful accounts
as of June 30, 2023,
         December 31, 2022 and 2021. Please revise your disclosure to more
fully describe the
         judgments, methods, inputs, and assumptions involved in your
determination.
Business, page 48

15.      Please revise your disclosures in this section and throughout the
prospectus as appropriate
         to clarify the current status of your various programs, solutions,
products, and product
         candidates. For example, please clarify their current stage of
development and/or
         commercialization; which of them require regulatory approval and where
they are in the
         approval process; and your timelines and anticipated plans for
marketing, distributing, and
         otherwise commercializing the same. In this regard, we note references
in this section and
         elsewhere in the prospectus to your extensive portfolio of IVD
products designed to cater
         to diverse diagnostic needs, your comprehensive range of products
encompassing
         solutions for various applications, your advanced diagnostic
capabilities, your versatile
         range of products, and other similar characterizations that imply you
have a broad product
         line available. However, we also note your disclosure on page 53 that
your product lineup
         primarily features rapid antigen tests for COVID-19, as well as your
disclosures
         throughout the prospectus that 99% of your revenues were generated
from sales of your
         SARS-CoV-2 and SARS-CoV-2/Flu A/Flu B Antigen Rapid Test Kit.
16.    We note your disclosure that you developed and distributed a
comprehensive range of
       robust solutions to meet the growing demand in the POCT and OTC markets.
Given your
       limited operating history, your disclosure on page 61 that you only
incurred nominal
       research and development expenses in 2022, and the broad product lineup
you discuss
FirstName LastNameMichael Lau
       throughout the prospectus, please briefly describe the research and
development activities
Comapany    NameAnbio
       you have           Biotechnology
                  conducted  to date. To the extent that you acquired products
and solutions from
Januarythird parties,
         23, 2024     please
                   Page  5 briefly describe that aspect of your business
strategy.
FirstName LastName
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024      Biotechnology
January
Page 6 23, 2024 Page 6
FirstName LastName
Our Products
Types of Products, page 54

17.      Please revise the table to clearly identify which products, if any,
require regulatory
         approvals; which regulatory approvals, if any, the products have
received; which products
         are commercially available and/or ready for commercialization; and
your plans and
         expectations for the same. In this regard, we note general disclosure
on page 51 that
         certain of your non-COVID-19 related products are registered for
commercialization in
         the EU under CE Mark authority and that you plan to commercialize
non-COVID-19
         related products via distributors for the fiscal year ending December
31, 2023 and beyond.
         For any products not yet commercially available or ready for
commercialization, please
         identify where the product is in the development process.
Clinical Results, page 60

18.      We note references in this section to conclusions related to the data
generated from your
         studies. For example, you disclose conclusions related to the
suitability of your SARS-
         CoV-2 Antigen Rapid Test and characterize the results as exhibiting
excellent
         sensitivity and specificity. In addition, you disclose that a study
concluded that your
         SARS-CoV-2/Influenza A/B Antigen Rapid Test is    accurate, sensitive,
specific, and
         user-friendly, requiring minimal training, and is suitable for
point-of-care and home use to
         detect COVID-19, Influenza A, and Influenza B.    While we do not
object to your
         disclosure of objective data resulting from the trials, please delete
any conclusions you
         drew from such data as inappropriate given the regulatory authorities
  role in the approval
         process for medical devices. Please make similar revisions throughout
the registration
         statement as appropriate.
Our Suppliers, page 63

19.      We note your supplier concentration for the periods presented. Please
disclose whether
         you have contracts with your suppliers and the material terms of such
contracts. Please file
         any material contract as an exhibit to your registration statement or
provide us with an
         analysis as to why that would not be appropriate.
Intellectual Property, page 64

20.      Please disclose whether you own or license your intellectual property.
In addition, please
         disclose the specific products or product groups to which your patent
and trademark
         applications relate.
Employees, page 66

21.      Please disclose the breakdown of employees by main category of
activity and geographic
         location. Refer to Item 4.a of Form F-1 and Item 6.D in Part I of Form
20-F. Also, given
         that you appear to have only incurred research and development
expenses in 2022, please
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024      Biotechnology
January
Page 7 23, 2024 Page 7
FirstName LastName
         tell us how to reconcile your disclosure that around 15% of your staff
members are
         involved with research and development with the expenses shown on the
financial
         statements included in your filing.
Management, page 71

22.      We note your disclosure that Michael Lau has served as a Vice
President of Global Head
         of GMP Operations and Diagnostics for Genscript Biotech Corp. since
July 2017 and that
         he is responsible for management of a business development and sales
team for 28 states
         in the United States and South America. Please revise your disclosure
to clarify whether
         Mr. Lau continues to hold this position and, if not, when he left this
position. If Mr. Lau
         continues to hold this position, please:

                disclose how Mr. Lau   s time and attention is allocated
between the Company and
              Genscript and whether the Company is party to any arrangements
regarding the same;
                disclose, as appropriate in the prospectus, any competing
interests between the
              Company and Genscript and what measures, if any, the Company has
taken to protect
              its confidential information and its intellectual property from
Genscript; and
                include risk factor disclosure in the    Risk Factors
section of the prospectus
              regarding any potential conflicts of interest, the diversion of
Mr. Lau   s time and
              attention away from the Company, and any other material risks
associated with Mr.
              Lau   s dual roles.

         To the extent material, please provide similar disclosures regarding
Richard Chen   s dual
         role as Chief Financial Officer of the Company and as a partner of CLC
LLP, particularly
         as such disclosures relate to the allocation of Mr. Chen   s time and
attention between the
         Company and CLC.
23.      Please disclose any arrangement or understanding with major
shareholders or others
         pursuant to which any of the executive officers were selected as a
member of senior
         management or Mr. Xu was selected as a director. Refer to Item 4.a of
Form F-1 and Item
         6.A.5 of Part I of Form 20-F.
Board of Directors, page 72

24.      We note your disclosure that    [a] director may exercise all the
powers of the company....
         Please clarify whether a single director may exercise these powers or
whether the exercise
         of such powers requires action by the board of directors.
Executive Compensation
Agreements with Named Executive Officers, page 76

25.      We note your disclosure that you    plan    to implement incentive
compensation
         arrangements with your senior executive officers under an executive
incentive
         compensation plan if the Company exceeds a target market cap for six
consecutive
         months. Please disclose how the target market cap will be calculated
for this purpose or
 Michael Lau
Anbio Biotechnology
January 23, 2024
Page 8
         cross reference to the exhibit, if applicable, where the    Market
Capitalized Target    is
         defined. In addition, please clarify whether you are obligated to pay
the specified amounts
         upon achievement of the target and whether, like the payment to be
made to Mr. Lau, the
         payments to Mr. Chen and Mr. Tian will be made in stock. Finally,
please include a brief
         description of the executive incentive compensation plan, file a copy
of the plan as an
         exhibit to the registration statement, and disclose here how many
shares will be authorized
         under the plan. Refer to Item 8.a of Form F-1 and Item 601(b)(10)(iii)
of Regulation S-K.
Principal Shareholders, page 77

26.      Although we note your disclosure that James Howard is the sole proxy
holder of the
         shares held by CVC Investment, and that Mark Martinez is the sole
proxy holder of the
         shares held by Northwestern Investment, please revise your disclosure
to clarify the
         natural person or persons who have ultimate voting control and
investment control of the
         shares held by these entities. Also, if Messrs. Howard and Martinez
were granted their
         proxies by other natural persons, please make that clear.
Description of Share Capital
Ordinary Share, page 79

27.      We note your disclosure in the first sentence that all of your issued
and outstanding Class
         A ordinary shares and Class B ordinary shares are fully paid and
nonassessable. We note a
         similar statement on page 80. Please reconcile these disclosures with
the statement on
         page II-1 of the registration statement that the consideration for the
June 30, 2023 private
         placement of Class A ordinary shares and Class B ordinary shares has
not been paid as of
         the date of the prospectus.
Class B Ordinary Shares, page 80

28.      Please clarify how the amount of the repayment of capital on the Class
B ordinary shares
         would be calculated. Also indicate whether the Class B ordinary shares
are convertible
         into Class A ordinary shares and the conversion terms, if any. We also
note that the Class
         B ordinary shares do not have any economic interest in your company.
If such shares are
         convertible into Class A ordinary shares, please disclose any
resulting impact on the Class
         A ordinary shareholders, including dilution, and include appropriate
risk factor disclosure.
Underwriting
Underwriters' Warrants, page 101

29.    Your disclosure that the underwriters    warrants will be exercisable
for five years from the
       commencement of sales in the offering appears to be inconsistent with
your disclosure that
FirstName LastNameMichael Lau
       the underwriters    warrants will terminate on the third anniversary of
the commencement
Comapany    NameAnbio
       of sales           Biotechnology
                in the offering. Please revise your disclosure to clarify the
term of the
Januaryunderwriters
         23, 2024 Pagewarrants.
                         8
FirstName LastName
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024      Biotechnology
January
Page 9 23, 2024 Page 9
FirstName LastName
Expenses Relating to this Offering, page 107

30.      Please include a line item in the table for transfer agent fees and
expenses and for any
         premiums paid to insure directors or officers for liabilities in
connection with
         the registration, offer or sale of the securities you are registering.
Refer to Instruction to
         Item 9.F of Form 20-F.
Note 2- Summary of Significant Accounting Policies
Revenue Recognition, page F-23

31.      Please revise your revenue recognition policy to specifically state
when control is
         transferred (i.e. shipping point or delivery) as    generally upon
contract terms    is vague.
Item 7. Recent Sales of Unregistered Securities, page II-1

32.      We note that upon incorporation, the company issued 50 ordinary shares
to founding
         shareholders, and that on June 30, 2023 the company issued Class A
Ordinary Shares to
         "other shareholders" that were not CVC Investment or Northwestern
Investment. Please
         name the persons or identify the class of persons to whom these
securities were sold.
         Refer to Item 7 of Part II of Form F-1 and Item 701(b) of Regulation
S-K.
33.      We note that the securities disclosed in this section were sold for
nominal consideration,
         some of which has not been paid as of the date of this prospectus, and
we note no cash
         flows from financing activities in your consolidated statements of
cash flows for the fiscal
         years ended December 31, 2021 and 2022. With a view towards revised
disclosure, please
         tell us how you obtained capital to commence operations.
Signatures, page II-4

34.      Please revise the signature block to identify which officer is signing
in his capacity as the
         Company   s controller or principal accounting officer. Refer to
Instructions 1 and 2 to
         Signatures in Form F-1.
Signature of Authorized Representative in the United States, page II-5

35.      Please revise the preamble to this section as appropriate. In this
regard, although it appears
         you intend to have a representative of Cogency Global Inc. sign the
registration statement,
         the preamble refers to    Star Venture Investment Holding Limited.
General

36.      Please supplementally provide us with copies of all written
communications, as defined in
         Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
         present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
         not they retain copies of the communications.
 Michael Lau
FirstName  LastNameMichael Lau
Anbio Biotechnology
Comapany
January 23,NameAnbio
            2024       Biotechnology
January
Page 10 23, 2024 Page 10
FirstName LastName
       Please contact Sasha Parikh at 202-551-3627 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jessica Dickerson at 202-551-8013 or Tim Buchmiller at 202-551-3635
with any other
questions.



                                                         Sincerely,

                                                         Division of
Corporation Finance
                                                         Office of Life
Sciences
cc:      William S. Rosenstadt, Esq.
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