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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

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Anbio Biotechnology
January 23, 2024
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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

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Anbio Biotechnology
January 23, 2024
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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
request to the extent material and whether you enter into contractual agreements with your
suppliers regarding the same. In addition, if your suppliers are not obligated to provide the
requested advance notice to you, please revise your disclosure to state that fact.

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Anbio Biotechnology
January 23, 2024
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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

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 Comapany NameAnbio Biotechnology
 January 23, 2024 Page 5
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Anbio Biotechnology
January 23, 2024
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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
throughout the prospectus, please briefly describe the research and development activities
you have conducted to date. To the extent that you acquired products and solutions from
third parties, please briefly describe that aspect of your business strategy.

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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 suppli