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United States securities and exchange commission logo
January 18, 2023
Vicky Zhang
Chief Financial Officer
Adlai Nortye Ltd.
c/o PO Box 309, Ugland House
Grand Cayman, KY1-1104
Cayman Islands
Re:Adlai Nortye Ltd.
Draft Registration Statement on Form F-1
Submitted December 21, 2022
CIK No. 0001944552
Dear Vicky Zhang:
            We have reviewed your draft registration statement and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
            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 our comments apply 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 these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form F-1
Cover Page
1.Please disclose whether your offering is contingent on final approval of your NASDAQ
listing on your cover page.  Ensure the disclosure is consistent with your underwriting
agreement.
2.We note your statement on the cover page that Adlai Nortye Ltd. is "not an operating
company but [y]our Cayman Islands holding company."  Please revise this statement to
specifically state that Adlai Nortye is not a Chinese operating company, but is a Cayman
Islands holding company.

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3.We note your disclosure on the cover page about the legal and operational risks associated
with being based in or having the majority of the company’s operations in China.  Please
revise this disclosure to make clear whether these risks could result in a material change in
your operations and/or the value of your securities or could significantly limit or
completely hinder your ability to offer securities to investors and cause the value of your
securities to significantly decline or be worthless.
4.Please prominently disclose whether your auditor is subject to the determinations
announced by the PCAOB on December 16, 2021 and whether and how the Holding
Foreign Companies Accountable Act and related regulations will affect your company.
5.Clearly disclose how you will refer to the holding company and subsidiaries when
providing the disclosure throughout the document so that it is clear to investors which
entity the disclosure is referencing and which subsidiaries or entities are conducting the
business operations.  For example, disclose, if true, that your subsidiaries conduct
operations in China.  Disclose clearly the entity (including the domicile) in which
investors are purchasing an interest.
6.We note your discussion of how cash is transferred through your organization on the
cover page.  Please further revise this disclosure to disclose your intentions to distribute
earnings.  State whether any transfers, dividends, or distributions have been made to date
between the holding company, its subsidiaries, or to investors, and quantify the amounts
where applicable.  Please also address restrictions on your PRC subsidiary's ability to
transfer funds, as disclosed elsewhere in the filing, and provide a cross-reference to the
consolidated financial statements.
Prospectus Summary
Overview, page 1
7.Please revise your disclosure regarding your ongoing clinical trials for AN0025 and
AN4005 to state the jurisdictions where such trials are taking place.
8.We note your statement used throughout the prospectus that you are actively
advancing four in-house preclinical programs "considered to have high global commercial
viability".  Please provide support for this statement or revise to frame the statement as
a belief or opinion.
9.Revise the summary to provide a clear description of how cash is transferred through your
organization.  Disclose your intentions to distribute earnings.  Quantify any cash flows
and transfers of other assets by type that have occurred between the holding company and
its subsidiaries, and direction of transfer.  Quantify any dividends or distributions that a
subsidiary have made to the holding company and which entity made such transfer, and
their tax consequences.  Similarly quantify dividends or distributions made to U.S.
investors, the source, and their tax consequences.  Your disclosure should make clear if no
transfers, dividends, or distributions have been made to date.  Describe any restrictions on
foreign exchange and your ability to transfer cash between entities, across borders, and to

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U.S. investors.  Describe any restrictions and limitations on your ability to distribute
earnings from the company, including your subsidiaries, to the parent company and U.S.
investors.
AN2025: the vanguard for recurrent or metastatic HNSCC after anti-PD-1/PD-L1 therapy, page
2
10.On page 2, you refer to AN2025 as “the vanguard” for recurrent or metastatic HNSCC
after anti-PD-1/PD-L1 therapy.  Please revise your use of the term in all places in which
it appears to be expressed as a goal, belief or opinion.  For instance, you may state, if
accurate, that the Company aims to be the vanguard for recurrent or metastatic HNSCC
after anti-PD-1/PD-L1 therapy.
11.On page 2, you reference studies demonstrating safety and efficacy.  Similarly, on page 4,
you reference that AN2025 demonstrated promising efficacy and safety data.  Please
revise these and similar statements throughout your prospectus to eliminate conclusions or
predictions that the candidates are safe and effective, as determinations of safety and
efficacy are solely within the authority of the FDA. You may provide an objective
summary of the data that you used to draw such conclusions.

12.On page 3, we note your statement that you received Fast Track designation from the
FDA for AN2025.  Please balance this statement with the disclosure on page 43 that a Fast
Track designation by the FDA may not lead to a faster development or regulatory review
or approval process, and does not increase the likelihood that your drug candidates will
receive marketing approval.
13.We note your references to the NMPA and the PMDA both here and throughout the
document.  Please revise your disclosure on page 3 where the terms are first used to
indicate the jurisdiction of each authority.
Our company history and team, page 4
14.We note the last paragraph of the above referenced section on page 4.  Please limit the
disclosure of specific investors to those identified in the Principal Shareholder table on
page 161.  Additionally, indicate that prospective investors should not rely on the named
investors’ investment decision, that these investors may have different risk tolerances and
that the shares purchased in the referenced financings were conducted at a significant
discount to the IPO price, if true.
Our strengths , page 4
15.Please balance your disclosure by adding a discussion of serious adverse events and
deaths caused by treatment with AN2025.

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Summary of risk factors, page 6
16.Please revise your summary risk factors relating to your operations in the PRC to disclose
the risks that your corporate structure and being based in or having the majority of the
company’s operations in China poses to investors.  In particular, describe the significant
regulatory, liquidity, and enforcement risks with cross-references to the more detailed
discussion of these risks in the prospectus.  For example, specifically discuss risks arising
from the legal system in China, including risks and uncertainties regarding the
enforcement of laws and that rules and regulations in China can change quickly with little
advance notice; and the risk that the Chinese government may intervene or influence your
operations at any time, or may exert more control over offerings conducted overseas
and/or foreign investment in China-based issuers, which could result in a material change
in your operations and/or the value of the securities you are registering for sale.
Acknowledge any risks that any actions by the Chinese government to exert more
oversight and control over offerings that are conducted overseas and/or foreign investment
in China-based issuers could significantly limit or completely hinder your ability to offer
or continue to offer securities to investors and cause the value of such securities to
significantly decline or be worthless.
Conventions that apply to this prospectus, page 11
17.We note that your definition of China and the PRC excludes Hong Kong, Macau and
Taiwan.  Revise your definition and disclosure to clarify that the legal and operational
risks associated with operating in China also apply to any operations
in Hong Kong and/or Macau.
Risk Factors
Uncertainties with respect to the PRC legal system could materially and adversely affect us.,
page 61
18.Given the Chinese government’s significant oversight and discretion over the conduct of
your business, please revise to highlight separately the risk that the Chinese government
may intervene or influence your operations at any time, which could result in a material
change in your operations and/or the value of the securities you are registering.  Also,
given recent statements by the Chinese government indicating an intent to exert more
oversight and control over offerings that are conducted overseas and/or foreign investment
in China-based issuers, acknowledge the risk that any such action could significantly limit
or completely hinder your ability to offer or continue to offer securities to investors and
cause the value of such securities to significantly decline or be worthless.
Use of Proceeds, page 77
19.Although we note your statements that you intend to have broad discretion over the use of
the net proceeds from the offering, please revise your use of proceeds disclosure to
provide more granularity regarding the first bullet point, namely how far in the

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development process you estimate that the proceeds will enable you to reach, including
specific phases of clinical trials, if applicable.  For example, please indicate if you expect
to be able to fund the entirety of any ongoing or planned clinical trials or phases without
raising additional capital.  In this regard, we note your disclosure on pages 47 and 86 of
the prospectus that while you believe, based on your current operating plan, that following
the offering you will have sufficient cash on hand to fund operations for at least the next
12 months you will require substantial additional capital to support your business
operations in the future.
Change in auditor, page 94
20.You state herein that you provided a copy of the change in auditor disclosure to Ernst
& Young, and requested it to furnish you with a letter addressed to the SEC stating
whether it agrees with the above statements, and if not, stating the respects in which it
does not agree.  Please revise your filing to indicate whether you ever obtained such a
letter and, if so, to file it as an exhibit to your document.
Business
Phase Ia trial in patients with advanced solid tumors by Novartis, page 106
21.Per the table, it appears that 34.9% of patients treated with AN2025 experienced deaths
and 43.4% experienced SAEs, for which 13.3% were drug related.  Please provide
clarification on the number of deaths determined to be drug-related, and identify the types
of serious adverse events observed in the trials.
License and Collaboration Agreements, page 127
22.Please revise your disclosure to address the following:
•On page 127, quantify the upfront payment paid to Novartis in 2018.
•On page 129, you state that Roche will supply its atezolizumab for use at no cost
"unless otherwise provided in the clinical supply agreement supplement".  Please
revise to describe the payment terms and obligations of the agreement, including the
referenced supplement.
•On page 130, in relation to the Biotime collaboration agreement, include the payment
amounts in USD in addition to RMB and summarize the term and termination
provisions of the agreement.
23.Please file as exhibits your agreements with Roche, MSD and Biotime.  Alternatively,
please provide an analysis supporting your determination that such filing is not required.
See Item 601(b)(10) of Regulation S-K.
Management
Employment agreements and indemnification agreements, page 158
24.Please revise your disclosure in this section to include a summary of the material terms of
the employment agreement between the company and each named executive officer.

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Compensation of directors and executive officers, page 158
25.We note your disclosure in this section.  Please confirm that disclosure of compensation is
not required on an individual basis in the company's home country and is not otherwise
publicly disclosed by the company.
Principal Shareholders , page 161
26.Please identify any natural persons who have or share voting and/or dispositive power
with respect to the shares owned by the entities listed in your table for Nortye Talent
Limited, Nortye International Limited and UNIQUE MARK VENTURES LIMITED.
History of share capital, page 173
27.Please revise to disclose the nature of the relationship between you and Lucy Zhang, the
only holder of ordinary shares.
Notes to the Consolidated Financial Statements
1. Corporate and Group Information, page F-8
28.You disclose that the Company and its subsidiaries now comprising the Group "underwent
the reorganization as set out in the paragraph headed “Reorganization” in the section
headed “History, Development and Corporate Structure” in the Document (the
“Reorganization”)."  You make similar reference to such separate section on page F-9.
However, we were unable to locate a paragraph entitled "Reorganization" and the
"History, Development and Corporate Structure" section appears to be labeled "Corporate
History and Structure".  Please revise your disclosures hereunder accordingly.
29.We note your disclosure on page 63 regarding limitations on your PRC subsidiary's ability
to pay dividends, which may impact your ability to pay dividends.  Please tell us your
consideration of providing the disclosures required by Rule 4-08(e) of Regulation S-X as
well as the consolidated financial information of registrant (Schedule I) required by Rule
5-04.
4. Revenue, page F-25
30.We note that revenue of $45.7 million for the year ended December 31, 2021 was derived
from the sale of intellectual property to Xiamen Biotime Biotechnology Co., Ltd
(Biotime) pursuant to a collaboration agreement entered into on November 15, 2021.
Your accounting policy disclosure on page F-21 states that revenue from sales of
intellectual property is recognized when you have sold the rights to the intellectual
property and after there is no future performance obligation to be performed.  Please
explain how the potential milestone payments and sales-based royalties, as described on
page 130, were considered in determining the transaction price for this collaboration
agreement.  To the extent that you determined that this variable consideration is fully
constrained, please discl