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SEC Comment Letter 0000000000-24-009387 to ASCENTAGE PHARMA GROUP INTERNATIONAL (AAPG)

ASCENTAGE PHARMA GROUP INTERNATIONAL
Date: Aug. 15, 2024 · CIK: 0002023311 · Accession: 0000000000-24-009387

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
August 15, 2024
Author
Dajun Yang
Form
UPLOAD
Company
ASCENTAGE PHARMA GROUP INTERNATIONAL

Letter

August 15, 2024 Dajun Yang Chairman and Chief Executive Officer Ascentage Pharma Group International 68 Xinqing Road Suzhou Industrial Park Suzhou, Jiangsu China Re:Ascentage Pharma Group International Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted July 31, 2024 CIK No. 0002023311 Dear Dajun Yang: We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our July 12, 2024, letter. Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted July 31, 2024 Cover Page We note the following statement on the cover page and elsewhere throughout the prospectus: "Ascentage Pharma Group International’s ability to pay dividends, if any, to its shareholders and to service any debt it may incur will partially depend upon dividends paid by PRC subsidiaries." Please revise your disclosure, both on the cover page and elsewhere as appropriate, to clarify whether the company's PRC subsidiaries have ever paid dividends to Ascentage Pharma Group International. In addition, describe any restrictions on foreign exchange and your ability to transfer cash between entities, across 1.

August 15, 2024 Page 2 borders, and to 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. Please also disclose whether the company has any cash management policies. Prospectus Summary Overview, page 1 2.We note your response to our prior comment 5 and we reissue the comment. Please revise the Overview section of the prospectus summary to provide an equally prominent discussion of the challenges faced by the company and the risks and limitation that could harm the business or inhibit strategic plans. In this regard, please note that clinical data obtained in China may not be accepted by the FDA or other foreign regulators to support ongoing or future clinical trials, that the company only has an approved product in China, and that the outcome of clinical trials is uncertain. 3.We note your response to our prior comment 6 and resissue the comment. Please revise the prospectus to remove all statements concluding or implying safety or efficacy other than those relating to olverembatinib as approved in China, as such determinations are solely within the authority of the FDA and comparable foreign regulatory bodies. For example, but without limitation, we note the following: •Your statement that “lisaftoclax, with its short half-life, patient-friendly ramp-up schedule, reduced risk of drug-drug interactions, or DDIs, favorable safety profile and high response rate, can serve as a backbone molecule for combination therapies for many hematological malignancies, including and beyond CLL/SLL.” •Your references to “positive” preliminary results. •Your references to "abundant real-world patient safety and efficacy data". •Your statements that your pipelines “demonstrate a robust efficacy and safety profile”. •Your statement that you have “identified several compounds that are capable of rapidly reducing the levels of the Bcl-xL protein in human cancer cell lines and thereby inhibiting cancer cell growth in human cancer cell lines that are dependent on Bcl-xL.” You may present clinical trial end points and objective data resulting from trials without concluding safety and efficacy, and you may state that your product candidates are well tolerated, if accurate. 4.We note your response to our prior comment 7 and we resissue the comment. In all instances outside of your discussion of strategy, please remove references to your product candidates and future pipeline candidates as potentially "best-in-class" or "first-in-class" products. Given the current stage of development of the company’s products, such claims are speculative and premature. 5.We note your response to our prior comment 9. Please revise your disclosure to either include a defined term for your use of "global" in the context of "global registrational" trials, or to specifically name each country in which regulatory trials are taking place in each instance where the term is used. Please also ensure footnote 2 to the pipeline table is revised accordingly.

August 15, 2024 Page 3 6.We note your response to our prior comment 11 and reissue the comment. Please revise this section to include a discussion of your agreements with AstraZeneca, Innovent, Merck, and Pfizer. We note your qualification that these are "clinical collaboration agreements" and as such, this discussion should describe the cost-sharing arrangement, including each party's rights and obligations, how much of the costs each party is obligated to fund and what rights, if any, each party will have to the data resulting from the trial. To the extent that these agreements provide any rights to olverembatinib and lisaftoclax , please describe such rights. Alternatively, please provide an analysis supporting the statement in your response letter that the company is not substantially dependent on each agreement. See Item 8 of Part II of Form F-1 and Item 601(b)(10) of Regulation S-K. 7.We note your statement in this section and elsewhere that the company is eligible to be paid "double-digit royalties on net sales" under the Takeda exclusive option agreement. Please revise this disclosure in all places in which it appears to disclose the royalty rate within a range of ten percentage points. As drafted, "double-digit royalties" could refer to a royalty of 10% or 99%. Risk Factors Even if this offering is successful, we will need to obtain additional financing to fund our operations..., page 24 8.We note your response to our prior comment 17. Please further revise your disclosure to identify the “local governments” that provided subsidies to fund the company’s operations in the past. We have entered into collaborations and other relationships with leading biotechnology companies and research institutions..., page 78 9.We note the newly added disclosure on pages 79 and 80 that the company cannot guarantee that Takeda will not seek to change the terms of the exclusive option agreement and that the company cannot guarantee that Takeda will exercise the option "on terms acceptable" to the company. Please revise your disclosure to explain these statements in light of the executed agreement entered into between the parties. Capitalization, page 127 10.We note your revised disclosures in response to comment 22. Please explain to us why interest-bearing bank and other borrowings that are classified as current liabilities are not included in your capitalization. Management's Discussion and Analysis of Financial Condition and Results of Operations Research and Development Expenses, page 141 11.We note your response to our prior comment 25. Please clarify if you track your external research and development costs and explain the level on which costs are tracked (compound, target, indications and treatments, etc.). Given the significance of your research and development costs, your current disclosure indicating that you refocused your resources on developing key product pipelines does not sufficiently convey to investors the matters that materially impacted your research and development expenses.

August 15, 2024 Page 4 Business Takeda exclusive option agreement, page 200 12.We note your response to our prior comment 16 and we reissue the comment in part. Please revise your disclosure regarding the termination provision of the Takeda exclusive option agreement to define “Option Initiation Period” and “Option Exercise Period” in the prospectus itself rather than referring to the agreement. Note 17 - Investment in a Joint Venture, page F-40 13.We note your response to our prior comment 32. Please disclose the significant judgements and assumptions that you used in determining that you have significant influence over Suzhou Ascentage Harvest Venture Capital LLP. Refer to paragraph 9(e) of IFRS 12. Please contact Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you have questions regarding comments on the financial statements and related matters. Please contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc:David Sharon

Show Raw Text
August 15, 2024
Dajun Yang
Chairman and Chief Executive Officer
Ascentage Pharma Group International
68 Xinqing Road
Suzhou Industrial Park
Suzhou, Jiangsu
China
Re:Ascentage Pharma Group International
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted July 31, 2024
CIK No. 0002023311
Dear Dajun Yang:
            We have reviewed your amended 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. Unless we note otherwise, any references to prior comments are to comments in our
July 12, 2024, letter.
Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted July 31, 2024
Cover Page
We note the following statement on the cover page and elsewhere throughout the
prospectus: "Ascentage Pharma Group International’s ability to pay dividends, if any, to
its shareholders and to service any debt it may incur will partially depend upon dividends
paid by PRC subsidiaries." Please revise your disclosure, both on the cover page and
elsewhere as appropriate, to clarify whether the company's PRC subsidiaries have ever
paid dividends to Ascentage Pharma Group International. In addition, describe any
restrictions on foreign exchange and your ability to transfer cash between entities, across 1.

August 15, 2024
Page 2
borders, and to 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. Please also disclose whether the company has any cash management
policies.
Prospectus Summary
Overview, page 1
2.We note your response to our prior comment 5 and we reissue the comment. Please revise
the Overview section of the prospectus summary to provide an equally prominent
discussion of the challenges faced by the company and the risks and limitation that could
harm the business or inhibit strategic plans. In this regard, please note that clinical data
obtained in China may not be accepted by the FDA or other foreign regulators to support
ongoing or future clinical trials, that the company only has an approved product in China,
and that the outcome of clinical trials is uncertain.
3.We note your response to our prior comment 6 and resissue the comment. Please revise
the prospectus to remove all statements concluding or implying safety or efficacy other
than those relating to olverembatinib as approved in China, as such determinations are
solely within the authority of the FDA and comparable foreign regulatory bodies. For
example, but without limitation, we note the following:
•Your statement that “lisaftoclax, with its short half-life, patient-friendly ramp-up
schedule, reduced risk of drug-drug interactions, or DDIs, favorable safety profile and
high response rate, can serve as a backbone molecule for combination therapies for
many hematological malignancies, including and beyond CLL/SLL.”
•Your references to “positive” preliminary results.
•Your references to "abundant real-world patient safety and efficacy data".
•Your statements that your pipelines “demonstrate a robust efficacy and safety
profile”.
•Your statement that you have “identified several compounds that are capable of
rapidly reducing the levels of the Bcl-xL protein in human cancer cell lines and
thereby inhibiting cancer cell growth in human cancer cell lines that are dependent on
Bcl-xL.”
You may present clinical trial end points and objective data resulting from trials without
concluding safety and efficacy, and you may state that your product candidates
are well tolerated, if accurate.
4.We note your response to our prior comment 7 and we resissue the comment. In all
instances outside of your discussion of strategy, please remove references to your product
candidates and future pipeline candidates as potentially "best-in-class" or "first-in-class"
products. Given the current stage of development of the company’s products, such claims
are speculative and premature.
5.We note your response to our prior comment 9. Please revise your disclosure to either
include a defined term for your use of "global" in the context of "global registrational"
trials, or to specifically name each country in which regulatory trials are taking place in
each instance where the term is used. Please also ensure footnote 2 to the pipeline table is
revised accordingly.

August 15, 2024
Page 3
6.We note your response to our prior comment 11 and reissue the comment. Please revise
this section to include a discussion of your agreements with AstraZeneca, Innovent,
Merck, and Pfizer. We note your qualification that these are "clinical collaboration
agreements" and as such, this discussion should describe the cost-sharing arrangement,
including each party's rights and obligations, how much of the costs each party is
obligated to fund and what rights, if any, each party will have to the data resulting from
the trial. To the extent that these agreements provide any rights to olverembatinib and
lisaftoclax , please describe such rights. Alternatively, please provide an analysis
supporting the statement in your response letter that the company is not substantially
dependent on each agreement. See Item 8 of Part II of Form F-1 and Item 601(b)(10) of
Regulation S-K.
7.We note your statement in this section and elsewhere that the company is eligible to be
paid "double-digit royalties on net sales" under the Takeda exclusive option agreement.
Please revise this disclosure in all places in which it appears to disclose the royalty rate
within a range of ten percentage points. As drafted, "double-digit royalties" could refer to
a royalty of 10% or 99%.
Risk Factors
Even if this offering is successful, we will need to obtain additional financing to fund our
operations..., page 24
8.We note your response to our prior comment 17. Please further revise your disclosure to
identify the “local governments” that provided subsidies to fund the company’s operations
in the past.
We have entered into collaborations and other relationships with leading biotechnology
companies and research institutions..., page 78
9.We note the newly added disclosure on pages 79 and 80 that the company cannot
guarantee that Takeda will not seek to change the terms of the exclusive option agreement
and that the company cannot guarantee that Takeda will exercise the option "on terms
acceptable" to the company. Please revise your disclosure to explain these statements in
light of the executed agreement entered into between the parties.
Capitalization, page 127
10.We note your revised disclosures in response to comment 22.  Please explain to us why
interest-bearing bank and other borrowings that are classified as current liabilities are not
included in your capitalization.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Research and Development Expenses, page 141
11.We note your response to our prior comment 25.  Please clarify if you track your external
research and development costs and explain the level on which costs are tracked
(compound, target, indications and treatments, etc.).  Given the significance of your
research and development costs, your current disclosure indicating that you refocused
your resources on developing key product pipelines does not sufficiently convey to
investors the matters that materially impacted your research and development expenses.

August 15, 2024
Page 4
Business
Takeda exclusive option agreement, page 200
12.We note your response to our prior comment 16 and we reissue the comment in part.
Please revise your disclosure regarding the termination provision of the Takeda exclusive
option agreement to define “Option Initiation Period” and “Option Exercise Period” in the
prospectus itself rather than referring to the agreement.
Note 17 - Investment in a Joint Venture, page F-40
13.We note your response to our prior comment 32.  Please disclose the significant
judgements and assumptions that you used in determining that you have significant
influence over Suzhou Ascentage Harvest Venture Capital LLP.  Refer to paragraph 9(e)
of IFRS 12.
            Please contact Eric Atallah at 202-551-3663 or Daniel Gordon at 202-551-3486 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:David Sharon