Lisaftoclax Phase III HR-MDS trial cleared by FDA, EMA (AAPG)

Rhea-AI Filing Summary

Ascentage Pharma Group International submitted a Form 6-K noting that it has furnished two communications about a key clinical milestone for its oncology candidate lisaftoclax. On August 17, 2025, the company issued a press release announcing that a global registrational Phase III trial of lisaftoclax for the first-line treatment of patients with myelodysplastic syndrome was cleared by the US FDA and the European Medicines Agency (EMA). On August 18, 2025, it also published a voluntary announcement on the Hong Kong Stock Exchange describing a global registrational Phase III study of lisaftoclax for first-line treatment of higher-risk myelodysplastic syndrome (HR-MDS) cleared by the FDA and EMA.

Insights

Biotech equity analyst

Regulators cleared a global Phase III lisaftoclax study in first-line HR-MDS.

Ascentage Pharma highlights that a global registrational Phase III trial of lisaftoclax for first-line treatment of myelodysplastic syndrome has been cleared by both the US FDA and EMA. A registrational Phase III study is typically designed to provide the pivotal data needed to support a potential marketing application if results are favorable.

The communications also specify the target population as higher-risk myelodysplastic syndrome in the voluntary announcement, which is a serious hematologic condition with limited treatment options. Dual clearance from the FDA and EMA for the same global Phase III protocol may streamline development by aligning requirements across major regulatory regions.

The actual impact for investors will depend on the design details, enrollment progress, and eventual trial outcomes, which are referenced only through the attached press release and announcement. Subsequent disclosures about study initiation, interim analyses, or top-line results would further clarify lisaftoclax’s prospects in first-line HR-MDS.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

For the month of August 2025

Commission File Number: 002-023311

ASCENTAGE PHARMA GROUP INTERNATIONAL

(Translation of Registrant’s name into English)

68 Xinqing Road

Suzhou Industrial Park

Suzhou, Jiangsu

China

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒     Form 40-F ☐

On August 17, 2025, Ascentage Pharma Group International issued a press release entitled, “Ascentage Pharma Announces Global Registrational Phase III Trial of Lisaftoclax for the First-Line Treatment of Patients with Myelodysplastic Syndrome Cleared by US FDA and EMA”. A copy of the press release is furnished as Exhibit 99.1 to this Report. In addition, on August 18, 2025, Ascentage Pharma Group International issued a voluntary announcement on the Hong Kong Stock Exchange entitled, “Global Registrational Phase III Study of Lisaftoclax for First-Line Treatment of HR-MDS Cleared by FDA and EMA”. A copy of the announcement is furnished as Exhibit 99.2 to this Report.

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INDEX TO EXHIBITS

Exhibit Number		Exhibit Title
99.1		Press release dated August 17, 2025
99.2		Voluntary Announcement dated August 18, 2025

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	ASCENTAGE PHARMA GROUP INTERNATIONAL
Date: August 18, 2025	/s/ Dajun Yang
	Name:	Dajun Yang
	Title:	Chief Executive Officer

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FAQ

What did Ascentage Pharma (AAPG) disclose in this Form 6-K?

Ascentage Pharma disclosed that it furnished a press release and a Hong Kong Stock Exchange voluntary announcement about a global registrational Phase III trial of lisaftoclax for first-line treatment of myelodysplastic syndrome, which has been cleared by the US FDA and EMA.

What is the focus of Ascentage Pharma’s new lisaftoclax Phase III trial?

The trial is described as a global registrational Phase III study of lisaftoclax for the first-line treatment of patients with myelodysplastic syndrome, with the voluntary announcement specifying higher-risk MDS (HR-MDS).

Which regulators cleared Ascentage Pharma’s Phase III lisaftoclax study?

The Form 6-K states that the global registrational Phase III trial of lisaftoclax for first-line treatment of myelodysplastic syndrome was cleared by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

When did Ascentage Pharma (AAPG) issue its lisaftoclax announcements?

Ascentage Pharma issued a press release on August 17, 2025 and a voluntary announcement on the Hong Kong Stock Exchange on August 18, 2025, both concerning the global Phase III lisaftoclax study.

Where can investors find details of Ascentage Pharma’s lisaftoclax Phase III trial?

Details are provided in the documents furnished as Exhibit 99.1 (press release dated August 17, 2025) and Exhibit 99.2 (voluntary announcement dated August 18, 2025) to the Form 6-K.

Does the Form 6-K itself include clinical data for lisaftoclax?

The Form 6-K mainly notes the existence of a global registrational Phase III trial of lisaftoclax cleared by the FDA and EMA and furnishes related announcements; clinical data, if any, would be contained in the attached exhibits.