Ascentage Pharma's Lisaftoclax Trial Cleared by FDA & EMA
Ticker: AAPG · Form: 6-K · Filed: Aug 18, 2025 · CIK: 2023311
Sentiment: bullish
Topics: regulatory-approval, clinical-trial, pharmaceuticals
TL;DR
FDA & EMA greenlight Ascentage's Phase III lisaftoclax trial for MDS.
AI Summary
Ascentage Pharma Group International announced on August 17, 2025, that the US FDA and EMA have cleared their global registrational Phase III trial for lisaftoclax. This trial will evaluate lisaftoclax as a first-line treatment for patients diagnosed with myelodysplastic syndrome.
Why It Matters
This clearance allows Ascentage Pharma to proceed with a crucial Phase III trial, potentially bringing a new first-line treatment option to patients with myelodysplastic syndrome.
Risk Assessment
Risk Level: medium — Regulatory approvals and trial success are inherently uncertain, and the outcome of this Phase III trial will significantly impact the company's future.
Key Players & Entities
- Ascentage Pharma Group International (company) — Registrant
- Lisaftoclax (drug) — Investigational drug
- US FDA (company) — Regulatory agency
- EMA (company) — Regulatory agency
- Myelodysplastic Syndrome (medical_condition) — Indication for treatment
FAQ
What is the specific indication for the Phase III trial of lisaftoclax?
The Phase III trial will evaluate lisaftoclax as a first-line treatment for patients with myelodysplastic syndrome.
Which regulatory bodies have cleared the Phase III trial?
The US FDA and the EMA have cleared the global registrational Phase III trial.
When was the press release announcing the clearance issued?
The press release was issued on August 17, 2025.
What is the company's full name and ticker symbol?
The company's full name is Ascentage Pharma Group International. The ticker symbol is not provided in this excerpt.
What is the address of Ascentage Pharma's principal executive offices?
The address is 68 Xinqing Road, Suzhou Industrial Park, Suzhou, Jiangsu, China.
Filing Stats: 268 words · 1 min read · ~1 pages · Grade level 13.3 · Accepted 2025-08-18 07:17:35
Filing Documents
- ea0253650-6k_ascentage.htm (6-K) — 12KB
- ea025365001ex99-1_ascentage.htm (EX-99.1) — 28KB
- ea025365001ex99-2_ascentage.htm (EX-99.2) — 19KB
- ex99-1_001.jpg (GRAPHIC) — 3KB
- ex99-2_001.jpg (GRAPHIC) — 5KB
- 0001213900-25-077704.txt ( ) — 72KB
From the Filing
OF FOREIGN PRIVATE ISSUER 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. 1 INDEX TO EXHIBITS Exhibit Number Exhibit Title 99.1 Press release dated August 17, 2025 99.2 Voluntary Announcement dated August 18, 2025 2 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 3