This section highlights FDA-related milestones and regulatory updates for drugs developed by Ascentage Pharma Group International (AAPG).
Over the past two years, Ascentage Pharma Group International has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
lisaftoclax and Olverembatinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
lisaftoclax - FDA Regulatory Timeline and Events
lisaftoclax is a drug developed by Ascentage Pharma Group International for the following indication: In Venetoclax-Refractory Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- lisaftoclax
- Announced Date:
- July 10, 2025
- Indication:
- In Venetoclax-Refractory Patients
Announcement
Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has been approved by China's National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton's tyrosine kinase (BTK) inhibitors, which makes lisaftoclax the first Bcl-2 inhibitor receiving conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally.
AI Summary
Ascentage Pharma announced that its novel Bcl-2 selective inhibitor lisaftoclax (APG-2575) has received conditional approval from China’s National Medical Products Administration (NMPA). The approval is for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously undergone at least one systemic therapy, including treatment with Bruton's tyrosine kinase (BTK) inhibitors. This marks a significant milestone as lisaftoclax becomes the first Bcl-2 inhibitor to achieve conditional approval and marketing authorization for CLL/SLL in China. Globally, it is only the second Bcl-2 inhibitor approved for this patient group. This development is an important step for Ascentage Pharma, highlighting its commitment to addressing unmet medical needs with innovative therapies, and reinforces the company’s expanding role in the global biopharmaceutical landscape.
Read Announcement- Drug:
- lisaftoclax
- Announced Date:
- May 22, 2025
- Indication:
- In Venetoclax-Refractory Patients
Announcement
Ascentage Pharma announced that new clinical data from two ongoing investigational studies evaluating lisaftoclax in various blood cancers and alrizomadlin in solid tumors will be presented during an oral presentation and poster presentation, respectively, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 - June 3 in Chicago, Ill., USA.
AI Summary
Ascentage Pharma has announced that new clinical data for its investigational drugs will be featured at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Ill., from May 30 to June 3. The company will present data on two key studies: an oral presentation on lisaftoclax in various blood cancers and a poster presentation on alrizomadlin in solid tumors. Lisaftoclax, a novel Bcl-2 inhibitor, has shown promising antitumor activity when combined with azacitidine in patients with myeloid malignancies, including those who have previously been treated with venetoclax. Alrizomadlin, an MDM2-p53 inhibitor, also demonstrated encouraging activity in different solid tumor types. These presentations support the further clinical development of both drugs, highlighting their potential to address critical treatment gaps in cancer care.
Read Announcement
Olverembatinib - FDA Regulatory Timeline and Events
Olverembatinib is a drug developed by Ascentage Pharma Group International for the following indication: Chronic Myeloid Leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Olverembatinib
- Announced Date:
- March 5, 2025
- Indication:
- Chronic Myeloid Leukemia
Announcement
Ascentage Pharma
AI Summary
Ascentage Pharma, a global biopharmaceutical company, announced that its drug olverembatinib has been granted a Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration through its Center for Drug Evaluation. This designation is for olverembatinib used in combination with low-intensity chemotherapy for the first-line treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
The BTD highlights the promise of olverembatinib in treating Ph+ ALL—a condition where patients historically have had poor survival outcomes with standard chemotherapy. This status helps speed up communications with regulators and could potentially lead to priority reviews and faster approvals. Ascentage Pharma is committed to advancing this clinical program to address the unmet needs of patients suffering from this challenging blood cancer.
Read Announcement
