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
Olverembatinib and lisaftoclax. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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 17, 2026
- Indication:
- Chronic Myeloid Leukemia
Announcement
Ascent announced that four abstracts highlighting the latest preclinical results from its pipeline programs have been selected for poster presentations at the American Association of Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026, in San Diego, CA, USA.
AI Summary
Ascentage Pharma announced that four preclinical abstracts from its pipeline have been accepted for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego. The company will present new preclinical results that advance its oncology research and engage the broader cancer research community at this major scientific meeting.
The data cover three investigational drug candidates: the BCR-ABL tyrosine kinase inhibitor olverembatinib (HQP1351), the FAK/ALK/ROS1 inhibitor APG-2449, and the PRC2/EED inhibitor APG-5918. Four abstracts (Nos. 4583, 5875, 1858, and 4500) are scheduled across poster sessions on experimental and molecular therapeutics, tyrosine kinase inhibitors, targeting drug resistance, and epigenetic modulators on April 20–21, 2026.
Ascentage notes these compounds are under investigation and have not been approved by the U.S. FDA. The presentations aim to share preclinical findings that could inform future clinical development.
Read Announcement- Drug:
- Olverembatinib
- Announced Date:
- December 8, 2025
- Indication:
- Chronic Myeloid Leukemia
Announcement
Ascentage Pharma Group International announced that it presented four year follow-up data from its randomized controlled, registrational Phase II study of Olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant/intolerant chronic-phase chronic myeloid leukemia (CML-CP), in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, Florida.
AI Summary
Ascentage Pharma presented four‑year follow‑up results from its randomized, registrational Phase II study of Olverembatinib in patients with TKI‑resistant or ‑intolerant chronic‑phase CML at the 67th ASH meeting in Orlando. The data showed strong, durable responses: patients who failed first‑line treatment with second‑generation TKIs achieved a 76.7% complete cytogenetic response (CCyR). Overall, CCyR and major molecular response (MMR) rates were high and continued to deepen with treatment, reaching about 60% MMR by 21 cycles, indicating increasingly deeper molecular control over time.
Safety findings were consistent with prior reports and showed no new signals. The company highlighted that these efficacy and tolerability results support evaluating Olverembatinib earlier in the treatment course for a broader CML‑CP population, offering a potential new option for patients who do not respond to or cannot tolerate existing TKIs.
Read Announcement- 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
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:
- December 7, 2025
- Indication:
- In Venetoclax-Refractory Patients
Announcement
Ascentage Pharma Group International announced that it presented the latest results from a Phase Ib/II study of Lisaftoclax (APG-2575), a key investigational drug candidate in the Company's pipeline, in combination with azacitidine (AZA) in patients with newly diagnosed or prior venetoclax–exposed myeloid malignancies in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, Florida.
AI Summary
Ascentage Pharma presented Phase Ib/II results for lisaftoclax (APG-2575) combined with azacitidine at the 67th ASH Annual Meeting in Orlando. The poster summarized data from 103 patients with newly diagnosed or prior venetoclax‑exposed myeloid malignancies, including AML, MPAL, CMML and higher‑risk MDS.
In 44 evaluable relapsed/refractory AML/MPAL patients the overall response rate (ORR) was 43.2% with a complete response (CR) rate of 31.8%. Among 22 venetoclax‑exposed relapsed/refractory patients the ORR was 31.8% and CR 22.7%, suggesting activity in venetoclax‑resistant disease. In 15 evaluable newly diagnosed high‑risk MDS/CMML patients the ORR was 80%, with 40% CR and 40% marrow CR. Median overall survival was 7.6 months for relapsed/refractory AML/MPAL and 11.3 months for relapsed/refractory HR MDS/CMML; median OS was 6.3 months in newly diagnosed AML and not reached in newly diagnosed HR MDS/CMML.
No dose‑limiting toxicities were reported across cohorts. Common grade ≥3 adverse events included neutropenia (41.7%), febrile neutropenia (35.0%), thrombocytopenia (26.2%) and anemia (17.5%). Investigators concluded the combination appears promising for overcoming venetoclax resistance and warrants further study.
Read Announcement- Drug:
- lisaftoclax
- Announced Date:
- December 6, 2025
- Indication:
- In Venetoclax-Refractory Patients
Announcement
Ascentage Pharma Group International Inc. announced that it has presented an oral report featuring the latest results from a registrational Phase II study conducted in China of Lisaftoclax (APG-2575), a key drug candidate in the Company‘s pipeline, as a monotherapy in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had failed Bruton's tyrosine kinase inhibitors (BTKis), at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, FL.
AI Summary
Ascentage Pharma Group International reported that it presented an oral report at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando on the latest results from a registrational Phase II study in China of Lisaftoclax (APG‑2575). The study evaluated Lisaftoclax as a single agent in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who had progressed after treatment with Bruton’s tyrosine kinase inhibitors (BTKis). The oral presentation highlighted this program as a key element of the company’s pipeline and underscored the clinical focus on patients with limited treatment options after BTKi failure.
Lisaftoclax is an oral, selective Bcl‑2 inhibitor designed to restore programmed cell death in cancer cells. By presenting registrational Phase II data at a major hematology meeting, Ascentage emphasized the drug’s potential clinical value in BTKi‑refractory CLL/SLL and the company’s continued development efforts to bring new options to these patients.Read Announcement
- Drug:
- lisaftoclax
- Announced Date:
- August 17, 2025
- Indication:
- In Venetoclax-Refractory Patients
Announcement
Ascentage Pharma announced that it has received clearance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, in combination with azacitidine (AZA), for the treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
AI Summary
Ascentage Pharma has received clearance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct GLORA-4 (NCT06641414), a global registrational Phase III study of lisaftoclax (APG-2575), a proprietary Bcl-2 inhibitor, combined with azacitidine (AZA) for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS).
GLORA-4 is a multi-center, randomized, double-blind trial comparing lisaftoclax plus AZA against placebo plus AZA in adult patients with HR-MDS to assess safety and efficacy.
The study is enrolling participants simultaneously in China, the U.S., and Europe to accelerate clinical development and potential market approval.
If positive, lisaftoclax could become the first Bcl-2 inhibitor approved worldwide for first-line treatment of HR-MDS, filling a long-standing treatment gap.
Higher-risk MDS mainly affects older adults and has few effective options. By targeting Bcl-2, lisaftoclax aims to restore normal cell death in cancer cells and improve outcomes.
Read Announcement- 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
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