Ascentage Pharma Announces Global Registrational Phase III Study of Olverembatinib in First-Line Treatment of Ph+ ALL Cleared by US FDA and EMA
Rhea-AI Summary
Ascentage Pharma (NASDAQ: AAPG) announced that the US FDA and the EMA cleared a global registrational Phase III study (POLARIS-1; NCT06051409) of olverembatinib plus chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
The POLARIS-1 trial is a randomized, open-label, global study already initiated in China after CDE clearance in 2023 and is simultaneously enrolling across multiple countries to accelerate registration in the US and Europe. An ASH 2025 abstract reported ~65% MRD-negativity and molecular MRD-negative CR rates after three cycles and described a favorable safety profile. Olverembatinib is China-approved for drug-resistant CML, covered by the China NRDL, and is subject to an exclusive option agreement with Takeda (June 14, 2024). The drug is not yet FDA-approved in the US.
Positive
- FDA and EMA clearance for global Phase III POLARIS-1
- ASH 2025: MRD-negative rate ~65% after three cycles
- Olverembatinib approved in China and listed on NRDL
- Global simultaneous enrollment to accelerate US/EU registration
Negative
- Olverembatinib is not yet FDA-approved in the US
- First registrational dataset pending public release at ASH 2025
Key Figures
Market Reality Check
Peers on Argus
Peers show mixed moves: ACAD up 3.97%, MIRM up 1.51%, ARWR modestly positive, while ZLAB and ACLX are down, indicating stock-specific rather than sector-wide drivers.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 24 | Clinical data publication | Positive | +1.1% | Phase Ib olverembatinib GIST data with durable PFS and high CBR. |
| Nov 19 | Investor conferences | Neutral | +0.6% | Planned participation in three December investor conferences. |
| Nov 03 | ASH lisaftoclax data | Positive | -3.1% | Registrational Phase II lisaftoclax data in CLL/SLL for ASH 2025. |
| Nov 03 | ASH olverembatinib data | Positive | -3.1% | Multiple olverembatinib datasets including first POLARIS-1 results. |
| Oct 29 | Investor conferences | Neutral | -2.0% | Announcements of participation in two November healthcare conferences. |
Clinically focused news has often been positive in tone, with share reactions frequently diverging, especially around conference and data updates.
Over the last months, Ascentage has highlighted multiple clinical milestones for olverembatinib, lisaftoclax, and alrizomadlin. Notable events include publication of Phase Ib olverembatinib data in SDH-deficient GIST on Nov 24, 2025, repeated ASH 2025 and ASCO 2025 data presentations, and clearance of a global Phase III lisaftoclax trial in HR-MDS on Aug 17, 2025. Price reactions ranged from about -3.82% to +10.03%, showing that positive data have not always translated into immediate share gains.
Market Pulse Summary
This announcement details FDA and EMA clearance of a global registrational Phase III study of olverembatinib in first-line Ph+ ALL, supported by early data showing MRD-negative and complete response rates around 65%. Prior clinical milestones across the pipeline have produced varied share reactions, emphasizing execution and durability of results. Investors may watch upcoming ASH 2025 data, future regulatory interactions, and additional safety and efficacy readouts to gauge the long-term impact.
Key Terms
complete response medical
open-label medical
AI-generated analysis. Not financial advice.
ROCKVILLE, Md. and SUZHOU, China, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct a global registrational Phase III study (POLARIS-1; NCT06051409) of its compound under investigation, olverembatinib, in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). As the second global registrational Phase III study of olverembatinib that has been cleared by regulators in the US and Europe, the POLARIS-1 study is simultaneously enrolling patients across trial centers in multiple countries in order to accelerate olverembatinib’s path to registration worldwide, particularly in the US and European markets.
The POLARIS-1 trial is a global, multicenter, randomized controlled, open-label Phase III study designed to evaluate the efficacy and safety of olverembatinib in combination with chemotherapy in newly diagnosed patients with Ph+ ALL. The POLARIS-1 study was also initiated in China after it was cleared by the China Center for Drug Evaluation (CDE) in 2023.
The POLARIS-1 study is set to release its first dataset at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting. Data disclosed in the ASH 2025 abstract showed that among treatment-naïve patients with Ph+ ALL who received olverembatinib in combination with low-intensity chemotherapy, the minimal residual disease (MRD) negativity rate and the molecular MRD-negative complete response (CR) rate at the end of three treatment cycles both reached approximately
Accounting for
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, “Clearances from the U.S. FDA and the EMA for this global registrational Phase III study mark a significant step forward in the global development of olverembatinib in Ph+ ALL. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will press ahead with the clinical development of olverembatinib in Ph+ ALL and strive to bring a new treatment option to patients around the world as soon as possible.”
Developed by Ascentage Pharma, olverembatinib is an orally administered, third-generation TKI and the first China-approved third-generation BCR-ABL inhibitor, currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. Olverembatinib has already been approved in China in multiple indications in drug-resistant chronic myeloid leukemia (CML) and all of the approved indications are now covered by the China National Reimbursement Drug List (NRDL). Being developed for the treatment of Ph+ ALL, olverembatinib has received consecutive recommendations in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and a Breakthrough Therapy Designation by the China CDE.
On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.
* Olverembatinib is currently under investigation and has not yet been approved by the FDA in the US.
About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that includes inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, as well as next-generation kinase inhibitors.
The lead asset, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All indications are covered by the China National Reimbursement Drug List (NRDL). The Company is currently conducting a US FDA-cleared, global registrational Phase III trial, or POLARIS-2, of olverembatinib for CML, as well as global registrational Phase III trials for patients with newly diagnosed Ph+ ALL and SDH-deficient GIST patients.
The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax is being commercialized in China following National Medical Products Administration (NMPA) approval 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. The Company is currently conducting four global registrational Phase III trials: the US FDA-cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with acute myeloid leukemia (AML); and the GLORA-4 study in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR MDS), a study that was simultaneously cleared by the US FDA, the EMA of the EU, and China CDE.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition.
These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Special note regarding forward-looking statements and industry data” in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed “Forward-looking Statements” and “Risk Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.
As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investor Relations:
Stella Yang
Ascentage Pharma
Stella.Yang@ascentage.com
+1 (301) 792-6286
Stephanie Carrington
ICR Healthcare
AscentageIR@icrhealthcare.com
+1 (646) 277-1282
Media Relations:
Sean Leous
ICR Healthcare
AscentagePR@icrhealthcare.com
+1 (646) 866-4012
FAQ
What did Ascentage Pharma announce on December 5, 2025 about olverembatinib (AAPG)?
What efficacy data did the ASH 2025 abstract report for olverembatinib in Ph+ ALL?
Is olverembatinib approved in China and covered by reimbursement?
What is the status of global commercialization rights for olverembatinib (AAPG)?
When will POLARIS-1 data be available for investors and clinicians?
How does FDA/EMA clearance affect FDA approval for olverembatinib in the US?
