ASH 2025 | Ascentage Pharma Presents First Dataset from Phase III POLARIS-1 Study of Olverembatinib in Newly Diagnosed Ph+ ALL Shows a Best MRD-Negativity CR Rate Exceeding 60%

Rhea-AI Summary

Ascentage Pharma (NASDAQ:AAPG) presented first dataset from the global registrational Phase III POLARIS-1 study of olverembatinib plus low-intensity chemotherapy in newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) at ASH 2025.

Key results (as of July 18, 2025): among 53 efficacy-evaluable patients, 50 (94.3%) achieved CR/CRi; best MRD negativity 66.0% and MRD-negative CR 64.2% by end of three induction cycles. IKZF1plus subgroup showed 90% molecular response (9/10). Common grade ≥3 TEAEs included neutropenia 63.6%, thrombocytopenia 56.4%, and pneumonia 30.9%. POLARIS-1 was cleared by FDA and EMA; an option agreement with Takeda is in place for ex-China rights.

Positive

• CR/CRi rate 94.3% (50/53 patients)
• Best MRD negativity 66.0% by end of 3 induction cycles
• MRD-negative CR 64.2% by end of induction
• IKZF1plus molecular response 90% (9/10 patients)
• POLARIS-1 cleared by FDA and EMA

Negative

• Grade ≥3 neutropenia 63.6%
• Grade ≥3 thrombocytopenia 56.4%
• Grade ≥3 pneumonia 30.9%
• Small efficacy cohort of 53 efficacy-evaluable patients limits generalizability

Key Figures

Best MRD negativity rate 66.0% By end of 3 induction cycles in POLARIS-1

MRD-negative CR rate 64.2% By end of 3 induction cycles in POLARIS-1

Molecular response in IKZF1plus 90% High-risk IKZF1plus patients at end of induction (9/10)

Efficacy-evaluable patients 53 patients Patients included in POLARIS-1 efficacy analysis

CR/CRi rate 94.3% (50/53) CR or CR with incomplete hematologic recovery by end of induction

High-risk genotype patients 10 patients Patients with IKZF1plus genotype in POLARIS-1

Grade ≥3 neutropenia 63.6% Common treatment-emergent adverse event with combination regimen

Grade ≥3 thrombocytopenia 56.4% Common treatment-emergent adverse event with combination regimen

Market Reality Check

$31.31 Last Close

Volume Volume 3,055 is below 20-day average 4,633 (relative volume 0.66). low

Technical Price 31.31 is below 200-day MA 31.79, 35.38% under 52-week high 48.45, and 84.18% above 52-week low 17.00.

Peers on Argus

AAPG fell 4.77% while biotech peers were mixed: MIRM (-1.22%), ZLAB (-0.94%), ACAD (-3.29%), ACLX (-1.16%), ARWR (+2.25%). No peers appeared in the momentum scanner, pointing to a stock-specific move rather than a broad sector rotation.

Common Catalyst Several peers also issued clinical trial and acquisition updates, but no single shared catalyst explains AAPG’s move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Phase III clearance	Positive	+1.1%	FDA and EMA cleared global Phase III POLARIS-1 trial with encouraging early data.
Nov 24	Phase Ib GIST data	Positive	+1.1%	Published olverembatinib Phase Ib data in SDH-deficient GIST with durable responses.
Nov 19	Investor conferences	Neutral	+0.6%	Announced participation in three December 2025 investor conferences for corporate updates.
Nov 03	ASH lisaftoclax data	Positive	-3.1%	Announced ASH 2025 lisaftoclax presentations with registrational Phase II data in CLL/SLL.
Nov 03	ASH olverembatinib data	Positive	-3.1%	Flagged upcoming ASH 2025 presentations including first POLARIS-1 dataset with 64.2% MRD-negative CR.

Pattern Detected

Clinical and regulatory trial updates have often produced positive 24h moves, but major conference-related datasets have sometimes coincided with short-term selloffs.

Recent Company History

Over the past six months, AAPG has repeatedly highlighted progress across its oncology pipeline. On Dec 4, 2025, regulators cleared the global Phase III POLARIS-1 study of olverembatinib in Ph+ ALL, with an abstract citing roughly 65% MRD-negative responses and favorable safety. Prior updates showcased Phase Ib activity in SDH-deficient GIST with 23.1% ORR and 25.7-month median PFS, multiple ASH 2025 and ASCO 2025 presentations for lisaftoclax and alrizomadlin, and strong response rates across hematologic and solid tumors. Today’s detailed POLARIS-1 dataset fits this pattern of data-rich clinical communication.

Market Pulse Summary

This announcement details the first Phase III POLARIS-1 dataset for olverembatinib in newly diagnosed Ph+ ALL, showing best MRD negativity and MRD‑negative CR rates above 60% with a defined safety profile. High‑risk IKZF1plus patients achieved a 90% molecular response rate, reinforcing the drug’s potential in difficult disease subsets. In context of prior ASH and ASCO data across the pipeline, this expands evidence for olverembatinib’s activity. Investors may focus on longer‑term outcomes, regulatory milestones, and how these results compare with existing Ph+ ALL standards.

Key Terms

minimal residual disease medical

"the best minimal residual disease (MRD) negativity rate and the MRD-negative"

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

complete response medical

"MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively"

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

tyrosine kinase inhibitor medical

"adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase"

A tyrosine kinase inhibitor is a type of drug that blocks specific proteins in cells that act like on/off switches for growth and survival signals, often used to stop cancer cells from multiplying. For investors, these drugs matter because their clinical trial results, regulatory approvals, safety profiles, and patent status drive sales potential and company valuation—think of them as precision tools whose effectiveness and market exclusivity determine commercial success.

treatment-emergent adverse events medical

"grade ≥ 3 treatment-emergent adverse events (TEAEs) were neutropenia"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

neutropenia medical

"treatment-emergent adverse events (TEAEs) were neutropenia (63.6%), thrombocytopenia"

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

thrombocytopenia medical

"TEAEs were neutropenia (63.6%), thrombocytopenia (56.4%), leukopenia"

Thrombocytopenia is a medical condition marked by an abnormally low number of platelets, the blood cells that act like a patching crew to stop bleeding. It matters to investors because it can signal safety risks for drugs or procedures, affect clinical trial outcomes, trigger regulatory scrutiny, lead to additional costs or label changes, and influence a company’s stock if treatments must be halted or modified.

AI-generated analysis. Not financial advice.

• By the end of 3 induction cycles, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively
• High-risk IKZF1^plus patients showed 90% molecular response rate
• Low-intensity chemotherapy combination achieved deep responses with favorable safety profile
  

ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 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 presented the first dataset from the global registrational Phase III study (POLARIS-1) of the company’s novel, investigational drug, Olverembatinib (HQP1351), in combination with low-intensity chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL), in a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting, being held in Orlando, Florida.

The ASH Annual Meeting is one of the largest gatherings of the international hematology community, aggregating cutting-edge scientific research and the latest data on investigational therapies that represent leading scientific and clinical advances in the global hematology field. Once again, Ascentage Pharma’s innovative pipeline has garnered significant attention at this year’s conference. Results from multiple clinical and preclinical studies on three of Ascentage Pharma’s investigational drug candidates (Olverembatinib, Lisaftoclax, and APG-5918) have been selected for presentation, including an oral report, at this year’s ASH Annual Meeting.

This poster presentation on the registrational Phase III POLARIS-1 study highlighted the promising therapeutic potential of Olverembatinib in Ph⁺ ALL. The data showed that, for the treatment of newly diagnosed patients who received Olverembatinib in combination with low-intensity chemotherapy, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate by the end of 3 induction cycles were 66.0% and 64.2%, respectively, alongside a favorable safety profile.

Olverembatinib is a novel drug developed by Ascentage Pharma and represents the first third-generation BCR-ABL inhibitor approved in China. Olverembatinib is currently being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. The drug is currently approved in China for: adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first- and second-generation TKIs, with all approved indications now covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting three global registrational Phase III studies to evaluate Olverembatinib in multiple indications, including CML-CP, Ph⁺ ALL, and succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors. Notably, the POLARIS-1 study was recently cleared by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), marking another major milestone in the global development of olverembatinib. Ascentage Pharma has 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.

Professor Suning Chen, presenter of this study from the Department of Hematology, The First Affiliated Hospital of Soochow University, commented, “Olverembatinib is emerging as a cornerstone in investigational combination chemotherapy regimens for patients with Ph⁺ ALL. It achieved both deep responses and low toxicity and therefore having the potential to bring a long-awaited new treatment to this indication. At this year’s ASH Annual Meeting, we presented data from the first part of the POLARIS-1 study that showed deep MRD-negative responses in more than 60% of previously untreated patients with Ph⁺ ALL who received Olverembatinib in combination with low-intensity chemotherapy, at the end of three induction cycles . These encouraging results validate Olverembatinib’s global potential for reshaping the therapeutic landscape for Ph⁺ ALL.”

Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, said, “At ASH 2025, we presented the first dataset from the POLARIS-1 study that positioned Olverembatinib as a highly promising potential new treatment option for patients with Ph⁺ ALL. Supported by the favorable clinical benefit and tolerability that Olverembatinib demonstrated in Ph⁺ ALL, the POLARIS-1trial was recently cleared by FDA and EMA. We are optimistic that Olverembatinib-based innovative regimens will bring a new paradigm to the treatment of Ph⁺ ALL. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will strive to accelerate our clinical programs to bring more safe and effective therapies to patients as soon as possible.”

Highlights of the data this study reported at ASH 2025 are as below:

Results of POLARIS-1, a global phase 3 study (Part A): olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Philadelphia chromosome-positive (Ph⁺) acute lymphoblastic leukemia (ALL)
Format: Poster Presentation
Abstract#: 1574
Session: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Poster I
Time: Saturday, December 6, 2025; 5:30 PM – 7:30 PM EST
First Author: Professor Suning Chen, Ph.D. Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China
Presenter: Professor Suning Chen, Ph.D., Department of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, China
Highlights:
Background:
Ph⁺ ALL, the most common genetic subtype of adult ALL, is associated with high relapse risk and poor outcomes. Ph⁺ ALL is increasingly being managed with targeted therapies. Olverembatinib is a third-generation TKI with potent inhibitory activity against wild-type and mutant BCR-ABL1.

Introduction:
POLARIS-1 (NCT06051409) is a global registrational Phase III study designed to evaluate the efficacy and safety of olverembatinib combined with low-intensity chemotherapy in patients with newly diagnosed (ND) Ph⁺ ALL. The primary endpoint of the study was MRD (BCR-ABL/ABL1 ≤ 0.01% by qPCR) negativity rate by the end of three induction cycles.

Efficacy Results:

• As of July 18, 2025, among 53 efficacy‑evaluable patients, 50 (94.3%) achieved a CR or CR with incomplete hematologic recovery by the end of induction therapy. The best MRD negativity and MRD-negative CR rates were 66.0% and 64.2%, respectively.
• IKZF1^plus (particularly with concurrent BTG1 deletion) is a widely recognized high-risk factor associated with poor prognoses in B-cell ALL (B-ALL) because it can often cause resistance to chemotherapies and a high propensity to relapse. Among the 10 patients in this study who had this genotype, the molecular response rate at the end of the induction therapy was 90% (9/10).

Safety Results: Olverembatinib in combination with low-dose chemotherapy was well tolerated. Common (incidence >15%) grade ≥ 3 treatment-emergent adverse events (TEAEs) were neutropenia (63.6%), thrombocytopenia (56.4%), leukopenia (54.5%), anemia (49.1%), pneumonia (30.9%), hypokalemia (20%), and abnormal hepatic function (16.4%).

Conclusion:
In patients with ND Ph⁺ ALL, olverembatinib in combination with chemotherapy demonstrated an MRD-negative CR rate of 64.2% by the end of the induction therapy and a favorable safety profile.

*Olverembatinib, Lisaftoclax, and APG-5918 are currently under investigation and have not yet been approved by the US FDA.

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 an 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 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 U.S. 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 were the MRD results for Ascentage Pharma's POLARIS-1 study (AAPG) presented at ASH 2025?

By the end of three induction cycles the study reported best MRD negativity 66.0% and MRD-negative CR 64.2%.

How many patients achieved CR or CRi in the POLARIS-1 olverembatinib trial (AAPG)?

50 of 53 efficacy-evaluable patients achieved CR or CRi (94.3%) as of July 18, 2025.

What safety signals were reported for olverembatinib plus low-intensity chemotherapy in Ph+ ALL (AAPG)?

Common grade ≥3 TEAEs included neutropenia 63.6%, thrombocytopenia 56.4%, and pneumonia 30.9%.

Did regulators clear the POLARIS-1 study for olverembatinib (AAPG)?

Yes; the POLARIS-1 trial was reported as cleared by the FDA and EMA for global development.

What were the POLARIS-1 results for high-risk IKZF1plus patients in AAPG's presentation?

Among 10 IKZF1plus patients the molecular response rate at end of induction was 90% (9/10).

What is Takeda's role with olverembatinib and how does it affect AAPG rights?

Ascentage has an exclusive option agreement with Takeda; if exercised, Takeda would license global rights outside specified Greater China territories.