Ascentage Pharma Announces Inclusion of Lisaftoclax in China's 2026 National Reimbursement Drug List and Successful Renewal of Coverage for Olverembatinib

Rhea-AI Summary

Ascentage Pharma (NASDAQ: AAPG) secured first-time Chinese national reimbursement coverage for lisaftoclax and renewed coverage for olverembatinib, effective January 1, 2027.

The 2026 National Reimbursement Drug List covers lisaftoclax for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with at least one systemic therapy including a BTK inhibitor. Olverembatinib coverage continues for adults with chronic-phase chronic myeloid leukemia resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors, and adults with chronic- or accelerated-phase disease carrying the T315I mutation. All approved indications for both drugs are now covered. The company expects lisaftoclax's inclusion to improve treatment access in China.

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Positive

• Moderate pointLisaftoclax gained first-time NRDL coverage for previously treated adult CLL/SLL, including prior BTK inhibitor therapy.
• Moderate pointOlverembatinib renewed NRDL coverage for both approved chronic myeloid leukemia indications through renegotiation.

Negative

• None.

Key Figures

NRDL effective date: January 1, 2027 Prior-treatment threshold: At least one systemic therapy

NRDL effective date

January 1, 2027

Updated NRDL takes effect

Prior-treatment threshold

At least one systemic therapy

Lisaftoclax eligibility for adult patients with CLL/SLL

Key Terms

nrdl, btk inhibitor, bcl-2 selective inhibitor, apoptosis, +1 more

5 terms

nrdl regulatory

"covered by China's 2026 National Reimbursement Drug List (NRDL)"

A national reimbursement drug list is an official roster of medicines that a country’s public health insurance will pay for, either fully or partially. For investors, inclusion means a drug can reach many more patients at lower out‑of‑pocket cost, often boosting sales and predictability—think of it as a product being accepted by a large wholesale buyer, which can make revenue more reliable and impact a company’s valuation.

btk inhibitor medical

"including a Bruton’s tyrosine kinase (BTK) inhibitor"

A BTK inhibitor is a drug that blocks Bruton's tyrosine kinase, a protein that helps certain immune cells grow and communicate; by interrupting that signal it can reduce harmful immune activity or slow the growth of some blood cancers. For investors, BTK inhibitors matter because their clinical trial results, regulatory approvals, and market uptake can drive large, recurring sales or create competitive advantages for drugmakers, while failures or safety issues can sharply reduce a developer’s value—think of the drug as a targeted tool that can make or break a biotech’s prospects.

bcl-2 selective inhibitor medical

"a novel, oral, Bcl-2 selective inhibitor"

A BCL-2 selective inhibitor is a drug that binds to and blocks the activity of the BCL-2 protein, a member of the BCL-2 family that helps cells avoid programmed cell death (apoptosis). By inhibiting BCL-2, these drugs restore the cell’s ability to undergo apoptosis, a mechanism exploited mainly in treating certain cancers; “selective” indicates the drug preferentially targets BCL-2 over related anti‑apoptotic proteins (for example BCL‑XL or MCL‑1), which affects both its therapeutic effects and its side‑effect profile (different selectivity patterns can alter toxicity and resistance risks).

apoptosis medical

"restoring the normal apoptosis process in cancer cells"

Apoptosis is a controlled, built‑in process where cells deliberately shut down and are safely removed, like a person retiring and clearing out their belongings so the house stays orderly. Investors care because many drugs and diagnostics target or measure this process: how well a therapy triggers or avoids apoptosis can determine clinical trial success, safety profiles, regulatory approval, and ultimately a company’s valuation.

bcr-abl inhibitor medical

"a novel, oral, third-generation BCR-ABL inhibitor"

A BCR-ABL inhibitor is a drug that blocks the abnormal BCR-ABL protein, a continuously active tyrosine kinase produced by a specific gene fusion. By binding to and inhibiting that kinase’s activity, these drugs stop the signal that drives uncontrolled growth of certain leukemia cells; different inhibitors vary in how tightly they bind and which resistance-causing mutations they still block.

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ROCKVILLE, Md., Nov. 15, 2026 (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, today announced that its two core assets are covered by China's 2026 National Reimbursement Drug List (NRDL), providing more patients with greater access to innovative treatment options. Specifically:

• Lisaftoclax has been included in the 2026 NRDL for the first time 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 a Bruton’s tyrosine kinase (BTK) inhibitor.
• Olverembatinib has successfully renewed its NRDL coverage through renegotiation for the treatment of (1) adult patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors (TKIs); and (2) adult patients with CML-CP or accelerated phase (CML-AP) harboring the T315I mutation.
  
  

With these developments, all approved indications for both of Ascentage Pharma's novel drugs are now covered by the NRDL. The updated NRDL will officially take effect on January 1, 2027.

Lisaftoclax is a novel, oral, Bcl-2 selective inhibitor independently developed by Ascentage Pharma to treat patients with malignancies by selectively blocking the anti-apoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. Approved in China in July 2025, lisaftoclax became the first domestically developed, original Bcl-2 inhibitor to receive marketing approval in the country. Its inclusion in the updated NRDL is expected to significantly improve treatment accessibility for patients with CLL/SLL in China, enabling more patients to gain timely access to new treatment options.

Olverembatinib is a novel, oral, third-generation BCR-ABL inhibitor independently developed by Ascentage Pharma, with support from China's National Major New Drug Innovation Program. It is jointly commercialized in China by Ascentage Pharma and Innovent Biologics. Approved in China in November 2021, olverembatinib became the first third-generation BCR-ABL inhibitor to receive marketing approval in the country. The successful renewal of its NRDL coverage will continue to benefit more patients with CML in China by further improving the affordability and accessibility of long-term treatment.

Dr. Dajun Yang, Chairman and Chief Executive Officer of Ascentage Pharma, commented: "The successful inclusion of lisaftoclax in the NRDL and the renewal of olverembatinib’s coverage mark that all approved indications of Ascentage Pharma’s two core assets are now covered by the NRDL. For patients, it means greater access to innovative treatment options; for the company, it provides a solid basis for commercialization and sustained innovation; and for the industry, it demonstrates that China's national reimbursement system supports domestically developed innovative drugs and further recognizes their value, boosting confidence across the pharmaceutical industry to continuously advance original innovation.”

Olverembatinib and lisaftoclax 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 include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders.

The Company’s first approved product, 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 and/or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3.

The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax 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. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- 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 AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS.

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/.

Cautionary Note Regarding 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 “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks 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 where the Company’s ordinary shares are listed it has made or it makes 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.

Contact Information

Investor Relations:

Ascentage Pharma
IR@ascentage.com
+1 (301) 792-6286

astr partners
brian.korb@astrpartners.com
+1 (917) 653-5122

FAQ

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When does Ascentage Pharma's new Chinese reimbursement coverage take effect?

The updated National Reimbursement Drug List takes effect on January 1, 2027, adding lisaftoclax and renewing olverembatinib coverage. All approved indications for both drugs are covered.

Who commercializes Ascentage Pharma's olverembatinib in China?

Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.