ROCKVILLE,Md. andSUZHOU,China,Nov. 28,2024 -- Ascentage Pharma (6855.HK),a global biopharmaceutical company engaged in discovering,developing and commercializing therapies to address global unmet medical needs primarily for malignancies,today announced that the new indication - adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation tyrosine kinase inhibitors (TKIs) - of its novel drug,olverembatinib (HQP1351),has been included into the China 2024 National Reimbursement Drug List (NRDL),effective January 1,2025. This indication was added to the NRDL through the simple contract renewal process. The previously included indication of adult patients with CML-CP or accelerated-phase CML (CML-AP) harboring the T315I mutation will maintain its reimbursable status on the NRDL.

Olverembatinib is a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development Program in China and the first third-generation BCR-ABL inhibitor approved by the China National Medical Products Administration (NMPA). As a novel drug,olverembatinib can effectively target BCR-ABL and a spectrum of BCR-ABL mutants,including the T315I mutation. In November 2021,olverembatinib received its first approval in China,thus became the first therapy approved for the treatment of T315I mutant CML in the country. In November 2023,olverembatinib was approved for the treatment of adult patients with CML-CP resistant and/or intolerant of first-and second-generation TKIs. Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the management of CML. However,TKI resistance is still a global challenge for CML treatment. 20%-40% of patients fail to achieve desired treatment outcome due to resistance or intolerance to TKIs1-3,thus leading to disease progression or even death. The successful renewal and the inclusion of additional indication of olverembatinib in the NRDL is expected to greatly improve the drug's accessibility,bringing benefit to more and a broader population of patients with CML in China.

"We are glad that the new indication of olverembatinib has been included into the NRDL through the simple contract renewal process," said Dr. Dajun Yang,Chairman and CEO of Ascentage Pharma. "This decision reaffirms the importance of olverembatinib as an innovative drug that has the potential to fulfill the urgent unmet needs and treatment gaps in CML. With its new indication included into the NRDL at the third anniversary of the initial approval in China,olverembatinib is positioned to bring renewed hope to more patients with CML,thereby helping countless families and communities. Moving forward,we will work actively to ensure the rapid rollout of the expanded insurance coverage. We are confident these efforts will make olverembatinib more accessible and affordable,ultimately allowing more patients and their families to benefit from this novel therapeutic as soon as possible."

References

O'Brien SG,Guilhot F,Larson R,et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. Engl J Med. 2003 Mar 13;348(11):994-1004.

Jabbour E,Kantarjian H. Chronic myeloid leukemia: 2014 update on diagnosis,monitoring,and management. Am J Hematol. 2014 May;89(5):547-56.

Larson R,Hochhaus A,Hughes T,et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012 Oct;26(10):2197-203.

* Olverembatinib is an investigational drug that has not been approved for any indication outside China.

About Olverembatinib

Developed by Ascentage Pharma,the novel drug olverembatinib is an orally-available third-generation tyrosine kinase inhibitor (TKI),and the first China-approved third-generation BCR-ABL inhibitor that can effectively target BCR-ABL and a spectrum of BCR-ABL mutants,including the T315I mutation. Olverembatinib,developed with support from the National Major New Drug Development Program in China,has also been granted Priority Review designations and Breakthrough Therapy designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA).

At present,olverembatinib has been approved in China for the treatment of adult patients with 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 and/or intolerant of first-and second-generation TKIs.

In addition to CML,olverembatinib has also shown potential clinical benefits to patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). A global registrational Phase III study of olverembatinib in newly diagnosed patients with Ph+ ALL is currently underway,potentially paving the way for olverembatinib become the first China-approved TKI for the treatment of patients with Ph+ ALL in the first-line setting. In the area of solid tumors,olverembatinib is being evaluated in a global registrational Phase III study for the treatment of succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) and has already been granted a Breakthrough Therapy designation by the China CDE.

As a novel drug,olverembatinib has received widespread interest from the global hematology community. The clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) Annual Meetings for seven consecutive years. To date,olverembatinib has been granted four Orphan Drug Designations and a Fast Track Designation by the US Food and Drug Administration (FDA),and an Orphan Designation by the EMA of the EU. In February 2024,olverembatinib was cleared by the US FDA to enter a global registrational Phase III study.

In July 2021,Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

In June 2024,Ascentage Pharma and Takeda,a multinational pharmaceutical company,entered into an Exclusive Option Agreement for olverembatinib. If exercised,the Option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of,among others,the mainland China,Hong Kong China,Macau China,and Taiwan China.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global,integrated biopharmaceutical company engaged in discovering,developing and commercializing therapies to address global unmet medical needs primarily in malignancies. On October 28,2019,Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

The company has built a rich pipeline of innovative drug candidates that includes novel,highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors,as well as candidates aimed at IAP and MDM2-p53 pathways,and next-generation TKIs. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company has conducted more than 40 clinical trials in the US,Australia,Europe,and China,including 13 registrational studies (completed/ ongoing/planned).

Olverembatinib,the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China,has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date,the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore,olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA,and an Orphan Designation by the EMA of the EU.

To date,Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. 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; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute,Mayo Clinic,National Cancer Institute and the University of Michigan.

The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs,in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

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