Olverembatinib Approved for Commercialization in Macau China

ROCKVILLE, Md. and SUZHOU, China, July 8, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class therapies for hematological malignancies, announced today that its novel BCR-ABL1 tyrosine kinase inhibitor (TKI), olverembatinib, has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of the People's Republic of China for the treatment of adult patients with tyrosine kinase inhibitors (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. This approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications.

Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program, is the first third-generation BCR-ABL1 inhibitor approved by China's National Medical Products Administration (NMPA). As a potential global best-in-class drug that can effectively target BCR-ABL1 and a spectrum of BCR-ABL1 mutants, including the T315I mutation, clinical trial results of olverembatinib have already been included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of CML.^[1] Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. All lead drug candidates are being studied as they are an investigational drug and not approved in the US.

"Olverembatinib has the potential to be a global best-in-class drug. We are glad that the drug is set to benefit patients with CML in Macau, China, with the approval marking another major milestone in the clinical development of olverembatinib," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. "Since its inception, Ascentage Pharma has steadfastly committed to its mission of addressing unmet clinical needs in China and around the world. We are confident that over time, olverembatinib and our other investigational drugs will bring greater benefits to more patients globally."

Reference:

1. Shah N, Bhatia R, Altman JK et al. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Chronic Myeloid Leukemia Version 2.2024 (December 5, 2023). Available from: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. 

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a fully integrated global biopharmaceutical company engaged in discovering, developing and commercializing both first-in-class and best-in-class therapies to address global unmet medical needs primarily in hematological 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 pipeline of 9 clinical-stage drug candidates, including 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 is conducting more than 40 clinical trials, including 6 global registrational Phase III studies, in the US, Australia, Europe, and China.

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 with numerous leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships 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, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan.

The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class 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.

Forward-Looking Statements

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source: Ascentage Pharma