ROCKVILLE,Md. and SUZHOU,China,Sept. 9,2024 -- Ascentage Pharma (6855.HK),a global biopharmaceutical company engaged in discovering,developing and commercializing both first-in-class and best-in-class therapies for malignancies,today announced that it will present the latest clinical data of olverembatinib (HQP1351),the company's novel drug candidate,in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST),in a Mini Oral at the 2024 European Society of Medical Oncology (ESMO) Congress.

As one of the world's leading and most influential oncology congresses,the ESMO Congress showcases the latest results in some of the most cutting-edge cancer research from around the world. This year,the ESMO Congress will be held from September 13 to 17 in Barcelona,Spain.

"We are pleased to have this opportunity to showcase olverembatinib's therapeutic potential for the treatment of SDH-deficient GIST," said Dr. Yifan Zhai,Chief Medical Officer of Ascentage Pharma. "As a third-generation TKI developed in house by Ascentage Pharma,olverembatinib was recently cleared by the China CDE to enter a registrational Phase III study in patients with SDH-deficient GIST. We will expeditiously advance this clinical development program in efforts to bring more treatment options to patients around the world."

Details of the Mini Oral presentation at this year's ESMO Congress are as follows:

Updated efficacy results of olverembatinib (HQP1351) in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and potential mechanisms of action (MOA)

Format: Mini oral

Presentation#: 1722MO

Category: Sarcoma

Date & Time: Friday September 13,2024,16:30 - 16:35 CEST

Speaker: Haibo Qiu,MD,PhD,Sun Yat-sen University Cancer Center

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global,integrated 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 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 11 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,MD Anderson Cancer Center,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.

Forward-Looking Statements

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