Ascentage Pharma to Present Updated Olverembatinib Data for SDH-Deficient GIST at ESMO 2024

ROCKVILLE, Md. and SUZHOU, China, Sept. 8, 2024 -- Ascentage Pharma (6855.HK), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative therapies for malignancies, has announced plans to present the latest clinical data on its novel drug candidate, olverembatinib (HQP1351). This data pertains to patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) and will be presented as a Mini Oral at the 2024 European Society of Medical Oncology (ESMO) Congress.

The ESMO Congress, recognized as one of the world's leading oncology events, will be held from September 13 to 17 in Barcelona, Spain. This congress is a platform for showcasing pioneering cancer research from across the globe. 

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, expressed enthusiasm about presenting olverembatinib's therapeutic potential for SDH-deficient GIST. Olverembatinib, a third-generation tyrosine kinase inhibitor (TKI) developed internally by Ascentage Pharma, has recently been approved by the China Center for Drug Evaluation (CDE) to enter a registrational Phase III study for patients with SDH-deficient GIST. Dr. Zhai emphasizes the company's commitment to advancing this clinical development program swiftly to offer more treatment options to patients worldwide.

The details of the Mini Oral presentation at the ESMO Congress are as follows:
- Title: 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, from 16:30 to 16:35 CEST
- Speaker: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center

Ascentage Pharma (6855.HK) is a globally integrated biopharmaceutical company focused on developing first-in-class and best-in-class therapies to address unmet medical needs in the field of malignancies. The company was listed on the Main Board of the Stock Exchange of Hong Kong Limited on October 28, 2019, under the stock code 6855.HK.

Ascentage Pharma boasts a rich pipeline of innovative drug candidates, including novel and potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates targeting the IAP and MDM2-p53 pathways, and next-generation TKIs. The company is unique in that it has active clinical programs targeting all three major classes of key apoptosis regulators. To date, Ascentage Pharma has conducted more than 40 clinical trials across the US, Australia, Europe, and China, including 11 registrational studies.

Olverembatinib, one of the company’s leading assets, is aimed at treating drug-resistant chronic myeloid leukemia (CML) and is also Ascentage Pharma's first approved product in China. The drug has received Priority Review Designations and Breakthrough Therapy Designations from the China National Medical Products Administration (NMPA). It has also been included in the China National Reimbursement Drug List (NRDL) and granted Orphan Drug Designations and a Fast Track Designation by the US FDA, as well as an Orphan Designation by the EMA of the EU.

Ascentage Pharma has garnered a total of 16 Orphan Drug Designations from the US FDA and 1 Orphan Designation from the EMA for four of its investigational drug candidates. With a strong emphasis on research and development, the company has established a portfolio of global intellectual property rights and formed strategic partnerships with prominent biotechnology and pharmaceutical companies like Takeda, AstraZeneca, Merck, Pfizer, and Innovent. Additionally, it collaborates with leading research institutions, including the Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute, and the University of Michigan.

The company has assembled a team with extensive global experience in innovative drug discovery and development, alongside fully functional commercial manufacturing and sales and marketing teams. A central goal of Ascentage Pharma is to continuously enhance its R&D capabilities and accelerate its clinical development programs to address unmet medical needs in China and worldwide, benefiting more patients.

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