ESMO 2023 | Ascentage Pharma to Present Results from Two Clinical Studies, including One Oral Presentation, at 2023 ESMO Congress

SUZHOU,China,and ROCKVILLE,Md.,Aug. 3,2023 --Ascentage Pharma (6855.HK),a global biopharmaceutical company engaged in developing novel therapies for cancer,chronic hepatitis B (CHB),and age-related diseases,announced today that it is going to release results from two clinical studies at the 2023 European Society of Medical Oncology (ESMO) Congress. These presentations include a Mini Oral featuring the latest data from a study of pelcitoclax (APG-1252),a Bcl-2/BcL-xL dual-targeted inhibitor,combined with osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC); and a Poster on a study evaluating olverembatinib (HQP1351),the first and only China-approved third-generation BCR-ABL inhibitor,in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST).

As one of the most authoritative and influential congresses in oncology globally,the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world. This year,the ESMO Congress will take place on October 20 to October 24,local time,in Madrid,Spain.

"We are pleased that results from the study of pelcitoclax combined with osimertinib in patients with NSCLC and that from the study evaluating olverembatinib in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST) have been selected for presentations at the 2023 ESMO Congress," said Dr. Yifan Zhai,Chief Medical Officer of Ascentage Pharma. "These presentations highlight Ascentage Pharma's robust capabilities in clinical development and global innovation,as well as our strong potential in solid tumors. Remaining steadfastly committed to our global innovation roadmap,we will expeditiously advance the global clinical development of our lead drug candidates with the hope to bring benefit to patients in China and around the world as soon as possible."

These two clinical studies to be presented at the ESMO Congress this year are as follows:

Pelcitoclax

Updated study results of pelcitoclax (APG-1252) combined with osimertinib in patients (pts) with EGFR-mutant non-small cell lung cancer (NSCLC)

Format: Mini Oral

Abstract#: 5586

Category: NSCLC,Locally Advanced

First Author: Yuxiang Ma,MD,Sun Yat-sen University Cancer Center

Olverembatinib

Antitumor activity of olverembatinib (HQP1351) in patients (pts) with TKI-resistant succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST)

Format: Poster

Abstract#: 5746

Category: Sarcoma

First Author: Haibo Qiu,PhD,Sun Yat-sen University Cancer Center

*Pelcitoclax is an investigational drug that has not been approved in any country and region.

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland. This drug is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers,chronic hepatitis B,and age-related diseases. 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.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis,or programmed cell death. The company has built a pipeline of 9 clinical 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 tyrosine kinase inhibitors (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 Phase I/II clinical trials in the US,Australia,Europe,and China. Ascentage Pharma has been designated for multiple Major National R&D Projects,including five Major New Drug Projects,one New Drug Incubator status,four Innovative Drug Programs,and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib,the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product,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 2022 National Reimbursement Drug List (NRDL). Furthermore,olverembatinib has been granted an Orphan Drug Designation (ODD) 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 renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology,MD Anderson Cancer Center,Mayo Clinic,Dana-Farber Cancer Institute,MSD,and AstraZeneca. 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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