Ascentage Pharma Announces Clinical Trial Agreement to Evaluate the Combination of Lisaftoclax (APG-2575) and the CDK4/6 Inhibitor IBRANCE® (Palbociclib) in Metastatic ER+/HER2- Breast Cancer

SUZHOU,China,and ROCKVILLE,Md.,Nov. 8,2021 -- Ascentage Pharma (6855.HK),a globally focused,clinical-stage biotechnology company engaged in developing novel therapies for cancers,chronic hepatitis B (CHB),and age-related diseases,today announced a clinical trial collaboration and supply agreement with Pfizer Inc. to study the combination of Ascentage Pharma's lisaftoclax (APG-2575),a Bcl-2 selective inhibitor,in combination with Pfizer's IBRANCE® (palbociclib),a CDK4/6 inhibitor,in patients with recurrent,locally advanced or metastatic estrogen receptor-positive (ER+),human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Under the terms of the agreement,Ascentage Pharma is responsible for conducting the trial and Pfizer is responsible for supplying study drug for a global,multicenter,open-label Phase Ib/II dose-escalation and expansion study,which is designed to evaluate the safety,tolerability,and anticancer activity of lisaftoclax in combination with palbociclib in patients with metastatic breast cancer.

Lisaftoclax is a novel,orally administered Bcl-2selective inhibitor being developed by Ascentage Pharma. Lisaftoclax is designed to treat a variety of malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells. Globally,lisaftoclax is one of the few Bcl-2 selective inhibitors in clinical development after VENCLEXTA®(venetoclax). Since June 2021,the company has received approvals and clearances in China and the US for the study of lisaftoclax as a single agent or in combinations in ER+ breast cancer and other solid tumors. Previously,Ascentage Pharma also advanced its clinical development of lisaftoclax in a variety of hematologic malignancy indications in the US,Europe,and Australia.

"This is the first clinical trial cleared and approved in the US and China,respectively,of lisaftoclax in solid tumor. Lisaftoclax is a key drug candidate in our apoptosis-targeting pipeline,with great potential in the treatment of hematologic malignancies and several refractory solid tumors,and this agreement with Pfizer will help to accelerate our global clinical development of lisaftoclax," said Dr. Dajun Yang,Chairman & CEO of Ascentage Pharma. "We hope that lisaftoclax combined with palbociclibwill show synergistic effects in the treatment of patients with metastatic breast cancer progressing on CDK4/6 inhibitors,offering additional treatment options to patients with otherwise limited treatment options around the world."

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 eight 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,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. HQP1351,the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML),has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA. A New Drug Application (NDA) for HQP1351 has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. To date,Ascentage Pharma has obtained a total of 12 ODDs from the US FDA 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. Ascentage Pharma aims to continuously strengthen its R&D capabilities and accelerate its clinical development programs to fulfil its mission of 'addressing unmet clinical needs in China and around the world' for the benefit of more patients.

Forward-Looking Statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law,we undertake no obligation to update or revise publicly any forward-looking statements,whether as a result of new information,future events,or otherwise,after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article,statements of,or references to,our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

View original content to download multimedia:https://www.prnewswire.com/news-releases/ascentage-pharma-announces-clinical-trial-agreement-to-evaluate-the-combination-of-lisaftoclax-apg-2575-and-the-cdk46-inhibitor-ibrance-palbociclib-in-metastatic-erher2--breast-cancer-301418529.html