Ascentage Pharma Presents Updates on its Global Clinical Development at the J.P. Morgan 39th Annual Healthcare Conference

SUZHOU, China and ROCKVILLE, Md., Jan. 14, 2021 /PRNewswire/ -- 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, presented at the J.P. Morgan 39^th Annual Healthcare Conference (a virtual event) in the evening of January 13, Beijing Time. During the presentation, Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, provided business updates with a focus on the company's global R&D blueprint.

Multiple milestone achievements with global clinical development

Dr. Yang delivered a well-received presentation on the company's product pipeline and clinical development progress. As a global leader in the development of therapeutics targeting the protein-to-protein interactions, Ascentage Pharma has built a pipeline of highly competitive assets, many of which with first-in-class or best-in-class potentials (Table 1). To date, Ascentage Pharma has received 33 clinical trial approvals or clearances, with over 40 clinical studies on-going around the world.

Furthermore, Dr. Yang highlighted many milestones successfully achieved in 2020, despite the challenges posed by the COVID-19 pandemic:

• Submitted the company's first New Drug Application (NDA) for HQP1351 (olverembatinib) in China, which was subsequently granted Priority Review status, marking another step forward in Ascentage Pharma's transition from clinical-stage to commercialization.
• The clinical results of HQP1351 (olverembatinib) were selected for oral presentation at the American Society of Hematology (ASH) annual meeting for the third year in a row.
• Granted nine Orphan Drug Designations and one Fast-Track Designation by the US Food and Drug Administration (FDA). The number of ODDs granted was the highest for any biopharmaceutical company globally in 2020, and an all-time record among Chinese biopharmaceutical companies.
• Established clinical Proof of Concept with the Bcl-2 inhibitor APG-2575, a key drug candidate in Ascentage Pharma's apoptosis-targeting pipeline.
• Initiated a clinical study in multiple countries in Europe for the first time.
• Entered global clinical collaborations with MSD, and Acerta Pharma, the hematology research and development center of excellence of AstraZeneca.

The Bcl-2 inhibitor APG-2575 showed promising activities and therapeutic potential

As a leading biopharmaceutical company focusing on the development of apoptosis-targeting therapies, Ascentage Pharma has built a rich and robust pipeline, with five drug candidates targeting the three key apoptotic pathways - Bcl-2, IAP, and MDM2-p53, and has advanced all these five candidates into clinical development. APG-2575, the company's orally-administered novel small-molecule Bcl-2 inhibitor, attracted a great deal of interest from the industry and research community, as it is one of the few Bcl-2 selective inhibitors, after venetoclax, that have entered clinical development. It is also the first China-developed Bcl-2 inhibitor entering clinical development.

In December 2020, Ascentage Pharma released updated results from the clinical studies of APG-2575 in the treatment of relapsed/refractory chronic lymphocytic lymphoma (r/r CLL) which have enrolled over 30 patients. Preliminary results show that a highly encouraging objective response rate (ORR) of 70% has been reached in evaluable patients. At this conference, Dr. Yang shared additional details on these results.

In the presentation, Dr. Yang highlighted two important observations of the data from the clinical studies of APG-2575: first, with the key efficacy measure of absolute lymphocyte counts (ALC), the ALC levels of three high-risk patients have returned to normal after the first treatment cycle (Figure 1); second is the noticeable reduction in the evaluable patients' lymph nodal sizes from baseline (Figure 2).

In addition, Dr. Yang stressed that positive preclinical results have demonstrated APG-2575's tumor-suppressing activity in BTK resistant patient-derived xenograft (PDX) Waldenström macroglobulinemia (WM) models in which venetoclax showed no activity (Figure 3). These results provide a solid basis for the future clinical development of APG-2575 as a potential therapeutic treating BTK resistant WM.

"It is a great pleasure to speak at the J.P Morgan Healthcare Conference this year, and to share our recent progresses with investors from around the world," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Despite the challenges posed by the COVID-19 pandemic in 2020, Ascentage Pharma has achieved many milestones, demonstrating our capability in global innovation. We will press forward with our global innovation strategy, accelerate our global clinical development program, strengthen our leadership position in the development of apoptosis-targeting therapeutics, in doing so, we hope to bring these potential new therapies to market as early as possible."

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, 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. 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, and a New Drug Application (NDA) for the drug candidate has been submitted in China. To date, Ascentage Pharma has obtained a total of nine ODDs from the US FDA for four of the company's investigational drug candidates.

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