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WuXi STA Forms Strategic Partnership with Ascentage Pharma

SHANGHAI, CHINA, June, 3, 2021 –STA Pharmaceutical Co., Ltd., (“WuXi STA”), a leading Contract Development and Manufacturing Organization – and Ascentage Pharma (6855.HK), announced the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Ascentage Pharma, providing integrated CMC (Chemical, Manufacturing and Control) services for Ascentage Pharma's projects in current and future pipeline, including the process development and manufacturing of both drug substances and drug products, regulatory support for IND filing and the following commercial manufacturing.

Ascentage Pharma is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and aging-related diseases. The collaboration between Ascentage Pharma and WuXi STA started in 2016. Due to the rapid progress made in multiple projects, both companies decided to establish a comprehensive partnership to cover the entire pipeline.

Ascentage Pharma remains committed to its global innovation strategy and has built a robust pipeline including eight clinical-stage and four preclinical-stage small-molecule drug candidates. The company has over 40 Phase I or Phase II ongoing clinical trials in the United States, Australia, Europe and China. Furthermore, Ascentage Pharma has obtained a total of 11 Orphan Drug Designations (ODDs) from the US FDA for 4 investigational drug candidates of the company.

As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA has industry-leading capabilities and expertise. In the year of 2020 alone, WuXi STA supported 10 new drugs approved globally, and is experienced in accelerating the development of Orphan, fast-track and breakthrough therapies. Under China’s (Marketing Authorization Holder) MAH policy, WuXi STA has successfully enabled a number of innovative drugs to launch in China, including Danoprevir, Fruquintinib, Zanubrutinib, Orelabrutinib, etc.

The signing of the strategic partnership agreement has further strengthened collaboration between Ascentage Pharma and WuXi STA. Leveraging the end-to-end CMC platform and proven quality systems, WuXi STA will provide Ascentage Pharma with flexible and high quality solutions for all projects at different stages.

SHANGHAI, CHINA, June, 3, 2021 –STA Pharmaceutical Co., Ltd., (“WuXi STA”), a leading Contract Development and Manufacturing Organization – and Ascentage Pharma (6855.HK), announced the signing of a strategic partnership agreement. Under the terms of this agreement, WuXi STA will become the preferred Contract Development and Manufacturing Organization (CDMO) partner of Ascentage Pharma, providing integrated CMC (Chemical, Manufacturing and Control) services for Ascentage Pharma's projects in current and future pipeline, including the process development and manufacturing of both drug substances and drug products, regulatory support for IND filing and the following commercial manufacturing.

Ascentage Pharma is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and aging-related diseases. The collaboration between Ascentage Pharma and WuXi STA started in 2016. Due to the rapid progress made in multiple projects, both companies decided to establish a comprehensive partnership to cover the entire pipeline.

Ascentage Pharma remains committed to its global innovation strategy and has built a robust pipeline including eight clinical-stage and four preclinical-stage small-molecule drug candidates. The company has over 40 Phase I or Phase II ongoing clinical trials in the United States, Australia, Europe and China. Furthermore, Ascentage Pharma has obtained a total of 11 Orphan Drug Designations (ODDs) from the US FDA for 4 investigational drug candidates of the company.

As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA has industry-leading capabilities and expertise. In the year of 2020 alone, WuXi STA supported 10 new drugs approved globally, and is experienced in accelerating the development of Orphan, fast-track and breakthrough therapies. Under China’s (Marketing Authorization Holder) MAH policy, WuXi STA has successfully enabled a number of innovative drugs to launch in China, including Danoprevir, Fruquintinib, Zanubrutinib, Orelabrutinib, etc.

The signing of the strategic partnership agreement has further strengthened collaboration between Ascentage Pharma and WuXi STA. Leveraging the end-to-end CMC platform and proven quality systems, WuXi STA will provide Ascentage Pharma with flexible and high quality solutions for all projects at different stages.

Dr. Ming Guo, Co-Founder, President & Chief Operating Officer of Ascentage Pharma, commented, “Thanks to WuXi STA for their long-term support for Ascentage Pharma 's projects. The partnership between us are very fruitful. Ascentage Pharma has reached the inflection point in its expansion from R&D to manufacturing and commercialization, and we are very happy to expand the collaboration scope with WuXi STA at such an important stage. I believe that this strong alliance will accelerate our development pathway to market, and fulfill our mission of ‘addressing unmet clinical needs in China and around the world’ for the benefit of more patients.”

Dr. Minzhang Chen, CEO of WuXi STA, commented, “we are delighted to strengthen our partnership with Ascentage Pharma after many years of successful collaboration. This is another great example how WuXi STA’s end-to-end CMC platform empowered our partner. We are fully committed to accelerating the development and commercialization of Ascentage Pharma’s pipeline drugs to benefit patients around the world.”

About WuXi STA

WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com . and follow us onLinkedIn.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused, clinical-stage biotechnology 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, Europe and China. Olverembatinib (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 olverembatinib 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 11 ODDs from the US FDA for four of the company’s investigational drug candidates.