Ascentage Pharma Enters into Strategic Partnership with WuXi STA to Advance Drug Development and Manufacturing

Dr. Ming Guo, Co-Founder, President and Chief Operating Officer of Ascentage Pharma (on the left), and Dr. Minzhang Chen, Chief Executive Officer of WuXi STA (on the right)

SUZHOU, China and ROCKVILLE, MD., U.S., June XX, 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 entered into a collaboration agreement that will further deepen its strategic partnership with WuXi STA, a subsidiary of WuXi AppTec (603259.SH/2359.HK). According to the agreement, WuXi STA will become Ascentage Pharma’s preferred Contract Development and Manufacturing Organization (CDMO) partner supporting Ascentage Pharma’s development of innovative therapies. In this partnership, WuXi STA will provide integrated chemical, manufacturing, and control (CMC) services in process development and manufacturing of both drug substances and drug products; and offer regulatory support for the investigational new drug (IND) filing and the future commercial manufacturing of Ascentage Pharma’s pipeline products. Dr. Ming Guo, Co-Founder, President and Chief Operating Officer of Ascentage Pharma, and Dr. Minzhang Chen, Chief Executive Officer of WuXi STA attended the signing ceremony.

Being a frontrunner in the development and commercialization of innovative therapies, Ascentage Pharma has developed a proprietary drug design platform focused on the targeted pathways in protein-to-protein interactions, and has emerged as a global leader in the research and development of apoptosis-targeted therapies. Ascentage Pharma and WuXi STA began collaborating as early as in 2016. The rapid progress with multiple prior projects has led to this decision to establish a comprehensive partnership covering Ascentage Pharma’s entire pipeline.

Ascentage Pharma has built a pipeline of eight novel drug candidates that are at the clinical stage. These drug candidates include inhibitors of key proteins in the apoptotic pathway such as Bcl-2, IAP, and MDM2-p53, as well as 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 currently conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has submitted a new drug application (NDA) for its core drug candidate, olverembatinib (HQP1351), in China, and was subsequently granted the Priority Review status and a Breakthrough Therapy Designation (BTD). Moreover, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA. To date, Ascentage Pharma has obtained a total of eleven ODDs from the US Food and Drug Administration (FDA) for four of the company’s investigational drug candidates.

As a premier CDMO, WuXi STA has industry-leading capabilities and expertise. In 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 the launch of a number of innovative drugs in China.

This strategic partnership agreement further deepens and broadens the 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 various stages.

“We appreciate WuXi STA’s strong support to our programs and the very fruitful partnership in recent years,” said Dr. Ming Guo, Co-Founder, President & Chief Operating Officer of Ascentage Pharma. “Ascentage Pharma is currently at an inflection point in its expansion from R&D toward manufacturing and commercialization. We are glad to expand our collaboration with WuXi STA at this critical juncture. I am confident that this alliance between the two industry leaders will effectively accelerate the development of our drug candidates, and help us to make safe and effective innovative therapies available to patients as soon as possible, in fulfilling our founding mission of ‘addressing unmet clinical needs in China and around the world’.”

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 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.

About WuXi STA

STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. 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) requirements from preclinical to commercial uses. For more information, please visit: http://www.STApharma.com

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.