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WuXi STA and Dizal sign CMC Development and Manufacturing Agreement

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WuXi STA will now provide Dizal integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services ranging from API to drug product

STA Pharmaceutical, (WuXi STA), a subsidiary of WuXi AppTec, and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product, a press release issued by STA Pharmaceutical stated.

Dizal Pharmaceutical is a research-based biotechnology joint venture company between AstraZeneca and Advanced Manufacturing Industry Investment Fund (FIIF) managed by private equity firm China Sate Development & Investment Corporation, dedicated to the discovery, development and commercialization of first-in-class/best-in-class medicines. Since its inception in October 2017, Dizal has worked closely with WuXi STA on CMC for an innovative drug.

According to the press release, throughout the course of this venture, WuXi STA has provided process optimization, API manufacturing from grams to kilograms, drug product development and manufacturing for clinical trials, and IND filling in both China and USA. WuXi STA has utilized its innovative drug development and manufacturing platform, regulatory CMC support and quality systems to enable Dizal Pharmaceutical to successfully implement phase I clinical research in China and the USA, it added.

Dizal Pharmaceutical is currently leading several projects in the clinical development stage, covering physical and liquid tumors, chronic kidney disease, respiratory infections and other fields. In the future, WuXi STA will provide integrated CMC services from pre-clinical to commercial, for both API and formulation for Dizal Pharmaceutical research projects.

“We are delighted to sign a comprehensive strategic cooperation agreement with WuXi STA. The innovative capabilities and scale advantage of WuXi STA, as well as many excellent and experienced scientists will empower us to potentially accelerate our project pipelines. Ultimately, bringing new therapies to China and USA more quickly.” said Dr. Zhang Xiaolin, founder and CEO of Dizal Pharmaceutical.

Dr. Minzhang Chen, CEO of WuXi STA, commented, “Our mission is to empower customers to develop innovative drugs from clinical to commercial – faster and more efficiently.  We are delighted to become the strategic partner of Dizal Pharmaceutical and look forward to helping them advance their drug candidates towards the clinic, bringing innovative medicines for the benefit of patients around the world.”

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