Dizal Pharma chooses WuXi STA for GMP production from API to drug product


The Chinese CDMO has become the preferred partner to provide Dizal integrated chemical, manufacturing and control, process research and manufacturing services

WuXi STA, the WuXi AppTec subsidiary, has signed a strategic partnership with Dizal Pharmaceutical, a biotechnology company launched in 2017 through a joint venture between AstraZeneca and China Advanced Manufacturing Fund.

Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal for GMP production, providing integrated chemical, manufacturing and control (CMC), process research and manufacturing services from API to drug product.

“We are delighted to sign a comprehensive strategic cooperation agreement with WuXi STA," said Dr Zhang Xiaolin, founder and CEO of Dizal Pharmaceutical.

Dr Xiaolin added: "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.”

Dizal is managed by private equity firm China State Development & Investment Corporation. The company is 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.

Throughout this period, 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 US.

WuXi STA has utilised its drug development and manufacturing platform, regulatory CMC support and quality systems to enable Dizal to successfully implement phase I clinical research in China and the US.

Dizal is currently leading several projects in the clinical development stage, covering physical and liquid tumours, 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.

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Dr Minzhang Chen, CEO of WuXi STA, commented: “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.”