WuXi STA and Dizal Pharmaceutical sign CMC development and manufacturing agreement
WuXi STA will provide integrated CMC services from pre-clinical to commercial, for both API and formulation for Dizal Pharmaceutical research projects.
STA Pharmaceutical – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical have announced 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.
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.
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 the US. 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 US.
The signing of the strategic cooperation agreement will further strengthen the deep and wide cooperation between the two companies. 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 the US 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.”Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance