spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement


STA Pharmaceutical Co., Ltd., (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.

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 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.

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 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.”

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.”

About Dizal Pharmaceutical

Founded in October 2017, Dizal Pharmaceutical is a research-based biotechnology company dedicated to the discovery, development and commercialization of first-in-class/best-in-class medicines. Dizal Pharmaceutical, formerly known as Asia and Emerging Markets, Innovative Medicines and Early Development, AstraZeneca (AEM iMED), was founded in Shanghai, China. One of AstraZeneca’s four global research operations (the other three being located in Cambridge, UK, Gothenburg, Sweden, and Gaithersburg, USA, respectively), Dizal Pharmaceutical is a cutting-edge, high-yield R&D center for innovative drugs, equipped with world-leading translational medicine platforms as well as new-drug molecular design and screening platforms. Dizal Pharmaceutical has accumulated extensive experience in the development of innovative therapies for the treatment of cancer, autoimmune diseases and chronic kidney disease among others. For more information, please visit: http://www.dizalpharma.com/

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 Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For more information, please visit: http://www.STApharma.com

Media Contacts:

De Facto Communications

Alex Heeley or Abdul khalifeh

 

+44 (0) 203 735 8167
 
Print this page
Send to a friend
   
spacer
News and Press Releases

CRO and Sponsor Quality Award Finalists Announced by ACRP, The Avoca Group

Washington, DC – The Association of Clinical Research Professionals (ACRP) and The Avoca Group will jointly recognize leading Sponsors and CROs at the ACRP Awards & Recognition Ceremony on Friday, May 1, during the ACRP 2020 annual conference in Seattle, Washington.
More info >>


White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>

Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement