Following MAH pilot, WuXi STA to support Antengene oncology research

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Jirsk)
(Image: Getty/Jirsk)

Related tags Oncology marketing authorization Marketing Packaging API

STA Pharmaceutical has entered an agreement with China-based Antengene to provide R&D for its oncology pipeline using its ‘end-to-end’ CMC platform.

The agreement between the Chinese contract development and manufacturing organization (CDMO) STA Pharmaceutical, a WuXi AppTec company, and Antengene, follows China’s 2016 Marketing Authorization Holder (MAH)​ pilot program.

The MAH program​ allows drug license holders to use a third party manufacturer instead of building GMP manufacturing capabilities in-house, as was previously required.

Jinling Chen, VP of pharmaceutical development services at STA Pharmaceutical, a WuXi AppTec company, told us the company was the first CDMO to support a drug launch through the MAH program. 

As an integrated CDMO, Chen explained that having both its drug substance and drug product research and development (R&D) services in the same facility enables “frictionless”​ communication as the molecule moves down the pipeline.

“Making the drug substance and drug product in one company in close proximity, working together with a shared quality program saves critical time in the race to reach patients,” ​said Chen.

"Having the supply chain within one company, with each group is geographic proximity, saves time in shipping, release testing, and method transfers," ​she added.

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