Ark Biosciences taps WuXI STA for CMC development

07-Mar-2019 - Last updated on 12-Mar-2019 at 17:19 GMT

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Related tags CMC RSV Wuxi apptec WuXi STA marketing authorization

WuXi AppTec subsidiary, STA Pharmaceutical partners with Ark Biosciences for CMC development of RSV therapy.

Ark Biosciences will use China’s Marketing Authorization Holder (MAH) system to accelerate its drug development.

Through the partnership with WuXi STA, Ark Biosciences will be able to optimize manufacturing processes, reduce commercial production costs, mitigate business risk, and improve operational efficiency.

The contract development and manufacturing organization (CDMO), WuXi STA, will provide its integrated process R&D manufacturing solution for the chemistry, manufacturing and controls (CMC) development for Ark’s drug candidate and current pipeline.

Ark Bioscience has a pipeline of active discovery programs and in-licensed drug assets for clinical development, including its drug candidate, Ziresovir (AK0529), an F-protein inhibitor for the treatment of respiratory syncytial virus (RSV). The therapy has completed three Phase I clinical trials and is currently in a global phase II clinical trial.

WuXi STA has been in collaboration with companies to enable domestic innovative drug development.