Research & Development
CMAB Biopharma's partner Innovent Biologics awarded FDA clearance for IND application for COVID-19 antibody candidate
3 March 2021 -

CMAB Biopharma (Suzhou) Inc said on Tuesday that its partner Innovent Biologics Inc (1801.HK) has received US Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) application for its antibody candidate targeting the COVID-19 virus.

Utilizing its state of the art facility and robust quality systems, CMAB has provided integrated CDMO services for Innovent's programme from cell bank construction to cGMP production of drug substance at the 2,000 L upstream scale.

Throughout Innovent's independently-developed project, the two organizations worked together to successfully complete the CMC activities efficiently, rapidly and according to international regulatory standards, added Dr Yongzhong Wang, CEO of CMAB,

CMAB is a flexible full-service CDMO dedicated to providing bespoke development manufacturing services of antibodies and biologics for clients in China and across the globe. CMAB complies with global quality standards with European commission EudraLex (EMA) Vol 4.

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