China's Innovent Biologics Emerges As Immuno-Oncology Competitor With Sintilimab Approval
Medicines regulators have cleared Innovent Biologics's anti-PD-1 therapy, sintilimab, for classical Hodgkin's lymphoma in China, where late-stage studies as a first-line therapy for advanced esopheageal cancer have also just started.
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BioNTech's $150m offering, after a prior large venture capital financing, gives it the third-largest market cap for a newly public drug developer in the US. Also, Innovent raises $300m in Hong Kong offering, Heron leads US follow-ons and Five Prime restructures to save $20m annually.
Despite multiple adverse factors including a leadership shakeup and the departure of its top regulator, the China FDA seemed determined to refresh itself after a name change and to speed up new drugs to market.
China biotechs blossom with millions in new funding for antibody developer Adagene and diabetes drug maker Hua Medicine, and a planned CNY5.7bn Shanghai listing for WuXi Apptec. However, national innovation darling Innovent Bio has withdrawn its PD-1 approval filing, dealing a setback to a crowded area.