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Chinese Regulator Rejects Domestic PD-1/L1 Contender In Latest Tightening Signal

Past Call For More Evidence

 
• By Dexter Jie Yan

After nearly three years of regulatory review, Genor Biopharma’s geptanolimab has become the first domestically-developed anti-PD-1/L1 drug to experience a major regulatory setback within the overcrowded class in China. Over the intervening years since it was submitted for approval, the country’s regulator has moved to tighten review standards.

PD-1 antibody rejection
Chinese regulator turns down home-grown PD-1/L1 antibody for first time • Source: Shutterstock

China’s National Medical Products Administration (NMPA), the main drug regulator in the country, has rejected for the first time a biologics license application for a home-grown anti-PD-1/L1 antibody, roughly three months after granting the 11th approval of an immuno-oncology drug developed inside the country.

Hong Kong-listed Genor Biopharma Co. Ltd. on 12 June disclosed it had been notified by the NMPA that its application for geptanolimab (GB226) for relapsed/refractory peripheral T-cell lymphoma (r/r...

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