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

Past Call For More Evidence

Executive Summary

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.

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