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.