BRIEF—China approves 6th home-grown anti-PD1 MAb

China's National Medical Products Administration (NMPA) has granted approval for the New Drug Application (NDA) for the new anti-PD1 monoclonal antibody (MAb) – zimberelimab - from Harbin Gloria Pharmaceutical and WuXi Biologics, as a second line treatment for recurrent/refractory classical Hodgkin's lymphoma (CHL).

This is China's sixth approved home-grown anti-PD1 MAb. The other five are penpulimab from Akeso/China National Biotec, camrelizumab from Hengrui, tislelizumab from BeiGene, toripalimab from Coherus BioSciences, and Innovent/Eli Lilly's Sintilimab.

Hengrui's camrelizumab so far has approval for five indications, more than any of its rivals. These indications are nasopharyngeal carcinoma, CHL, esophageal cancer and non-small cell lung cancer (NSCLC).

China's national drug reimbursement list covered most Chinese developed anti-PD1 MAbs, but none of the four imported counterparts – Merck & Co’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), Roche’s Tecentriq (atezolizumab) and AstraZeneca’s Imfinzi (durvalumab).