Posted by Michael Wonder on 25 Jul 2022
Anti-PD-1 monoclonal antibody Puyouheng (HX-008, pucotenlimab) co-developed by Lepu Biopharma and HanX Biopharmaceuticals was approved for marketing in China by NMPA
25 July 2022 - Anti-PD-1 monoclonal antibody – Puyouheng (HX-008, pucotenlimab), was conditionally approved by the NMPA for marketing in China to treat patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient advanced solid tumours.
The approval is based on a multi-centre, open-label, Phase 2 clinical study with a primary outcome of the objective response rate assessed by the Independent Review Committee according to the RECIST1.
