The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd’s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal cancer whose disease has progressed after previous chemotherapy; and (2) patients with other advanced solid tumors who have progressed after first-line treatment and lack satisfactory alternative options.
Drug Profile
Pucotenlimab is the eighth PD-1 inhibitor developed by a domestic Chinese biopharma. The molecule employs antibody engineering technology to introduce mutations in the Fc region, enhancing FcRn binding affinity and significantly extending its half-life. Early clinical studies demonstrated the drug’s efficacy and safety across multiple solid tumor types.
Additional Approvals
Lepu has another approval filing under review for pucotenlimab as a second-line treatment for melanoma, submitted in July 2021. The MSI-H/dMMR indication was filed in October 2021.
Market Context
Seven other PD-1 inhibitors developed in China include Hengrui Medicine’s camrelizumab, Innovent Bio’s Tyvyt (sintilimab), BeiGene’s tislelizumab, Junshi Bio’s Tuoyi (toripalimab), Akeso Bio’s penpulimab, Gloria Pharma’s zimberelimab, and Henlius Bio’s HaiSiZhuang (serplulimab).-Fineline Info & Tech
