Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan.
Tracon Pharmaceuticals Inc. tapped Biocytogen Pharmaceuticals Co. Ltd.’s wholly owned subsidiary, Eucure Biopharma Co. Ltd., for U.S. rights to CTLA4 antibody YH-001, which it plans to use in immunotherapy studies in combination with its PD-L1 inhibitor.
BEIJING – U.S. biotech Tracon Pharmaceuticals Inc., of San Diego, has in-licensed from Chinese drugmakers 3D Medicines (Beijing) Co. Ltd. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. the rights to develop envafolimab, a subcutaneous PD-L1 antibody, to treat soft tissue sarcoma in North America.