Iaso Biotechnology Co. Ltd. has announced that China’s National Medical Products Administration (NMPA) has approved the IND application for IASO-782 injection for a new indication – systemic lupus erythematosus.
Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
Innovent Biologics Inc.’s glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, mazdutide, met the primary endpoint and all key secondary endpoints in a phase III type 2 diabetes trial in Chinese adults. “Mazdutide is the first and fastest-developed GLP-1R/GCGR dual agonist in the world, and we are actively promoting the development of mazdutide for weight loss, T2D and other indications,” Lei Qian, Innovent’s vice president of clinical development, said.
Mabwell Bioscience Co. gained clearance in China to start a phase II study of its novel Nectin4-targeting antibody drug conjugate (ADC), 9MW-2821, for metastatic triple-negative breast cancer.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with SYS-6016, the company’s mRNA respiratory syncytial virus (RSV) vaccine.
Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma.
China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.).
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with the first mRNA-lipid nanoparticles (LNP)-based CAR T-cell injection, SYS-6020.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.