Innovent ready to file NDA for mazdutide on strong Phase III results
China-based Innovent Biologics (HKEX: 01801) has announced that the first Phase III clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity (GLORY-1) met the primary endpoints and all key secondary endpoints.
As a result, Innovent says it plans to submit the first new drug application (NDA) of mazdutide for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term.
Innovent acquired China rights to mazdutide from US pharma major Eli Lilly (NYSE: LLY), which itself is looking to grab a slice of the weight-loss market in China with tirzepatide, which is sold in the USA under the brand Zepbound.
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