Hengrui Unit's HRS-7535 Tablet NDA Accepted by NMPA for Type 2 Diabetes
Hengrui Medicine's subsidiary Shandong Shengdi Pharmaceutical received acceptance notice from China's National Medical Products Administration on September 2, 2026, for the new drug application of HRS-7535 tablet, intended for glycemic control in adults with type 2 diabetes. The oral small-molecule GLP-1 receptor agonist's filing is based on two pivotal Phase III trials in adult type 2 diabetes patients.
Hengrui Medicine's subsidiary Shandong Shengdi Pharmaceutical Co. , Ltd. received the Acceptance Notice from the National Medical Products Administration (NMPA) on September 2, 2026, with the new drug application for HRS-7535 tablet accepted by the NMPA. The proposed indication is glycemic control in adult patients with type 2 diabetes.
HRS-7535 tablet is a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist. The filing is based on two multicenter, randomized, parallel-controlled pivotal Phase III clinical studies conducted in adult patients with type 2 diabetes.
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