Hengrui's Ruiptipeptide Injection Application Accepted for Type 2 Diabetes
Hengrui Medicine announced that its subsidiary Fujian Shengdi Pharmaceutical received acceptance from China's National Medical Products Administration for the marketing application of Ruiptipeptide Injection, intended for glycemic control in adults with type 2 diabetes. The filing is supported by two pivotal Phase III trials. The company has invested about RMB 745.9 million in the project.
Hengrui Medicine announced on September 9 that its subsidiary Fujian Shengdi Pharmaceutical Co. , Ltd. received an Acceptance Notice from the National Medical Products Administration (NMPA), confirming that the marketing authorization application for Ruiptipeptide Injection has been accepted for review. The drug is indicated for glycemic control in adult patients with type 2 diabetes.
The submission is based on two multicenter, randomized, controlled pivotal Phase III clinical studies conducted in adults with type 2 diabetes, namely the PRIME-1 and PRIME-2 studies. Ruiptipeptide is a dual agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), independently developed by Hengrui Medicine. It promotes insulin secretion, enhances insulin sensitivity, suppresses appetite, and regulates glucose and lipid metabolism, thereby improving blood glucose and reducing body weight.
Globally, for the type 2 diabetes indication, only Eli Lilly's tirzepatide injection, which targets the same pathway, has been approved in the United States in May 2022 and in China in May 2024. As of now, cumulative research and development investment in the Ruiptipeptide project amounts to approximately RMB 745.9 million (unaudited).