HENGRUI PHARMA (01276.HK): NMPA Accepts Marketing Application for Ruippotipeptide Injection for Adults with Type 2 Diabetes

NewTimeSpace News: On 9 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., had recently received an acceptance notice from the National Medical Products Administration (NMPA) for the marketing authorisation application of the company's Ruippotipeptide Injection (acceptance numbers CXHS2600128 and CXHS2600129), with the proposed indication of glycaemic control in adult patients with type 2 diabetes.

According to the announcement, Ruippotipeptide is a glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) dual agonist independently developed by Hengrui, which promotes insulin secretion, enhances insulin sensitivity, suppresses appetite and regulates glucose and lipid metabolism. The application is based on two multicentre, randomised, controlled pivotal Phase III studies in adult T2DM patients: in PRIME-1 (led by Professor Zhou Zhiguang of the Second Xiangya Hospital of Central South University; 40 centres, 218 randomised subjects), the mean HbA1c reduction in the 4 mg group reached 2.67% at week 36; in PRIME-2 (led by Professor Chen Liming of Tianjin Medical University Chu Hsien-I Memorial Hospital; 107 centres, 884 randomised subjects), the mean HbA1c reductions in the 4 mg and 2 mg groups reached 2.78% and 2.34% respectively at week 36, both meeting non-inferiority versus semaglutide injection 1 mg (mean reduction 2.29%) on the primary endpoints, with the 4 mg group showing superiority in glucose lowering versus semaglutide 1 mg (one-sided superiority p<0.0001).

Citing International Diabetes Federation data, the announcement noted that there were 589 million people with diabetes globally in 2024, including approximately 148 million in China, the largest number worldwide; by 2050 the global figure is projected to reach 853 million, including 168 million in China. Currently, only Eli Lilly's same-target drug tirzepatide (Mounjaro in the US and Mufengda in China) has been approved for T2DM globally, with global sales of Mounjaro of approximately USD 22,965 million in 2025. Cumulative R&D investment in Ruippotipeptide to date is approximately RMB 745.9 million (unaudited). The announcement cautioned that drug development and commercialisation involve a long cycle and multiple stages with uncertainties, and investors should be mindful of investment risks.

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