China NMPA Accepts Marketing Authorization Application for Hengrui's Ripretinib Injection
核心洞察
China's NMPA has accepted a marketing authorization application from Hengrui Pharma subsidiary Fujian Shengdi Pharmaceutical (搜索) for rupobartide (搜索) injection in adults with type 2 diabetes.
The filing rests on two pivotal Phase III trials, PRIME-1 and PRIME-2, which tested rupobartide (搜索) against placebo and against 1 mg semaglutide injection.
In PRIME-2, rupobartide (搜索) 4 mg and 2 mg cut HbA1c by 2.78% and 2.34% at week 36, both non-inferior to semaglutide's 2.29%, with 4 mg superior on key secondary endpoints.
Hengrui Pharma announced that its subsidiary Fujian Shengdi Pharmaceutical (搜索) has received a Notice of Acceptance from China's National Medical Products Administration (搜索) for a marketing authorization application covering rupobartide (搜索) injection in adults with type 2 diabetes mellitus (搜索) (T2DM).
The application is supported by two pivotal Phase III multicenter, randomized, controlled studies. PRIME-1, run at 40 centers in China with 218 randomized subjects, evaluated rupobartide (搜索) against placebo in patients with inadequate glycemic control on diet and exercise alone, and reported a mean HbA1c reduction of 2.67% at week 36 in the 4 mg group. PRIME-2, conducted at 107 centers with 884 randomized subjects, tested rupobartide in patients inadequately controlled on metformin monotherapy or metformin plus SGLT2 inhibitors, with semaglutide 1 mg as comparator.
In PRIME-2, mean HbA1c reductions at week 36 were 2.78% for rupobartide (搜索) 4 mg and 2.34% for 2 mg, versus 2.29% for semaglutide 1 mg, meeting non-inferiority for the primary endpoint; the 4 mg dose was superior to semaglutide 1 mg on key secondary endpoints (one-sided superiority p<0.0001). Rupobartide was generally well tolerated, with a safety profile consistent with prior clinical data and other GLP-1 class drugs.
Rupobartide (搜索) is a dual GLP-1 and GIP agonist developed independently by Hengrui Pharma. Cumulative R&D investment in rupobartide-related projects is approximately RMB 745.9 million (unaudited). For the T2DM indication, the only approved drug with the same targets globally is Eli Lilly's tirzepatide injection (Mounjaro), cleared in the United States in May 2022 and in China in May 2024.
Source: moomoo