Both doses of ribupatide injection met the primary objective, demonstrating non-inferiority to semaglutide injection 1 mg

Ribupatide injection 4 mg demonstrated statistically significant superior HbA1c reduction compared to semaglutide injection 1 mg, with mean reductions of up to 2.78% versus 2.29%, respectively, at Week 36.

Ribupatide injection was generally well tolerated, with a safety profile consistent with other GLP-1-based treatments

Hengrui Pharma plans to submit a New Drug Application (NDA) for ribupatide injection for glycemic control in adults with type 2 diabetes in China

Shanghai, China, August 4, 2026 – Hengrui Pharma, a global pharmaceutical company focused on scientific and technological innovation, today announced positive topline results from the Phase 3 clinical trial (HRS9531-303) of ribupatide injection (HRS9531, known as KAI-9531 outside Greater China), a GLP-1/GIP dual receptor agonist, in adults with type 2 diabetes who had inadequate glycemic control after metformin monotherapy or combination therapy with an SGLT2 inhibitor in China¹. Both the 4 mg and 2 mg doses of ribupatide injection met the prespecified primary endpoint, demonstrating non-inferiority to semaglutide injection 1 mg in the change in HbA1c from baseline at Week 36. Based on these results, Hengrui Pharma plans to submit an NDA in China for ribupatide injection for glycemic control in adults with type 2 diabetes.

Based on the efficacy estimand, participants taking ribupatide injection 4 mg and 2 mg achieved mean HbA1c reductions of 2.78% and 2.34%, respectively, at Week 36, compared to 2.29% with semaglutide injection 1 mg. Both ribupatide injection doses met the primary endpoint of non-inferiority to semaglutide injection 1 mg. For the key secondary endpoints, the between-group difference in change from baseline in HbA1c between ribupatide injection 4 mg and semaglutide injection 1 mg was -0.49 percentage points, with statistically significant superiority demonstrated with a one-sided p-value of <0.0001. In terms of glycemic control, the proportions of participants taking ribupatide injection 4 mg and 2 mg who achieved HbA1c ≤6.5% were 85.0% and 69.0%, respectively, compared to 64.3% with semaglutide injection 1 mg. The proportions of participants achieving the composite endpoint of HbA1c <7.0% and body weight reduction of ≥5% were 66.2% and 43.2% with ribupatide injection 4 mg and 2 mg, respectively, compared to 42.8% with semaglutide injection 1 mg.

Ribupatide injection was generally well-tolerated, with a safety profile consistent with previously reported clinical data and other GLP-1-based treatments. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity and primarily gastrointestinal-related.

Hengrui Pharma intends to share further data from the Phase 3 clinical trial of ribupatide injection at upcoming scientific conferences.

About the HRS9531-303 Clinical Trial

HRS9531-303 is a multicenter, randomized, open-label, active-controlled Phase 3 clinical trial designed to evaluate the efficacy, safety and tolerability of ribupatide injection 4 mg and 2 mg compared with semaglutide injection 1 mg in adults with type 2 diabetes who had inadequate glycemic control after metformin monotherapy or combination therapy with an SGLT2 inhibitor. A total of 884 participants were enrolled and randomized in a 1:1:1 ratio to receive ribupatide injection 4 mg, ribupatide injection 2 mg or semaglutide injection 1 mg. The primary objective of the study was to evaluate whether ribupatide injection was non-inferior to semaglutide injection in glycemic control after 36 weeks of treatment. The primary endpoint was the change from baseline in HbA1c at Week 36.

About Ribupatide

Leveraging a forward-looking strategic layout in metabolic diseases, Hengrui Pharma has established a leading and differentiated GLP-1 portfolio alongside a robust pipeline of next-generation innovative therapies, with the goal of addressing significant unmet clinical needs in obesity and beyond.

Ribupatide (HRS9531, also known as KAI-9531 outside Greater China) is a GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent insulinotropic polypeptide) dual receptor agonist independently developed by Hengrui Pharma. It is being developed as both a once-weekly subcutaneous injection and a once-daily oral tablet. Clinical studies for the injectable formulation in China cover multiple indications, including weight management in adults and adolescents, type 2 diabetes, obesity with obstructive sleep apnea, metabolic dysfunction-associated steatohepatitis (MASH), and reduction in the risk of major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. The new drug application for ribupatide injection for long-term weight management in adults was accepted by China’s National Medical Products Administration (NMPA) in September 2025 and is currently under review. Hengrui Pharma plans to submit an NDA in China for ribupatide injection for glycemic control in adults with type 2 diabetes. The oral formulation is currently in a Phase 3 clinical trial in China for weight management and a Phase 2 clinical trial for the treatment of type 2 diabetes.

In May 2024, Hengrui Pharma granted Kailera Therapeutics exclusive global rights outside Greater China to develop, manufacture, and commercialize a portfolio of innovative GLP-1 therapeutics, including ribupatide. Kailera is currently evaluating ribupatide injection for the treatment of obesity in the KaiNETIC global Phase 3 clinical program.

About Hengrui Pharma

Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. For more information, visit us at Hengrui.com and follow us on LinkedIn.

Hengrui Pharma Cautionary Statement Regarding Forward-Looking Statements

This press release contains statements that reflect Hengrui Pharma’s beliefs or expectations about the future or future events as of the respective dates indicated therein (“forward-looking statements”). These forward-looking statements are based on a number of assumptions about Hengrui Pharma’s operations, its future development plans, market (financial and otherwise) conditions and growth prospects, and are subject to significant risks, uncertainties and other factors beyond Hengrui Pharma’s control, and accordingly, actual results may differ materially from those contemplated by these forward-looking statements. No reliance should be placed on such statements, which reflect the view of the management of Hengrui Pharma as at the date of this press release. Hengrui Pharma does not undertake any obligation to update these forward-looking statements for events or circumstances that occur subsequent to such dates.

Reference:

1. Compiled based on research data.