– Both dose groups of ribupatide injection achieved significant reductions in HbA1c from baseline, with mean reductions of up to 2.67%.

– The proportions of patients achieving HbA1c targets of <7% and <5.7% were significantly higher in both dose groups of ribupatide injection than in the placebo group, reaching up to 94.5% and 63.0%, respectively.

– 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 T2DM in China.

On July 20, 2026, Hengrui Pharma, a global pharmaceutical company focused on scientific and technological innovation, today announced positive topline data from the Phase 3 clinical trial (HRS9531-302) of ribupatide injection (HRS9531; known as KAI-9531 outside Greater China), a GLP-1/GIP dual receptor agonist, in treatment-naïve patients with type 2 diabetes with inadequate glycemic control despite diet and exercise interventions in China. Superiority was demonstrated for the primary endpoint and all key secondary endpoints. Hengrui Pharma plans to submit an NDA for ribupatide injection for glycemic control in adults with type 2 diabetes in China, while Kailera Therapeutics (U.S.) is advancing the global clinical development of ribupatide for the treatment of obesity.

Based on the efficacy estimand, participants taking ribupatide injection 2 mg and 4 mg achieved mean HbA1c reductions of 2.37% and 2.67%, respectively, at Week 36, compared to 0.36% for placebo. Based on the treatment policy estimand, participants taking ribupatide injection 2 mg and 4 mg achieved mean HbA1c reductions of 2.19% and 2.50%, respectively, at Week 36, compared to 0.66% for placebo. Based on the efficacy estimand, the proportions of participants taking ribupatide injection 2 mg and 4 mg achieving HbA1c <7% were 87.7% and 94.5%, respectively, compared to 16.7% for placebo. The proportions achieving HbA1c <5.7% were 39.7% and 63.0%, respectively, compared to 1.4% for placebo.

Regarding safety, ribupatide injection was generally well-tolerated, with a safety profile consistent with other GLP-1-based treatments and previously reported Phase 2 clinical data for the drug. 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 for glycemic control at upcoming scientific conferences.

About the HRS9531-302 Trial

HRS9531-302 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial (NCT06650007) designed to evaluate the efficacy, safety, and tolerability of ribupatide injection (2 mg and 4 mg) compared with placebo in adults with type 2 diabetes who had inadequate glycemic control despite diet and exercise interventions. A total of 218 participants were enrolled and randomized in a 2:1:2:1 ratio to receive once-weekly treatment with ribupatide injection 2 mg, matching placebo for 2 mg, ribupatide injection 4 mg, or matching placebo for 4 mg. The core treatment period was 36 weeks, with the primary endpoint being the change in HbA1c from baseline at Week 36, followed by a 16-week blinded extension treatment period.

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.