• In Phase 3 trial in obesity/overweight in China, HRS-7535 achieved a mean weight loss of up to 10.9% at Week 44 and a mean weight loss of up to 11.1% at Week 50
• In second Phase 3 trial in type 2 diabetes in China, HRS-7535 lowered HbA1c by an average of 1.50% to 1.68% across doses
• Liver safety findings in both Phase 3 trials consistent with data generated to date; no liver safety signals observed

Shanghai, China, July 7, 2026 -- Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, today announced positive topline data from two additional Phase 3 clinical trials of oral small molecule GLP-1 receptor agonist HRS-7535(also known as KAI-7535): the Phase 3 HARBOR-1 trial (NCT06904105) in adults living with obesity/overweight in China and the Phase 3 OUTSTAND-2 trial (NCT06589765) in adults with type 2 diabetes (T2D) in China.

HARBOR-1: HRS-7535  Phase 3 Trial in Obesity

HARBOR-1 met its primary endpoint, achievement of superior weight reduction at Week 44 with HRS-7535 compared to placebo.

• Based on the efficacy estimand¹, participants taking HRS-7535 120 mg and 180 mg achieved a mean weight loss of 9.5% and 10.9% from baseline at Week 44, respectively, compared to 2.5% with placebo. 
• Based on the treatment policy estimand², participants taking HRS-7535 120 mg and 180 mg achieved a mean weight loss of 8.0% and 9.8% from baseline at Week 44, respectively, compared to 2.4% with placebo.
• Based on the treatment policy estimand², at Week 44, 58.6% (120 mg) and 68.2% (180 mg) of HRS-7535 treated participants achieved at least 5% weight loss; 39.6% (120 mg) and 46.6% (180 mg) achieved at least 10% weight loss; and 18.5% (120 mg) and 26.0% (180 mg) achieved at least 15% weight loss.
•  At Week 50, based on an ad hoc analysis, participants taking HRS-7535 120 mg and 180 mg achieved a mean weight loss of 9.5% and 11.1% from baseline, respectively, compared to 2.6% with placebo, based on the efficacy estimand.¹
•  Improvements were also observed in Hba1c, systolic blood pressure, and lipid profiles.
•  Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related.
•  The most common TEAEs for participants treated with HRS-7535 (120 mg and 180 mg, respectively) were nausea (70.3% and 70.0% vs. 16.2% with placebo); vomiting (66.7% and 68.6% vs. 4.5% with placebo); and diarrhea (36.9% and 35.9% vs. 15.3% with placebo).
• Treatment discontinuation rates due to TEAEs were 4.1% (120 mg) and 3.1% (180 mg) for HRS-7535 vs. 2.7% with placebo.
•  No liver safety signal was observed, consistent with prior HRS-7535 clinical trials.

HARBOR-1 (HRS-7535-303, NCT06904105) was a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial conducted by Hengrui in China to evaluate the efficacy and safety of HRS-7535 in adults with overweight or obesity. The trial enrolled 556 adults with obesity with a mean baseline body weight of 94.1 kg and mean baseline body mass index (BMI) of 34.0 kg/m². The participant population was 62% female. Participants were randomized (2:2:1) to receive once-daily HRS-7535 120 mg, 180 mg, or placebo. The primary objective was to evaluate the efficacy of HRS-7535 compared to placebo in the percentage change in body weight at Week 44.

OUTSTAND-2: HRS-7535 Phase 3 Trial in Type 2 Diabetes (T2D)

OUTSTAND-2 met its primary endpoint, non-inferiority to dapagliflozin across all HRS-7535 dose levels (30 mg, 60 mg, and 90 mg) at Week 32, with the HRS-7535 90 mg group demonstrating significant HbA1c reduction compared to dapagliflozin. At Week 32:

• Based on the efficacy estimand³, the reductions in HbA1c from baseline for the HRS-7535 30 mg, 60 mg, and 90 mg groups and the dapagliflozin 10 mg group were 1.58%, 1.50%, 1.68%, and 1.28%, respectively.
• Improvements were observed in body weight, systolic blood pressure, lipid profiles, and the urinary albumin-to-creatinine ratio (UACR).
• Most TEAEs were mild to moderate and gastrointestinal-related.
• No Grade 3 hypoglycemic events were reported, and, consistent with prior HRS-7535 clinical trials, no liver safety signal was observed.

OUTSTAND-2 (HRS-7535-302, NCT06589765) was a multicenter, randomized, double-blind, dapagliflozin-controlled Phase 3 trial conducted by Hengrui Pharma in China. It aims to evaluate the efficacy and safety of HRS-7535 in adults with type 2 diabetes who have inadequate glycemic control despite metformin therapy. The trial enrolled 810 adults with type 2 diabetes with a mean baseline HbA1c of 8.60%, mean baseline body weight of 74.7 kg and mean baseline body mass index (BMI) of 27.1 kg/m². The participant population was 36% female. Participants were randomized in a 1:1:1:1 ratio to receive once-daily oral treatment with HRS-7535 (30 mg, 60 mg, or 90 mg) or dapagliflozin (10 mg). The core treatment period was 32 weeks, after which all participants entered an extended treatment period continuing through Week 52. The primary endpoint was change in HbA1c from baseline at Week 32.

Hengrui Pharma intends to share the full HARBOR-1 and OUTSTAND-2 clinical trial data at upcoming scientific conferences and plans to submit NDAs for HRS-7535 for the treatment of T2D and obesity in China.

About HRS-7535

HRS-7535 (being developed by Kailera as KAI-7535) is a small molecule GLP-1 receptor agonist, which was designed to improve upon the clinical profile of existing oral treatments. It was developed by Hengrui Pharma and licensed to Kailera outside of Greater China in 2024. Over 2,000 patients to date have been dosed with HRS-7535 in clinical trials in China. Kailera is conducting a global Phase 2 trial of KAI-7535 for the treatment of obesity, with data expected in 2027.

About Hengrui Pharma: Innovation to Benefit Patients Worldwide

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.

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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.

¹ Based on the efficacy estimand, which was pre-specified as a supplementary estimand in HRS-7535-303: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of medications or treatments with an obvious effect on body weight from the analysis.

² Based on the treatment policy estimand, which was pre-specified as the primary estimand in HRS-7535-303: treatment effect including the impact of premature discontinuations or use of medications or treatments with an obvious effect on body weight.

³ Based on the efficacy estimand, which was pre-specified as the primary estimand for non-inferiority in HRS-7535-302: treatment effect assuming participants adhered to protocol treatment and excludes data collected after premature treatment discontinuations or use of other glucose-lowering medications from the analysis.