Shanghai, China,  May 27, 2026 -- Hengrui Pharma (Hengrui), a global pharmaceutical company focused on scientific and technological innovation, today announced positive topline data from its first Phase 3 clinical trial of HRS-7535 (also known as KAI-7535), an oral small molecule GLP-1 receptor agonist, in adults living with type 2 diabetes (T2D) in China (OUTSTAND-1, NCT06672172). The company also reported positive topline first-in-human data from its Phase 1 clinical trial evaluating single-ascending doses (SAD) and multiple-ascending doses (MAD) of HRS-4729 (also known as KAI-4729), an injectable GLP-1/GIP/glucagon receptor tri-agonist peptide, in healthy participants in China (NCT06762600).

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

o       Reported positive topline data from OUTSTAND-1, Hengrui’s Phase 3 T2D clinical trial (NCT06672172): OUTSTAND-1, the first of multiple Phase 3 trials, met the primary endpoint at Week 32, demonstrating significant HbA1c reductions across all three HRS-7535 (KAI-7535) dose levels (30 mg, 60 mg, and 90 mg) compared to placebo.  The multi-center, randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy and safety of HRS-7535 in adult participants with T2D. The trial enrolled 284 participants with T2D with a mean baseline HbA1c of 7.95%, mean baseline body weight of 77.5 kg (171 lbs.) and mean body mass index (BMI) of 27.8 kg/m²and a median T2D duration of 1.60 years at baseline. Prior use of glucose-lowering medication was reported by 33.5% of the participants.  The participant population was 33.1% female.

• Based on the efficacy estimand¹, HbA1c reductions ranged from 1.40% to 1.68%, compared to 0.06% for placebo. Based on the treatment policy estimand², HbA1c reductions ranged from 1.38% to 1.63%, compared to 0.18% for placebo. HRS-7535 also demonstrated clinically meaningful benefit across multiple metabolic and organ function measures, including reduction in weight, urinary protein and blood pressure, and improvements in blood lipids.

• The trial results demonstrated favorable safety and tolerability data consistent with oral GLP-1-based treatments and previously reported HRS-7535 Phase 2 clinical data. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related. No Grade 3 hypoglycemic events were reported, and no liver safety signal was observed.

• Hengrui intends to share the full HRS-7535 Phase 3 T2D clinical trial data at an upcoming scientific conference, and plans to submit an NDA for HRS-7535 for the treatment of T2D in China.

• Data from Hengrui’s ongoing Phase 3 clinical trial in participants living with obesity is anticipated later this year.

HRS-4729 (KAI-4729) Phase 1 Trial in Healthy Participants

o       Reported positive topline data from Hengrui’s Phase 1 SAD/MAD trial (NCT06762600): The randomized, double-blind, placebo-controlled first-in-human trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 (KAI-4729) injection in healthy participants. The MAD portion of Phase 1 trial of KAI-4729 enrolled 60 participants with a mean baseline body weight of 87.3 kg (192 lbs) and mean baseline body mass index (BMI) of 31.4 kg/m².  Participants received once-weekly doses of 1 mg, 4 mg, 8 mg or 12 mg HRS-4729, 4 mg ribupatide (active control) or placebo for 12 weeks.   

• HRS-4729 demonstrated linear pharmacokinetics, with a half-life of approximately 4 to 5 days, supporting once-weekly dosing.

• In the MAD portion of the trial at Week 12, participants receiving multiple doses of 12 mg of HRS-4729 achieved a mean weight loss of up to 16.0% from baseline, compared to 5.4% with placebo. 

•HRS-4729 demonstrated favorable safety and tolerability data consistent with GLP-1-based treatments. Most treatment-emergent adverse events (TEAEs) were mild to moderate and gastrointestinal-related.

• HRS-4729 demonstrated dose-dependent reduction in liver fat content as measured by magnetic resonance imaging proton density fat fraction.

• Hengrui intends to share the full HRS-4729 Phase 1 clinical trial data at an upcoming scientific conference. 

• Hengrui plans to advance HRS-4729 to Phase 2 clinical trials including for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH) in China, and Kailera plans to initiate a Phase 1 clinical trial outside of China in 2026, 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.

¹ Based on the efficacy estimand, which was pre-specified as the supplementary estimand: 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.

² Based on the treatment policy estimand: treatment effect including the impact of premature discontinuations or use of other glucose-lowering medications therapies.