Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HENGRUI PHARMA) has announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., recently received the "Acceptance Notice" from China's National Medical Products Administration (NMPA) for the marketing authorization application of its HRS-7535 tablet. This application is based on two pivotal Phase III clinical studies, named OUTSTAND-1 and OUTSTAND-2, which were conducted as multicenter, randomized, parallel-controlled trials in adult patients with type 2 diabetes mellitus (T2DM).
The two studies separately evaluated the efficacy and safety of HRS-7535 in T2DM patients with inadequate glycemic control through diet and exercise alone, and in those with inadequate glycemic control after metformin treatment, respectively. The OUTSTAND-1 study, led by Professor Xiao Xinhua from Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, enrolled 284 participants across 46 centers nationwide. Results showed that in T2DM patients with poor glycemic control through lifestyle intervention alone, HRS-7535 tablet reduced glycated hemoglobin (HbA1c) by 1.40% to 1.68% across various dose groups.
The OUTSTAND-2 study, headed by Professor Guo Lixin from Beijing Hospital, enrolled 810 subjects across 104 centers nationwide. Findings indicated that in adult T2DM participants with inadequate glycemic control on metformin, HRS-7535 tablet achieved HbA1c reductions of 1.50% to 1.68% across dose groups, compared to a 1.28% reduction in the dapagliflozin group. Beyond glycemic control, HRS-7535 also demonstrated multifaceted benefits, including weight reduction, decreased urinary protein, lowered blood pressure, and improved lipid profiles, while maintaining a favorable safety and tolerability profile.
Diabetes is a metabolic syndrome characterized by hyperglycemia resulting from defective insulin secretion and/or impaired insulin action. In 2024, the global diabetic population reached 589 million, with approximately 148 million in China, ranking first worldwide. Projections indicate that by 2050, global diabetes cases will surge to 853 million, with China's patient count reaching 168 million. T2DM accounts for over 90% of all diabetes cases, driven primarily by insulin resistance and progressive pancreatic beta-cell dysfunction. Uncontrolled or poorly managed hyperglycemia can lead to irreversible vascular complications, including retinopathy, renal insufficiency, myocardial infarction, stroke, and amputation.
Current T2DM management adopts a comprehensive approach, incorporating dietary control, regular exercise, blood glucose monitoring, diabetes education, and pharmacological interventions. Lifestyle modification serves as the cornerstone of diabetes therapy; however, as the disease progresses, patients typically require stepwise addition of antidiabetic agents with complementary mechanisms of action. Clinical guidelines currently recommend GLP-1 receptor agonists for their ability to effectively lower blood glucose and body weight, while improving lipid profiles and reducing blood pressure. HRS-7535 represents a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that activates human GLP-1R to promote pancreatic insulin secretion, suppress glucagon release, and delay gastric emptying. Additionally, it enhances satiety and suppresses appetite through central mechanisms, thereby reducing energy intake for the treatment of T2DM and weight management.
Globally, the only oral small-molecule GLP-1R agonist approved to date is Eli Lilly's FOUNDAYO (orforglipron), which received FDA approval in April 2026. As of now, the cumulative research and development investment in the HRS-7535 project totals approximately RMB 494.4 million (unaudited).