Jiangsu Hengrui Pharmaceuticals (01276): The drug for HRS-7535 tablets has been accepted by the National Medical Products Administration.

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received a "Notice of Acceptance" issued by the National Medical Products Administration (NMPA) for the drug marketing application of HRS-7535 tablets. This application for market approval is based on two pivotal Phase III clinical studies (study names OUTSTAND-1 and OUTSTAND-2) conducted in adults with Type 2 Diabetes Mellitus (T2DM). These studies are multicenter, randomized, and parallel-controlled. The first study targets T2DM patients with inadequate glycemic control through diet and exercise alone, while the second study focuses on T2DM patients with inadequate glycemic control after metformin treatment, evaluating the efficacy and safety of HRS-7535 tablets. The OUTSTAND-1 study was led by Professor Xiao Xinhua from Peking Union Medical College Hospital, involving a total of 46 centers across China, randomly enrolling 284 subjects. The results showed that in T2DM patients with poor glycemic control through diet and exercise alone, the reduction in hemoglobin A1c (HbA1c) for each dose group of HRS-7535 tablets reached 1.40% to 1.68%. The OUTSTAND-2 study was led by Professor Guo Lixin from Beijing Hospital, with a total of 104 centers participating and randomly enrolling 810 subjects. The results indicated that among adult T2DM participants with poor glycemic control after metformin treatment, the HbA1c reduction for each dose group of HRS-7535 tablets reached 1.50% to 1.68% (with the dapagliflozin group showing a reduction of 1.28%). In addition to lowering blood sugar, HRS-7535 tablets also demonstrated multifaceted benefits such as weight loss, reduced urinary protein, decreased blood pressure, and improved blood lipid profiles, with good safety and tolerability. Diabetes is a metabolic syndrome characterized by hyperglycemia caused by defects in insulin secretion and/or inadequate insulin action. In 2024, the number of diabetic patients worldwide is expected to reach 589 million, with approximately 148 million in China, ranking first globally. It is projected that by 2050, the number of diabetic patients worldwide will rise to 853 million, with 168 million in China. T2DM accounts for more than 90% of all diabetes cases, primarily caused by insulin resistance and progressive decline in pancreatic beta-cell function. If hyperglycemia is not controlled timely or is poorly controlled, it can lead to irreversible vascular complications such as retinopathy, renal failure, myocardial infarction, stroke, and amputations. Currently, the treatment for T2DM mainly adopts a comprehensive management model, including dietary control, reasonable exercise, blood sugar monitoring, diabetes education, and the use of antidiabetic medications. Lifestyle intervention is a fundamental treatment measure for diabetes, and as the disease progresses, patients need to gradually increase the use of combined therapies with antidiabetic drugs of different mechanisms. Current clinical guidelines recommend that GLP-1 receptor agonists can effectively lower blood sugar and body weight, improve lipid profiles, and reduce blood pressure. HRS-7535 tablets are a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist, which can promote insulin secretion from the pancreas, reduce glucagon secretion, and inhibit gastric emptying by activating human GLP-1R. It also enhances satiety and suppresses appetite through central nervous system mechanisms, directly reducing energy intake, thus being used for the treatment of T2DM and weight loss. Globally, the only oral small-molecule GLP-1R agonist, Liraglutide's FOUNDAYO (orforglipron), is expected to be approved by the FDA for marketing in April 2026. As of now, the cumulative R&D investment for HRS-7535 tablets is approximately 494.40 million yuan (unaudited).