Hengrui Pharmaceutical (01276): The drug marketing license application for HRS-7535 tablets was accepted by the State Drug Administration

Zhitong Finance App News, Hengrui Pharmaceutical (01276) issued an announcement. Recently, Shandong Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received the “Notice of Acceptance” issued by the China Drug Administration (hereinafter referred to as the “State Drug Administration”), and the company's drug marketing license application for HRS-7535 tablets was accepted by the State Drug Administration.

The listing is based on two key multi-center, randomized, parallel-controlled phase III clinical studies of HRS-7535 tablets in adult type 2 diabetes (T2DM) patients (study names: OUTSTAND-1, OUTSTAND-2). The two studies evaluated the efficacy and safety of HRS-7535 tablets on T2DM patients with poor blood sugar control during simple diet and exercise, and T2DM patients with poor blood sugar control after treatment with metformin.

Professor Xiao Xinhua of Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences was the main researcher in the OUTSTAND-1 study. A total of 46 centers were launched nationwide, and 284 subjects were randomly enrolled. Research results showed that the decrease in glycated hemoglobin (HbA1c) in various dosage groups of HRS-7535 tablets was 1.40%-1.68% in type 2 diabetics with poor exercise control on a simple diet. Professor Guo Lixin of Beijing Hospital was the main researcher in the OUTSTAND-2 study. A total of 104 centers were launched nationwide, and 810 subjects were randomly enrolled. Research results showed that among adult type 2 diabetic participants with poor blood sugar after treatment with metformin, HbA1c decreased by 1.50%-1.68% in each dose group of HRS-7535 tablets (1.28% decrease in the dapagliflozin group). In addition to lowering sugar, HRS-7535 tablets also showed multi-dimensional benefits such as weight loss, lowering urinary protein, lowering blood pressure, and improving blood lipids, and had good safety and tolerability.

Diabetes is a metabolic syndrome characterized by high blood sugar levels due to deficient insulin secretion and/or insufficient insulin action. In 2024, the number of diabetics in the world reached 589 million, and the number of diabetics in China is about 148 million, ranking first in the world; it is estimated that the number of diabetics worldwide will increase to 853 million in 2050, and the number of Chinese patients will reach 168 million. T2DM accounts for more than 90% of all diabetes cases. It is mainly caused by insulin resistance and progressive decrease in pancreatic beta cell function. If hyperglycemia is not controlled in a timely manner or is not well controlled, it can cause irreversible vascular complications such as retinopathy, renal insufficiency, myocardial infarction, stroke, and amputation.

Currently, T2DM treatment mainly uses a comprehensive management model, including diet control, proper exercise, blood sugar monitoring, diabetes education, and application of hypoglycemic drugs. Lifestyle intervention is a basic treatment for diabetes. As the course of the disease progresses, patients need to gradually increase combined treatment with hypoglycemic drugs with different mechanisms of action. Current clinical guidelines recommend that GLP-1 receptor agonists can effectively reduce blood sugar and body weight, improve blood lipid profile, and lower blood pressure.

HRS-7535 tablets are a novel oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist. It can not only promote pancreatic insulin secretion, reduce glucagon secretion, and inhibit gastric emptying by activating human GLP-1R, but also enhance satiety and suppress appetite by directly reducing energy intake by influencing central mechanisms to treat type 2 diabetes (T2DM) and lose weight. Only Eli Lilly's FOUNDAYO (orforglipron), the global oral small molecule GLP1R agonist, was approved for marketing by the FDA in April 2026. Up to now, the total R&D investment for HRS-7535 film-related projects is about 494.4 million yuan (unaudited).