1d ago
HENGRUI PHARMA - Jiangsu Hengrui Pharmaceutical Co., Ltd.’s indicative announcement on acceptance of drug marketing authorization application
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Jiangsu Hengrui Pharmaceutical Co., Ltd.
(a joint stock limited company incorporated in the People's Republic of China)
(Stock code: 1276)
Overseas regulatory announcement
This announcement is made in accordance with Rule 13.10B of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited.
In accordance with the relevant laws and regulations of the People's Republic of China, Jiangsu Hengrui Pharmaceutical Co., Ltd. (the "Company") published the following announcement on the website of the Shanghai Stock Exchange (www.sse.com.cn). They are listed below for reference only.
By order of the board of directors
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Chairman
Mr. Sun Piaoyang
Shanghai, China
September 2, 2026
As at the date of this announcement, the members of the Board include (i) executive directors Mr. Sun Piaoyang, Mr. Dai Hongbin, Ms. Feng Ji, Mr. Zhang Lianshan, Mr. Jiang Ningjun and Mr. Sun Jieping; (ii) non-executive director Ms. Guo Congzhao; and (iii) independent non-executive directors Mr. Lou Liguang, Mr. Zeng Qingsheng, Mr. Sun Jinyun and Mr. Zhou Ji'en.
Securities code: 600276 Securities abbreviation: Hengrui Pharmaceutical Announcement Number: Lin 2026-134
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Indicative Announcement on Acceptance of Drug Marketing Authorization Application
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
Recently, Shandong Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received an "Acceptance Notice" from the State Food and Drug Administration (hereinafter referred to as the "State Food and Drug Administration"). The company's drug marketing authorization application for HRS-7535 tablets was accepted by the State Food and Drug Administration. The relevant information is now announced as follows:
- Basic information about drugs
Drug name: HRS-7535 tablets
Dosage form: tablet
Acceptance number: CXHS2600122, CXHS2600123
Application stage: listing
Applicant: Shandong Shengdi Pharmaceutical Co., Ltd.
Intended indications (or functional indications): For glycemic control in adults with type 2 diabetes.
- Clinical trials of drugs
This application for marketing is based on two multi-center, randomized, parallel-controlled pivotal phase III clinical studies of HRS-7535 tablets in adult patients with type 2 diabetes (T2DM) (study names OUTSTAND-1, OUTSTAND-2). Two studies respectively evaluated the effectiveness and safety of HRS-7535 tablets in T2DM patients with poor blood sugar control through diet and exercise alone and in T2DM patients with poor blood sugar control after metformin treatment.
The OUTSTAND-1 study is led by Professor Xiao Xinhua from the Chinese Academy of Medical Sciences and Peking Union Medical College Hospital. A total of 46 centers across the country were launched and 284 subjects were randomly enrolled. Research results show that among patients with type 2 diabetes who have poor diet and exercise control alone, the glycated hemoglobin (HbA1c) in each dose group of HRS-7535 tablets decreased by 1.40%-1.68%. The OUTSTAND-2 study is led by Professor Guo Lixin of Beijing Hospital as the principal investigator. A total of 104 centers were launched across the country and 810 subjects were randomly enrolled. The study results showed that among adult participants with type 2 diabetes and poor blood sugar after metformin treatment, HbA1c in each dose group of HRS-7535 tablets decreased by 1.50%-1.68% (the dapagliflozin group decreased by 1.28%). In addition to lowering blood sugar, HRS-7535 tablets also demonstrate multi-dimensional benefits such as weight loss, lowering urinary protein, lowering blood pressure and improving blood lipids, and has good safety and tolerability.
- Other information about drugs
Diabetes is a metabolic syndrome characterized by hyperglycemia caused by defective insulin secretion and/or insufficient insulin action. In 2024, the number of diabetic patients worldwide has reached 589 million, and the number of diabetic patients in China is approximately 148 million, ranking first in the world; it is expected that the global number of diabetic patients will increase to 853 million in 2050, and the number of Chinese patients will reach 168 million [1]. T2DM accounts for more than 90% of all diabetes cases and is mainly caused by insulin resistance and progressive decrease in islet β-cell function [2]. If hyperglycemia is not controlled in time or is poorly controlled, it can cause irreversible vascular complications such as retinopathy, renal insufficiency, myocardial infarction, stroke, and amputation.
At present, the treatment of T2DM mainly adopts a comprehensive management model, including diet control, reasonable exercise, blood sugar monitoring, diabetes education, and application of hypoglycemic drugs. Lifestyle intervention is the basic treatment for diabetes. As the disease progresses, patients need to gradually increase the combination of hypoglycemic drugs with different mechanisms of action. Current clinical guidelines recommend that GLP‑1 receptor agonists can effectively reduce blood sugar and weight, improve blood lipid profiles and lower blood pressure [3].
HRS-7535 tablets are a new 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 can also be used to treat type 2 diabetes (T2DM) and lose weight by affecting the central nervous system to enhance satiety, suppress appetite, and directly reduce energy intake. Among the world's oral small molecule GLP-1R agonists, only Eli Lilly's FOUNDAYO (orforglipron) was approved by the FDA in April 2026. Up to now, the cumulative R&D investment in projects related to HRS-7535 tablets has been approximately 494.4 million yuan (unaudited).
- Risk warning
The cycle from drug development, clinical trial approval to production is long and involves many steps. Drug research and development to launch are easily affected by some uncertain factors. Investors are advised to make prudent decisions and pay attention to guarding against investment risks. The company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations and fulfill its information disclosure obligations on the subsequent progress of the projects in a timely manner.
Announcement is hereby made.
Board of Directors of Jiangsu Hengrui Pharmaceutical Co., Ltd.
September 2, 2026
[1]International Diabetes Federation. The 11th edition of the diabetes atlas. 2025. http://www.diabetesatlas. org.
[2]American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1): S15-S33. doi:10.2337/dc21-S002
[3] Diabetes Branch of the Chinese Medical Association. Guidelines for the Prevention and Treatment of Diabetes in China (2024 Edition) [J]. Chinese Journal of Diabetes, 2025, 17(1):16-139..