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 3, 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 2026-135

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:

1. Basic information about drugs

Drug name: HRS-7535 tablets

Dosage form: tablet

Acceptance number: CXHS2600122, CXHS2600124

Application stage: listing

Applicant: Shandong Shengdi Pharmaceutical Co., Ltd.

Proposed indications (or functional indications): It is suitable for long-term weight management of adults whose initial body mass index (BMI) meets the following requirements based on diet control and increased exercise: ① ≥ 28kg/m2 (obesity), or ② ≥ 24kg/m2 (overweight) and accompanied by at least one weight-related comorbidity (such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, fatty liver, etc.).

2. Clinical trials of drugs

This application for marketing is based on a multi-center, randomized, double-blind, placebo-controlled, parallel-design pivotal Phase III clinical trial of HRS-7535 tablets in adult patients with overweight or obesity (study number: HRS-7535-303), aiming to evaluate HRS-7535 tablets 120 mg and 180 mg. Efficacy, safety, and tolerability of treatment compared with placebo in nondiabetic participants who are obese or overweight and have at least 1 weight-related comorbidity.

The HRS-7535-303 study is led by Professor Mu Yiming from the First Medical Center of the Chinese People's Liberation Army General Hospital as the principal investigator. A total of 50 centers across the country were launched and 556 subjects were randomly enrolled. The results of the study showed that all dose groups of HRS-7535 tablets achieved all primary endpoints and key secondary endpoints at 44 weeks of treatment. The average weight loss in the 180mg group could reach 10.9%; and the weight loss effect continued with continued treatment, and the average weight loss in the 180mg group could reach 11.1% at week 50. Improvements in multiple cardiometabolic indicators were also observed. Safety and tolerability data were consistent with other reported oral GLP-1 therapies, with no new safety signals observed and a favorable hepatic safety profile.

3. Other information about drugs

Overweight and obesity are chronic metabolic diseases caused by excessive total body fat content and/or increased local fat content and abnormal distribution, caused by the combined effects of genetic and environmental factors. China currently uses the criteria of 24.0kg/m2≤BMI<28.0kg/m2 and BMI≥28.0kg/m2 to diagnose overweight and obesity in adults respectively [1]. The main treatments for obesity include lifestyle intervention, weight loss drugs, and metabolic surgery [2]. When lifestyle intervention is ineffective, combined drug therapy or metabolic surgery can be considered. Among them, oral small molecule GLP-1 receptor agonists are convenient to administer, have fewer medication restrictions, and can avoid injection site reactions caused by injection preparations, so they are expected to become an important choice in weight loss drug treatment [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).

4. 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 3, 2026

[1] Chooi YC, Ding C, Magkos F. The epidemiology of obesity[J]. Metabolism. 2019;92:6-10.

[2] Chinese Nutrition Society Obesity Prevention and Control Branch, Chinese Nutrition Society Clinical Nutrition Branch, Chinese Society of Preventive Medicine Behavioral Health Branch, et al. Expert consensus on obesity prevention and treatment among Chinese residents [J]. Chinese Journal of Epidemiology. 2022;43(5):609-626.

[3] Patel D (April 16, 2026) Small-Molecule Oral Versus Injectable Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists: Comparative Efficacy, Safety, and Future Clinical Perspectives. Cureus 18(4): e107202. doi:10.7759/cureus.107202..