HENGRUI PHARMA - Announcement from Jiangsu Hengrui Pharmaceutical Co., Ltd. on Obtaining the Approval Notice for Drug Clinical Trials
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
July 29, 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 2026-109
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Announcement on Obtaining Drug Clinical Trial Approval Notice
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, Fujian Shengdi Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received the approval and issuance of the "Drug Clinical Trial Approval Notice" for HRS5580 for injection from the State Food and Drug Administration (hereinafter referred to as the "NMPA") and will conduct clinical trials in the near future. The relevant information is now announced as follows:
- Basic information about drugs
Drug name: HRS5580 for injection
Dosage form: injection
Application Matters: Clinical Trial
Acceptance number: CXHL2 600457
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, HRS5580 for injection, which was accepted on April 17, 2026, complies with the relevant requirements for drug registration, and it is agreed that this product can carry out Phase II clinical trials. Indications applied for: prevention of postoperative nausea and vomiting, combined with palonosetron hydrochloride injection for the prevention of postoperative nausea and vomiting.
- Other conditions of drugs
HRS5580 for injection is a selective neurokinin-1 (NK-1) receptor antagonist that blocks the binding of substance P to NK-1 receptors with high affinity, exerting a strong antiemetic effect. This variety has differentiated advantages such as high solubility, good safety, and long-lasting effects. After inquiry, it was found that drugs with the same target on the market globally, such as Heron Company’s aprepitant injection emulsion (APONVIE®), are short-acting NK-1 antagonists, and no long-acting preparations have yet been approved. Up to now, the cumulative R&D investment in HRS5580 related projects has been approximately 57.7 million yuan (unaudited).
- Risk warning
According to the laws and regulations related to drug registration in my country, after a drug obtains a drug clinical trial approval notice, it still needs to conduct clinical trials and undergo review and approval by the State Food and Drug Administration before it can be produced and marketed. 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.
July 29, 2026