HENGRUI PHARMA - Announcement of Jiangsu Hengrui Pharmaceutical Co., Ltd. on withdrawing its drug registration application
HENGRUI PHARMA - An announcement has just been published by the issuer in the Chinese section of this website, a corresponding version of which may or may not be published in this section
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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")
The Shanghai Stock Exchange website (www.sse.com.cn) published the following announcement. 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 June 23, 2026
As at the date of this announcement, members of the Board of Directors include (i) Executive Directors Mr. Sun Piaoyang, Mr. Dai Hongbin, and Mr. Feng Jinu; Mr. Zhang Lianshan, Mr. Jiang Ningjun and Mr. Sun Jieping; (ii) Ms. Guo Congzhao, a non-executive director; 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 Medicine Announcement number: Lin 2026-088
Jiangsu Suhenghengrui Medical Pharmaceutical Co., Ltd.
Announcement on the withdrawal of applications for drug registration
The board of directors and all directors of the company guarantee that the contents of this announcement do not contain any false records or misleading statements.
or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its content.
Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") received a notice from the National Drug Administration
The "Notice of Termination of Drug Registration Application" issued by the Administration (hereinafter referred to as "State Food and Drug Administration"), agrees
The company withdrew its drug registration application for aimaxitinib ointment. The relevant information is now announced as follows:
- The basic situation of pharmaceuticals and drugs
Drug name: Amaxitinib ointment (SHR0302 alkali ointment) Dosage form: ointment
Acceptance number: CXHS2500018
Applicant: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Proposed indications (or functional indications): This product is suitable for localized treatment of mild to moderate atopic dermatitis in adults.
External treatment. 22. Other situations of pharmaceuticals
In February 2025, the company submitted the application for amaxitinib ointment to the Drug Evaluation Center of the State Food and Drug Administration.
City permit application and accepted. Since the drug needs to further improve the application materials, it has been reviewed by the company and the national drug
After communication with the center, the company decided to withdraw its registration application. The company will promptly fulfill its information disclosure obligations based on project conditions.
service. Amaxitinib ointment is a topical, highly selective JAK1 inhibitor with high local exposure
Better inhibit JAK1 signaling and exert anti-inflammatory and immunosuppressive biological effects. Company's same target film
The pharmaceutical product amaxitinib sulfate tablets has been approved for marketing in March 2025, and has been approved for four indications, including
Including ankylosing spondylitis, atopic dermatitis, rheumatoid arthritis and alopecia areata.
For the indications of atopic dermatitis, there are currently similar smear drugs Incyte/CMZ Pharmaceuticals available globally.
Ruxolitinib Cream (OPZELURA®) and Delgocitinib Ointment from Japan Tobacco/Torii Pharmaceuticals
(CORECTIM®) was approved for marketing. After inquiry, the total global sales of similar products in 2025 and above will be approximately 7.29
billion dollars. Up to now, the total number of research projects related to Aimaxitinib (tablets, ointments and gels) has been
The investment in development is approximately RMB 1,222.4 million (unaudited). 33. Warnings on the impact and risks on the company
The withdrawal of the drug registration application for Amaxitinib Ointment will not have any impact on the company’s current and future production and operations.
It will have a significant impact on performance, and the company will efficiently promote follow-up work. Drug development and clinical trial submission
The cycle from production to production is long and involves many steps, and drug research and development to launch are easily affected by some uncertain factors.
Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks. The company will actively promote it in accordance with relevant national regulations The above-mentioned research and development projects, and promptly perform information disclosure obligations on the subsequent progress of the projects.
Announcement is hereby made.
Board of Directors of Jiangsu Hengrui Pharmaceutical Co., Ltd.
June 23, 2026