Announcement on Voluntarily Disclosing HY-1016 Sustained-Release Injection and Obtaining the Acceptance Notice for Drug Clinical Trial Application
Securities code: 688553 Securities abbreviation: Huiyu Pharmaceutical Announcement number: 2026-020
Sichuan Huiyu Pharmaceutical Co., Ltd.
Announcement on voluntary disclosure of HY-1016 sustained-release injection receiving drug clinical trial application acceptance 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 in accordance with the law.
Recently, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Huiyu Haiyue"), a wholly-owned subsidiary of Sichuan Huiyu Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company"), received an "Acceptance Notice" approved and issued by the State Food and Drug Administration, and the clinical trial application for HY-1016 sustained-release injection (project development code "HY-1016") for the treatment of endometriosis was accepted. Since drugs have a long research and development cycle and many approval processes, they are easily affected by some uncertain factors. Investors are advised to make prudent decisions and pay attention to guarding against investment risks. The relevant information is now announced as follows:
1. Basic information on drugs
Drug name: HY-1016 sustained-release injection
Application matters: Registration of clinical trials of domestically produced drugs
Acceptance number: CXHL2600466, CXHL2600467, CXHL2600468, CXHL2600469 Registration classification: Chemical drugs Class 2.2
Indications: This product is intended to be used in the treatment of endometriosis.
Applicant: Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd.
Approval conclusion: According to the provisions of Article 32 of the "Administrative Licensing Law of the People's Republic of China", after review, it is decided to accept the application.
2. Other related information about drugs
Dienogest is a highly selective progesterone receptor agonist that reduces the endogenous production of estradiol by inhibiting the hypothalamic-pituitary-ovarian axis, thereby inhibiting the stimulating effect of estradiol on normal and ectopic endometrium, and plays a role in endometriosis. When administered continuously, dienogest induces an endocrine environment of low estrogen and high progesterone, causing decidualization of endometrial tissue, thereby shrinking endometriosis lesions. HY-1016 sustained-release injection is a new dosage form and new route of administration containing dienogest, with the aim of reducing the frequency of medication for long-term treatment of endometriosis patients and improving medication compliance without reducing clinical efficacy or adding new important safety risks.
Dienogest may be the drug of choice for the long-term management of endometriosis. Dienogest tablets are launched in Japan, the European Union, China and other countries and regions. As of the date of this announcement, the original research and development of dienogest tablets and a number of generic pharmaceutical products have been approved for marketing in China.
3. Risk warning
Because pharmaceutical products are high-tech, high-risk, and high-value-added, the early stage of drug research and development and the product development, clinical trial approval, and production have long cycles and many links, and are easily affected by some uncertain factors. The company will actively promote the above-mentioned research and development projects and perform its information disclosure obligations on the subsequent progress of the projects in a timely manner in strict accordance with relevant regulations. Investors are kindly requested to make prudent decisions and pay attention to preventing investment risks.
Announcement is hereby made.
Board of Directors of Sichuan Huiyu Pharmaceutical Co., Ltd.
April 22, 2026