Announcement on Obtaining Notice of Approval for Drug Clinical Trial for Hydromorphone Hydrochloride Tablets
Securities code: 600079 Securities abbreviation: ST Renfu Number: Lin 2026-059
Renfu Pharmaceutical Group Co., Ltd.
Announcement on Hydromorphone Hydrochloride Tablets 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.
Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as "Yichang Renfu", in which the company holds 80% of the equity), a holding subsidiary of Renfu Pharmaceutical Group Co., Ltd. (hereinafter referred to as the "Company"), recently received the "Drug Clinical Trial Approval Notice" for Hydromorphone Hydrochloride Tablets approved and issued by the State Food and Drug Administration. The relevant information is now announced as follows:
1. Drug name: Hydromorphone Hydrochloride Tablets
2. Dosage form: tablet
3. Application matters: Registration of clinical trials of domestically produced drugs
4. Registration classification: Class 3 chemicals
5. Applicant: Yichang Renfu Pharmaceutical Co., Ltd.
- Review conclusion: After review, the clinical trial application for Hydromorphone Hydrochloride Tablets accepted on April 21, 2026 meets the relevant requirements for drug registration, and it is agreed that this product can be used to carry out randomized controlled clinical studies for the analgesia of moderate to severe postoperative pain in adults.
Hydromorphone is a semi-synthetic derivative of morphine that mainly acts on μ-opioid receptors in the central nervous system to exert analgesic effects. It has fewer adverse reactions than morphine and has more stable pharmacokinetics. The original research licensee of Hydromorphone Hydrochloride Tablets (trade name: Dilaudid) is Rhodes Pharmaceuticals L.P., and this product is currently not approved for marketing in China. Up to now, Yichang Renfu’s cumulative R&D investment in this project has been approximately RMB 5.4 million.
According to the laws and regulations related to drug registration in my country, Yichang Renfu needs to start the clinical research related work of the drug after receiving the above-mentioned drug clinical trial notice. After completing the clinical research, it will submit the clinical trial data and related information to the National Medical Products Administration and apply for production and marketing.
The early research and development of pharmaceutical products and the products from development, clinical trial approval to production have long cycles and many links, and are easily affected by some uncertain factors. Investors are advised to pay attention to investment risks. The company will fulfill its information disclosure obligations in a timely manner based on the actual progress of the project.
Announcement is hereby made.
Board of Directors of Renfu Pharmaceutical Group Co., Ltd.
July 7, 2026