Stock code: 600079 Stock abbreviation: Renfu Pharmaceutical No.: Lin No. 2022-070
Special Note
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content.
Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as “Yichang Renfu”, the company holds 80% of its equity), a holding subsidiary of Renfu Pharmaceutical Group Co., Ltd. The “Approval Notice for Supplementary Drug Application” for midazolam injection approved and issued by the State Drug Administration, the main contents of the approval document are hereby announced as follows:
1. Drug Name: Midazolam Injection
2. Approval number: 2022B02144, 2022B02145, 2022B02146
3. Dosage form: injection
4. Specifications: 10ml: 50mg, 1ml: 5mg, 5ml: 5mg
5. Registration Category: Chemicals
6. Drug approval number: National Medicine Zhunzi H20227064, National Medicine Zhunzi H20227065, National Medicine Zhunzi H20227066
7. Validity period of drug approval number: until May 6, 2026
8. Pharmaceutical manufacturer: Yichang Renfu Pharmaceutical Co., Ltd.
9. Approval conclusion: According to the “Pharmaceutical Administration Law of the People’s Republic of China” and relevant regulations, after review, the application for this product meets the relevant requirements for drug registration, and it is agreed that this product should be added 10ml:50mg, 1ml: 10ml: 50mg, 1ml: 5mg, 5ml: 5mg specifications, issued a drug approval number.
Midazolam injection is mainly used for preoperative sedation/anxiety/amnesia; diagnosis, treatment, endoscopic surgery; induction and maintenance of general anesthesia; sedation in patients with endotracheal intubation, mechanical ventilation and critical care treatment. Yichang Renfu submitted a supplementary application for 3 new specifications to the State Drug Administration in October 2021 and was accepted. Up to now, the cumulative R&D investment in this project is approximately RMB 3.6 million. According to the statistics of Minet.com, the sales of midazolam injection in the three major terminal public hospitals of cities, counties and townships in my country in 2021 are about 700 million yuan. The main manufacturers are Jiangsu Enhua Pharmaceutical Co., Ltd., Yichang people are blessed.
After the new specification of midazolam injection is approved, the company will arrange the production and listing according to the market demand. The new specifications of midazolam injection this time enrich the company’s product line, meet clinical needs to a greater extent, and help the company to further enhance its market competitiveness. The specific future sales of this product may be affected by factors such as industry policies and market environment, and there are uncertainties. Investors are advised to make decisions carefully and pay attention to preventing investment risks.
Special announcement.
Board of Directors of Renfu Pharmaceutical Group Co., Ltd.
June 11, 2022