Announcement by Renfu Pharmaceutical Regarding the Issuance of a Clinical Trial Notification for Remimazolam Benzenesulfonate Injection

Release time:

2021-09-22 08:08

Source:

Security Code: 600079; Short Name: Renfu Pharmaceutical; Reference No.: Lin 2021-093

Announcement by Renfu Pharmaceutical Group Co., Ltd. Regarding the Issuance of a Clinical Trial Notification for Remimazolam Benzenesulfonate Injection

Special Notice

The Board of Directors and all directors of this company hereby guarantee that the contents of this announcement do not contain any false records, misleading statements, or material omissions, and they assume individual and joint liability for the truthfulness, accuracy, and completeness of its contents.

Renfu Pharmaceutical Group Co., Ltd. (hereinafter referred to as the “Company”) recently received from the National Medical Products Administration an Approval Notice for Clinical Trials of Remimazolam Benzenesulfonate Injection, issued after approval, from its controlling subsidiary, Yichang Renfu Pharmaceutical Co., Ltd. (hereinafter referred to as “Yichang Renfu”; the Company holds an 80% equity stake in Yichang Renfu). The relevant details are hereby announced as follows:

I. Drug Name: Remimazolam Benzenesulfonate for Injection

2. Dosage Form: Injection

3. Application Item: Clinical

4. Registration Category: Chemical Drug, Class 2.4

V. Applicant: Yichang Renfu Pharmaceutical Co., Ltd.

VI. Approval Conclusion: In accordance with the Drug Administration Law of the People’s Republic of China and relevant regulations, after review, the Remimazolam Mesylate Injection submitted on July 14, 2021 meets the requirements for drug registration. We hereby approve the initiation of Phase II and Phase III clinical trials for this product, intended for sedation during intensive care unit (ICU) treatment.

Remimazolam mesylate for injection is a novel benzodiazepine drug jointly developed by Yichang Humanwell Pharmaceutical and the German company PAION. It is an ultra-short-acting GABAA receptor agonist. The indication approved this time for clinical trials is sedation during intensive care unit (ICU) stays. In November 2018, Yichang Humanwell Pharmaceutical submitted a marketing application for remimazolam mesylate for injection to the National Medical Products Administration, and the drug was approved for marketing in July 2020, with the approved indication being sedation for colonoscopy. To date, the cumulative investment in this project—including this latest approval—has amounted to approximately RMB 100 million. In November 2019, PAION of Germany submitted a marketing application to the European Medicines Agency for remimazolam mesylate for procedural sedation, and the application was approved in March 2021. With authorization from PAION of Germany, Mundipharma submitted a marketing application for remimazolam mesylate for general anesthesia in Japan, which was approved in January 2020; Cosmo submitted a marketing application for remimazolam mesylate for procedural sedation in the United States, and the application was approved in July 2020; and Hana Pharm submitted a marketing application for remimazolam mesylate for general anesthesia in South Korea in December 2019, receiving approval in January 2021.

In accordance with China’s laws and regulations governing drug registration, Yichang Humanwell will, upon receiving the above-mentioned clinical trial notification for the drug, promptly commence work related to the clinical study of the drug. After completing the clinical study, the company will submit the clinical trial data and relevant documentation to the National Medical Products Administration to apply for marketing approval and launch of the drug.

The early-stage R&D of pharmaceutical products, as well as the entire process—from product development and clinical trials to approval and production—takes a long time and involves numerous steps, making it susceptible to various uncertain factors. Investors are advised to pay close attention to investment risks. The company will promptly fulfill its information disclosure obligations based on the actual progress of drug development.

This is hereby announced.

Board of Directors, Renfu Pharmaceutical Group Co., Ltd.
September 18, 2021

Announcement by Renfu Pharmaceutical Regarding the Issuance of a Clinical Trial Notification for Remimazolam Benzenesulfonate Injection

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