Securities code: 002653 Securities abbreviation: Haisco Announcement No.: 2022-011
The company and all members of the board of directors warrant that the information disclosed is true, accurate and complete, and that there are no false records, misleading statements or Major omission.
Liaoning Haisco Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Haisco Pharmaceutical Group Co., Ltd. (hereinafter referred to as the “Company”), recently received the “Drug Registration Certificate” approved and issued by the State Drug Administration. The relevant information is now announced as follows:
1. Basic information of the drug
1. Drug name: Cyclopofol injection
Acceptance number: CXHS2101025 country
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Certificate No.: 2022S00106
Dosage Form: Injection
Specification: 20ml:50mg
Application Matters: Drug Registration (Domestic Production)
Registration classification: Class 2.4 of chemical drugs
Indications: New indication of “Induction and Maintenance of General Anesthesia”
Approval conclusion: According to the “Medicine Administration Law of the People’s Republic of China” ” and relevant regulations, after review, this product meets the relevant requirements for drug registration, and it is approved to increase the indications. The new indication is “general anesthesia induction and maintenance”, and a drug registration certificate is issued.
2. Drug-related situations
Cyclopofol injection is an intravenous anesthetic, and its active ingredient, cyclopofol, is a (R)-configuration isomer small-molecule drug, which is a GABAA receptor agonists, by acting on GABAA receptor-mediated chloride channels, increase current conduction and cause neuronal hyperpolarization. This hyperpolarization causes consistent neural signal transmission and reduces the success rate of action potential generation, thereby depressing the central nervous system and producing anesthesia.
Cyclopofol injection is generally safe and well tolerated, and its pharmacodynamic activity is about 5 times that of propofol. The effect on respiration was superior to that of propofol, the effect on heart rate and blood pressure was not inferior to that of propofol, and the lipid input was less than that of propofol.
3. Other information about the drug
Cyclopofol injection has been approved by the State Drug Administration for the following indications: “sedation during gastrointestinal endoscopy”, ” “Sedation in Bronchoscopy” and “General Anesthesia Induction and Maintenance”, “Sedation During Intensive Care” and “Sedation and Anesthesia for Outpatient Gynecological Surgery” are still under marketing application approval. The approval of the new indication “general anesthesia induction and maintenance” will further expand the clinical application market of cyclopofol injection and provide more patients with a more comfortable and safer anesthesia experience.
II. Main risk warnings
Due to the industry characteristics of pharmaceutical products, the future sales of cyclopofol injection may be affected by policy changes, market demand, market competition of similar drugs, etc. Due to the influence of uncertain factors, there are certain uncertainties. Investors are advised to make decisions carefully and pay attention to preventing investment risks.
It is hereby announced.
Haiseco Pharmaceutical Group Co., Ltd.
Board of Directors
February 25, 2022