Clinical approval of fospropofol sodium dihydrate in synthetic pharmaceutical industry

Announcement No.: 2015-042 securities code: 832077 securities abbreviation: Synthetic Pharmaceutical sponsor securities firm: Guohai Securities Shaanxi Synthetic Pharmaceutical Co., Ltd announcement on "phosphopropofol sodium dihydrate raw materials and preparations" obtaining approval for clinical trials of drugs The company and all members of the board of directors guarantee that the contents of the announcement do not contain any false records, misleading statements or major omissions, and bear individual and joint liabilities for the authenticity, accuracy and integrity of the contents Shaanxi Synthetic Pharmaceutical Co., Ltd (hereinafter referred to as "the company") has applied for "raw materials and preparations of phosphopropofol sodium dihydrate", a chemical medicine of category 3.1, and obtained the approval document for clinical trials of drugs issued by the State Food and drug administration, Now, the contents of the approval are announced as follows: drug name approval No dosage form specification application item registration classification approval result consent to this product phosphopropofol sodium II domestic pharmaceutical chemicals 2015l03052 API - Preparation hydrate registration class 3.1 clinical trial consent to this product phosphopropofol domestic pharmaceutical chemicals 2015l03398 injection 1.05g for clinical sodium phenolate dihydrate registration test 3.1 propofol sodium is a new type of short-acting intravenous general anesthesia drug, which is metabolized into active substance propofol in vivo to produce anesthetic effect Propofol is a kind of intravenous general anesthesia widely used in clinic Because of its fast onset, short half-life, high clearance rate and convenient target controlled infusion, it is widely used in clinical anesthesia and ICU sedation at home and abroad However, there are also some adverse reactions in the clinical application of propofol, which are mainly related to the preparation form of propofol with fat emulsion as carrier, such as causing pain at the injection site, thrombophlebitis, hyperlipidemia, potential fatal bacterial infection, allergic reaction and severe and rare propofol infusion syndrome By modifying the chemical structure of propofol, the product has good water solubility and does not need the fat emulsion carrier of propofol preparation, so as to reduce the occurrence of the above adverse reactions on the basis of its pharmacological effect We sincerely invite investors to invest rationally and pay attention to investment risks It is hereby announced Board of directors of Shaanxi Synthetic Pharmaceutical Co., Ltd November 16, 2015