Alfentanil Hydrochloride Injection Approved for the First Time in China

Recently, Yichang Renfu Pharmaceutical Co., Ltd. received the "Drug Registration Approval" approved and issued by the State Drug Administration, three specifications of alfentanil hydrochloride injection (trade name: Rejixin®) are all chemicals3ClassInFebruary26DayThis is the first time that alfentanil products have been approved for listing in China.

Alfentanil HydrochlorideFor Janssen, BelgiumOriginal researchProducts,First listed in the Netherlands in 1983,1987It was introduced to the U.S. market in 2010 and is widely used in Europe and the United States for up30The clinical effect can stand the test of time, but it has not yet been listed in China.

Alfentanil hydrochloride (Alfentanil Hydrochloride)

Chemical Name:N-[1-[2-(4-Ethyl-4,5-dihydrogen-5-Oxygen-1H-Tetrazole-1-Base)Ethyl]-4-(Methoxymethyl)-4-piperidinyl]-N-Phenyl propionamide hydrochloride monohydrateStructural formula:

Alfentanil hydrochloride is an analog of fentanyl, mainly acting onUth Opioid receptor and.Alfentanil hydrochloride is a short-acting strong analgesic used during anesthesia, mainly for the induction and maintenance of general anesthesia, especially during the day./short surgery, medium and long-term surgery, etc. The drug three-in-one: quick,30Secondsonset of effect; short effect, maintenance time15Minutes, between remifentanil and sufentanil; potent, the analgesic intensity is that of morphine15 times.At the same time, the incidence of respiratory depression, nausea, vomiting and cough is low, and the clinical application is safer.in addition,Because alfentanil has a relatively constant time-dependent half-life, it is an ideal choice for target-controlled infusion.

Comprehensive Drug Database (PDB) display,2018Global sales of Alfentanil Hydrochloride Injection in1420US $10,000, year-on-year growth4.41%. With the rapid development of day surgery, the clinical demand for medium and short-term analgesic drugs is further expanded.In addition, from2019Year5Month1Since then, China has implemented the whole class of fentanyl substances. Information shows that previously included in the tube.25Fentanyl, sufentanil, remifentanil, alfentanil4Varieties are medicines. Among them, fentanyl, sufentanil and remifentanil this3Varieties have previously been listed in China.

Yichang Renfu is a national designated manufacturer of narcotic drugs, with narcotic drugs as the core, star products include remifentanil, sufentanil, nalbuphine, hydromorphone, etc,Achieved net profit in the first half of 20194.99Billions of dollars. This time, Yichang Renfu's Alfentanil Hydrochloride Injection was approved for listing, making it the first company to occupy the domestic Alfentanil market,Take the leadhaveIt'sA full range of four fentanyl drugs, creating a new milestone in the development of narcotic analgesics in China, alsoPromoted the realization of human welfare in Yichang“cannabis layout”（Anesthesia Analgesiasedation).

The road to the listing of Alfentanil Hydrochloride of Renfu Medicine is not smooth sailing.20049Month, people are luckyNMPAApplication for fixed-point development shall be submitted and accepted;2008Year10Month, received clinical trial approval and in.2013Year1Monthly declaration of production; but in2015Year7Monthly voluntary withdrawal pending improvement of clinical data;2018Year3Monthly re-declaration and included in the priority review;2019Year5MonthNMPACheck the clinical data of the drug registration application;2020Year2month, finally approved for listing.

In addition to Renfu Medicine, the main foreign manufacturers of alfentanil hydrochloride includeAkorn is theHospiraAnd so on, the domestic Jiangsu Enhua Pharmaceutical has also been.2019Year10Monthly submission of listing applications. Alfentanil as a result of havingAboveQuick-acting, short-acting, strong-acting and other characteristics, its.Approved domestically.Listing will beOur countryClinicians offer more medication options for day surgery“Tailored”The treatment plan to better meet the medication needs of different patients,To promoteOur countryHigh-quality development of medical services increasedIt'sNew Power.