Yichang Renfu Class 3 Generic Alfentanil Hydrochloride Will Be Approved for Marketing

Recently, according to the nmpa official website, the listing application of three generic drugs of alfentanil hydrochloride injection (acceptance No.: cyhs1700408, cyhs1700409, cyhs1700410, representing different specifications) declared by humanwell pharmaceutical has been in the state of "approval" It is expected to be approved for listing in the near future and become the first approved alfentanil drug in China Alfentanil hydrochloride injection is a powerful analgesic for anesthesia, which is suitable for short-term operation (source: nmpa) as a kind of fentanyl analogue, alfentanil hydrochloride is a kind of twists and turns way of declaration It mainly acts on μ opioid receptor It is a short-term strong analgesic used in anesthesia and is suitable for short-term operation The drug has three effects in one: quick effect, 30s onset; short effect, 15min duration, between remifentanil and sufentanil; strong effect, 15 times of the intensity of morphine analgesia, because the time-dependent half-life of alfentanil is relatively constant, so it is one of the ideal choices for target controlled infusion Alfentanil hydrochloride was first listed in the Netherlands in 1983 and introduced into the U.S market in 1987 So far, it has been used in clinical safety for 30 years, and its clinical effect can stand the test of time At present, it has not been listed in China Renfu pharmaceutical's application for listing of alfentanil hydrochloride can be described as twists and turns In September 2004, humanwell has submitted the designated development application of alfentanil hydrochloride to nmpa and accepted it; then in October 2008, humanwell obtained the approval document of clinical trial and applied for production in January 2013; however, on July 22, 2015, after Announcement No 117, humanwell took the initiative to withdraw the application of the variety and decided to apply after the clinical data was improved On March 28, 2018, the drug was included in the priority review with "the applicant voluntarily withdraws and changes to the generic drug registration application which is improved according to the standard consistent with the quality and efficacy of the original research drug"; on May 24, 2019, nmpa decided to check the clinical data of the three drug registration applications related to the clinical trial declaration and production of humanwell's alfentanil hydrochloride injection The examination and approval status has changed It should have passed the clinical data verification and will be approved for listing soon (source: CDE) if alfentanil hydrochloride goes on the market successfully, Yichang humanwell will be equipped with mainstream fentanyl products, including fentanyl, remifentanil, sufentanil and alfentanil From May 1, 2019, the whole class of fentanyl is in line in China According to the data, among the 25 kinds of fentanyl substances previously included in the pipeline, four varieties of fentanyl, sufentanil, remifentanil and alfentanil are drugs, among which three varieties of fentanyl, sufentanil and remifentanil have been listed in China In addition to humanwell pharmaceutical, currently the main foreign manufacturers of alfentanil hydrochloride include akorn, hospita, etc., and Jiangsu Enhua Pharmaceutical Co., Ltd has submitted the listing application in October 2019 (source: CDE) Yichang humanwell is a national designated manufacturer of narcotic drugs, with narcotic drugs as the core The star products include remifentanil, sufentanil, naborphine, hydromorphone, etc the net profit in the first half of 2019 is 499 million yuan In addition, Yichang humanwell, remazolam benzenesulfonate and disodium phosphopropofol, two class 1 new drugs, are in the stage of application and listing, and the author will continue to pay attention to the latest situation.