[hot spot] Hengrui inhaled desflurane will be listed in China, or it will break the monopoly situation of the original research

On August 6, Jiangsu Hengrui announced that its subsidiary, Shanghai Hengrui, had received the drug registration approval document approved and issued by the State Food and drug administration, and the drug name was desflurane for inhalation (240ml) Up to now, the company has invested about 31 million 980 thousand yuan in the R & D project of the product The second first generic desflurane launched by Hengrui in the US is suitable for anesthesia induction and / or maintenance of adult inpatients and outpatients, as well as anesthesia maintenance of infants and children Because desflurane belongs to inhalation preparation, it needs binding application of raw materials and devices, so it is difficult to develop Previously, only Baite's original research drug was approved for sale in the U.S market on September 18, 1992, and few imitations were made On February 26, 2018, Hengrui's inhaled desflurane (anda208234) was approved for marketing by FDA, becoming the first imitated enterprise of the drug in the United States Desflurane has also become Hengrui's second first drug in the United States after cyclophosphamide In addition, as early as July 2017, Hengrui's desflurane for inhalation was approved for listing in the European Union (UK, Germany and the Netherlands) According to the domestic situation, at present, only Baite company has been approved to import desflurane for inhalation, Hengrui company has been approved to produce, no other company in China has obtained production approval, and no other company has applied for clinical application and production of the generic drug Prior to the acceptance of registration of inhaled desflurane, on July 11, 2017, CDE included the domestic listing application of Hengrui inhaled desflurane into the priority review on the basis of "production in the same production line, listing in the European Union in 2017" After this listing, the product will continue to enjoy the preferential policies of consistency evaluation It is reported that there are two situations "deemed" to pass the consistency evaluation One is to use the same production line in China to produce and market the drugs approved to be listed in the European Union, the United States or Japan, and the acceptance and Reporting Center shall be responsible for the acceptance of the application materials; the consistency evaluation office shall notify the drug review center of the General Administration (hereinafter referred to as the drug review center) to review the original domestic and foreign listing application materials, and notify the food and drug review and inspection center of the General Administration (hereinafter referred to as the "center") Inspection Center) to inspect the production site It is deemed to pass the conformity assessment after being reviewed and approved by the conformity assessment office Second, for generic drugs that have been approved for listing in the EU, the US or Japan by domestic drug manufacturers, the application for generic drug registration shall be submitted in accordance with the relevant requirements of the announcement on the issuance of the work plan for the reform of the registration and classification of chemical drugs, which shall be reviewed by the drug Audit Center, and shall be deemed to have passed the consistency evaluation after being approved for listing And through the consistency evaluation of varieties, social security departments will give appropriate support in the aspect of medical insurance payment, medical institutions should give priority to purchasing and clinical selection The desflurane for Hengrui's inhalation meets these two requirements In addition, the approval conclusion of the approval document also mentioned that the quality and efficacy of this product are consistent with the original research product The details are as follows: or it will break the monopoly situation of the original research According to the announcement, the global sales volume of inhaled desflurane in 2017 is about 268 million US dollars, and the sales volume in China is about 3.25 million US dollars According to the bidding information query database of smart drugs, at present, only Baite company and Sinopharm holding distribution center won the bid in the domestic market From 2017 to 2018, the average bidding price of 240ml * 1 desflurane for inhalation was 777 yuan After winning the bid for desflurane, Hengrui's desflurane will be listed on the market, and supported by the domestic policies related to consistency evaluation varieties, which is likely to impact the high price monopoly situation of Baite in China At present, there is no news of declaration from other enterprises in China, which also shows that the market situation of desflurane for inhalation may last for a long time We will continue to pay attention to the specific situation Source of this article: relevant databases of yaozhi.com, juchao.com, China food and drug regulatory information network, etc