Kinsey pharmaceutical industry: heavy biological drugs will be listed on the market and import substitution will be realized immediately or rapidly

Jinlei, general manager of Changchun jinshai Pharmaceutical Co., Ltd., recently, according to the information on the website of CFDA, the on-site inspection of recombinant human follicle stimulating hormone for injection and the combined inspection of GMP certification of jinshai Pharmaceutical Co., Ltd., a subsidiary of Changchun High Tech Co., Ltd., have been reviewed and passed, and the publicity period is 10 working days, from June 26, 2015 to July 9, 2015 It is worth mentioning that recombinant human follicle stimulating hormone for injection has been approved for production at the end of last month, and the drug approval number is: gyzz s20150007 GMP certification means that the products can be arranged for production and marketing Recombinant human follicle hormone for injection was used to treat infertility Guotai Junan research report pointed out that at present, the recombinant follicle stimulating hormone in the domestic market is only an imported product, which is expensive The follicle stimulating hormone of Jinsai pharmaceutical is the first domestic recombinant product, which is expected to be priced at half of the price of imported products, with good safety and efficacy It is expected to rapidly realize import substitution after listing It is a new drug for Changchun hi tech According to the public information, Kinsey pharmaceutical applied for the clinical approval document of the drug in October 2006 and was approved for clinical application in 2008 In July 2010, the company applied for production approval documents, and was twice notified to issue supplements, so the approval process was rather rough In August last year, the product entered the drug registration site inspection and the new GMP certification of the production workshop at the same time.