Jinsai Pharmaceutical Co., Ltd. is about to be approved for production of follicle stimulating hormone

According to the information on the website of CFDA on June 4, the processing status of recombinant human follicle stimulating hormone for injection of heavy biological products of Jinsai Pharmaceutical Co., Ltd., a subsidiary of Changchun hi tech (000661 SZ), was changed to "approval completed pending certificate", and the drug approval number was: gyzz s20150007, which means the drug was approved successfully In March this year, at the 2014 annual performance presentation, Yang Zhanmin, chairman of the board of directors of the company publicly stated that follicle stimulating hormone is in the stage of three in one review, and it will be approved in early June if it goes smoothly 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 FSH 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 be replaced by imported products quickly 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.