It is expected that the recombinant human follicle stimulating hormone for injection will be approved for market within this year

According to the information on August 4 on the website of the State Food and Drug Administration (CFDA), the recombinant human follicle stimulating hormone for injection of the heavy biological products of Jinsai pharmaceutical, a subsidiary of Changchun hi tech, will enter the site for inspection this month, and the production workshop of the product will carry out the new GMP certification at the same time Industry insiders pointed out that after the on-site inspection, there are three in one comprehensive review and CFDA signature, and the drug is expected to be approved for market within this year At the same time, carrying out GMP certification in the workshop will accelerate the product listing 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 the imported products of Swiss xuelanuo and oganon, which are 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 Recombinant human follicle stimulating hormone and long-term growth hormone for injection are two major new drugs of Changchun hi tech Kinsey Pharmaceutical Co., Ltd applied for the clinical approval of the drug in October 2006, obtained the clinical approval in 2008, and applied for the production approval in July 2010 During this period, it was notified to issue the supplement two times, and the approval process was quite bumpy.