Changchun high tech Jinsai Pharmaceutical Co., Ltd. gained clinical approval for new indication of long-term growth hormone

According to the website of the State Food and drug administration, the latest status of pegylated recombinant human growth hormone injection (referred to as long-acting growth hormone) applied for clinical application by Jinsai pharmaceutical, a subsidiary of Changchun Hi Tech Holding Co., Ltd., is "certificate preparation completed - issued approval document" According to people familiar with the matter, the approval is a clinical approval for the new indication "SGA" According to the data, SGA was first used to treat SGA indications in 1970 in the world FDA of the United States approved SGA as one of the indications of SGA in July 2001 In Europe, it was approved in March 2003 for the long-term treatment of SGA dwarfs who failed to achieve catch-up growth when they were 2 years old After receiving the approval documents, the company will start phase 1-3 clinical trials of the indication one after another The long-term growth hormone is the heavyweight new drug approved for production by Kinsey pharmaceutical in January this year for the first time in the world The approved indication is "children's slow growth caused by the lack of endogenous growth hormone" According to Yang Zhanmin, chairman of Changchun hi tech, the company is promoting the GMP certification of the product and striving for the long-term growth hormone to be listed at the end of this year Industry insiders said that long-term growth hormone has not been approved for production in the world, and will truly establish Changchun hi tech's position in this field after listing, and build its widest moat in the field of growth hormone Yang Zhanmin also once said that there are not many real new drugs on the market, and there is no problem in the market of several hundred million long-term growth hormone In addition, Zhou Weiqun, director of Changchun hi tech, once said that the new indication of long-term growth hormone, anti-aging, is in the process of application According to the 2013 half year report of Changchun Hi Tech Co., Ltd., at present, the indications of long-term growth hormone application in clinical include: increasing SGA, Turner syndrome, AGHD and ISS.