Hengrui medicine degree tatamine soft capsules were approved! Second in the country

On January 7, NMPA's latest approval showed that Hengrui Pharmaceuticals' Class 4 generic drug "Dothamide SoftGel" was approved for market and approved as if it had passed a consistent evaluation, becoming the second domestic company to be approved.
the drug is a prostate hyperplation treatment.
dutrsteride is a 5-alpha-reductase inhibitor that inhibits both type I. and type II.2 5-alpha reductase for the treatment of moderate to severe symptoms of benign prostate hyperplus (BPH).
the drug, developed by GlaxoSmithKline and listed in the U.S. in 2001, expired in 2015 and sold for 572 million pounds in 2018;
The benign prostate hyperplus drugs used in our country are mainly tansolosin, finasteride, trasone, pyridoxine, alfazole, Eplett, Serodosin, dothamide and other varieties.
public data show that the overall domestic market reached 3.35 billion in 2018.
drug Tansorosin, which was the number one drug in sales, accounted for 49.7%, followed by non-anarenaline at 40%, traginate in third place at 6.9% and 3 varieties at 94.6% of the overall market.
, it is understood that dotamphetamine is more rapid than non-nataxiong, the effect is more significant, with the advantage of double inhibition.
Insight database shows that, in addition to the original research GSK in China, only Sichuan was approved for the first imitation of pharmaceutical companies, Hengrui was approved as the second.
addition, the variety also has two companies declared, respectively, people Fupuk and Qilu Pharmaceuticals, the latter just reported production yesterday.
Wangao Pharmaceuticals and Jiangxi National Pharmaceuticals are in the BE trial phase, and another 8 enterprises have been approved for clinical treatment.
's Dotaxamine from Insight Database () was produced on August 29, 2018, less than a week later than Hengrui, and has been included in the priority review for "production on the same production line, listed in the U.S. in 2017", but it appears that the review is slower than that of non-priority reviewer Hengrui.
addition, the varieties associated with dothamphetamine also have their compound preparation tyroamine tanlo new capsule (i.e., dothamphetamine /tanloxin compound preparation).
drug, also developed by GSK, was approved by the U.S. FDA in June 2010 to treat symptomatic benign prostate hyperplosy.
the original research has not yet applied for imports, the domestic progress of only Jiangsu Hengrui Pharmaceutical, Chongqing Medical Institute 2 enterprises, have been approved clinical.