Sichuan Guowei is expected to win the first model of dutasteride

Original: dopine Recently, Sichuan Guowei Pharmaceutical Co., Ltd.'s listing application for class 4 generic drug "dutasteride capsule" was changed to "under approval" in nmpa, which is expected to become the first domestic enterprise to win the dutasteride generic drug This is also good news from Sichuan Province in the field of first imitation of heavy-duty products after winning solina's new first imitation in 2018 Dutasteride (trade name: avodart) is a 5 α reductase inhibitor developed by GlaxoSmithKline It was approved by FDA in 2001 for the treatment of prostatic enlargement In 2008, it was approved by FDA in combination with tamsulosin for the treatment of prostatic hyperplasia In 2011, it was approved by nmpa to enter China There are two kinds of 5 α reductase in human body, I type and II type Type I is mainly distributed in liver and skin, and type II is mainly in prostate 5 α reductase can promote the transformation of testosterone to dihydrotestosterone, which is more active, leading to the hyperplasia of prostate cells and prostate hypertrophy It is worth mentioning that the treatment with I and II * 5 alpha reductase can reduce the volume of prostate quickly and continuously, improve the symptoms of lower urinary tract, reduce the risk of acute urinary retention and related prostate surgery, and make patients benefit from enduring, especially the majority of moderate and severe BPH patients However, finasteride and elistramine, the same kind of competitive drugs, belong to type II 5 α - reductase inhibitors, which have a slow effect They are not suitable for the patients with severe symptoms of BPH, the patients with a serious slowdown in urinary flow rate, and the patients with a large amount of residual urine In recent years, the global sales of dutasteride has declined, as shown in the figure below In 2018, the global sales of dutasteride was £ 572 million, down 6.7% from 2017 In China, at present, only the original developed dutahostalamine soft capsule (trade name: anfuda) has been approved for listing According to minenet, its sales in public hospitals in key provinces and cities in China reached 270000 yuan in 2018, up 4.73% year on year Among them, the generic drug listing applications put forward by humanwell and Sichuan Guowei have obtained priority review, but only the generic drug listing applications put forward by Sichuan Guowei are in the "approval" stage It is worth mentioning that humanpoke Pharmaceutical (Wuhan) Co., Ltd has received the approval number of dultiazem soft capsule from the U.S Food and Drug Administration (FDA) in November 2017 At present, Sichuan Guowei also has a generic drug celecoxib in the stage of listing application (acceptance No cyhs1900040, 41), and celecoxib is also a heavy anti-inflammatory drug with domestic sales exceeding 1 billion yuan Domestic Hengrui and Zhengda Qingjiang generic drug applications have been approved In addition, there are two approved products in Sichuan in the past two years, namely moxifloxacin hydrochloride tablets and solina Succinate Tablets Among them, the most proud is solina succinate new film, which is the first imitation product approved by Sichuan The original manufacturer of the drug is Astaire, which is a new muscarinic receptor (M receptor) antagonist It was approved in the European Union in 2003, approved in the United States in 2004, and approved for import in China in 2009 Its trade name is Weixikang It is mainly used in the treatment of urinary incontinence and / or frequency of urination and urgency of urination in patients with overactive bladder (OAB) Its sales reached 102.3 billion yen in 2017 reference material: [1] Insight database