Sichuan Guowei is expected to win the first imitation of dutasteride

Release date: 2020-01-10 Views: 0

Source: CPhI Pharmaceutical Online

Recently, Sichuan Guowei Pharmaceutical Co., Ltd.'s 4 generic drugs "dutasteride capsules" have been listed in the NMPA status as "under approval". It is expected to become the first domestic company to win dutasteride generic drugs. This is also the good news for Sichuan Guowei for the first imitation of blockbuster products after winning the new first imitation of Solina in 2018.

Dutasteride (Avodart) is a 5α reductase inhibitor developed by GlaxoSmithKline. It was approved by the FDA in 2001 for the treatment of prostate enlargement, and was approved by the FDA in 2008 in combination with tamsulosin for the prostate treatment. Hyperplasia, was approved to enter the country in 2011 by NMPA. There are two types of 5α reductase in the human body, namely type I and type II. Type I is mainly distributed in the liver and skin, and type II is mainly found in the prostate. 5α reductase can promote the conversion of testosterone to the more active dihydrotestosterone, which leads to the proliferation of prostate cells and the enlargement of the prostate.

It is worth mentioning that dutasteride can inhibit both type I and type II 5α reductase, rapidly and continuously reduce the volume of the prostate, significantly improve lower urinary tract symptoms, reduce the risk of acute urinary retention and related prostate surgery, and make patients lasting Benefit, especially the majority of patients with moderate to severe benign prostatic hyperplasia. And its competitors, finasteride and eritoride, are type II 5α-reductase inhibitors, which have a slow onset of action, and are not suitable for those with severe symptoms of benign prostatic hyperplasia, severely slowing urine flow rate, and more residual urine volume. By.

In recent years, the global sales of dutasteride have declined, as shown in the figure below. In 2018, its global sales were 572 million pounds, a 6.7% decrease from 2017. In China, only the original research dutasteride soft capsule (trade name Anfuda) has been approved for listing. According to, its sales in public hospitals in key domestic provinces and cities in 2018 were 270,000 yuan, a year-on-year increase of 4.73%.

According to the insight database, 12 domestic companies are currently deploying the androstamine soft capsule market, but only 3 companies have submitted listing applications (see the table below for details).

Among them, Renfu Puke and Sichuan Guowei's generic drug listing applications have received priority review, but only Sichuan Guowei's generic drug listing applications are in the "in approval" stage. It is worth mentioning that Renfu Puke Pharmaceutical (Wuhan) Co., Ltd. has received the US Food and Drug Administration (FDA) approval for dutasteride soft capsules in November 2017.

At present, Sichuan Guowei also has a generic drug Celecoxib in the market application stage (Acceptance Nos. CYHS1900040, 41), and Celecoxib is also a blockbuster anti-inflammatory drug with domestic sales exceeding 1 billion yuan. Domestic Hengrui and Chia Tai Qingjiang generic drug application has been approved.

In addition, two products approved by Sichuan State for the past two years are moxifloxacin hydrochloride tablets and solinacin succinate tablets. The most proud of them is the new Solina succinate film, which is the first imitation product approved by Sichuan Guowei. The original manufacturer of the drug is Astellas, 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. Trade name Wei Xikang, clinically used for the treatment of urinary incontinence and / or frequent urination and urgency symptoms associated with overactive bladder (OAB) patients, with sales of 102.3 billion yen in 2017.


[1] insight database

[2] Sichuan Guowei's official website

[3] CDE, NMPA official website

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