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On July 30, the official website of NMPA released the approval document, and Shanghai Huilun Jiangsu Pharmaceutical "Serodosin Capsule" was approved for listing and deemed to have passed the consistency evaluation, becoming the first domestically-produced generic drug of Serodosin in China
.
Click here to view the acceptance number
Source: NMPA official website
Xerodosin is an α1-receptor antagonist developed by Kissei Pharmaceutical Company of Japan.
Jusheng and Daiichi Sankyo licensed Xerodosin to Watson Pharmaceutical Company of the United States, which in 2008 In August, it was approved by the U.
S.
Food and Drug Administration (FDA) for marketing
.
Serodosin is a third-generation drug for the treatment of BPH.
It can block the sympathetic nervous system mediated by α1A-adrenergic receptor subtypes distributed in the prostate, urethra and bladder triangle of the lower urinary tract tissue, and relax the smooth muscle of the lower urinary tract tissue Tighten and inhibit the increase in urethral pressure, thereby improving urination disorders caused by benign prostatic hyperplasia
.
Benign prostatic hyperplasia (BPH) is one of the common diseases in elderly men and is characterized by non-malignant enlargement of the prostate
.
More than 50% of elderly people 60 years of age or older suffer from this disease, and more than 90% of elderly people aged 85 years or older suffer from this disease
Compared with tamsulosin, xylodosin has obvious advantages in improving lower urinary tract symptom groups and patients with benign prostatic hyperplasia.
It has 7.
5 times higher selectivity for the urethra than tamsulosin, with lower side effects, and may become its alternative.
.
A number of foreign studies have confirmed the effectiveness and safety of xylodosin in the treatment of BPH/LUTS symptoms
.
A randomized, double-blind, placebo and positive drug controlled phase III clinical trial conducted by Japanese scholars included 457 BPH patients, divided into xerodoxine group (N=176) and tamsulosin group (N= 192) and placebo group (N=89), the results showed that xerodoxine improved the total IPSS score significantly better than placebo (P <0.
The Chinese phase III clinical trial of xerodoxine included 516 patients with BPH, which were divided into xerodoxine group (N=344) and placebo group (N=172)
.
The results showed that from the first week, compared with placebo, xerodoxine can significantly improve the IPSS score and patient QOL (P<0.
In addition, the safety evaluation results of the China Phase III clinical trial showed that the incidence of dizziness and bradycardia in the xerodoxine group were 3.
5% and 2.
04%, respectively, compared with that in the placebo group (4.
17%) and bradycardia (2.
98%).
The incidence is comparable
.
The safety evaluation results of phase III clinical trials in the United States showed that the incidence of orthostatic hypotension in the xylodosin group was low (2.
According to the Insight database, currently only Uniform produced by the original Daiichi Sankyo Pharmaceutical has been approved for listing
.
In addition to Shanghai Huilun, which is making the fastest progress, four types of generic drugs from Kunming Jida Pharmaceuticals and Hainan Wanwei Pharmaceuticals have also submitted applications for listing
Source: Insight database (http://db.
dxy.
cn/v5/home/)
Serodosin is a Category B product of the National Medical Insurance in 2019 and 2020.
According to the Insight database, its latest bid-winning online price in 2020 is 4.
15 yuan/4mg
.
Public information shows that the market for benign prostatic hyperplasia drugs in public hospitals in key provinces and cities in China in 2018 was 615 million yuan, and the overall domestic market has reached a market size of 3.
