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    Home > Medical News > Latest Medical News > Anti-ED "miracle drug" broke 4 billion for the first time! Baiyun Mountain is firmly in the lead, and Qilu has soared

    Anti-ED "miracle drug" broke 4 billion for the first time! Baiyun Mountain is firmly in the lead, and Qilu has soared

    • Last Update: 2022-11-04
    • Source: Internet
    • Author: User
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    Men's Health Day
    is October 28.
    Erectile dysfunction (ED) is one of the common diseases affecting men's health, Intranet data shows that in recent years, the anti-ED drug market has expanded year by year, and the sales scale of retail pharmacy terminals in 2021 will exceed 5.
    5 billion yuan, of which urban physical pharmacies are the "main battlefield", and sales are expected to further increase in 2022; The rise of domestic brands, Baiyun Mountain ranked first, and new products such as Qilu and Tasly were significantly released; In terms of research, 57 varieties are under review with new classifications, and 14 new drugs (8 Class 1 new drugs) are in the clinical application stage or above, of which 5 have entered the phase III clinical stage and above, and can be marketed
    .
     
    The market is expanding year after year! Anti-ED drugs sold more than 5.
    5 billion yuan
     
    In recent years, due to factors such as the accelerated pace of life, increased work pressure, and unhealthy lifestyle habits, the number of erectile dysfunction (ED) patients has shown an upward trend and is developing
    younger.
    According to the National Health and Health Survey data, the prevalence of ED in the male group over 40 years old in China is about 40%.

     
    At present, oral phosphodiesterase type 5 (PDE5) inhibitors are still the preferred treatment of ED, and the more popular drugs include sildenafil, tadalafil, vardenafil, etc
    .
     
    PDE5 inhibitors that have been marketed in China
    Source: New version of the Intranet database
     
    More than 20 pharmaceutical companies' generic tadalafil tablets, more than 10 pharmaceutical companies' sildenafil citrate tablets generic drugs have been approved for marketing, valdenafil hydrochloride tablets, avanafil tablets, sildenafil citrate oral collapse tablets, etc.
    have also ushered in the first imitation enterprises; In terms of innovative drugs, the improved new drug tadalafil oral lytic film was approved in February 2022, and the first anti-ED domestic Class 1 new drug, edinafil citrate, was also approved for marketing at the end of 2021, bringing new options
    for ED patients.
     
    Retail pharmacies are the main way for
    ED patients to purchase drugs.
    According to data from Intranet, the sales of PDE5 inhibitors in China's retail pharmacy terminals (urban physical pharmacies + online pharmacies) have increased year by year in recent years, exceeding 5.
    5 billion yuan in 2021, a year-on-year increase of more than 30%.

     
    Sales of terminal PDE5 inhibitors in retail pharmacies in China in recent years (10,000 yuan)
    Source: Intranet database
     
    From the perspective of market segmentation, urban physical pharmacies are the "main battlefield" of PDE5 inhibitors, with a market size of more than 4 billion yuan for the first time in 2021, and is expected to further expand in 2022, with a year-on-year increase of about 1.
    5%; Driven by the epidemic and policies, PDE5 inhibitors have risen rapidly in online pharmacies, with sales growth of more than 50% in the past two years, exceeding 1.
    5 billion yuan in 2021, a year-on-year increase of about 78%.

     
    From the perspective of subdivided varieties, the market size of the anti-ED "miracle drug" sildenafil has been far ahead since its listing, exceeding 4 billion yuan for the first time in 2021, of which more than 1 billion yuan in online pharmacies for the first time, a year-on-year increase of more than 60%; Since the expiration of the patent in 2020, generic drugs have been put on sale, and the overall market size of tadalafil has soared, exceeding 1.
    4 billion yuan in 2021, a year-on-year increase of 44%, and it is expected that the sales of physical pharmacy terminals in Chinese cities will exceed 1 billion yuan
    for the first time in 2022.
    In addition, there are few approved manufacturers such as vardenafil, avanafil, and edinafil, and the market is still waiting to be
    released.
     
    Baiyun Mountain was firmly at the top of the list, and Qilu broke out
     
    Pfizer's sildenafil citrate tablets (Viagra) were the first PDE5 inhibitors to enter the domestic market, and for a long time after, the domestic anti-ED drug market was dominated
    by Pfizer, Lilly, and Bayer.
    Until the end of Via's patent protection period in China in 2014, generic drugs were successively approved for marketing, and domestic brands began to emerge.

     
    Among domestic pharmaceutical companies, Qilu Pharmaceutical has 3 PDE5 inhibitors approved for marketing, among which tadalafil oral dissolved film is a new drug for improved preparation; Kelun, Langsheng Pharmaceutical, Guangshengtang and Dongguang Yao all have 2 PDE5 inhibitors approved for marketing, of which 2 products of Kelun are the first to generate; Baiyunshan, Yangtze River, Renfu, Nanjing Zhengda Tianqing, Hengrui, Haisco and many other companies have 1 PDE5 inhibitor approved for marketing
    .
     
    The approval of PDE5 inhibitors by some pharmaceutical companies
    Source: MID Drug Index Comprehensive Database of Intranet
     
    Baiyun Mountain's sildenafil citrate tablets (Jinge) were approved in 2014 as the first imitation, and after listing, they have overcome difficulties all the way, and their sales and market share have gradually increased, and in 2019, they successfully replaced Pfizer as the leader of sildenafil, and are expected to rank first
    in sales in 2022.
     
    2022E China's urban physical pharmacy terminal PDE5 inhibitor TOP10 brand
    Note: Sales below 100 million yuan are represented by *
     
    Source: Intranet China's urban physical pharmacy terminal competition pattern
     
    Tasly, Qilu, Guangzhou Langsheng Pharmaceutical, Chengdu Shengdi Pharmaceutical and other pharmaceutical companies have significantly
    increased the number of newly approved varieties.
    Tasly's tadalafil tablets were approved for marketing at the end of 2019, and it is expected that the sales of physical pharmacy terminals in Chinese cities will exceed 300 million yuan in 2022, a year-on-year increase of about 77%; Qilu's sildenafil citrate tablets and tadalafil tablets were approved in August 2020 and November 2019 respectively, and the sales growth rate is expected to reach 75.
    69% and 85.
    78%
    in 2022, respectively.
     
    57 new products are on the way, and 3 Class 1 new drugs can be expected to be launched
     
    With more and more companies entering the market, the current domestic anti-ED drug market has been a red sea
    .
    In addition to the approved varieties, there are currently 57 newly classified varieties declared and under review (in terms of drug name + enterprise name), involving 4 products (in terms of drug name).

     
    The new classification is declared as a generic PDE5 inhibitor drug under review
    Source: MED2.
    0 China Drug Evaluation Database
     
    Tadalafil tablets are the most competitive, the product has been approved by more than 20 companies of generic drugs, and more than 30 companies are currently under review; Sildenafil citrate tablets have been approved for generic drugs from more than 10 companies, and there are currently 8 companies whose products are under review
    .
    The above two products have been included in the national centralized procurement
    .
     
    In terms of innovative drugs, the first anti-ED domestic Class 1 new drug, edinafil citrate, has been approved for marketing
    at the end of 2021.
    In addition, according to incomplete statistics, there are currently 14 new anti-ED drugs in the approved clinical stage
    and above.
     
    Some of the new anti-ED drugs under research in China
    Source: China Drug Clinical Trial Publicity Database on Intranet
     
    Three Class 1 new drugs have entered phase III clinical trials, and all of them are PDE5 inhibitors, namely ukonafil hydrochloride tablets (Yangtze River), TPN729MA tablets (Tianfang Pharmaceutical/Shanghai Institute of Materia Medica, Chinese Academy of Sciences) and TPN171H tablets (Shanghai Institute of Materia Medica, Chinese Academy of Sciences/Wangshan Wangshui Biotechnology).

     
    The improved new drug focuses on oral lytic film preparations, and Kelun Pharmaceutical's sildenafil citrate oral lytic film and Hengrui/Haosen's tadalafil oral lytic film are under review; Sichuan Baili Pharmaceutical's tadalafil oral instant film and Lipin Pharmaceutical's tadalafil oral instant film have been approved for clinical trials
    .
     
    Source: Intranet database
     
    Note: Intranet's "Terminal Competition Pattern of China's Urban Physical Pharmacies", the statistical scope is: urban physical pharmacies at the prefecture level and above nationwide, excluding county and rural pharmacies; Intranet's "Competition Pattern of China's Online Pharmacy Terminals", the statistical scope is: all drug data of online pharmacies nationwide, including Tmall, Jingdong and other third-party platforms and all online pharmacies on private domain platforms; The above sales are calculated
    based on the average retail price of the product.
    Data statistics as of October 26, if there are any omissions, welcome to correct!
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