Anti ed domestic class 1 new drug is coming! 3 billion market to be challenged, can Viacom hold on?

Wonderful content recently, China Pharmaceutical announced that the phase II and phase III clinical application of tpn729ma, a new anti ed class 1 drug of Tianfang Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, has been approved by the State Food and drug administration The data of phase I clinical trial showed that in the study of activity and selectivity of tpn729ma with other PDE inhibitors, the action intensity of tpn729ma was equal to or stronger than sildenafil; the selectivity of tpn729ma with PDE6 was higher than sildenafil to a certain extent; the selectivity of pde11 was higher than tadalafil; it was expected that the adverse reactions of tpn729ma caused by poor selectivity in clinic would occur The rate will be lower The first-line treatment of ED is mainly oral medication The commonly used drugs in clinic are type 5 phosphodiesterase inhibitors (PDE5) At present, the PDE5 inhibitors on the market include sildenafil, tadalafil, vardenafil, etc In the global market, Lilly's sales volume of hilly (tadalafei) has already exceeded US $2 billion; in the domestic market, the total sales volume of sildenafil has also exceeded US $2 billion In the face of tpn729ma, can Heineken and Viagra survive? None = "shifumousedownstyle ('shifu bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; font family: - apply system font, BL inkmacsystemfont," Helvetica Neue "," Pingfang SC "," hiragino sans GB "," Microsoft YaHei UI "," Microsoft YaHei ", Arial, sans serif; US $100 million Table 1: global sales of three original anti ed products in 2015-2017 (data source: performance database of MNEs in minai.com) Pfizer's Viagra (sildenafil) is the pioneer in the field of anti ed after being approved for listing in the United States in 1998, the sales volume has been rising steadily, among which the sales peak appeared in 2012, and the global sales volume in that year was US $2051 million With the expiration of patents of products in various countries, Viagra has been continuously impacted by generic drugs, and its sales volume has declined sharply In 2017, the global sales volume fell to $1.204 billion Viagra belongs to short acting medicine, with action time of 4-5 hours; it can't be mixed with nitrates, or it may reduce blood pressure, and can't drink alcohol while taking medicine, or it will also reduce its effect; clinical proof shows that Viagra has some short acting and slight side effects Lilly's Heineken (tadalafi) was approved in 2002 and listed in France in 2003 Although its initial performance is not as good as that of Viacom, its growth rate has become rapid since 2007, and its global sales in 2017 reached US $2.323 billion Hilly's compound patents expire in January 2015, but ED use patents expire in April 2020 It is expected that global sales will still have the potential to increase in the next few years Hierlich is a long-acting drug, with action time of 36 hours; it is different from Viagra, which is not affected by alcohol and high-fat diet; it has better safety than Viagra, less adverse reactions after taking medicine, and no drug residues are found in the body Bayer's Alida (vardenafil) launched in 2003, but compared with Pfizer and Lilly, Bayer is relatively weak in the market layout, and its post IPO report card is not bright In 2015, the global sales volume was only 226 million euros (about 264 million US dollars) Compared with Viagra and hilly, Aida has the fastest onset time, about 15 minutes, similar to Viagra, about 4-5 hours none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; font-family: -apple-system-font, Bl inkMacSystemFont, "Helvetica Neue", "PingFang SC", "Hiragino Sans GB", "Microsoft YaHei UI", "Microsoft YaHei", Arial, sans-serif; font-size: 17px; letter-spacing: 0.544px; widows: 1; line-height: 25.6px; color: rgb(62, 62, 62); border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> sildenafil is far ahead in the domestic market, and generic drugs are tied with the original research Figure 1: Sales of three major anti ed products in China from 2015 to 2017 (unit: 100 million yuan) (data source: minenet database) According to the data of minenet, in 2017, the total sales of sildenafil in China's urban public hospitals, county-level public hospitals, urban community centers, township hospitals (referred to as China's public medical institutions) terminals and China's urban retail drugstores terminal chemical medicine market have exceeded 2.2 billion yuan, while the total sales of tadalafil have exceeded 700 million yuan Figure 2: the proportion of sildenafil in each terminal from 2015 to 2017 (data source: minernet database) Figure 3: the brand pattern of sildenafil in China's urban retail drugstores from 2015 to 2017 (source: minernet China's urban retail drugstore terminal competition pattern) The main sales markets of sildenafil in China's urban retail drugstore terminals accounted for more than 90% in 2015-2017 At present, there are 6 enterprises that have obtained the production approval of sildenafil citrate tablets The main competitors in the market include Pfizer, Baiyunshan Pharmaceutical General Factory and Jiangsu Yabang Epson pharmaceutical With the approval and listing of domestic generic drugs, the market share of the original research manufacturers has declined rapidly, while Baiyunshan Pharmaceutical Co., Ltd is also constantly seizing the share In 2017, it has formed a tie with Pfizer According to the data of Baiyunshan's 2017 annual report, the sales volume of sildenafil citrate increased by 52.25% year-on-year as a result of continuous efforts to develop new products, expand the market, promote promotion means and drive the growth of terminal sales Figure 4: the proportion of tadalafil in all terminals (data source: minenet database) from 2015 to 2017 Due to the patent is not expired, currently there is only one manufacturer in tadalafil in the market, and the main sales market of this product is also the terminal of China's urban retail drugstores, accounting for more than 80% in 2015-2017 Although tadalafil's sales in the world are far higher than that of sildenafil, sildenafil's performance in the Chinese market is excellent In addition to the obvious price advantage of generic drugs, the potential of this product in the Chinese market is expected to be stronger than that of tadalafil none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; 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Im portant; word wrap: break word! Im portant; "> inside and outside pinch! Can Viagra hold on? Table 2: approval of sildenafil citrate tablets in China (data source: midindex comprehensive database of midnet) Currently, in the domestic market, there are 5 enterprises besides Pfizer with approval of sildenafil citrate tablets In addition, according to the 2.0 data of midnet Med China drug review database, the generic production application of sildenafil citrate tablets of Guangzhou Langsheng Pharmaceutical Co., Ltd is under review and approval According to the data of minenet China clinical trial publicity database, the human bioequivalence study of sildenafil citrate tablet of Guangzhou Langsheng Pharmaceutical Co., Ltd is in the "completed" state, and a new competitive enterprise of sildenafil citrate tablet will be established in China Table 3: at present, there is no generic drug of tadalafil in the domestic market As of August 8, 2018, 9 domestic enterprises have applied for the production of 4 types of generic drugs of tadalafil, and the current processing status is "under review and approval" According to the data of minenet China clinical trial publicity database, in addition to Guangdong dongyangguang Pharmaceutical Co., Ltd., the test status of tadalafei tablet bioequivalence test of 8 enterprises declared earlier is "completed" Which product will be the first to be imitated is very worthy of expectation In July 2000, Pfizer's sildenafil was approved to be listed as Viagra in China; in September 2001, the State Intellectual Property Office approved the patent right for use in China; in May 2004, Pfizer's sildenafil was approved to be retail in pharmacies However, after the expiration of the patent, Viagra is facing the increasingly serious impact of domestic generic drugs, and its market share is gradually being snapped up The generic drugs of tadalafil, a similar product, have also become the new target of domestic pharmaceutical companies, and the pressure has never abated In addition, tpn729ma, which was approved for clinical use in China, is a more selective and innovative PDE5 inhibitor with independent intellectual property rights, which can reduce the side effects of listed drugs to a certain extent and reduce the economic burden of patients Under the internal and external attack, what will be the future performance of Viacom in China? Welcome to leave a comment Source: minenet database, announcement of listed companies