Hengruihua takes the first endocrine medicine, imitates Zhengda Tianqing and grabs GSK anti asthma medicine

Medical network, July 11 news, July 10, Hengrui pharmaceutical released a notice that its subsidiary Chengdu Shengdi pharmaceutical recently received the approval of drug registration issued by the State Food and drug administration, and four kinds of imitation of abitrone acetate tablets (250mg) were approved for production, which was the first imitation in China and deemed to have passed the consistency evaluation According to the data of minenet, in 2018, the global sales of the original product Xi'an Janssen's abitrone acetate tablets exceeded US $3 billion, and the total sales at domestic terminals also exceeded RMB 600 million Over US $3 billion in endocrine therapy drugs in the world, hengruihua 40 million won the first copy of Figure 1: Sales of abitrone in the global and domestic markets (source: data from minenet) It is reported that abitrone acetate tablets are transformed into abitrone in vivo Abitrone is an androgen biosynthesis inhibitor that inhibits 17 α - hydroxylase / C17, 20 lyase (CYP17) This product is combined with prednisone or prednisolone to treat metastatic castration resistant prostate cancer (mcrpc) and newly diagnosed high-risk metastatic endocrine therapy sensitive prostate cancer (mhspc) without endocrine therapy or with endocrine therapy for up to 3 months Abitron was approved to be listed in the United States as early as April 2011, and now it has been listed and sold in Canada, the European Union, Japan and other countries In 2015, abitron was approved in China In 2018, the total sales of abitron in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminals and China's urban retail drugstores terminals exceeded 600 million yuan Hengrui pharmaceutical said in the announcement that up to now, the R & D cost of the product project has been about 39.05 million yuan Seven global heavyweight products with more than 1 billion US dollars are to be imitated for the first time, and domestic giants are in fierce competition Table 1: global sales of heavyweight products with more than 1 billion US dollars dominating the domestic market with more than 100 million US dollars (source: data of minenet) The total sales volume of these seven global large varieties of over US $1 billion in the domestic terminal market (China's public medical institutions terminal and China's urban retail drugstores) is over 100 million yuan Currently, there is no imitated product in the domestic market In recent years, on the one hand, innovation is encouraged at the national level, on the other hand, consistency evaluation is vigorously promoted In 2019, centralized mining will continue to expand the scope of pilot projects and the number of products The pharmaceutical industry in China is developing rapidly The priority review has also accelerated the entry of some global new drugs into China, especially the heavy-duty varieties with global sales of over US $1 billion, which have become hot in the domestic market, making domestic enterprises salivate and the first imitation war is imminent Table 2: application for copying the above-mentioned heavy-duty products (source: medchina drug review database 2.0) According to the 2.0 data of medchina drug review database of minenet, up to now, 7 global large varieties with more than 1 billion US dollars have applied for generic drug listing, among which rivaroxaban is the most competitive, 16 drug companies are in the review and approval process, and 7 drug companies of sigletin phosphate are competing for the first copy It's sunny! Domestic sales of salmeterotikasson exceed 1 billion yuan Figure 2: Sales of salmeterotikasson in the global and domestic markets (source: data from the Internet) According to the data from the Internet, sales of salmeterotikasson of GlaxoSmithKline in the global market have declined in recent years, reaching 2.422 billion pounds (about 3.016 billion US dollars) in 2018 In the domestic market, in recent years, salmeterotikasson has shown an upward trend In 2018, the total sales volume of terminals of China's urban public hospitals, county-level public hospitals, urban community centers, township hospitals (referred to as China's public medical institutions) and China's urban retail drugstores reached nearly 1.8 billion yuan At present, in the domestic market, salmeterol ticasone powder inhaler and salmeterol ticasone aerosol are imported products of GlaxoSmithKline, and the proportion of salmeterol ticasone powder inhaler is more than 90% It is reported that the patent of the product has expired in 2013, and the acceptance numbers cyhs1700680 and cyhs1700681 of Zhengda Tianqing pharmaceutical group were successfully included in the priority review in December 2018 At present, the status is "issued" If approved, it will become the first domestic imitation of the product According to the 2 data of China drug review database of MED, the company still has 4 applications of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation, such as Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation pharmaceutical products (3 acceptance numbers), Sichuan pat medicine technology (1 accepted numbers), and Heng Rui medicine (2 acceptance numbers), which are being listed in the review and approval process Conclusion: as early as December 29, 2018, 12 departments including the national health and Health Commission, the national development and Reform Commission and the Ministry of Education jointly issued the work plan on accelerating the implementation of the supply guarantee and use policy of generic drugs, clearly proposed to release the first batch of drug catalogs to encourage imitation according to the clinical drug demand before the end of June 2019, to guide the enterprise's R & D, registration and production On June 20, 2019, the first batch of recommended list of encouraged generic drugs came as agreed The list involves 34 varieties According to the plan published earlier, priority review and approval shall be given to generic drugs included in the encouraged generic drugs list according to regulations, and the principle of consistent with the quality and efficacy of original research drugs shall be adhered to It can be seen that in the future, the domestic competition for the first imitation will become more and more fierce Which ones will be spent in the end? Minenet will continue to follow the report Source: data statistics of meter net database as of July 10, 2019