"God of medicine effect"! 12 more than 1 billion anti-tumor drugs are about to pass the consistency evaluation, and the price reduction trend of the original research drugs is coming?

Recently, the movie "I'm not the God of medicine" burst the circle of friends, causing a heated discussion among the whole people What's more exciting is that Jiangsu hausen has confirmed that it has received the approval document of "imatinib" supplementary drug application issued by the State Food and drug administration, which means that Xinwei has become the first imatinib to pass the consistency evaluation, and the same type of anti-tumor drug in "God of medicine" is coming! According to the data of minenet, as of July 13, four antineoplastic drugs have passed the consistency evaluation Among the 193 acceptance numbers (excluding those that have passed or failed the consistency evaluation) applied for the consistency evaluation, there are 28 acceptance numbers belonging to antineoplastic drugs (involving 15 products), and 12 of the 15 antineoplastic drugs have a national sales volume of more than 1 billion yuan in 2017 With the continuous promotion of the consistency evaluation of domestic generic drugs, its price forcing effect gradually appears In the future, a large number of imported anti-cancer drugs may join the ranks of active price reduction   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(51, 51, 51); 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; line-height: 27.2px; widows: 1; 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; "> 5 billion varieties lead the way, and 4 anti-tumor drugs have been copied According to the data of MED drug evaluation database 2.0, among the generic drugs that have passed or are deemed to have passed the consistency evaluation at present, four belong to antitumor drugs, among which gefitinib is the first batch of generic drugs that have passed the consistency evaluation, imatinib mesylate may appear in the fifth batch of generic drug consistency evaluation list that will be published soon, while paclitaxel for injection (albumin binding Type) and pemetrexed disodium for injection are listed in the catalogue of Chinese listed drugs, which are deemed to have passed the consistency evaluation Table 1: imatinib mesylate (trade name: Gleevec) is the prototype of "life-saving drug" in the hit film "I am not the God of medicine" It was developed by Novartis and first approved by FDA on May 10, 2001 According to the sales database data of MNE listed companies, the global sales of Gleevec in 2017 reached 1943 million US dollars Imatinib is an oral tyrosine kinase inhibitor, known as "CML lifesaving drug", which was first listed in China in 2001 According to the data of mienei.com, in 2017, the total market of imatinib mesylate in the 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 pharmacies was 3.046 billion yuan, of which the sales of imatinib mesylate in the terminals of China's public medical institutions was 1.932 billion yuan, an increase of 17.96% over the previous year Figure 1: brand pattern of imatinib mesylate tablets in China's public medical institutions in 2017 (source: minenet terminal competition pattern of China's public medical institutions) From the perspective of brand structure, the former manufacturer Novartis' Gleevec occupies most of the market share Imatinib mesylate tablet (trade name: Xinwei) of hausen pharmaceutical ranks second with 17.37% of the market share This time, Xinwei of hausen pharmaceutical has passed the consistency evaluation, and may gradually replace the original research drug in China by virtue of its safety and effectiveness equivalent to the original research drug and the price more beneficial to the people Internal market share In addition, imatinib mesylate capsule of Zhengda Tianqing Pharmaceutical Co., Ltd is also under the review of consistency evaluation If there is no accident, it will be approved at the end of this year or the beginning of next year Gefitinib, like imatinib, is an oral tyrosine kinase inhibitor Gefitinib is suitable for locally advanced or metastatic non-small cell lung cancer According to the data of minenet, in 2017, the sales volume of gefitinib at the terminals of public medical institutions and urban retail pharmacies in China was 2.187 billion yuan Figure 2: brand pattern of gefitinib in China's public medical institutions in 2017 (source: minenet China's public medical institutions terminal competition pattern) At present, there are only yiruisha of AstraZeneca and IRICO of Qilu Pharmaceutical (Hainan) listed in China From the perspective of brand structure, the domestic market of gefitinib is basically monopolized by the original research, while yiruisha of AstraZeneca owns 91.61% of the market share Although Qilu Pharmaceutical (Hainan) has a small share, IRICO has passed the consistency evaluation , can enjoy the policy dividend, and is expected to quickly seize the market share of the original research drug   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(51, 51, 51); 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; line-height: 27.2px; widows: 1; 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; "> there are 15 anti-tumor drug declaration conformity evaluation, 8 are injections According to the data of midnet Med drug evaluation database 2.0, as of July 13, there are 193 acceptance number applications for conformity evaluation (excluding the acceptance number that has passed or failed the conformity evaluation), including 28 acceptance numbers belonging to anti-tumor drugs, involving 15 products and 10 enterprises Table 2: antineoplastic drugs applying for conformity assessment note: pemetrexed disodium for injection of Sichuan Huiyu Pharmaceutical Co., Ltd has passed the conformity assessment, so it is not included (source: minenet database, data statistics as of July 13) In terms of dosage form, 8 of the 15 anti-tumor drugs are injections, accounting for half of the total; in terms of the declared enterprises, Hengrui has the most eye-catching performance, including its subsidiaries, a total of 6 products have been declared, followed by Qilu pharmaceutical, including its subsidiaries, a total of 3 products have been declared; in terms of the review status, most of the acceptance numbers are in the review and approval status, only Hainan Jinshan The acceptance application of gemcitabine hydrochloride for injection of ruipharma is in the issued state If there is no accident, the conformity evaluation of the product will be passed soon By analyzing the competition of each product declaration, it can be found that two enterprises, oxaliplatin for injection, bortezomib for injection and irinotecan hydrochloride injection, have declared the conformity evaluation at the same time, while pemetrexed disodium for injection and imatinib mesylate capsule for injection have passed or deemed to have passed the conformity evaluation According to the national sales of various products in 2017, 12 anti-tumor drugs are over 1 billion varieties, and pemetrexed disodium for injection leads the way with 5 billion sales; 8 of 15 anti-tumor drugs accounted for a large proportion of central research in China's public medical institutions in 2017, and 5 anti-tumor drugs have successfully occupied the share of the original research drugs 8 generic drugs replace the original research space table 3: among the 15 antitumor drugs, oxaliplatin for injection accounted for a large proportion in the original research of public medical institutions in China in 2017 (source: minenet database) In recent years, the sales volume of public medical institutions in China has been growing steadily According to the data of mienei.com, 22 manufacturers have obtained the production approval of the product, and the competition is still fierce Sanofi, the original research manufacturer, accounts for more than half of the market share The domestic market of bortezomib and lenadelamine capsules for injection is monopolized by the original research, and the original research manufacturers occupy 100% of the market share It is conducive to quickly seize the original research market by first passing the consistency evaluation There are only eight new manufacturers of thymus injection method In the brand competition pattern, saisheng, the original manufacturer, accounts for half of the total Hainan Shuangcheng Pharmaceutical Co., Ltd., which has applied for conformity assessment, ranks the third with a market share of 15.21% After 2013, the generic drugs of capecitabine tablets have been listed one after another, competing for market share However, according to the sales situation in 2017, the market share of Roche, the original manufacturer, is still as high as 69.42% Hengrui pharmaceutical is the first to apply for the conformity evaluation of the product and is expected to be the first to be approved 5 generic drugs successfully occupy the original research drug market Table 4: products whose market share of 15 antitumor drugs in China's public medical institutions exceeded that of the original research drugs in 2017 (source: minenet database) Imatinib in recent years The overall market sales growth is rapid There are three generic pharmaceutical enterprises in China, namely, Zhengda Tianqing Pharmaceutical Co., Ltd., Ouyi Pharmaceutical Co., Ltd and Jiangsu Haosen Pharmaceutical Co., Ltd Novartis, the original research manufacturer, occupies most of the market of imatinib tablets, but the market of imatinib capsules is still dominated by Zhengda Tianqing Pharmaceutical Co., Ltd Docetaxel injection is the main product of Jiangsu Hengrui medicine In 2017, its market share exceeded that of Sanofi, the original manufacturer Jiangsu Hengrui medicine is also the first to apply for conformity assessment If it can pass the assessment smoothly, it will help to consolidate its leading position Pemetrexed disodium for injection is a traditional cytotoxic drug commonly used in clinic In recent years, it has kept a steady growth According to the data of mienei.com, 16 domestic enterprises have obtained the production approval of pemetrexed disodium for injection Although there are many manufacturers, the market concentration is relatively high Jiangsu Haosen Pharmaceutical Co., Ltd ranks first with 41.4% The overall sales growth of temozolomide capsules is also very fast In the domestic market, there are only two generic pharmaceutical manufacturers in Jiangsu tianshidiyi Pharmaceutical Co., Ltd and Beijing Shuanglu Pharmaceutical Co., Ltd each of them accounts for half of the market Tianshili takes the lead in submitting three specification one-way evaluation applications, aiming to consolidate the existing market advantages   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(51, 51, 51); 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; line-height: 27.2px; widows: 1; 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; "> promote consistency evaluation, but force the price reduction of imported anticancer drugs Influenced by multiple factors such as high R & D cost, the" sky high price "of imported anticancer drugs has deterred many cancer patients Even the price of original research drugs that have passed the patent protection period is still high for a long time, and the price is much higher than that of surrounding countries The patent cliff in the global pharmaceutical market has not happened in China In February 2016, the State Council issued the opinions on the evaluation of the consistency of quality and efficacy of generic drugs, marking the comprehensive opening of the consistency evaluation The core goal of the consistency evaluation of generic drugs is to comprehensively improve the quality of generic drugs and realize the clinical substitution of domestic generic drugs for the original drugs With the development of consistency evaluation and the implementation of zero tariff policies for imported drugs, a large number of high-quality generic drugs have emerged in China