6 big target R & D hot 5 over 1 billion varieties have been born who is the "antibody king"?

Recently, the first adamumumab biological similar drug in China was approved for marketing, and this product has won the title of "global medicine king" for many years in a row According to the data of minenet, in 2018, the total sales of terminal antibody drugs in public medical institutions in China exceeded 16 billion yuan Zhang Buyong, General Manager / chief researcher of minenet, predicted at the national pharmaceutical economic information conference in 2019 that the sales scale of antibody drugs is expected to reach 50-55 billion yuan in the next five years At present, there are more than 150 enterprises in China with 311 antibody drugs, of which VEGF, HER2, TNF α, PD-1 / PD-L1, EGFR and CD20 are the most popular targets What are the representative drugs of these targets? How is the domestic R & D progress? On November 7, the State Food and Drug Administration issued a document, and the application for listing and registration of adalimumab injection (trade name: gelelib) developed by baiaotai was approved recently, becoming the first approved biological analogue of adalimumab in China, which is used to treat autoimmune diseases such as ankylosing spondylitis, rheumatoid arthritis and psoriasis According to the data of minenet, adamumumab (trade name xiumeile) developed by Aberdeen has won the title of "global medicine king" since 2012 In 2013, the global sales exceeded 10 billion US dollars for the first time and reached 9.32 billion US dollars in the first half of 2019 Although adamumumab has made sales miracles in the global market, its sales in the Chinese market is not booming In 2018, the sales in the terminals of public medical institutions in China was only 87.15 million yuan, which may be related to the fact that sumeriab has few approved indications in China and is squeezed by similar competitive products, the high price of medical insurance in China and the low accessibility of drugs Table 1: recent price reduction of xiumeile in some provinces and cities (unit: yuan / piece) (source: bidding and mining platforms of all provinces and cities) In May 2019, xiumeile unexpectedly participated in the price competition In Jiangxi Province, the online price was adjusted to 3160 yuan / PC, with a decrease of nearly 60% Afterwards, xiumeile successively took the initiative to reduce prices in Beijing, Shaanxi, Jiangsu, Gansu, Yunnan, Liaoning and other provinces and cities The reasons are as follows: first, to prepare for the "integration" of medical insurance, the medical insurance negotiation has been carried out in 2019, according to the industry news, adamutumab has successfully entered the medical insurance, which will be very helpful to improve the sales situation of xiumeile; second, more than 20 domestic pharmaceutical enterprises have distributed adamutumab biological similar drugs, 5 of which have been declared for listing, the market competition is fierce, and the price reduction is helpful to snatch ahead of time Market The bioequivalent drug of adamumumab of baiaotai has been approved for marketing successfully In the face of Sumeria's active price reduction, it may bring some pressure to its pricing With more and more biological similar drugs approved for marketing, the drug availability of adalimumab will be greatly improved in the future Whether it can become the "king of medicine in the new era of China" remains to be seen! According to the statistics of mienei.com, at present, there are more than 40 antibody drugs (including fusion protein, the same below) approved to be imported / approved to be listed in the domestic market (calculated by drug name + enterprise name), including 14 domestic monoclonal antibodies and 28 imported monoclonal antibodies In 2018, the total sales quota of the terminals in China's public medical institutions exceeded 16 billion yuan Zhang Buyong, General Manager / chief researcher of minenet, predicted at the national pharmaceutical economic information conference in 2019 that the sales scale of antibody drugs is expected to reach 50-55 billion yuan in the next five years At present, the approved antibody drugs include anti-tumor, autoimmune diseases, musculoskeletal system, sensory system and other treatment fields The combination of anti-tumor drugs and autoimmune diseases accounts for more than 30 varieties, leading far ahead; followed by ophthalmic drugs, three drugs belong to the treatment field, which shows that antibody drugs are widely used in anti-tumor, autoimmune diseases and ophthalmology Table 2: over 100 million antibody drugs sold at the end of public medical institutions in China in 2018 Note: approved after the end of 2018 is not included (source: meter net database) In 2018, China's public medical institutions sold 12 antibody drugs (in terms of drug names) with a terminal sales volume of over 100 million, including 8 anti-tumor drugs, 2 autoimmune diseases drugs, and the total sales volume of these 10 drugs in 2018 exceeded 12 billion yuan; 2 ophthalmic drugs, including rapunzumab and conbercept From the perspective of sales, Roche's "troika" has made outstanding achievements in imported antibody drugs, with sales of over 2 billion yuan in public medical institutions in China in 2018; among domestic antibody drugs, CITIC Guojian's recombinant human tumor necrosis factor II receptor antibody fusion protein for injection has become the first and only domestic antibody drug that has exceeded 1 billion yuan since 2015, However, this pattern is expected to be broken soon According to the announcement of the listed company, PD-1 of Junshi and Xinda achieved sales of 308 million yuan and 332 million yuan respectively in the first half of 2019, and it is expected to break through the sales scale of 1 billion yuan in the first year of listing From the point of view of drug treatment targets, 12 antibody drugs cover VEGF, TNF α, PD-1, EGFR, HER2, CD20 and other treatment targets, which are also hot targets in domestic research and development at present Figure 1: proportion of different R & D targets of antibody drugs (source: minenet global new drug research and development monitoring database) As of September 2019, more than 150 enterprises in China have deployed 311 antibody drugs, including 47 varieties targeted at VEGF, 44 varieties targeted at PD-1 / PD-L1, 34 varieties targeted at TNF α, 30 varieties targeted at HER2, 23 varieties targeted at EGFR and CD20 The research and development of these six targets is the most popular Zhang Buyong believes that in the next two years, 10-15 antibody drugs will be approved and listed in succession in China Figure 2: enterprises applying for more than 5 kinds of antibody drugs in China (source: meter net database) From the perspective of antibody drug declaration enterprises, there are currently more than 5 varieties declared by 16 enterprises, including Hengrui medicine, Xinda biology, Qilu pharmaceutical, Fuhong Hanlin, and Haizheng pharmaceutical There are bevacizumab, Leizhu mAb and arbacizumab which have been marketed in China The research and development of bevacizumab is the hottest At present, the products of Qilu and Xinda have applied for listing, among which Qilu has made the fastest progress and is expected to win the first bevacizumab bio similar drug in China In addition, more than 10 enterprises, such as Zhengda Tianqing, Hengrui pharmaceutical, Fuhong Hanlin, have conducted phase III clinical trials and are in the first tier of development The anti TNF α drugs on the market in China include adalimumab and infliximab The first adamuzumab bioequivalent drug has been approved for marketing, while hualuobai Aotai has been approved In addition, the products of Haizheng, Xinda, Fuhong Hanlin and Junshi have submitted for marketing applications The products of Zhengda Tianqing, Shenzhou cell engineering, Tonghua Dongbao and other enterprises have undergone phase III clinical trials Shanghai baimeibo pharmaceutical is the first to submit infliximab bioequivalent drug, which is expected to be approved for the first time In addition, the products of Haizheng, Jiahe biology and other enterprises are all in phase III clinical The antibody drugs which target HER2 in China are trastuzumab and patorzumab Sansheng Guojian and Fuhong Hanlin have submitted applications for the listing of trastuzumab biological analogues, among which Sansheng Guojian has made rapid progress In addition, the products of Jiahe biology, Zhengda Tianqing and Anke biology are in phase III clinical Rituximab, an antibody drug targeting CD20, has been marketed in China The first rituximab biological similar drug has been approved for marketing, hualuofuhong Hanlin In addition, Xinda's products have been submitted for marketing The products of Shenzhou cell engineering, Hualan gene, Xikang biology, Zhengda Tianqing, Haizheng pharmaceutical and other enterprises are in clinical phase III The antibody drugs that target EGFR in China are cetuximab and nitorzumab Cetuximab biological analogues of mabotaco Pharmaceutical Co., Ltd in Taizhou are in clinical phase III, and products of Qilu pharmaceutical, Sansheng Guojian, Jingze biological and other enterprises are in clinical phase I.