The growth rate exceeds 20%! Four major varieties lead the tens of billions of antibody drugs market

In the new round of drug price negotiation, 36 negotiated drugs are included in the category B scope of the 2017 edition of the national directory of drugs for basic medical insurance, industrial injury insurance and maternity insurance, with an average price reduction of 44% and a maximum of 70% Among them, the most attractive drugs are anti-tumor monoclonal antibody drugs, including trastuzumab, bevacizumab, nitzumab and rituximab, with an average decrease of 54.74% After antibody drugs enter the national medical insurance catalogue, it will directly promote the expansion of antibody market in China According to the latest authoritative data of 44 major varieties of markets, the market of biological products in China reached 135 billion yuan in 2016, accounting for 9.2% of the total drug market, an increase of 11.5% compared with 2015 Among them, the top 100 public hospitals in key cities in China have spent 13.611 billion yuan on bioengineering drugs, an increase of 13.78% over the previous year In recent two years, the proportion of bioengineering drugs is increasing year by year, and the trend of the proportion of chemical drugs in the market has become a foregone conclusion   　　 In the market of biomacromolecule drugs, there are 12 subcategories, including anti-tumor antibodies, immune stimulating organisms, ophthalmic bioengineering agents, plasmin biological agents, human coagulation factors, growth factors, biological recombinant hormones, biological insulin, biological vaccines, immunosuppression and biological immunoglobulins, which are potential varieties in clinical treatment According to Thomson Reuters data, 243 antibody drugs have been approved and entered phase III clinical research in the world, and 121 varieties have been approved by FDA in the United States CFDA data shows that there are 1653 CFDA approved biomacromolecule drugs "Guoyao Zhuzi s" approvals, and more than 95% of the varieties have been put into the market At present, the four anti-tumor drugs are trastuzumab, bevacizumab, nitzumab and rituximab According to the data of HDM system of the punctuation information company of CFDA Southern Medical Economics Research Institute, in 2016, the amount of four antibody drugs used in public hospitals in key cities in China was 1.846 billion yuan, an increase of 21.38% over the previous year The overall market size of the four varieties has reached 4.4 billion yuan, accounting for half of the domestic antibody market Rituximab: the leading product of antibody drugs, rituximab, is the backbone product of Roche company, with the trade name of rituxan / mabtera In November 1997, it was approved by the FDA of the United States, and in 2000, China approved the listing of rituximab, the trade name of which is "rituximab" Rituximab is a gold standard drug for the treatment of non Hodgkin's lymphoma, and is also approved as a first-line drug for advanced colon cancer With the development of clinical medicine, the theory of anti-tumor therapy of biotechnological drugs with the same genotypes, different locations and different tissues has been comprehensively promoted At present, rituximab has been approved for use in rheumatoid arthritis and other new immune indications, promoting the rapid development of the market of monoclonal antibodies HDM system data shows that in 2016, the amount of rituximab used in public hospitals in key cities in China was 734 million yuan, an increase of 22.94% over the previous year; the overall market of rituximab in China has reached 1.667 billion yuan, showing a continuous growth trend The results of a new round of drug price negotiation showed that the price of melowa 50ml: 500mg injection decreased from 16041 yuan / dose to 8289.87 yuan / dose, with a decrease rate of 48.32%; the price of another 10ml: 100mg injection decreased from 3416 yuan / dose to 2418 yuan / dose, with a decrease rate of 29.22% It is clinically used for recurrent or drug-resistant follicular central lymphoma, CD20 positive stage Ⅲ - Ⅳ follicular non-Hodgkin's lymphoma and CD20 positive diffuse large B cell non-Hodgkin's lymphoma With the expiration of the patent of rituximab, the research and development of biological analogues have been carried out in China According to the latest data of CFDA, many domestic enterprises have obtained clinical approval documents, such as rituximab (cxsl15000056 Su) of Zhengda Tianqing Pharmaceutical Group, recombinant anti lymphoma (CD20) MAb (rituximab) injection (cxsl1400096 Yu) of Hualan genetic engineering, and biological drug "hsk-Ⅲ-001 injection" (2016l10582) of HISCO After the domestic rituximab is put on the market, the users will be expanded and it is expected to replace some markets of rituximab Trastuzumab: continuous growth in the field of breast cancer treatment Trastuzumab is another backbone of Roche company It was approved by FDA in 1998 It is the first monoclonal antibody of human epidermal growth factor receptor 2 (HER2) approved for the treatment of metastatic breast cancer and early breast cancer It is widely used in the treatment of all stages of HER2 positive breast cancer Its trade name is Herceptin In 2016, Roche's trastuzumab sales reached CHF 7.613 billion, an increase of 4.19% over the previous year In 2003, trastuzumab injection of Roche company entered the Chinese market, with the trade name of Herceptin In 2016, the amount of trastuzumab used in public hospitals in key cities in China was 607 million yuan, an increase of 14.2% over the previous year; the overall market of trastuzumab in China has reached 1.19 billion yuan, showing a continuous growth trend in the anti breast cancer treatment market The results of a new round of drug price negotiation show that the price of Herceptin 440mg injection decreased from 21613 yuan / dose before the negotiation to 7600 yuan / dose, with a decrease rate of 64.80%, which is the highest anti-tumor drug With the expiration of the patent of trastuzumab, the research and development of generic drugs have been carried out in China According to the latest data of CFDA, two domestic enterprises have obtained clinical approval documents in 2016, namely, trastuzumab for injection (cxsl1400013 Su) of Zhengda Tianqing Pharmaceutical Group and trastuzumab for injection (cxsl1400077 Yu) of recombinant anti human epidermal growth factor receptor 2 (HER2) of Hualan genetic engineering Bevacizumab: bevacizumab is the heavyweight product of Roche company and the first anti-tumor angiogenesis drug in the world In February 2004, it was approved by the US FDA for the treatment of metastatic colorectal cancer The trade name is Avastin At present, its indications include colorectal cancer, non-small cell lung cancer, platinum resistant ovarian cancer, cervical cancer and renal cancer Bevacizumab officially entered the Chinese market in May 2010, under the trade name of avidin The first indication was advanced metastatic colorectal cancer, which was treated with 5-fluorouracil or irinotecan In August 2015, CFDA approved avidin for the first-line treatment of advanced, metastatic or recurrent non-small cell lung cancer Bevacizumab combined with carboplatin and paclitaxel chemotherapy can bring significant benefits to patients with advanced lung cancer and reduce the risk of death In 2016, the amount of bevacizumab used in public hospitals in key cities in China was 360 million yuan, an increase of 37.43% over the previous year; the overall market of bevacizumab in China has reached 1196 million yuan After the increase of indications, the sales of avidin in 2016 increased by 63% compared with 2014 The results of drug price negotiation showed that the injection of avidin 4ml: 100mg decreased from 5176 yuan / dose to 1998 / dose, with a decrease rate of 61.40%, which was the second variety of anti-tumor drugs Nitzumab: nitzumab, the first domestic anti-cancer antibody drug, is the first functional antibody drug for the treatment of malignant tumors in China In 2008, it was launched and listed by Baitai bio, with the commodity name of taixinsheng, breaking the foreign monopoly for the first time Nitzumab is the first monoclonal antibody targeting EGFR in the world Taixinsheng combined with radiotherapy and chemotherapy for solid tumors, such as nasopharyngeal carcinoma, head and neck tumor, glioma, colorectal cancer, pancreatic cancer, esophageal cancer, liver cancer, non-small cell lung cancer, is a highly selective and safe antibody drug, which can specifically target the solid tumor cells In 2016, the amount of nitzumab used in public hospitals in key cities in China was 145 million yuan, an increase of 11.96% over the previous year Since its listing, nitzumab has exceeded 2 billion yuan in the domestic public hospital drug market The results of a new round of drug price negotiation showed that the 10 ml: 50 mg injection of taixinsheng decreased from 2378 yuan / dose to 1700 yuan / dose, with a decrease rate of 28.50% The combination of radiotherapy and radiotherapy was limited to the treatment of stage III / IV NPC with EGFR positive expression It is expected that after the price reduction and entering the class B medicine of medical insurance, the market volume will be promoted If it can be upgraded to class A, the market share will be greatly increased, and more enterprises will be encouraged to invest in new drug research and development.