Top 3, the world's best-selling monoclonal antibody, has a mediocre performance in China

Source: according to statistics in medical economics report 2017-2-20, the total sales volume of the top 10 best selling drugs in the world in 2016 is expected to reach US $83.121 billion, with monoclonal antibodies accounting for 6 seats, accounting for 65.1% In 2016, the top five McAbs sold in the world were adamumab, enacep, infliximab, rituximab and bevacizumab Among the major application fields of monoclonal antibodies, anti-tumor and anti rheumatic drugs account for the largest proportion With the expiration of several global heavy-duty monoclonal antibody patents in 2016-2019, coupled with the policy support of the state for the biotechnology drug industry, it will further stimulate the enthusiasm of domestic enterprises to imitate, and China's monoclonal antibody industry will usher in a period of rapid development It is estimated that in 2016, the market scale of McAb in China will be 8.3 billion yuan, and the products of foreign-funded enterprises will account for nearly 4 components At present, only more than 10 of the 60 kinds of monoclonal antibody products that have been listed in the world have been approved for listing in China, and the domestic monoclonal antibody market has great growth potential Xiumeile: adamutumab, developed by abbvie company in the United States, was first marketed in January 2003 for rheumatoid arthritis After that, sumil's indications extended to other autoimmune diseases, including psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, juvenile idiopathic arthritis and ulcerative colitis In the future, the indications will continue to expand According to the statistics of global best-selling drugs, the sales volume of adalimumab in 2003 was US $280 million, and that in 2015 was US $14.001 billion In 2005-2016, the compound annual growth rate of the product was 25.3% In December 2016, the drug faced the expiration of U.S patents, and pharmaceutical giants Amgen, MSD and Pfizer are all developing related generic drugs It is predicted that in 2017, Biomimetic Drugs of Sumeria will enter the U.S market, and 2018 will be its most difficult year According to the data statistics of domestic sample hospitals, the sales of adamumumab in 2010 was 940000 yuan, the sales in 2015 was 23850000 yuan, the sales in the first three quarters of 2016 was only 14.02 million yuan, and the sales in 2016 is expected to be nearly 20 million yuan The growth of this product has been relatively slow since it was launched in China Adalimumab was imported from Abbott in 2010, and approved to treat rheumatoid arthritis In 2013, adalimumab was approved to relieve the symptoms of active ankylosing spondylitis At present, many domestic pharmaceutical companies are carrying out the imitation development of adalimumab At present, the fastest application progress is the biota and Cinda biology, both of which have entered phase III clinical In addition, Beijing green bamboo biology, Jiahe biology, Jiangsu Zhonghe medicine, Corning Jerry, Fuhong Hanlin and Zhejiang Haizheng have all obtained clinical approval documents In addition, more than 10 enterprises have applied for clinical trials of generic drugs At present, adamumumab of Huahai pharmaceutical industry is the most attractive In 2013, Huahai pharmaceutical and oncobiology Inc of the United States signed the strategic alliance and cooperative operation, joint venture, joint development and Technology License Agreement on biopharmaceutics At the end of 2015, Huahai received a notice from the US strategic partner oncobiologics that adalimumab's US phase I clinical practice ended and directly entered phase III clinical practice At the same time, the company issued a notice to adjust the cooperation agreement with oncobiologics of the United States on adamumumab Huahai will choose to publicly transfer its 51% interest in adamumumab in European and American markets and focus on domestic market development Enry: similar products occupy space Etanercept was developed by Amgen company of the United States It was approved by FDA in 1998, and its trade name is "Enbrel" This product is the first approved TNF inhibitor in the world, and also the first one approved for the treatment of ankylosing spondylitis in the world In October 2012, the Enbrel patent expired, but Amgen won a new patent that could extend the Enbrel patent protection to 2028 The European patent for Enbrel's biosimilars expired in 2015, allowing generic products to dominate the market for the treatment of spondylitis, psoriasis and arthritis It should be noted that in November 2016, Amgen Etanercept was approved by FDA for the treatment of pediatric patients with chronic moderate to severe plaque psoriasis According to the statistics of global best-selling drug data, the sales volume of etanercept in 1999 was 367 million US dollars, the global sales volume reached a peak of 8.941 billion US dollars in 2014, and 8.697 billion US dollars in 2015 The sales volume is expected to reach 8.54 billion US dollars in 2016, down 1.8% compared with the same period The compound annual growth rate from 2005 to 2016 was 8.0% In 2015, the European patent of the drug expired, and the global sales volume declined slightly in the past two years According to the data statistics of domestic sample hospitals, the sales volume of etanercept in 2010 was 2.45 million yuan, the sales volume in 2015 was 16.92 million yuan, the sales volume in the first three quarters of 2016 was 15.68 million yuan, an increase of 28.5% over the same period, and the sales volume in 2016 is expected to be 2015 million yuan Due to the late launch of the product, the high cost of treatment, and not in the scope of medical insurance, the pharmaceutical giants are not very interested in introducing it into China However, driven by the rigid demand in the domestic market, many domestic enterprises are full of expectations for the market prospect of this product Etanercept was approved by Pfizer in 2010 by CFDA to be listed in China Its trade name is "enri" Its dosage form is powder injection with a specification of 25mg The domestic approved indications of the product are rheumatoid arthritis and ankylosing spondylitis At present, there are recombinant human tumor necrosis factor receptor antibody fusion protein for injection in domestic similar products It was developed by CITIC Guojian company and approved for market in 2005 Its trade name is "yisaipu" Its dosage form is powder injection with specifications of 12.5mg and 25mg At present, in addition to CITIC gypsip, the other two approved for listing are "qiangke" of Shanghai SAIJIN in 2011 and "ambeno" of Haizheng pharmaceutical in 2015 The enterprises that have obtained the approval documents for clinical trials of this variety include Qilu pharmaceutical, Shuanglu pharmaceutical and Suzhou Jinmeng Clover biology has applied for clinical trials Lik: in recent ten years, the domestic market growth is not obvious Infliximab was developed by Johnson & Johnson company of the United States Its trade name is "REMICADE" It was listed in the United States in October 1998 for the treatment of moderate and severe segmental ileitis The main indications include: segmental ileitis, ulcerative colitis, rheumatoid arthritis, mandatory spondylitis, psoriasis, etc the drug is a disease control anti rheumatic drug The European patent of the drug expired in 2014, and the U.S patent will expire in 2018, when it will face more competition from generic pharmaceutical companies According to the statistics of global best-selling drug data, the sales volume of infliximab in 1999 was US $150 million, 2015 was US $8.355 billion, and the sales volume is expected to reach US $8.141 billion in 2016, down 2.6% compared with the same period In 2005-2016, the compound annual growth rate of the product was 7.8% According to the statistics of domestic sample hospitals, the sales volume of infliximab in 2007 was 720000 yuan, that in 2015 was 110 million yuan, that in the first three quarters of 2016 was only 88.23 million yuan, and that in 2016 is estimated to be nearly 120 million yuan The product has been in a steady growth trend since it was launched in China Infliximab is the first biological agent in clinical use in China, and its market growth is not obvious in the past decade Infliximab was imported and listed in China in 2007 by Qiang Qiang Its trade name is "Lei Ke" Its dosage form is powder injection, and its specification is 100mg It has been approved for psoriasis indication in China The product is not included in the national medical insurance or basic drug catalog, and similar drugs are scarce in China, but the price of the drug is relatively high, and it is not approved to be used solely for the treatment of rheumatoid arthritis, so the clinical use will be limited At present, the enterprises that have obtained clinical approval for infliximab analogues include Shanghai baimibo, Jiahe biology and Haizheng pharmaceutical.