The "anti-cancer drug PD-1" is strong. Who will be the first domestically marketed PD-1/PD-L1 drug?

none="shifuMouseDownStyle('shifu_bus_005')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border: none; box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> recently, the application for withdrawal of Xinda PD-1 monoclonal antibody, Xindi monoclonal antibody, has been widely spread in the circle of friends At present, it has been officially confirmed that Cinda biology has actively withdrawn its listing application of SINDI mAb after too many rounds of communication with CDE, and will submit the supplementary materials again However, it can also be seen that the industry pays close attention to the domestic PD-1 / PD-L1 drugs, and a little bit of agitation can cause a fire in the industry none="shifuMouseDownPayStyle('shifu_t_050')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; width: 520px; text-align: center; box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> PD-1 / PD-L1 drug fengzhengqiang PD-1 / PD-L1 suppressive immune signal is achieved by promoting lymph node antigen-specific T cell apoptosis and reducing regulatory T cell apoptosis The representative drugs are pembrolizumab (keytruda), nivolumab (opdivo), atezolizumab (tecentriq), avelumab (bavencio), durvalumab (imfinzi) At present, the competition in the field of PD-1 / PD-L1 immunotherapy is extremely fierce According to foreign media reports, the market peak of PD-1 / PD-L1 anti-cancer immunotherapy is as high as US $35 billion According to the prediction of the latest tumor drug sales volume in the article "top 10 of the best-selling anti-tumor drugs in the next five years", the total sales volume of opdivo and keytruda in the next five years will reach 43.3 billion US dollars and 41.3 billion US dollars respectively, ranking the second and third best-selling anti-tumor drugs In the next five years, the best-selling anti-tumor drugs top 1 billion US dollars At present, MSD, BMS, AZ and Roche are all pushing forward their clinical projects There are five PD-1 / PD-L1 drugs listed in the world, among which keytruda of MSD and opdivo of BMS were approved successively in 2014, tecentriq of Roche was listed in 2016, bavencio of Pfizer and MSD and imfinzi of AstraZeneca were listed in 2017, but these five drugs have not been listed in China yet, and opdivo and keytruda have submitted listing applications in China Xinkangjie expects opdivo to be approved by CFDA to enter the Chinese market in the first half of this year In this paper, the author analyzes the characteristics of 1 Width: 520px; text align: Center; box sizing: border box! 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Im portant; "> opportunities and challenges of domestic pharmaceutical enterprises according to the data of China Health CMH, the market scale of anti-tumor and immunomodulator in China keeps a rapid growth trend, reaching 129.3 billion yuan in 2016, an increase of 11.4% compared with 2015 At the same time, due to the low awareness and popularity of early cancer screening in China, the proportion of cancer cases in the middle and late stage is much higher than that in developed countries Combined with the huge population base, immunotherapy for late cancer has great potential in the domestic market According to Deutsche Bank, the total market volume of PD-1 / PD-L1 in China (treating all cancers) will reach 25 billion yuan in 2025 The overseas original research drugs have not yet been listed, and the domestic demand is huge and unsatisfied, which brings great opportunities and challenges to the domestic PD-1 / PD-L1 drug research and development enterprises "Huiju innovation" sponsored by Guangzhou Pharmaceutical Group on March 28 At the sub forum of biomedical and health industry of 2018 Guangzhou International Investment annual conference, Zhou Xinhua, an expert in the thousand talents plan of the Central Organization Department, chief executive officer of Jiahe biopharmaceutical Co., Ltd and vice president of Watson biology, said in an interview with Xinkang press that the development of antibody drugs has become a trend of global pharmaceutical enterprises In any single antibody field, including PD-1 / PD-L1 drugs, Chinese enterprises are competing with multinational pharmaceutical enterprises If Chinese pharmaceutical enterprises want to find a way out in the competition, they must reduce the cost of R & D under the condition of controllable quality and achieve the best of the same kind Although domestic PD-1 / PD-L1 drug research and development started late, with the help of late development advantages and policy guidance, many enterprises have participated in the R & D competition According to incomplete statistics of Xinkangjie, up to 20 enterprises have involved in drug research of PD-1 / PD-L1 target, and 11 kinds of PD-1 monoclonal antibodies and 5 kinds of PD-L1 monoclonal antibodies are under research Data source: CFDA At present, there are two local pharmaceutical enterprises that have submitted the application for listing of PD-1 / PD-L1 in China They are Xinda bio's Xindi MAb (Code: ibi308, application indication: Hodgkin's lymphoma) and Junshi's trepril MAb (Code: js001, application indication: melanoma) Opdivo will soon open the door to the Chinese market We believe that keytruda, an old rival of opdivo, will not lag far behind PD-1 / PD-L1 is invested heavily in R & D, but the risks in the R & D process are difficult to predict, and the return is not likely to meet the expectation Under the dual pressure of internal and external, China's PD-1 / PD-L1 R & D enterprises can continue to pay attention to how to advance and retreat.