The latest priority review list will be publicized and 3 domestic PD-1 varieties will be listed!

Source: from April 23, 2018 to April 24, 2018, the CDE official website released the public list of the 28th batch of drug registration applications to be included in the priority review procedure Recently, several PD-1 varieties of the fever have been on the list, such as carrizumab for injection (PD-1) of Hengrui medicine, treprizumab injection (PD-1) of junshibio, and xindalimab injection (PD-1) of xindabio Source of the public list of the twenty eighth batch of drug registration applications to be included in the priority review procedure: it is noteworthy on CDE official website that the application for listing of Henri PD-1 monoclonal antibody camrelizumab injection (shr-1210) to be included in the public list of drug registration applications to be included in the priority review procedure was accepted by CDE on the same day So far, five companies have applied for the listing of PD-1 monoclonal antibody in China, and the opdivo of BMS has been the first to obtain the qualification of priority review According to insight database, the new competitors in the first tier submitted clinical application as early as January 19, 2015, and obtained clinical approval documents on February 4, 2016, indicating advanced solid tumor In the subsequent clinical trials, Hengrui registered and carried out 20 clinical studies related to shr-1210, involving single and combined treatment of multiple tumor indications Among them, non-small cell lung cancer, esophageal cancer and liver cancer have reached stage III On April 19, the application for marketing of PD-1 mAb cindilimab injection (cxss1800008) resubmitted by Cinda bio was officially accepted by the drug review center It's only about two months since the initial listing application of sindelimab was withdrawn The industry believes that the preparation must be more adequate, and the results are also worth looking forward to On December 13, 2017, the initial listing application of cindilimab injection (ibi308) submitted by Cinda biology was accepted by CDE, and it was also the first listing application of domestic PD-1 / PD-L1 monoclonal antibody Baiji Shenzhou also announced recently that it is developing the PD-1 antibody tislilizumab for a global phase 2 clinical trial in patients with previously treated advanced liver cancer (HCC or liver cancer) to achieve the first patient administration Data shows that up to now, there are 164 new PD-1 products in the global market, and 1502 clinical trials involving PD-1 / L1 are under way, including 1105 joint drug studies The process of PD-1 / L1 product R & D and test of Chinese pharmaceutical companies is strengthening At present, more than 10 enterprises have carried out clinical trials, among which Junshi biology, Xinda biology, Hengrui medicine and Baiji Shenzhou are in the first echelon of R & D following the four leaders, many local Chinese companies have been added, with fierce competition According to statistics, a total of 25 domestic anti-PD-1 / PD-L1 McAbs are in full swing A list of current research and development status of PD-1 / PD-L1 McAb in domestic enterprises (data source: comprehensive arrangement of minenet, statistics of domestic clinical trials) domestic varieties are expected to compete with imported varieties in the same line According to pharmcube prediction, in the first half of 2019, Xinda biology, Junshi biology, Baiji Shenzhou and Hengrui medicine will all put their PD-1 / L1 on the market PD-1 has become a superstar in the anti-tumor drug market, and also a shining new star in tumor immunotherapy Since its launch in 2014, opdivo and keytruda have only had three full years, with total sales of US $8.757 billion in 2017 According to the forecast of evaluate Pharma, in 2022, the total revenue of opdivo and keytruda is expected to exceed US $19.4 billion, with a compound growth rate of 17% in 2017-2022, which is the anti-tumor target drug with the largest market potential As the pioneer of tumor immunotherapy, PD-1 / PD-L1 monoclonal antibody has been highly sought after in the market since its listing, and has become the indisputable place for pharmaceutical enterprises Who will become the first domestic enterprise to be approved for listing of PD-1 / PD-L1 McAb? According to the analysis of the industry, according to the clinical progress and the time of submitting the application for listing, the difference between domestic and imported anti-PD-1 monoclonal antibodies, including Junshi biology, Hengrui medicine, Baiji Shenzhou and Xinda biology, is only 4-6 months, and the time of being approved for listing in the future will be small The domestic varieties are expected to compete with the imported varieties in the same line, and occupy the main market with the advantage of cost performance.