List of domestic application of PD-1 / PD-L1 antibody: Hengrui junshixinda takes the lead

July 13, 2017 is widely known as "car-t day" Novartis car-t product tisagenlecleucel (ctl-019) passed the review of FDA Expert Committee at 10:0 There is not much suspense about the world's first car-t product going on the market It is expected to be approved in October this year for relapsed or refractory children and young adults with acute lymphoblastic leukemia (all) In recent years, PD-1 / PD-L1 inhibitors and car-t cell therapy have become the two most important representatives of tumor immunotherapy At present, five PD-1 / PD-L1 inhibitors have been approved for listing by FDA Among them, MSD keytruda and opdivo of Bristol Myers Squibb have become the most shining stars in the listed PD-1 / PD-L1 inhibitors The market share and opportunity of PD-1 / PD-L1 inhibitors are very narrow, but the development heat of PD-1 / PD-L1 inhibitors is still not reduced The author makes statistics of PD-1 / PD-L1 inhibitor antibody drugs in the development process in the domestic market, so as to provide reference for the corresponding enterprises, count their positions and understand the latest competitive situation 1 list of domestic application of PD-1 / PD-L1 antibody: 10 anti-PD-1 antibodies, 5 anti-PD-L1 antibodies On July 5, 2017, Baiji Shenzhou raised its eyebrows and officially announced to reach a comprehensive strategic cooperation with the pharmaceutical giant Xinji Baiji Shenzhou paid a milestone of US $980 million (R & D, registration and sales) for its rights and interests in the development of solid tumors outside Japan and Asia in the research of the blockbuster drug bgb-a317 to authorize Xinji, and Xinji will make equity investment in Baiji Shenzhou In addition, Baiji Shenzhou was awarded Exclusive authorization of approved products of Dexin China, including atraxane ® paclitaxel for injection (albumin binding type), refumex ® (lenalidomide) and vidaza ® azacytidine for injection This is a noteworthy news The injection of 1 billion yuan of cash flow will more strongly support the development of Baiji Shenzhou in bgb-a317, undoubtedly making its advantages show The development of PD-1 / PD-L1 antibody has been overcrowded, and there is almost no chance of overtaking in the corner for the PD-1 / PD-L1 antibody project which is still in the early stage of development According to CDE and public data, the author summarizes the current domestic PD-1 / PD-L1 antibody projects in clinical application or clinical stage, with reference to the following: drug categories of domestic PD-1 / PD-L1 antibody project companies in clinical application or clinical stage Research and development progress of Xinda bio ibi308 PD-1 phase III (1 item), non-small cell lung cancer; phase II (2 items), esophageal cancer, Hodgkin's lymphoma Js001 PD-1 phase II (2 items), bladder cancer, melanoma; phase I (9 items), Sanyin breast cancer, neuroendocrine tumor, renal cancer Camrelizumab (shr-1210) PD-1 phase III (3 items), NSCLC, esophageal cancer; phase II (4 items), HCC, Hodgkin's lymphoma; phase I (4 items), melanoma, NPC Bgb-a317 PD-1 phase II (3 items), Hodgkin's lymphoma, urothelial cancer, gastric cancer, esophageal cancer; phase I (1 item), Liver cancer drug mingkant / Yuheng biology gls-010 PD-1 phase I (1 item), solid tumor Jiahe biology Genomab PD-1 phase I, biorecombinant solid tumor baiaotai anti PD-1 humanized mAb PD-1 Ind kangfang biological ak103 PD-1 ind Lizhu pharmaceutical lzm009 PD-1 ind recombinant anti PD-1 humanized McAb PD-1 ind Thingdi / kangningjierui kn035 PD-L1 phase I (1 item), solid tumor Li's large pharmaceutical factory sti-a1014 PD-L1 Ind cornerstone pharmaceutical cs1001 (formerly code wbp3155) PD-L1 ind application, approved on July 17, 2017 Kelun pharmaceutical kl-a167 PD-L1 ind Hengrui pharmaceutical shr-1316 PD-L1 In the above table of ind, we can see that Hengrui medicine shr-1210, Xinda biology ibi308, Junshi biology js001 and Baiji Shenzhou bgb-a317 are in an advantageous competitive position In general, there are 15 drugs in the stage of ind application or clinical trial PD-1 / PD-L1's early R & D products have no opportunity to overtake in a curve 2 Weak anti risk ability of innovative enterprises: rational design and differentiated competition PD-1 / PD-L1 antibody is a hot development project of tumor immunotherapy in recent years, both at home and abroad, but there are less and less opportunities left for latecomers Five kinds of PD-1 / PD-L1 antibodies have been approved for market in foreign countries, and the clinical benefits and market performance of PD-1 are better, so the development of PD-1 / PD-L1 antibody is very risky For example, in the recent kestruda clinical trial of MSD, due to the patients in the medication group The death rate was higher than that of the control group, and FDA stopped the recruitment of new patients in kn813 and 185 trials This has no significant impact on the product, but it also brings uncertainty to the clinical development of the product Compared with the pharmaceutical giant MSD, many domestic PD-1 / PD-L1 antibody development enterprises are start-ups or small-scale innovative enterprises, without MSD's strong anti risk ability, antibody drug development should pay attention to differentiation For the development of multi-pd-1 / PD-L1 antibody, we should choose PD-1 or PD-L1 target, which early screening method to use, which IgG subtype to use, whether to carry out glycosylation modification, and the affinity modification of FC γ R, etc., which are the early issues we should pay attention to.