In April 23rd, the listing application of Heng Rui PD-1 monoclonal antibody Camrelizumab injection (SHR-1210) (CXSS1800009) was accepted by CDE.
So far, 5 companies have applied for PD-1 mAb in China, and BMS’s Opdivo has been the first to receive priority assessment. The indications of the 5 companies were different.
HengRui’s SHR-1210 (Camrelizumab) was first submitted to clinical application in 2015/1/19, and 2016/2/4 received clinical approval. The indication was advanced solid tumor. In the following clinical trials,HengRui registered 20 SHR-1210 related clinical studies, involving single use and combination therapy for multiple tumor indications. Among them, non-small cell lung cancer, esophageal cancer and hepatocellular carcinoma have reached the stage of III.
In February 8, 2018, CDE issued the basic requirements for data data on the declaration of anti PD-1/PD-L1 mAb varieties, allowing enterprises to submit their applications with the alternative end point of ORR and allow enterprises to submit clinical data in a phased form by rolling application. According to the time of SHR-1210 registration and the differential competition strategy, it is speculated that the indication of SHR-1210 is classic Hodgkin’s lymphoma (cHL).
In June 2017,HengRui published the I phase clinical trial data of SHR-1210 treatment solid tumor at the ASCO2017 conference: 29 cases of squamous cell carcinoma of the esophagus ORR, 8 cases of gastric cancer ORR 37.50%, 3 cases of lung cancer in 1 cases, 3 cases of nasopharyngeal carcinoma in 1 response, 3 cases of hepatocellular carcinoma in 1 response, 3 colorectal cancer in 1 response, 1 case of bladder cancer. Answer。 The total response rate was 31%, and the disease control rate was 46.5%.
Up to now, there are 5 global PD-1/PD-L1 drugs listed in the world, namely, Opdivo (BMS, FDA approval time 2014/12/22), Keytruda (merschon, 2014/9/4), Tecentriq (Roche, 2016/5/18), Imfinzi (AstraZeneca, 2017/5/1), Bavencio (Merck / Pfizer).