Promote the rapid listing of Hengrui PD-1, and carrelizumab will be included in the priority review

On June 3, Hengrui Medicine released an enterprise announcement that its company's carrelizumab for injection was recently included in the list of products to be prioritized for evaluation by the drug evaluation center of the State Drug Administration, with a publicity period of 10 days According to the announcement, recently, Hengrui medicine submitted the phase II clinical trial report of carrelizumab for injection to the State Drug Administration, applied for conditional approval for listing, which has been undertaken by the evaluation center and included in the list of products to be prioritized for evaluation In addition, the company has submitted the results of phase III major clinical trials of the drug for esophageal cancer to the State Drug Administration Carrizumab for injection is a humanized anti-PD-1 monoclonal antibody, which can combine with human PD-1 receptor and block PD-1 / PD-L1 pathway, restore the anti-tumor immunity of the body, thus forming the foundation of cancer immunotherapy It is found that the anti-PD-1 antibody products nivolumab, pembrolizumab and cemiplimab rwlc have been approved for marketing Nivolumab was developed by Bristol Myers Squibb with the trade name of opdivo, which was approved for listing in the United States as early as 2014; pembrolizumab was developed by Merck sharp & Dohme with the trade name of keytruda, which was approved for listing in the United States as early as 2014; ceiplimab rwlc was jointly developed by regeneron and Sanofi Aventis with the trade name of libtayo, which was approved for listing in the United States as early as 2018 Two of them, nivolumab and pembrolizumab, have been approved for marketing in China At present, the similar anti-PD-1 monoclonal antibody injection developed by Xinda biology and Junshi biology has been approved for listing in 2018, and the related drugs of Baiji Shenzhou and other enterprises are in the stage of listing application and approval In the field of HCC, nivolumab and pembrolizumab were approved by the U.S Food and Drug Administration in September 2017 and November 2018, respectively, as priority varieties for HCC treatment At present, there is no approved indication of the same kind of monoclonal antibody PD-1 / L1 in China After querying IMS database, the global sales volume of anti-PD-1 antibody in 2018 is about US $14178.02 million, and the domestic sales volume is about US $6.4375 million Up to now, the R & D cost of the product project has been about 504.13 million yuan.