On April 20, Hengrui Medicine issued an announcement stating that its subsidiary Suzhou Shengdia Biomedical Co.
has recently received approval from the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" for SHR-1314 injection.
Carry out clinical trials for the indications of adult lupus nephritis.
SHR-1314 injection is a recombinant humanized monoclonal antibody that targets human IL-17A independently developed by the company and is intended to treat autoimmune diseases related to the IL-17 pathway.
At present, 2 IL-17A antibodies have been approved for marketing worldwide.
Novartis' secukinumab (trade name Cosentyx) has been approved for listing in many countries and regions including the United States, Europe and Japan since 2015.
Eli Lilly’s ixekizumab (trade name Taltz) has been approved for listing in the United States, Europe, Japan and other countries and regions since 2016.
Secukinumab and ixekizumab were approved for marketing in China as the first batch of clinically urgently needed new overseas drugs in April and September 2019, respectively.
After querying the EvaluatePharma database, the sales of secukinumab in 2020 will be 3.
995 billion U.
dollars, and ixekizumab will be 1.
789 billion U.
According to the announcement, up to now, the accumulated research and development expenses of SHR-1314 related research and development projects have been about 211.
25 million yuan.