On the evening of January 5, Hengrui Pharmaceutical issued an announcement that the company and its subsidiary Suzhou Shengdia Biopharmaceutical Co., Ltd. received the approval of the State Food and Drug Administration to issue a "Drug Clinical Trial Approval Notice" on apatinib mesylate tablets and SHR-1701 injection, which will carry out clinical trials in the near future.
According to the announcement, apatinib mesylate tablets (trade name: Aetam) were approved in November 2014 for the treatment of patients with advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma who had progressed or recurred after receiving at least two previous systemic chemotherapy, and in December 2020 for the treatment of patients with advanced hepatocellular carcinoma who had failed or were intolerable after receiving at least one-line systematic therapy.
Apatinib mesylate tablets at home and abroad have sorafenib, sunitinib, pezopanib and other similar products approved for listing. Up to now, Apatinib mesylate related projects have invested about 404.78 million yuan in research and development costs. SHR-1701 can promote the activation of effector T cells, and can also effectively improve the immunomodulatory effect in the tumor microenvironment, and ultimately promote the immune system to kill tumor cells. SHR-1701 injection has conducted several solid tumor clinical trials in China and Phase I clinical trials in Australia. No similar products at home and abroad have been approved for listing, and there is no relevant sales data. Up to now, SHR-1701 related projects have invested about 239.94 million yuan in research and development expenses. (Wu Wenfeng)
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