Hengrui Medicine's SHR-1701 injection and bevacizumab injection were approved for clinical trials

September 07, 2021

On September 6, Hengrui Medicine issued an announcement stating that its subsidiary Shengdia Biomedicine had recently received NMPA’s approval and issuance of the "Drug Clinical Trial Approval Notice" for SHR-1701 injection and bevacizumab injection. .

SHR-1701 can promote the activation of effector T cells, and at the same time can effectively improve the immune regulation in the tumor microenvironment, and ultimately effectively promote the immune system to kill tumor cells. SHR-1701 injection has carried out a number of solid tumor clinical trials in China, and a phase I clinical trial in Australia. After inquiries, similar products of Merck KGaA, Pumis Biotech, Suzhou Chuangsheng Group, and Boji Biomedicine are currently in clinical trials at home and abroad, and their indications are mainly advanced malignant tumors. No similar products at home and abroad have been approved for listing, and there is no relevant sales data. Up to now, the accumulated research and development expenses of SHR-1701 related projects are about 222.17 million yuan. Bevacizumab is a humanized anti-VEGF monoclonal antibody developed by Chugai Pharmaceutical and Roche’s subsidiary Genentech. Vitin), is currently on the market in China and many countries around the world. The company's bevacizumab injection (trade name: Erito) was approved for listing in June 2021. In addition to Avastin and Erreto, there are currently 3 bevacizumab injections approved for marketing in China. They are Amta (Qilu Pharmaceutical) approved in December 2019 and approved in June 2020. Dayotong (Xinda Bio) and Boyouno (Shandong Boan Bio) approved in April 2021. At the same time, many domestic companies’ similar products have submitted applications to the National Medical Products Administration. The current status is "under review and approval", including Luye Pharmaceutical, Betta Pharmaceutical, Biotech, Toyo Pharmaceutical, and Acer Hanlin, Chia Tai Tianqing, etc. Upon inquiry, Avastin's global sales in 2020 will be approximately US$5.324 billion. Up to now, the accumulated research and development expenses of bevacizumab-related projects are approximately RMB 263.10 million.

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