A clinical trial of Hengrui Pharmaceutical Beva Pearl Single Anti-Injection Drug was approved

On January 15, Hengrui Pharmaceuticals announced that its subsidiary, Suzhou Shengdia Biopharmaceuticals, had recently received a "Notice of Approval for Clinical Trials of Drugs" for Beva-Zhu single anti-injection and SHR-1701 injections approved by the State Drug Administration, and that clinical trials would be conducted in the near future.
1, the drug's basic condition 2, the drug's other condition Beva bead monoclonal antibody is a humanized anti-VEGF monoclonal antibody, developed by Roche subsidiary Genentek and Sino-foreign pharmaceutical cooperation, as early as 2004 by the U.S. Food and Drug Administration approved the listing, the commodity named Avastin, a metastatic colorectal cancer, has been approved for the treatment of non-small cell lung cancer, malignant glioma, metastatic renal cell carcinoma, metastatic cervical cancer, peritiotic cancer, hepatocellular carcinoma and other adaptive disorders, has been listed in China and a number of countries around the world.
In addition to Avitin, there are currently two Beva Bead monoantigen injections approved for the market in China, namely Anda (Zilu Pharmaceuticals) approved in December 2019 and Davyon (Zinda Bio) approved in June 2020.
At the same time, a number of domestic enterprises of similar products have submitted to the State Drug Administration for listing applications, the current status of "in the review and approval", including Suzhou Shengdia, Green Leaf Pharmaceuticals, Beda Pharmaceuticals, Baiotai, Dongyu Pharmaceuticals, Fuhong Hanxuan and so on.
to the Evaluate Pharma database, Beval beads will have global sales of approximately $7.263 billion in 2019, of which Avastin will have sales of approximately $7.118 billion.
, the product has invested approximately $179.39 million in research and development.
SHR-1701 can promote the active effect of T cells, but also can effectively improve the tumor micro-environment immune regulation, and ultimately effectively promote the immune system on tumor cells.
inquiries, Merck KGaA's similar products at home and abroad are in the clinical trial stage, adaptive to advanced malignancies mainly.
domestic and foreign products have not been approved for listing, there is no relevant sales data.
, the product has invested a cumulative total of about 126.34 million yuan in research and development.
in accordance with the relevant laws and regulations of China's drug registration requirements, drugs after obtaining the drug clinical trial approval notice, still need to carry out clinical trials and by the State Drug Administration review, approval and approval before production and listing.