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On November 26, the official website of the Food and Drug Administration showed that Bevacizumab biosimilar (MIL60) of Betta Pharmaceuticals was approved for marketing for the treatment of advanced, metastatic or recurrent non-small cell lung cancer and metastatic colorectal Cancer patients
MIL60 is a recombinant anti-human vascular endothelial growth factor (VEGF) humanized monoclonal antibody jointly developed by Betta Pharmaceuticals and Tianguangshi.
MIL60 can selectively bind to VEGF and block its biological activity.
The original research Avastin has been approved for 6 indications in China, namely colorectal cancer, first-line treatment of non-small cell lung cancer, glioblastoma, hepatocellular carcinoma, first-line treatment of epithelial ovarian cancer, fallopian tube cancer or primary Peritoneal cancer, cervical cancer
In September of this year, Betta Pharmaceuticals announced the Phase III clinical (NCT03196986) results of MIL60 at the ESMO annual meeting
The primary endpoint is to compare the objective response rate (ORR12) of the two groups of patients with advanced or recurrent non-squamous cell NSCLC for 12 weeks
The results show that MIL60 has the same clinical efficacy as BEV in the treatment of non-squamous NSCLC, and its safety, Pop PK and immunogenicity are similar to BEV
At present, five domestic companies have approved bevacizumab biosimilar drugs for the market, namely Qilu Pharmaceutical, Cinda Biological, Hengrui and Boan Biological, and Biotech