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On January 27th, Baotai announced that it had submitted to the FDA in the fourth quarter of 2020 an application for the listing of biological products for BAT1706 (Beva Pearl Monoantigen) injections (BLA), and had recently received a notification from the FDA.
BAT1706 is a beva bead monoantigen injection developed by Baotai in accordance with the guidelines of china's State Drug Administration (NMPA), the FDA and the European Medicines Administration (EMA) biosychables, which work by combining with vascular endotrical growth factor (VEGF).
Bayval pearl monoantigens approved in the United States include metastatic colorectal cancer, non-squamous non-small cell lung cancer, reocgenerative glioblastoma, metastatic renal cell carcinoma, persistent, reococculative or metastatic cervical cancer, epithelial ovarian cancer, fallopian or primary peritonal cancer, and hepatocellular carcinoma.
as of the date of this announcement, Baeote has submitted BAT1706's listing license application to China's NMPA, the FDA and the European EMA.
