Shanghai Henlius Biotech Inc. announced that its Biologics License Application (BLA) for HANBEITAI (bevacizumab injection) has been accepted by the United States Food and Drug Administration (FDA). The application covers multiple proposed indications, including metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel for first-line treatment, recurrent glioblastoma in adults, metastatic renal cell carcinoma in combination with interferon alfa, epithelial ovarian, fallopian tube cancer or primary peritoneal cancer, and persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan. The BLA submission is based on data demonstrating high similarity and no clinically meaningful differences between HANBEITAI and its reference drug.

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