13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar (a recombinant anti-VEGF humanised monoclonal antibody), has been formally accepted for review by the US FDA. 

The application seeks approval for the treatment of multiple solid tumours, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.

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