SHANGHAI, China – JANUARY 13, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Biologics License Application (BLA) for HLX04, the Company’s independently developed bevacizumab biosimilar (a recombinant anti-VEGF humanized monoclonal antibody), has been formally accepted for review by the U.S. Food and Drug Administration (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. This marks the fifth product submitted by Henlius for marketing approval in the United States. Previously, Henlius’ trastuzumab biosimilar HANQUYOU (trade name: HERCESSI™ in the U.S., Zercepac® in Europe), denosumab biosimilars BILDYOS® and BILPREVDA®, and pertuzumab biosimilar POHERDY® have all been successfully approved in the U.S., further demonstrating the Company’s strong capabilities in international regulatory submissions and quality management.
As one of the earliest approved monoclonal antibodies targeting vascular endothelial growth factor (VEGF), bevacizumab inhibits tumour growth by blocking the binding of VEGF to its receptors, thereby suppressing downstream signalling pathways, inhibiting endothelial cell proliferation, and reducing angiogenesis.1 With its broad antitumor activity, bevacizumab has become part of standard treatment regimens for multiple solid tumours and has significantly improved patient outcomes. 2-7As the global cancer burden continues to rise, demand for long-term, standardized anti-VEGF therapy continues to grow.8
HLX04 was approved for marketing in China in 2021 and has since been approved in multiple Latin American countries and regions, including Bolivia, the Dominican Republic, and Mexico. The biosimilar product HLX04 is self-developed by Henlius with the reference to originator bevacizumab. The current BLA submission is supported by a comprehensive data package, including systematic analytical similarity studies, a Phase 1 clinical trial comparing the pharmacokinetic similarity of HLX04 and reference product in healthy subjects, and a randomized, double-blind, parallel-controlled, multicentre Phase 3 clinical trial in patients with metastatic colorectal cancer to further evaluate safety and immunogenicity. The totality of evidence demonstrates that HLX04 is highly similar to reference product in terms of quality attributes, pharmacokinetics, safety, and immunogenicity, supporting its development as a bevacizumab biosimilar.
Currently, Henlius is actively advancing a Phase 2/3 clinical trial evaluating HLX04 in combination with the Company’s core immunotherapy product, the anti-PD-1 mAb serplulimab (trade name: Hetronifly® in Europe), for first-line treatment of colorectal cancer. In addition, based on HLX04, Henlius has optimized the formulation, dosage strength, and manufacturing process—while maintaining the same active ingredient—to develop a new ophthalmic formulation, HLX04-O, intended for the treatment of wet age-related macular degeneration (wAMD). The New Drug Application (NDA) for HLX04-O for the treatment of wAMD has been accepted for review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) of China. To date, no bevacizumab product marketed in China has been approved for the wAMD indication. Meanwhile, the international multicentre Phase 3 clinical trial of HLX04-O has completed patient enrolment and is expected to support future marketing authorization applications in multiple countries and regions worldwide.
The FDA’s acceptance of the HLX04 BLA represents an important milestone in Henlius’ accelerated global expansion. Looking ahead, Henlius remains committed to addressing clinical needs for affordable biologic therapies, and will continue to bring high-quality, accessible, and affordable products and treatment options to patients worldwide.
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