Henlius' Bevacizumab Biosimilar HLX04 Advances Globally with FDA BLA Acceptance and Approvals in Three Latin American Markets

As a foundational anti-angiogenic therapy for solid tumors, bevacizumab has reshaped treatment paradigms by targeting vascular endothelial growth factor (VEGF) to block tumor blood vessel formation, curb tumor growth, and enhance the efficacy of concurrent chemotherapy. As demand for sustained, affordable anti-VEGF care rises worldwide, biosimilar candidates have emerged as a critical pathway to expanding patient access. Among these is HLX04, an independently developed bevacizumab biosimilar from Shanghai Henlius Biotech, Inc., which has achieved a series of global regulatory and clinical milestones-most notably an ongoing review by the U.S. Food and Drug Administration (FDA).

Product Profile and Approved Indications

As a recombinant humanized anti-VEGF monoclonal antibody developed as a biosimilar to the reference bevacizumab, HLX04 (marketed as HANBEITAI in mainland China) has been validated through head-to-head analytical, non-clinical, and clinical studies to be highly similar to the originator product in quality, safety, and efficacy.

First approved by China's National Medical Products Administration (NMPA) in 2021, HLX04 is indicated across a broad range of solid tumor settings aligned with the reference product's label. These include metastatic colorectal cancer used in combination with fluoropyrimidine-based chemotherapy; advanced, metastatic or recurrent non-squamous non-small cell lung cancer as first-line therapy paired with platinum-based chemotherapy; recurrent glioblastoma for adult patients; unresectable hepatocellular carcinoma in combination with atezolizumab for treatment-naive patients; epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer as first-line treatment with carboplatin and paclitaxel following initial surgical resection; and persistent, recurrent or metastatic cervical cancer combined with paclitaxel plus cisplatin or paclitaxel plus topotecan.

Global Regulatory and Commercialization Progress

HLX04's global footprint has expanded steadily since its initial Chinese approval, with progress across emerging markets and a key filing in the U.S.

Expanding Access in Emerging Markets

In Latin America, December 2024 marked the product's first overseas regulatory approval, granted by Bolivia's Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED) under the local brand name LONGIVA Registered . This approval made HLX04 Henlius' fourth self-developed product to secure ex-China regulatory approval, following trastuzumab, serplulimab, and rituximab.In 2022, Henlius entered into a collaboration with Eurofarma, a leading pharmaceutical company operating across Latin America, granting the company rights to develop, manufacture and commercialize multiple products, including HLX04, across 16 Latin American countries and territories. Following its approval in Bolivia, HLX04 subsequently received regulatory approval in the Dominican Republic and Mexico in 2025.

U.S. FDA Review Underway

The most high-profile regulatory milestone reached in January 2026, when the FDA formally accepted the Biologics License Application (BLA) for HLX04 for review. The submission marks Henlius' fifth product filed for U.S. marketing approval, following its successfully approved trastuzumab, denosumab, and pertuzumab biosimilars. The BLA seeks approval for HLX04 across multiple solid tumor indications, including metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and ovarian cancer.

The U.S. application is supported by a comprehensive evidence package: systematic analytical similarity assessments, a phase 1 clinical trial comparing pharmacokinetic profiles of HLX04 and the reference product in healthy subjects, and a randomized, double-blind, parallel-controlled multicenter phase 3 trial conducted in patients with metastatic colorectal cancer to further verify safety and immunogenicity. The totality of data confirms HLX04 is highly similar to the reference bevacizumab across quality, pharmacokinetic, safety, and immunogenicity endpoints.

Clinical Development: Combination Therapy Exploration

Beyond its development as a standalone biosimilar, HLX04 has served as a core partner agent in Henlius' immuno-oncology combination strategy, paired with its proprietary anti-PD-1 antibody serplulimab (HANSIZHUANG / Hetronifly Registered ).

For metastatic colorectal cancer, the phase 2 stage of the international phase 2/3 ASTRUM-015 trial explored serplulimab plus HLX04 and XELOX chemotherapy as first-line treatment. Published in Med in 2024, the results showed numerically longer median progression-free survival of 17.2 months in the serplulimab arm versus 10.7 months in the placebo arm (stratified hazard ratio 0.60), with benefit also observed in the microsatellite-stable patient subgroup. No new safety signals were identified. Supported by these findings, the phase 3 portion of ASTRUM-015 has completed full patient enrollment across China, Japan and Indonesia to support future global submissions. Henlius has also leveraged the HLX04 molecule to develop HLX04-O, an optimized ophthalmic formulation for wet age-related macular degeneration. Its new drug application has been accepted for review by China's NMPA, and an international multicenter phase 3 trial has successfully met its pre-specified primary endpoint.

The ongoing FDA review, together with established approvals in China and expanding regulatory approvals across Latin America, positions HLX04 as a growing presence in the global bevacizumab biosimilar landscape. Beyond its role in expanding patient access as a biosimilar, HLX04 is strategically embedded within Henlius' broader immuno-oncology and anti-angiogenic portfolio, enabling Henlius to independently advance anti-PD-1/anti-VEGF combination regimens. This strategy aligns with the clinically validated paradigm combining immune checkpoint inhibition and VEGF blockade, while unlocking flexible opportunities for clinical development and lifecycle management across multiple tumor types.

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