Henlius Submits Fifth US Product for FDA Review as Bevacizumab Biosimilar HLX04 Receives BLA Acceptance
核心洞察
Shanghai Henlius Biotech (搜索) announced that the FDA has accepted its Biologics License Application for HLX04, a bevacizumab biosimilar targeting multiple solid tumor indications including colorectal, lung, and ovarian cancers.
The submission marks Henlius' fifth product filed for US marketing approval, following successful approvals of trastuzumab, denosumab, and pertuzumab biosimilars that demonstrate the company's regulatory capabilities.
HLX04 joins a competitive bevacizumab biosimilar market where existing products capture approximately 92% market share, with comprehensive clinical data supporting similarity to the reference product.
Shanghai Henlius Biotech (搜索) has achieved a significant regulatory milestone with the FDA's acceptance of its Biologics License Application for HLX04, a bevacizumab biosimilar targeting multiple solid tumor indications. The announcement, made on January 13, 2026, represents the company's fifth product submission for US marketing approval and underscores its expanding presence in the American biosimilar market.
Broad Oncology Indication Portfolio
The BLA submission seeks approval for HLX04 across six major cancer indications: metastatic colorectal cancer (搜索), first-line treatment for unresectable locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer (搜索) in combination with carboplatin and paclitaxel, recurrent adult glioblastoma (搜索), metastatic renal cell carcinoma (搜索) in combination with interferon alpha, epithelial ovarian cancer (搜索), fallopian tube cancer, or primary peritoneal cancer, and persistent, recurrent, or metastatic cervical cancer (搜索) treated in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
As one of the earliest approved monoclonal antibodies targeting vascular endothelial growth factor (VEGF (搜索)), bevacizumab inhibits tumor growth by blocking the binding of VEGF to its receptors, thereby suppressing downstream signaling pathways, inhibiting endothelial cell proliferation, and reducing angiogenesis. With its broad antitumor activity, bevacizumab has become part of standard treatment regimens for multiple solid tumors and has significantly improved patient outcomes.
Comprehensive Clinical Development Program
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 (搜索) 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.
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.
Competitive Market Landscape
HLX04 enters a well-established bevacizumab biosimilar market in the United States. According to Samsung Bioepis (搜索)'s Q4 2025 Biosimilar Market Report, Avastin biosimilars account for about 92% of the bevacizumab market share, with Mvasi capturing the largest share of the market at about 54%. Six Avastin biosimilars have been approved in the US to date, beginning with Amgen/Allergan's Mvasi (bevacizumab-awwb), FDA-approved in September 2017.
Other pending publicly announced aBLAs for Avastin biosimilars include Samsung Bioepis (搜索)'s SB8 and Centus/Fujifilm Kyowa Kirin's FKB238, both accepted by the FDA in November 2019.
Expanding Pipeline and Strategic Development
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 (搜索) mAb serplulimab (trade name: Hetronifly in Europe), for first-line treatment of colorectal cancer.
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 (搜索) (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. The international multicentre Phase 3 clinical trial of HLX04-O has completed patient enrollment and is expected to support future marketing authorization applications in multiple countries and regions worldwide.
Proven US Regulatory Track Record
This submission builds on Henlius' established US regulatory success. Previously, Henlius' trastuzumab biosimilar HANQUYOU (trade name: HERCESSI in the US, Zercepac in Europe), denosumab biosimilars BILDYOS and BILPREVDA, and pertuzumab biosimilar POHERDY have all been successfully approved in the US, further demonstrating the company's strong capabilities in international regulatory submissions and quality management.
The FDA's acceptance of the HLX04 BLA represents an important milestone in Henlius' accelerated global expansion, as the global cancer burden continues to rise and demand for long-term, standardized anti-VEGF (搜索) therapy continues to grow.