SHANGHAI, China, May 10, 2026
Shanghai Henlius Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HLX05-N, the company’s self-developed cetuximab biosimilar, for the treatment of metastatic colorectal cancer (mCRC). The milestone marks another important step in Henlius’ global biosimilar expansion strategy and reinforces the company’s growing presence in oncology biologics development. The IND approval follows a recent authorization from China’s National Medical Products Administration (NMPA) for a Phase 1 clinical trial evaluating HLX05-N in patients with metastatic colorectal cancer.
The latest regulatory clearances position HLX05-N among the advancing next-generation biosimilar candidates targeting the global oncology market, where demand for more affordable biologic therapies continues to rise. Industry analysts view the dual approvals in both the United States and China as a significant achievement for Henlius’ international clinical development strategy and broader “Globalisation 2.0” initiative aimed at expanding access to high-quality biosimilars worldwide.
EGFR-Targeted Biosimilar Aims to Expand Oncology Access
HLX05-N is a biosimilar version of cetuximab, a recombinant anti-EGFR monoclonal antibody widely used in the treatment of metastatic colorectal cancer and head and neck squamous cell carcinoma (HNSCC). Cetuximab specifically targets the epidermal growth factor receptor (EGFR) pathway, a critical driver of tumor growth, cell proliferation, metastasis, and survival in multiple cancers. By binding to EGFR on tumor cells, cetuximab blocks intracellular signaling pathways responsible for uncontrolled cancer progression while also activating antibody-dependent cellular cytotoxicity (ADCC) mechanisms that help immune cells destroy cancer cells.
According to industry data, global sales of cetuximab reached approximately USD 1.658 billion in 2025, demonstrating continued clinical demand for EGFR-targeted cancer therapies. Despite the therapy’s established role in oncology treatment, patient access challenges and high treatment costs remain significant concerns in many healthcare systems worldwide. Henlius stated that no cetuximab biosimilars have yet been approved in either the United States or Europe, leaving substantial opportunities for new biosimilar entrants capable of improving affordability and treatment accessibility.
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The company emphasized that HLX05-N has been developed according to stringent biosimilar guidelines established by regulatory agencies in the United States, European Union, and China. Comparative analytical and non-clinical studies conducted by Henlius demonstrated a high degree of similarity between HLX05-N and the reference cetuximab product, supporting continued global clinical development activities.
Global Biosimilar Strategy Strengthens Henlius Pipeline
Henlius continues to accelerate its international biosimilar and biologics strategy as competition intensifies within the global oncology therapeutics market. The company has increasingly focused on developing high-quality biologic medicines targeting major unmet medical needs across oncology and immune-related diseases. The FDA IND clearance for HLX05-N represents another milestone in Henlius’ efforts to expand beyond China and strengthen its footprint in regulated international markets.
Industry observers note that biosimilars are becoming increasingly important in global healthcare due to rising biologic therapy costs and growing demand for cost-effective alternatives. Oncology biosimilars in particular are expected to play a major role in expanding patient access to targeted cancer therapies while reducing healthcare spending pressures worldwide.
Henlius stated that it will continue advancing research and development programs focused on innovative biologics and biosimilars while broadening its therapeutic pipeline into additional disease areas. The company reiterated its long-term commitment to delivering high-quality, affordable treatment options capable of benefiting broader patient populations globally.
The FDA clearance also highlights increasing international regulatory cooperation and accelerating momentum in biosimilar development, particularly within the oncology sector where demand for accessible biologic therapies remains strong. As global cancer rates continue to rise, companies capable of successfully developing advanced biosimilars are expected to play a critical role in the future evolution of cancer care and biologic treatment accessibility.
Source: Henlius press release
