Henlius Doses First Patient in Phase 1 Trial for Cetuximab Biosimilar HLX05-N
I'm LongbridgeAI, I can summarize articles.Shanghai Henlius Biotech has dosed the first patient in a Phase 1 trial for HLX05-N, a cetuximab biosimilar for metastatic colorectal cancer. The study compares HLX05-N against Erbitux to demonstrate pharmacokinetic similarity and assess safety and efficacy. This milestone supports HLX05-N as a potential alternative in the global biosimilar oncology market. Analysts maintain a 'Buy' rating on Henlius stock (HK:2696) with a HK$99.78 price target.
Shanghai Henlius Biotech has initiated a key clinical milestone with the first patient dosed in a phase 1 trial of its cetuximab biosimilar HLX05-N for metastatic colorectal cancer in mainland China. The study design compares HLX05-N against U.S.- and EU-sourced Erbitux in combination with standard mFOLFOX6 chemotherapy in a randomized, double-blind, parallel-controlled setting.
The trial aims primarily to demonstrate pharmacokinetic similarity and secondarily to assess efficacy, safety and immunogenicity, supporting the product’s positioning as a viable alternative to branded cetuximab. With global cetuximab sales of about USD1.658 billion in 2025, successful development of HLX05-N could open substantial market opportunities and enhance Henlius’s standing in the biosimilar oncology space, though the company cautions that development and commercialization are not guaranteed.
The most recent analyst rating on (HK:2696) stock is a Buy
with a HK$99.78 price target.
To see the full list of analyst forecasts on Shanghai Henlius Biotech, Inc. Class H stock,
see the HK:2696 Stock Forecast page.
More about Shanghai Henlius Biotech, Inc. Class H
Shanghai Henlius Biotech, Inc. is a China-based biopharmaceutical company focused on developing and commercializing biosimilar and innovative monoclonal antibody therapies. Its portfolio targets oncology and other immune-related diseases, with a growing emphasis on the global market for antibody-based cancer treatments.
The company is expanding its presence in the colorectal and head and neck cancer segments through independently developed biosimilar products aligned with Chinese, U.S. and EU regulatory standards.
Henlius aims to strengthen its competitive position in the global biologics arena by leveraging its R&D capabilities and adherence to international biosimilar guidelines, addressing large, established markets for targeted oncology drugs.
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Technical Sentiment Signal: Strong Buy
Current Market Cap: HK$37.54B
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