HENLIUS(02696.HK): First Patient Dosed in Phase I Clinical Trial of HLX05-N, a Cetuximab Biosimilar, for Metastatic Colorectal Cancer
NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) announced that the Phase I clinical trial of HLX05-N, its self-developed cetuximab injection biosimilar, has completed first patient dosing in Chinese Mainland for patients with metastatic colorectal cancer (mCRC). Global sales of cetuximab injection reached approximately USD1.658 billion in 2025 based on IQVIA data. The IND applications for the Phase I trial of HLX05-N were approved by NMPA and the FDA in April and May 2026 respectively. Investors are reminded of uncertainties in drug research and development.
NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. issued a voluntary announcement dated 8 July 2026. The Phase I clinical study of HLX05-N, an in-house developed biosimilar of cetuximab injection, has completed dosing of the first patient in Chinese Mainland among patients diagnosed with metastatic colorectal cancer (“mCRC”).
This is a multicenter, randomised, double-blind, parallel-controlled Phase I clinical trial, designed to compare the pharmacokinetic similarity, safety, efficacy and immunogenicity of HLX05-N versus Erbitux® sourced from the US and EU when combined with chemotherapy. Subjects will be randomised in a 1:1:1 allocation ratio. HLX05-N is being developed for the treatment of mCRC and head and neck squamous cell carcinoma. The investigational new drug (IND) applications for its Phase I trial were approved by the National Medical Products Administration (NMPA) in April 2026 and the U.S. Food and Drug Administration (FDA) in May 2026. Per IQVIA industry statistics, global annual sales of cetuximab injection totalled around USD1.658 billion in 2025.
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