HENLIUS (ASX: 02696) has announced that the first patient in China (excluding Hong Kong, Macau, and Taiwan) has been dosed in a Phase 1 clinical study of its self-developed cetuximab injection biosimilar, HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for patients with metastatic colorectal cancer (mCRC).

This study is a multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical trial comparing HLX05-N combined with chemotherapy (mFOLFOX6) to US- and EU-sourced Erbitux® combined with chemotherapy in participants with KRAS/NRAS wild-type and BRAF V600E mutation-negative metastatic colorectal cancer.

Participants will be randomly assigned in a 1:1:1 ratio to either the HLX05-N group, the US-sourced Erbitux® group, or the EU-sourced Erbitux® group, with stratification based on ECOG performance status and gender.

For the first three cycles, participants in each group will receive the corresponding investigational drug combined with chemotherapy. Subsequently, participants in the US- or EU-sourced Erbitux® groups will be switched to HLX05-N under blinded conditions and will continue with combination chemotherapy until meeting the protocol-defined discontinuation criteria.

The primary objective of this study is to evaluate the pharmacokinetic (PK) similarity between HLX05-N and Erbitux® following single and multiple intravenous infusions. Secondary objectives include comparing the pharmacokinetic (PK) profiles, efficacy, safety, and immunogenicity of the two treatments.