Globalisation 2.0 | Henlius Completes First Patient Dosed in China for MRCT of pimurutamab (HLX07) Plus serplulimab, Accelerating Global Development

Henlius (2696.HK) has announced that the first patient has been dosed in China in a randomized, double-blind, multicentre, parallel-controlled Phase 2/3 clinical trial evaluating its self-developed recombinant anti-EGFR mAb pimurutamab (HLX07) in combination with the anti-PD-1 mAb serplulimab and chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC).

This milestone marks the official initiation of the study’s clinical execution phase in China.

The study adopts a multi-regional clinical trial (MRCT) design and is being advanced simultaneously in both China and ex-China markets, accelerating global clinical development.

The Phase 2/3 trial (HLX07-sqNSCLC301) aims to evaluate pimurutamab plus serplulimab and chemotherapy versus placebo plus serplulimab or pembrolizumab and chemotherapy in patients with advanced sqNSCLC.

The study consists of two parts; Part I is a Phase 2 study with participants randomized to receive pimurutamab at 1000 mg or 600 mg dose or placebo, each with serplulimab and chemotherapy for four 3‑week cycles, followed by maintenance therapy.

Positive Phase 2 data (HLX07-sqNSCLC-201) showed an objective response rate of about 70% and a disease control rate over 90%, with median progression-free survival reaching 17.4 months in the high-dose cohort and no new safety signals.

The trial has already completed Clinical Trial Notification (CTN) in Australia, underscoring Henlius’s Globalisation 2.0 strategy and its push to bring innovative, first‑line treatment options for EGFR‑overexpressing sqNSCLC to global markets.