First Patient Dosed in China for MRCT of pimurutamab (HLX07) Plus serplulimab
Henlius 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. Recently, the study also completed Clinical Trial Notification (CTN) in Australia, with global clinical development progressing steadily.
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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”
Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).