Henlius Secures NMPA IND Clearance for First-in-Class Bispecific ADC HLX48 in Advanced Solid Tumors

Bulletin Express05-21

Shanghai Henlius Biotech, Inc. (Henlius) announced that China’s National Medical Products Administration has approved the investigational new drug (IND) application for the Phase 1 clinical trial of HLX48, a bispecific antibody-drug conjugate targeting both EGFR and c-MET in patients with advanced or metastatic solid tumors.

HLX48 combines dual-targeted binding with a cytotoxic payload. Preclinical data show that the molecule induces receptor-mediated endocytosis, delivers DNA-damaging agents directly to tumor cells, blocks ligand-receptor interactions on EGFR and c-MET, and activates antibody-dependent cell-mediated cytotoxicity. This multi-pronged mechanism is designed to provide synergistic anti-tumor activity while maintaining a favorable safety profile.

No bispecific ADC simultaneously targeting EGFR and c-MET has received marketing approval worldwide, underscoring HLX48’s potential first-in-class position. An earlier ethics endorsement and acknowledgement by Australia’s Therapeutic Goods Administration in May 2026 further support Henlius’s global development strategy for the candidate.

The company reiterates that clinical development carries inherent uncertainties and successful commercialization is not guaranteed. Shareholders and potential investors are advised to exercise caution when dealing in Henlius shares.

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