HENLIUS(02696.HK): Bispecific EGFR/c-MET ADC HLX48 Doses First Patient

NewTimeSpace · 2026/06/30 18:03 · By Xuran Lin

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) announced that HLX48 for injection, an antibody-drug conjugate (ADC) targeting EGFR and c-MET independently developed by the Company, has completed first patient dosing in the Phase I clinical study for the treatment of advanced/metastatic solid tumors in China. As of the date of this announcement, no bispecific antibody-drug conjugates targeting both EGFR and c-MET have been approved for marketing worldwide.

NewTimeSpace News: Shanghai Henlius Biotech Co., Ltd. (02696.HK) issued a voluntary announcement on 30 June 2026, disclosing that HLX48 for injection, self-developed by the Company, has completed first patient dosing.

HLX48 is a proprietary bispecific antibody-drug conjugate (BsADC) targeting c-MET and EGFR, intended for the treatment of advanced/metastatic solid tumors. Its antibody binds to tumor cells positive for c-MET/EGFR expression and triggers receptor-mediated endocytosis into tumor cells, where toxic payloads are released to induce DNA damage and cell death. It also eliminates adjacent tumor cells via the bystander killing effect.

This is an open-label, dose-escalating first-in-human Phase I clinical trial covering six dose groups ranging from 1.5 mg/kg to 15 mg/kg. Subjects will receive intravenous infusion once every three weeks. The primary endpoint is to evaluate the incidence of dose-limiting toxicities and determine the maximum tolerated dose.

In May 2026, the Phase I clinical trial application for HLX48 was approved by the National Medical Products Administration (NMPA) of China. It also obtained clinical trial notification clearance from the Therapeutic Goods Administration (TGA) of Australia and ethics approval from the Human Research Ethics Committee. The Company plans to conduct relevant clinical trials in Australia when conditions permit.

As at the date of this announcement, no bispecific antibody-drug conjugates simultaneously targeting EGFR and c-MET have obtained marketing approval globally.

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