HLX48 / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

Henlius Doses First Patient with c-MET x EGFR Bispecific ADC HLX48 (Henlius Press Release) - "This open-label, dose-escalation, first-in-human phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) profiles, and preliminary efficacy of HLX48 in patients with advanced/metastatic solid tumors."

First-in-human • Trial status • Solid Tumor

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Hepatocellular Cancer • Oncology • Solid Tumor • EGFR • MET

Henlius Wins NMPA Nod for First-in-Human Trial of Bispecific ADC HLX48 (TipRanks)

New P1 trial • Solid Tumor

Henlius (02696): Phase 1 clinical trial of HLX48 for Injection (an antibody-drug conjugate targeting EGFR and c-MET) for the treatment of advanced/metastatic solid tumors has been approved for commencement in Australia. (FUTU)

New P1 trial • Solid Tumor

Hanjugator camptothecin platform: Effective, low-toxicity design maximizing antibody functionality and delivering potential best-in-class EGFR/cMet bispecific antibody-drug conjugate (AACR 2026) - "In vivo efficacy of EGFR/cMet-LPA003 was tested in multiple xenograft models (LU387, SW48, HT29, NCI-H1975)...Medium-potency LPA003, conjugated to EGFR/cMet bispecific antibody, induced significant tumor regression at single 3 mg/kg doses in various xenograft models, outperforming AZD9592 in the HT29 CDX model... We have developed Hanjugator, a versatile camptothecin-based linker-payload platform with tunable toxin potency. This modular design accommodates diverse targets and ADC programs, optimizing dosing regimens and broadening clinical applications. The LPA003-conjugated EGFR/cMet bispecific ADC exhibits a superior therapeutic index, maximizing antibody-mediated signaling blockade, and positions as best-in-class molecule with Investigational New Drug submission anticipated in Q1 2026."

ADC • Bispecific • Oncology

At this year’s AACR conference, Henlius will showcase seven early-stage innovative assets with first-in-class (FIC) or best-in-class (BIC) potential. (Henlius Press Release) - "These include...multiple novel ADC candidates developed based on proprietary platform Hanjugator, including the EGFR×cMET bispecific ADC HLX48, HER2 biparatopic ADC HLX49, ADAM9 ADC HLX402, and ALPP/ALPPL2 ADC HLX85."

Preclinical • Oncology

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

First-in-human • New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor • EGFR • MET