HLX6018 / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

Safety, pharmacokinetics, and immunogenicity of HLX6018, a monoclonal antibody targeting the GARP/TGF-β1 complex, in healthy subjects: A randomized, double-blind, placebo-controlled, phase I clinical study. (ASCO 2026) - P1 | "HLX6018 is safe and well tolerated across the investigated doses. Further clinical investigation of its efficacy is warranted."

Clinical • First-in-human • P1 data • PK/PD data • Immunology • Pulmonary Disease • Respiratory Diseases • TGFB1

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Idiopathic Pulmonary Fibrosis

First Subject Dosed for Phase 1 Clinical Trial of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 (Henlius Press Release) - "Shanghai Henlius Biotech...announced the first subject was dosed for a phase 1 clinical trial of HLX6018 (NCT06310746), a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company. HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases, and it was recently approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF)."

Trial status • Idiopathic Pulmonary Fibrosis

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects (clinicaltrials.gov) - P1 | N=66 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Idiopathic Pulmonary Fibrosis

The IND Application of Henlius’ Novel Anti-GARP/TGF-β1 mAb HLX6018 Approved by NMPA (Henlius Press Release) - "Shanghai Henlius Biotech...announced the investigational new drug (IND) application for clinical trial of HLX6018, a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF)."

New trial • Idiopathic Pulmonary Fibrosis