HLX18 (nivolumab biosimilar) / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

A Study of HLX18 vs. OPDIVO in Multiple Resected Solid Tumors (clinicaltrials.gov) - P1 | N=174 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor • Urothelial Cancer

Shanghai Henlius Biotech has begun dosing the first patient in a global, multicenter phase 1 clinical trial of HLX18, its nivolumab biosimilar, in patients with multiple resected solid tumors in mainland China. (TipRanks) - "The randomized, double-blind study compares pharmacokinetics, efficacy, safety and immunogenicity of HLX18 against OPDIVO in cancers including esophageal, gastroesophageal junction, melanoma and urothelial carcinoma."

Trial status • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma • Urothelial Cancer

Henlius Wins NMPA Nod for Phase 1 Trial of Nivolumab Biosimilar HLX18 (TipRanks)

New P1 trial • Melanoma • Non Small Cell Lung Cancer • Solid Tumor

Shanghai Henlius Biotech has received approval from the U.S. Food and Drug Administration for its investigational new drug application to begin a phase 1 clinical trial in the United States of HLX18, a nivolumab biosimilar designed as a recombinant anti-PD-1 humanized monoclonal antibody injection for multiple solid tumors. (TipRanks)

IND • New P1 trial • Solid Tumor