HLX17 (pembrolizumab biosimilar) / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda in Multiple Resected Solid Tumors (clinicaltrials.gov) - P1 | N=174 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors (clinicaltrials.gov) - P1 | N=174 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors (clinicaltrials.gov) - P1 | N=174 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Henlius Starts Global Phase 1 Trial of Pembrolizumab Biosimilar HLX17 in U.S. and China (TipRanks) - "Shanghai Henlius Biotech has dosed the first patient in an international, multi-center phase 1 clinical trial of HLX17, its independently developed biosimilar to pembrolizumab, in patients with multiple resected solid tumors in the U.S. and simultaneously in Mainland China. The randomized, double-blind study compares HLX17 with U.S.-sourced Keytruda, with a primary focus on pharmacokinetic similarity and secondary evaluation of efficacy, safety, and immunogenicity."

Trial status • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma

Recently, the first patient has been dosed in an international multi-center phase 1 clinical trial of a biosimilar of pembrolizumab HLX17…in patients with multiple resected solid tumors in mainland China (excluding Hong Kong, Macau and Taiwan regions of China)… (iis.aastocks.com)

Trial status • Solid Tumor

THE INVESTIGATIONAL NEW DRUG APPLICATION OF A BIOSIMILAR OF PEMBROLIZUMAB HLX17 (RECOMBINANT HUMANISED ANTI-PD-1 MONOCLONAL ANTIBODY INJECTION) IN PATIENTS WITH MULTIPLE RESECTED SOLID TUMOURS APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) (HKEXnews)

IND • Solid Tumor

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=772 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IND Application of Henlius’ Pembrolizumab Biosimilar Approved by NMPA (Henlius Press Release) - "Shanghai Henlius Biotech...announced the investigational new drug (IND) application for clinical trial of HLX17, a pembrolizumab biosimilar independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of indications that reference pembrolizumab has been approved, including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite instability-high or mismatch repair deficient cancer, and gastric cancer, etc."

New trial • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer