Core Viewpoint - The company has completed the first patient dosing of its self-developed biosimilar HLX17 in an international multi-center Phase 1 clinical study for patients with various resected solid tumors, with plans to expand trials to the US, Europe, and Australia once conditions permit [1]. Group 1: Clinical Study Overview - The Phase 1 clinical study is a multi-center, randomized, double-blind, parallel-controlled trial aimed at evaluating the pharmacokinetics (PK), efficacy, safety, and immunogenicity similarity of HLX17 compared to KEYTRUDA in patients with various resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma [2]. - Eligible participants will be randomly assigned in a 1:1 ratio to either Group A (receiving HLX17) or Group B (initially receiving KEYTRUDA followed by HLX17), with treatment continuing for up to 12 months or until certain endpoints are met [2]. - The primary endpoint of the study is the area under the serum drug concentration-time curve from 0 to 21 days (AUC0-21d) after the first dose, along with secondary endpoints including other PK parameters, efficacy, safety, and immunogenicity [2]. Group 2: Product and Regulatory Status - HLX17 is a biosimilar of pembrolizumab, with potential indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, cholangiocarcinoma, triple-negative breast cancer, and other tumors with specific genetic defects [3]. - The mechanism of action involves blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby enhancing the immune response against tumor cells [3]. - The clinical trial application for HLX17 was approved by the National Medical Products Administration (NMPA) in September 2024, and the Investigational New Drug (IND) application for the Phase 1 trial in the US was approved by the FDA in September 2025 [3].
复宏汉霖(02696)自主研发的帕博利珠单抗生物类似药HLX17在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国境内完成首例患者给药