An international multi-center phase 1 clinical study of HLX17, a pabolizumab biosimilar drug independently developed by Fu Hong Hanlin (02696) in patients with various resected solid tumors completed the first patient administration in China

Zhitong Finance App News, Fu Hong Han Lin (02696) announced that recently, the Pabolizumab antibiotic analogue HLX17 (recombinant anti-PD-1 anthropogenic clonal antibody injection) (HLX17), which was independently developed by the company, completed the first patient administration in China (excluding Hong Kong, Macao and Taiwan regions of China) in an international multi-center phase 1 clinical study in patients with various resected solid tumors. The company will also conduct this international multi-center clinical trial in countries and regions such as the United States, Europe and Australia when conditions are met.

This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 clinical study to evaluate pharmacokinetic (PK) characteristics, efficacy, safety, and immunogenicity similarities between HLX17 and KEYTRUDA ^® (sold in the US) in a variety of resected solid tumors (including non-small cell lung cancer, melanoma, or renal cell carcinoma). ^{Eligible subjects were randomly assigned to groups A and B at a ratio of 1:1; participants in group A received HLX17 every 3 weeks; participants in group B received KEYTRUDA® every 3 weeks for the first 8 cycles (24 weeks) and then switched to HLX17 treatment. All subjects continued to receive treatment until 12 months (about 17 cycles) after randomization or the disease as assessed by the researcher, died, started a new anti-tumor treatment, developed intolerable drug toxicity, withdrew informed consent, or terminated the study (prior to occurrence)} (Standard). The main study endpoints of this study were the area under the serum drug concentration-time curve from 0 to 21 days after the first dose (AUC0-21d) and the area under the serum drug concentration-time curve (AuCSS) within a single administration interval in a steady state after the 6th dose. Secondary study endpoints included other PK parameters, efficacy, safety, and immunogenicity.

According to reports, HLX17 is a pabolizumab biosimilar drug independently developed by the company. Potential indications include melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, biliary tract cancer, triple-negative breast cancer, microsatellite-highly unstable or mismatched gene-deficient tumors, and gastric cancer. PD-1 receptors expressed by T cells bind to their ligands PD-L1 and PD-L2 to inhibit T cell proliferation and cytokine production. PD-1 ligands in some tumor cells are upregulated, and signaling through this pathway can inhibit immune monitoring of tumors by activated T cells. Pabolizumab is a monoclonal antibody that binds to the PD-1 receptor. It blocks the interaction of PD-1 with PD-L1 and PD-L2, relieves immunosuppression mediated by the PD-1 pathway, including anti-tumor immune responses, and enhances the immune system's ability to kill tumor cells. In September 2024, the clinical trial application for HLX17 was approved by the National Drug Administration (NMPA). In September 2025, the US Food and Drug Administration (FDA) approved a Phase 1 clinical trial application (IND) for HLX17 in patients with multiple resected solid tumors.