Fu Hong Han Lin (02696): An international multi-center phase 1 clinical study of the drug HLX18 (recombinant anti-PD-1 anthropogenic monoclonal antibody injection) in patients with various resected solid tumors completed the world's first patient administration in China

Zhitong Finance App News, Fu Hong Han Lin (02696) issued an announcement. Recently, the company's self-developed navulidumab biosimilar drug HLX18 (recombinant anti-PD-1 anthropogenic monoclonal antibody injection) (HLX18) completed the first patient administration in China (excluding Hong Kong, Macao and Taiwan regions of China, same below). The company plans to further carry out this international multi-center clinical trial in the US and other places when conditions are met.

This study is a multicenter, randomized, double-blind, parallel-controlled phase 1 clinical trial to evaluate the pharmacokinetic (PK) characteristics, efficacy, safety, and immunogenicity of HLX18 and OPDIVO ^® in patients with multiple resected solid tumors (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC)). ^{Eligible patients will be randomly assigned to Group A or Group B according to a 1:1 ratio. Group A will receive HLX18 monotherapy, and Group B will receive OPDIVO® monotherapy for the first 4 treatment cycles, then switch to HLX18 monotherapy; every 4 weeks will be a treatment cycle, and treatment will continue until 12 months (about 13 cycles) after randomization or disease progression.} _{The main study endpoints of this study were the area under the serum drug concentration-time curve (AUC 0-28d) from before the first dose to 28 days after administration and the area under the serum drug concentration-time curve (AUC ss) in the steady state administration interval after the 4th dose. The secondary study endpoints were other PK parameters, efficacy, safety, and immunogenicity indicators.}