Gelonghui July 29th 丨Fuhong Hanlin-B (02696.HK) issued an announcement. Today, the company recombinant anti-PD-1 monoclonal antibody injection (”HLX10”) Combined recombinant anti-EGFR humanized monoclonal antibody injection (”HLX07”) A phase 2 clinical study for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) completed the first patient administration in mainland China.

This study is an open, phase 2 clinical trial to evaluate the clinical efficacy and safety of HLX10 combined with HLX07 in the treatment of patients with advanced recurrent or metastatic head and neck tumors. The main purpose of the trial was to evaluate the objective remission rate and safety of HLX10 and HLX07 in the treatment of advanced head and neck squamous cell carcinoma at week 16. The second aim was to evaluate other efficacy endpoints, immunogenicity, and pharmacokinetic characteristics. Exploratory purposes include monitoring treatment response and/or biomarkers of drug resistance.

HLX10 is an innovative biopharmaceutical independently developed by the company for the treatment of solid tumors. Currently, the possibility of using it in the treatment of chronic hepatitis B (that is, chronic hepatitis B) is being further explored. HLX07 is an improved innovative biomedical targeting EGFR developed independently by the company. It is expected to be used for treatment of various solid tumors such as colorectal cancer and nasopharyngeal cancer.As of the date of the announcement, in mainland ChinaNo similar combination therapy has been approved for marketing by the State Drug Administration.