Shanghai, China, September 29th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for its HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC).
HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and maintain high affinity of the product. Pre-clinical studies have shown that HLX07 binds EGFR with similar affinity and has better bioactivity compared to cetuximab. HLX07 can significantly inhibit the growth of tumour cells in different tumour models and synergize with immune checkpoint inhibitors such as HANSIZHUANG (serplulimab).
As of now, Henlius holds patents of HLX07 in several jurisdictions including China, the United States, the European Union, Australia, and Japan. Moreover, Henlius has received clinical trial approvals for HLX07 in China and the United States,. The phase 1b/2 clinical trial has been conducted in China for the treatment of solid tumours. As for used in the combination immunotherapies with HANSIZHUANG (serplulimab), the first patients were dosed in China in phase 2 clinical trials of HLX07 in combination with HANSIZHUANG (serplulimab) for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck (HNSCC) and EGFR high expression squamous non-small cell lung cancer (sqNSCLC). In addition, the IND for the phase 2 clinical trial of HLX07 in combination with HANSIZHUANG (serplulimab) and HANBEITAI (bevacizumab biosimilar) for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA).
Underpinned by the patient-centric strategy, Henlius has achieved an overall layout of the immune checkpoint products of PD-1/L1, CTLA-4, LAG-3, etc., proactively exploring immuno-oncology combination therapy. Meanwhile, Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer. Looking forward, Henlius will continue conducting clinical studies for more innovative products and exploring therapies with improved efficacy to provide patients with quality and affordable biologics.