Shanghai Henlius Biotech, Inc products

HLX04-O, recombinant anti-VEGF humanised monoclonal antibody injection.  It is indicated for wet age-related macular degeneration (wAMD). HLX04-O was granted Phase 3 clinical study approvals in Australia, the United States, Singapore and the EU countries such as Latvia, Hungary and Spanish. In April 2022, the first patient in Australia and Latvia was dosed in the global multicentre phase 3 clinical trial, respectively. In November 2021, the first patient has been dosed in a phase 3 clinical trial in China for HLX04-O for the treatment of wAMD.

HANBEITAI (bevacizumab injection) was approved by the NMPA in November 2021. It is indicated for metastatic colorectal cancer (mCRC), advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), recurrent glioblastoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. It is the only bevacizumab with metastatic colorectal cancer Phase III clinical data in China and proposed to be combined with HANSIZHUANG (PD-1) for immuno-oncology combination therapies to treat various tumors.

HLX14, recombinant anti-RANKL human monoclonal antibody injection, a denosumab biosimilar. It is potentially indicated for the treatment of postmenopausal women with OP at high risk for fracture. First subject has been doesd in the international multi-centre phase 3 clinical trial in China for the treatment of postmenopausal osteoporosis in women with high fracture risks.

HLX07, recombinant anti-epidermal growth factor receptor (EGFR) humanised monoclonal antibody injection independently researched and developed as biobetter. It was granted IND approvals to be evaluated in clinical trials in China and the United States. It demonstrated favorable safety and tolerability profile in a prospective, open-label, dose-escalation Phase 1 clinical study (HLX07FIH, NCT02648490) for the treatment of advanced solid tumours. Tumour response was observed in this study and preliminary efficacy of HLX07 was established.

The Company`s first product indicated for the treatment of autoimmune diseases. (adalimumab injection) was approved by the NMPA in December 2020. It is indicated for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and uveitis. It is the first China-developed adalimumab biosimilar that is manufactured in a China and Europe GMP certificated manufacturing site, as well as the only adalimumab biosimilar evaluated in a Phase 3 clinical study among Chinese patients with plaque psoriasis.