Henlius adopts a differentiation strategy to initiate the clinical trial of rituximab injection for RA as the indication has not been approved in China, making HLX01-RA the only rituximab filing NDA for RA in China. Its NDA was accepted for review by the NMPA in December, 2020.

HLX03.  Adalimumab Injection, an adalimumab biosimilar, is mainly for the treatment of plague psoriasis (PS), rheumatoid arthritis (RA) and ankylosing spondylitis (AS). A Phase 3 clinical trial in China was completed. HLX03 received a New Drug Application (NDA) acceptance from the NMPA in January, 2019.

HLX03 was assigned to priority review list by the NMPA in April, 2019.  

HLX04. Bevacizumab Injection, a bevacizumab biosimilar, is potentially for the treatment of mCRC and nsNSCLC. Its NDA has been accepted for review by the NMPA. It shows great potential to be combined with Serplulimab (anti-PD-1 mAb) for immuno-oncology therapy to treat more solid tumors.

Serplulimab injection, a novel anti-PD-1 monoclonal antibody, independently researched and developed by Henlius, can be potentially indicated for various solid tumors and applied in combination with other products for immuno-oncology therapy. Currently, its clinical trial approvals have been granted in China, the United States, the EU countries, etc. with multiple clinical trials ongoing. 

Its Phase 2 clinical trial as monotherapy for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors that fail to respond to the standard therapy has met primary endpoints. The NDA has been accepted by the NMPA and granted priority review status. It is expected to launch in the first half year of 2022, promising to become the first anti-PD-1 mAb indicated for MSI-H solid tumors in China.

HLX06. Recombinant Anti-Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) Fully Human Monoclonal Antibody Injection independently researched and developed by Henlius, is for the treatment of solid tumors. It was granted Investigational New Drug (IND) approvals to be evaluated in trials in the US, Chinese mainland and Taiwan China, and a Phase 1 clinical trial was commenced in Taiwan China.

HLX55. HLX55 Monoclonal Antibody for Injection. It is a novel humanised monoclonal antibody targeting the HGF/c-MET (hepatocyte growth factor/c-MET) signalling pathway. It has received clinical approval in China. The first patient was dosed in a Phase 1 study for the treatment of advanced solid tumours refractory to standard therapy.

HLX20. Recombinant Fully Human Anti-PD-L1 Monoclonal Antibody Injection developed independently by Henlius, can be applied in combination with other products for immuno-oncology therapy in the future. HLX20 received clinical approvals in Australia and China. A Phase 1 clinical trial was commenced in Australia.

HLX56 is an innovative anti-DR4 mAb, which can specifically bind to DR4 expressed on the surface of tumour cells, and induce tumour cell apoptosis. Two mutations are introduced into the Fc regions of HLX56 to amplify the apoptotic signal and improve the safety. HLX56 was granted clinical approval in Taiwan China. It has the potential to be the first-in-class drug targeting DR4.