HLX01. Rituximab Injection (Biosimilar). It was granted New Drug Application (NDA) approval by the NMPA for the treatment of non-Hodgkin lymphoma (NHL) in February, 2019. Meanwhile, Henlius adopts a differentiation strategy to commence the clinical trial for rheumatoid arthritis (RA) as the indication has not been approved in China, highlighting Henlius' commitment to benefiting more patients. The NDA for RA was accepted for review by the NMPA in December, 2020.

HLX04. Bevacizumab Injection, a bevacizumab biosimilar, is potentially for the treatment of metastatic colorectal cancer (mCRC) and non-squamous non-small cell lung cancer (nsNSCLC). Its NDA has been accpeted for review by the NMPA. It shows great potential to be combined with Serplulimab (a recombinant humanised anti-PD-1 monoclonal antibody injection) for immuno-oncology therapy to treat more solid tumors.

Serplulimab injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb), 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. It is also further developed for the treatment of chronic hepatitis b virus infection (HBV). Currently, its clinical trial approvals have been granted in China and the US. Its Phase 2 clinical trial as mono-therapy 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. Its NDA application has been accepted by the National Medical Products Administration (NMPA) and granted priority review status. First patient has been dosed in its Phase 2 clinical trials for the treatment of HBV in China.

Meanwhile, its combination with chemotherapy, HLX04 (bevacizumab injection) and HLX07 (anti-EGFR mAb) have been granted clinical approvals with Phase 2/3 clinical studies initiated in China, Turkey, Poland, Ukraine, Russia, etc.

It is the first mAb combination therapy to receive Investigational New Drug (IND) approval from the NMPA for the treatment of advanced solid tumor. The first patients were dosed in a Phase 2 clinical trial for the treatment of advanced hepatocellular carcinoma (HCC), a Phase 3 clinical trial for the treatment of non-squamous, non-small cell lung cancer (nsNSCLC) and a Phase 2/3 clinical trial for the treatment of metastatic colorectal cancer (mCRC).

Henlius' second dual mAbs combination therapy. It is for the treatment of squamous cell carcinoma of the head and neck (SCCHN). The first patient was dosed in China in a Phase 2 clinical trial for the treatment of recurrent or metastatic SCCHN.

HLX07. Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Humanised Monoclonal Antibody Injection independently researched and developed as biobetter, is for the treatment of solid tumors. It was granted Investigational New Drug (IND) approvals to be evaluated in clinical trails China and the US, and a Phase 1b/2 clinical trial was commenced in China. 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.

HLX22. HLX22 Monoclonal Antibody Injection. It is a humanised IgG1 monoclonal antibody injection targeting human epidermal growth factor receptor-2 (HER2). It received Investigational New Drug (IND) approval from the NMPA and can be potentially used for the treatment of solid tumors like breast cancer (BC) and  gastric cancer (GC). Currently, the first patient was dosed in Phase 1 clinical study in 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.

HLX11. Recombinant Anti-human Epidermal Growth Factor Receptor 2 (HER2) Domain II Humanised Monoclonal Antibody Injection, a pertuzumab biosimilar. It can be used in combination with trastuzumab and chemotherapy for adjuvant treatment and neoadjuvant treatment for patients with HER2-positive breast cancer (BC) and HER2-positive metastatic breast cancer (mBC).

HLX05. Recombinant Anti- Endothelial Growth Factor Receptor (EGFR) Human/Murine Chimeric Monoclonal Antibody Injection, a cetuximab biosimilar, is mainly for the treatment of metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN). It received two Investigational New Drug (IND) approvals for the two indications successively in August and October 2016. Its commercialisation rights in China has been licensed out.

HLX12. Recombinant Anti-Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) Domain II-III Fully Human Monoclonal Antibody Injection, a ramucirumab biosimilar, is for the treatment of advanced gastric cancer (GC), metastatic non-small cell lung cancer (mNSCLC) and metastatic colorectal cancer (mCRC). Phase 1 clinical trial for HLX12 was commenced.

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 approval in Australia and China. A Phase 1 clinical trial was commenced in Australia.

HLX26, recombinant anti-LAG-3 human monoclonal antibody injection, is an innovative monoclonal antibody independently researched and developed by Henlius. LAG-3 is an immune checkpoint receptor and is regarded as a new generation of immunotherapy target after PD-1/L1 and CTLA-4. Its IND application has been approved by the National Medical Products Administration (NMPA) for the treatment of solid tumors and lymphomas.