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 as the specified indication has not been approved in China, highlighting its commitment to benefiting more patients. Currently, a Phase 3 clinical trial for rheumatoid arthritis (RA) is ongoing in China.

HLX02. Trastuzumab for Injection, is the first China-developed biosimilar to enter a multi-centre Phase 3 clinical trial in China, Poland, Ukraine and the Philippines. It is mainly for the treatment of breast cancer (BC) and metastatic gastric cancer (mGC). 

HLX02 received a New Drug Application (NDA) acceptance from the NMPA in April, 2019 and was subsequently assigned to priority review list. It was then under Marketing Authorization Application (MAA) review by EMA in June, 2019. The drug substance (DS) line and drug product (DP) line for HLX02 have successfully passed the European United (EU) Good Manufacturing Practice (GMP) on-site inspection. Upon the results,  Henlius received two EU GMP Certificates (Certificate of GMP Compliance of a Manufacturer) from Poland’s Chief Pharmaceutical Inspector in April, 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, was evaluated in a Phase 3 clinical trial in China. It’s mainly for the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer (nsNSCLC), wet age-related macular degeneration (wAMD), and diabetic retinopathy (DR). It shows great potential to be combined with HLX10 (a recombinant humanised anti-PD-1 monoclonal antibody injection) for immuno-oncology therapy to treat more solid tumors.

HLX10. Recombinant Humanised Anti-PD-1 Monoclonal Antibody Injection independently researched and developed by Henlius, is for the treatment of various solid tumours and can be applied in combination with other products for immuno-oncology therapy. Currently, HLX10 is also further developed for the treatment of chronic hepatitis b virus infection (HBV). HLX10 was approved to be evaluated in clinical trials in the US, Taiwan China and Mainland China. The first patients were dosed in a Phase 2 clinical study of HLX10 as mono-therapy in patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors who failed to respond to standard therapy and a Phase 2 clinical study in patients with HBV.

HLX10 plus HLX04 and HLX10 plus HLX07 combination therapies have both received Investigational New Drug (IND) approval from the NMPA. Phase 2/3 clinical studies were initiated for HLX10 plus HLX04 combination therapy in China.

It is the first mAb combination therapy to receive Investigational New Drug (IND) approval from the NMPA for the treatment of advanced solid tumor. A Phase 1 clinical trial is ongoing in China. The first patients were dosed in a phase 2 clinical trial for the treatment of advanced hepatocellular carcinoma (HCC) and in a phase 3 clinical trial for the treatment of non-squamous, non-small cell lung cancer (nsNSCLC).

Henlius' second dual mAbs combination therapy. It is for the treatment of squamous cell carcinoma of the head and neck (SCCHN). The NMPA granted approval for its Investigational New Drug (IND) application in December, 2019.

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 in Mainland China, the US, and Taiwan China, and a Phase 1b/2 clinical trial was commenced in Mainland 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.

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, Mainland China and Taiwan China, and a Phase 1 clinical trial was commenced in Taiwan China.

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. It 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) or adenocarcinoma of gastroesophagogastric junction (GEJ), 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 approval to be evaluated in clinical trials in Australia and China. A Phase 1 clinical trial was commenced in Australia.

HLX22. HLX22 Monoclonal Antibody Injection. It is a humanised lgG1 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 Investigational New Drug (IND) approval from the NMPA in Mainland China and clinical approval in Taiwan China. The first patient was dosed in Taiwan China 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).

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.