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At present, Henlius has launched 5 products and 19 indications, and 6 marketing applications have been accepted for review in China and the EU, respectively.  Meanwhile, Henlius has conducted over 30 clinical studies for 16 products globally. HANLIKANG  (rituximab injection), the first product of Henlius, has been approved by the National Medical Products Administration (NMPA) as China's first biosimilar. The second product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) is a Chinese mAb biosimilar approved in the U.S. the EU and China, bringing more treatment options to patients with HER2 positive breast and gastric cancer worldwide. In March 2022, the company’s first self-developed innovative monoclonal antibody HANSIZHUANG (serplulimab injection), was launched. It has been approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors and squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC).

  • 5/19

    Products/Indications

  • 6

    Marketing applications under review

  • 16

    Candidates

  • 30+

    Clinical Studies

Clinical-stage Products
  • Serplulimab+Chemo
    		 PD-1
    PD-1
    • metastatic esophageal squamous-cell carcinomas (mESCC)

    • neo-/adjuvant treatment of gastric cancer (Neo/adj.GC)

    • limited-stage small cell lung cancer (LS-SCLC)

    NDA under Review in China

    Serplulimab (anti-PD-1 mAb) in combination with chemotherapy can be used for the treatment of ESCC, ES-SCLC, and GC. The Phase 3 clinical studies of Serplulimab in combination with chemotherapy for the treatment of Neo/adj. GC and LS-SCLC are on the fast track. Phase 3 clinical studies for sqNSCLC, ES-SCLC and LS-SCLC are global multi-centre trials. 


  • Serplulimab+HANBEITAI
    		 PD-1+VEGF
    PD-1+VEGF
    • hepatocellular carcinoma (HCC)

    • non-squamous, non-small cell lung cancer (nsNSCLC)

    • metastatic colorectal cancer (mCRC)

    Phase 3 Clinical Trial
    in China

    It is the first dual mAbs combination therapy to receive IND approval from the NMPA for the treatment of advanced solid tumours. Subject enrollment has been completed in a Phase 2 clinical trial for the treatment of advanced HCC. First patients have been dosed in a Phase 3 clinical trial for the treatment of nsNSCLC and a Phase 2/3 clinical trial for mCRC in China.

  • Serplulimab+HLX07
    		 PD-1+ EGFR
    PD-1+ EGFR

    • squamous cell carcinoma of the head and neck (SCCHN)

    • solid tumors

    • squamous non-small cell lung cancer (sqNSCLC）

    Phase 2 Clinical Trial in China

    The Company's second dual mAbs combination therapy. It is for the treatment of SCCHN. The first patient was dosed in China in a Phase 2 clinical trial for the treatment of recurrent or metastatic SCCHN.

    The Phase 2 IND application of serplulimab in combination with HLX07 for the treatment of solid tumours was granted by the NMPA.

    The first subject dosed of a Phase 2 study of serplulimab combined with HLX07 in first-line EGFR high expression sqNSCLC patients.

  • Serplulimab+HANBEITAI+HLX07
    		 PD-1+VEGF+EGFR
    PD-1+VEGF+EGFR
    • Hepatocellular Carcinoma
    Phase 2 Clinical Trial

    HANSIZHUANG (serplulimab) in combination with HANBEITAI (bevacizumab biosimilar) and HLX07 (innovative anti-EGFR mAb)  for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA).

  • Serplulimab+HLX26
    		 PD-1+LAG-3
    PD-1+LAG-3

    • Non-Small Cell Lung Cancer

    Serplulimab Injection
    Phase 1 Clinical Trial

    First subject doesd for phase 1 clinical trial  of HANSIZHUANG (serplulimab) in combination with HLX26, an innovative anti-LAG-3 mAb, for the treatment of advanced/metastatic solid tumours. 

  • Serplulimab+HLX60
    		 PD-1+GARP
    PD-1+GARP

    • solid tumours

    Clinical Trials Approved in Australia
    First patient has been dosed for the phase 1 clinical trial for HLX60, a novel anti-GARP monoclonal antibody, in combination with HANSIZHUANG (serplulimab) for the treatment of advanced or metastatic solid tumours in Australia. 
  • HLX04-O
    		 Recombinant Anti-VEGF Humanised Monoclonal Antibody Injection
    VEGF
    • wet age-related macular degeneration (wAMD)
    Bevacizumab Injection
    Phase 1 Clinical Trial in China

    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.

  • HLX11
    		 Pertuzumab Injection (Biosimilar)
    HER2
    • breast cancer neoadjuvant 
    Pertuzumab Injection
    Phase 1 Clinical Trial in China

    HLX11, recombinant anti-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 BC and HER2-positive mBC. The first subject has been dosed in multi-centre phase 3 clinical trial of HLX11 for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer. 

  • HLX14
    		 Denosumab Injection (Biosimilar)
    RANKL
    • osteoporosis (OP)
    Denosumab Injection
    Phase 1 Clinical Trial in China

    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.

  • HLX22
    		 HLX22 Monoclonal Antibody Injection
    HER2
    • breast cancer (BC) 
    • metastatic gastric cancer (mGC)
    HLX22 Monoclonal Antibody Injection
    Phase 2 Clinical Trial
    in China

    HLX22,  humanised IgG1 monoclonal antibody injection targeting human epidermal growth factor receptor-2 (HER2). 

    First patient has been dosed in Phase 2 clinical trial to compare HLX22 in combination with 汉曲优® (trastuzumab) and chemotherapy as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients in Chinese mainland.

  • HLX07
    		 Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Humanised Monoclonal Antibody Injection
    EGFR
    • Solid tumours (non-small cell lung cancer, esophageal carcinoma, etc.)
    Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Humanised Monoclonal Antibody Injection
    Phase 1b/2 Clinical Trial in China

    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.


  • HLX208
    		 Small-molecule Inhibitor of BRAF V600E
    BRAF V600E
    • solid tumors
    Small-molecule Inhibitor of BRAF V600E
    Phase 2 Clinical Trial in China


    HLX208 is a small-molecule inhibitor of BRAF V600E with the potential to become the best-in-class BRAF V600E inhibitor.

    The Phase 1b/2 clinical trials as monotherapy or in combination therapy for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumours has been approved by NMPA. First patient dosed in the Phase 2 clinical trial in LCH/ECD of HLX208.


  • HLX26
    		 Recombinant Anti-LAG-3 Human Monoclonal Antibody Injection
    LAG-3
    • solid tumours
    • lymphoma
    Recombinant Anti-LAG-3 Human Monoclonal Antibody Injection
    Phase 1 Clinical Trial in China

    HLX26, a 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. 


    The first subject has been dosed with HLX26 for the Phase 1 clinical trial in patients with advanced/metastatic solid tumours or lymphomas.

  • HLX60
    		 Recombinant Anti-GARP Humanised Monoclonal Antibody Injection
    GARP
    • solid tumours and lymphomas 
    Recombinant Anti-GARP Humanised Monoclonal Antibody Injection
    Phase 1 Clinical Trial

    HLX60, an recombinant anti-GARP humanised monoclonal antibody injection.


    The IND application for clinical trial of HLX60 was approved by the NMPA for the treatment of solid tumours and lymphomas. HLX60 is the first IND approved anti-GARP monoclonal antibody in China and is expected to be the first-in-class anti-GARP mAb. 
  • HLX6018
    		 a novel anti- GARP/TGF-β1 mAb
    GARP/TGF-β1
    • idiopathic pulmonary fibrosis (IPF)
    anti- GARP/TGF-β1 mAb
    Phase 1 Clinical Trial in China

    HLX6018 is a novel anti-GARP/TGF-β1 monoclonal antibody (mAb). Its IND application has been approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases. As of now, no mAb targeting GARP/TGF-β1 has been approved for marketing globally.

  • HLX43
    		 PD-L1-targeting ADC
    PD-L1
    • advanced/metastatic solid tumors
    HLX43 for Injection
    Phase 1 Clinical Trial in China

    HLX43 is a novel PD-L1-targeting ADC, comprised of a high-affinity humanized IgG1 mAb targeting PD-L1 conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. As of now, the IND applications of HLX43 has been approved by the by the China NMPA and U.S. FDA, for the treatment of advance/metastatic solid tumours. Meanwhile, the first subject was dosed for a phase 1 clinical trial of HLX43 in China. 

  • HLX42
    		 EGFR-targeting ADC
    EGFR
    • advanced/metastatic solid tumors
    HLX42 for Injection
    Phase 1 Clinical Trial in China

    HLX42 is a novel EGFR-targeting ADC, comprised of a high-affinity humanized IgG1 mAb targeting EGFR conjugated with a novel cytotoxic payload through cleavable linkers, with the drug-to-antibody ratio is about 8. As of now, the IND applications of HLX42 has been approved by the by the China NMPA and U.S. FDA, for the treatment of advance/metastatic solid tumours.

  • HLX05
    		 Cetuximab Injection (Biosimilar)
    EGFR
    • squamous cell carcinoma of the head and neck (SCCHN)
    • metastatic colorectal cancer (mCRC)
    Cetuximab Injection
    Phase 1 Clinical Trial (licensed out)

    HLX05, recombinant anti- endothelial growth factor receptor (EGFR) human/murine chimeric monoclonal antibody injection, a cetuximab biosimilar, is mainly for the treatment of mCRC and SCCHN. 

    It received two IND approvals for the two indications successively. Its commercialisation rights in China has been licensed out.


  • HLX53
    		 an anti-TIGIT Fc fusion protein
    TIGIT
    • solid tumours and lymphomas 
    an anti-TIGIT Fc fusion protein
    Phase 1 Clinical Trial

    HLX53, an anti-TIGIT Fc fusion protein. 


    The first patient has been dosed in phase 1 clinical trial for the treatment of advanced or metastatic solid tumors or lymphomas in China.
  • HLX15
    		 Daratumumab Injection (Biosimilar)
    CD38
    • multiple myeloma
    Daratumumab Injection
    Phase 1 Clinical Trial

    HLX15, recombinant anti-CD38 fully human monoclonal antibody injection, a daratumumab biosimilar. 

    It is to be potentially used for the treatment of multiple myeloma. Its IND application has been approved by the NMPA. HLX15 is the Company's second self-developed product in the area of hematologic malignancy treatment. 

  • HLX13
    		 Ipilimumab Injection (Biosimilar)
    CTLA-4

    • unresectable or metastatic melanoma

    • adjuvant treatment of melanoma

    • advanced renal cell carcinoma (RCC)

    • microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (mCRC) 

    Ipilimumab Injection
    Phase 1 Clinical Trial

    HLX13, fully human anti-CTLA-4 monoclonal antibody, an ipilimumab biosimilar. 

    It can be potentially used in the treatment of unresectable or metastatic melanoma, adjuvant treatment of melanoma, RCC, and microsatellite instability-high or mismatch repair deficient mCRC.

  • HLX51
    		 Recombinant Anti- OX40 Humanised Monoclonal Antibody for Injection
    OX40
    • advanced/metastatic solid tumours and lymphomas
    OX40 humanised monoclonal antibody for Injection
    IND Approval in China

    HLX51 is a novel humanised agonistic anti-OX40 monoclonal antibody (mAb). Its IND application has been approved by the National Medical Products Administration (NMPA) for the treatment of patients with advanced/metastatic solid tumours and lymphomas. At present, there is no anti-OX40 mAb has been approved for marketing globally.

Target
Generic Name
Study Phase
Potential Indication
Study Phase
Product Pipeline

With the efficient and innovative in-house capabilities, Henlius has developed a diversified and advanced drug pipeline with a focus in the fields of oncology, autoimmune diseases etc. 

                             
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