In addition to 5 products and 13 indications launched commercially and 5 NDAs accepted for review, Henlius has conducted over 20 clinical studies for 13 products and 11 immuno-oncology combination therapies worldwide. 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, Zercepac® in the EU，Trade names in Australia: Tuzucip® and Trastucip®) is the first Chinese mAb biosimilar approved both in 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 approved by the NMPA for the treatment of Microsatellite Instability-High (MSI-H) solid tumors. Meanwhile, its NDAs for the treatment of squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC) , and esophageal squamous cell carcinoma (ESCC) are under review.
Products/Indications
NDAs accepted for review
Candidates/Combo Therapies under Clinical Studies
Clinical Studies
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Serplulimab+Chemo
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PD-1
PD-1
NDA under Review in China
Serplulimab (anti-PD-1 mAb) in combination with chemotherapy can be potentially used for the treatment of mESCC, sqNSCLC, ES-SCLC, LS-SCLC and Neo/adj. GC. NDA for the treatment of squamous non-small cell lung cancer (sqNSCLC) and extensive stage small-cell lung cancer (ES-SCLC) are under review. In addition, the Phase 3 clinical studies of Serplulimab in combination with chemotherapy for the treatment of mESCC, Neo/adj.GC and LS-SCLC are on fast track, and the phase III study for the treatment of advanced/metastatic esophageal squamous cell carcinoma has met the co-primary endpoints. Phase 3 clinical studies for sqNSCLC, ES-SCLC and LS-SCLC are global multi-centre trials.
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Serplulimab+汉贝泰
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PD-1+VEGF
PD-1+VEGF
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. |
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Serplulimab+HLX07
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PD-1+ EGFR
PD-1+ EGFR
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. |
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Serplulimab+HLX26
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PD-1+LAG-3
PD-1+LAG-3
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. |
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Serplulimab+HLX60
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PD-1+GARP
PD-1+GARP
Clinical Trials Approved in Australia
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.
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HLX07
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Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Humanised Monoclonal Antibody Injection
EGFR
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, is for the treatment of solid tumors. 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.
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HLX22
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HLX22 Monoclonal Antibody Injection
HER2
HLX22 Monoclonal Antibody Injection
Phase 2 Clinical Trial
in China
HLX22. HLX22 Monoclonal Antibody Injection. It is a 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.
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HLX11
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Pertuzumab Injection (Biosimilar)
HER2
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 phase 3 clinical trial of HLX11 for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer.
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HLX208
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Small-molecule Inhibitor of BRAF V600E
BRAF V600E
Small-molecule Inhibitor of BRAF V600E
Phase 1 Clinical Trial in China
BRAF V600E small-molecule inhibitor can be potentially used in the treatment of various solid tumors. HLX208 may be combined with the Company's proprietary EGFR or PD-1 targeted antibodies to enhance a high-quality, innovative and differentiated product portfolio for the treatment of various cancer types. |
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HLX05
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Cetuximab Injection (Biosimilar)
EGFR
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 in August and
October 2016. Its commercialisation rights in China has been licensed out.
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HLX12
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Ramucirumab Injection (Biosimilar)
VEGFR-2
Ramucirumab Injection
Phase 1 Clinical Trial
in China
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 GC, mNSCLC and mCRC. Phase 1 clinical trial for HLX12 was commenced.
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HLX20
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Recombinant Fully Human Anti-PD-L1 Monoclonal Antibody Injection
PD-L1
Recombinant Fully Human Anti-PD-L1 Monoclonal Antibody Injection
Phase 1 Clinical Trial in Australia
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. |
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HLX14
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Denosumab Injection (Biosimilar)
RANKL
Denosumab Injection
Phase 1 Clinical Trial in China
HLX14. Recombinant Anti-RANKL Human Monoclonal Antibody Injection, a denosumab biosimilar, is potentially indicated for the treatment of postmenopausal women with OP at high risk for fracture. The first patient was dosed in a Phase 1 clinical trial in China. |
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HLX04-O
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Recombinant Anti-VEGF Humanised Monoclonal Antibody Injection
VEGF
Bevacizumab Injection
Phase 1 Clinical Trial in China
HLX04-O, Recombinant Anti-VEGF Humanised Monoclonal Antibody Injection is indicated for wet age-related macular degeneration (wAMD). It was granted Phase 3 clinical study approvals in Australia, the United States, Singapore and the EU countries such as Latvia, Hungary and Spanish. |
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HLX26
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Recombinant Anti-LAG-3 Human Monoclonal Antibody Injection
LAG-3
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.
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HLX13
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Ipilimumab Injection (Biosimilar)
CTLA-4
Ipilimumab Injection
IND Approval in China
HLX13. Fully Human Anti-CTLA-4 Monoclonal Antibody, an ipilimumab biosimilar, 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. |
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HLX15
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Daratumumab Injection (Biosimilar)
CD38
Daratumumab Injection
IND Approval in China
HLX15. Recombinant Anti-CD38 Fully Human Monoclonal Antibody Injection, a daratumumab biosimilar, 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. |
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HLX23
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Recombinant Anti-CD73 Fully Humanised Monoclonal Antibody Injection
CD73
Recombinant Anti-CD73 Fully Humanised Monoclonal Antibody Injection
IND Approval in the U.S.
HLX23, recombinant anti-CD73 fully humanised monoclonal antibody injection, has been approved by the Food and Drug Administration (FDA) for the treatment of advanced solid tumours. Currently, there is no CD73-targeted product on global market. A number of early clinical studies have shown reliable safety in monotherapy or combination therapy with immunotherapy checkpoint inhibitors such as anti-PD-1/L1 monoclonal antibodies. |
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HLX35
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Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody
EGFR×4-1BB
Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody
Phase 1 Clinical Trial
HLX35, a Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody. The application for an investigational new drug (IND) of HLX35 for the treatment of advanced malignant solid tumors independently developed by the company was approved by the NMPA. irst Subject Dosed of the Phase 1 Clinical Trial on HLX35 for the Treatment of Advanced or Metastatic Solid Tumours.
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HLX301
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Recombinant Anti-PDL1 and Anti-TIGIT Bispecific Antibody
PD-L1×TIGIT
Recombinant Anti-PDL1 and Anti-TIGIT Bispecific Antibody
Phase I/II Clinical Trial
HLX301, a Recombinant Anti-PDL1 and Anti-TIGIT Bispecific Antibody. In February 2022, the first patient was dosed in Australia in Phase 1 clinical trial of HLX301 with solid tumours. First subject has been dosed in a phase 1/2 clinical trial for the treatment of locally advanced or metastatic solid tumours or lymphomas in China.
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Target
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Generic Name
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Study Phase
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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.