Product-Products in R&D

Products in R&D

HLX01-RA

Rituximab Injection

CD20

rheumatoid arthritis (RA)

Rituximab Injection

NDA under Review in China

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.

HLX10

Serplulimab Injection

PD-1

MSI-H solid tumours

Serplulimab Injection

NDA under Priority Review
in China

Serplulimab injection, a novel anti-PD-1 monoclonal antibody, independently researched and developed by Henlius, can be potentially indicated for various solid tumours 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 tumours 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.

Serplulimab+Chemo

PD-1

metastatic esophageal squamous-cell carcinomas (mESCC)
squamous non-small cell lung cancer (sqNSCLC）
extensive-stage small cell lung cancer (ES-SCLC)
neo-/adjuvant treatment of gastric cancer (Neo/adj.GC)

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 and Neo/adj.GC. The NDA for the treatment of sqNSCLC was accepted for review by the NMPA in September 2021. In addition, the Phase 3 clinical studies of Serplulimab in combination with chemotherapy for the treatment of mESCC, ES-SCLC and Neo/adj.GC are on fast track. Phase 3 clinical studies for sqNSCLC and ES-SCLC are global multi-centre trials.

Serplulimab+HLX04

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

squamous cell carcinoma of the head and neck (SCCHN)
solid tumors

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.

HLX07

Recombinant Anti-Epidermal Growth Factor Receptor (EGFR) Humanised Monoclonal Antibody Injection

EGFR

solid tumours

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.

HLX06

Recombinant Anti-Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) Fully Human Monoclonal Antibody Injection

VEGFR-2

solid tumours

Recombinant Anti-Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2) Fully Human Monoclonal Antibody Injection

Phase 1 Clinical Trial
in Taiwan 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 tumours. 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.

HLX22

HLX22 Monoclonal Antibody Injection

HER2

breast cancer (BC)
metastatic gastric cancer (mGC)

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.

HLX11

Pertuzumab Injection (Biosimilar)

HER2

HER2-positive breast cancer (BC)
HER2-positive metastatic breast cancer (mBC)

Pertuzumab Injection

Phase 1 Clinical Trial in China

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 BC and HER2-positive mBC. Phase 1 clinical study has been completed. The results of this study demonstrated that HLX11 had similar pharmacokinetic and safety profiles to the reference drugs from different sources.

HLX208

Small-molecule Inhibitor of BRAF V600E

BRAF V600E

solid tumors

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.

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 in August and October 2016. Its commercialisation rights in China has been licensed out.

HLX12

Ramucirumab Injection (Biosimilar)

VEGFR-2

advanced gastric cancer (GC)
metastatic non-small cell lung cancer (mNSCLC)
metastatic colorectal cancer (mCRC)

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.

HLX20

Recombinant Fully Human Anti-PD-L1 Monoclonal Antibody Injection

PD-L1

solid tumours

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.

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, 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.

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 is indicated for 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. The first patient has been dosed in Phase 1 clinical study in China in July, 2021.

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.

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

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.

HLX15

Daratumumab Injection (Biosimilar)

CD38

multiple myeloma

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.

HLX23

Recombinant Anti-CD73 Fully Humanised Monoclonal Antibody Injection

CD73

solid tumours

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.

HLX301

Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody

PD-L1×TIGIT

solid tumours

Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody

CTN Acknowledgement in Australia

HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody. The HLX301 filing of clinical trial in Patients with solid tumours has been approved by the Bellberry Human Research Ethics Committee (“HREC”), and Clinical Trial Notification (“CTN”) has been acknowledged by the Therapeutic Goods Administration (“TGA”), Australia.

Target	Generic Name	Study Phase