Product-Products in R&D

Products in R&D

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)
limited stage small-cell lung cancer

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.

Serplulimab+汉贝泰

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
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+汉贝泰+HLX07

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

advanced/metastatic solid tumours or lymphomas

Serplulimab Injection

Phase 1 Clinical Trial

HANSIZHUANG (serplulimab) in combination with HLX26, an innovative anti-LAG-3 mAb, for the treatment of advanced/metastatic solid tumours or lymphomas has been approved by the National Medical Products Administration.

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, 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.

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

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 phase 3 clinical trial of HLX11 for the neoadjuvant therapy in patients with HER2-positive, HR-negative early or locally advanced breast cancer.

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 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.
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.

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.

HLX35

Recombinant Humanized Anti-EGFR and Anti-4-1BB Bispecific Antibody

EGFR×4-1BB

solid tumours

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.

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. In February 2022, the first patient was dosed in Australia in Phase 1 clinical trial of HLX301 with solid tumours.
In March 2022, the filing of a Phase 1 clinical trial for HLX301 in Patients with advanced tumours has been approved by the National Medical Products Administration.

Target	Generic Name	Study Phase