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汉利康®

Rituximab Injection

汉利康® (rituximab injection) is our first proprietary product. It is the first-ever China-manufactured biosimilar approved by the NMPA in accordance with the Biosimilar Guidelines for the treatment of 1) relapsed or refractory, follicular lymphoma; 2) previously untreated stages III-IV follicular, non-Hodgkin lymphoma; and 3) CD20-positive, diffuse large B-cell, non-Hodgkin lymphoma (DLBCL), namely all the approved indications of the originator in China. Meanwhile, we are also conducting a Phase 3 clinical trial for rheumatoid arthritis (RA) in China.

Research Progress

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 15 products and 8 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China, which also makes it the first commercially launched monoclonal antibody biosimilar in accordance with the Biosimilar Guidelines in China. Progress

01

Product Commercially Launched

02

Products under NDA/MAA Review

15+8

Products/Combo Therapies under R&D

20+

Global Clinical Studies

Product Pipeline

With our efficient and innovative in-house capabilities, we have developed a diversified and advanced drug pipeline with a focus on fields like oncology and autoimmune diseases.

Biosimilar Portfolio

Product(Reference Drug)TargetIndicationPre-clinicalINDPhase 1Phase 2Phase 3NDALaunchedCommercial RightsPartner
HLX01(MabThera)CD20NHL
Launched
Worldwide
HLX02(Herceptin)HER2BC/mGC
NDA
Worldwide
HLX03(Humira)TNF-aPS/RA/AS
NDA
Worldwide
HLX04(Avastin)VEGFmCRC/nsNSCLC
Phase 3
Worldwide
HLX01(Erbitux)EGFRmCRC/SCCHN
Phase 1
Worldwide(exc.CN)
HLX12(Cyramza)VEGFR2Solid Tumors
Phase 1
Worldwide
HLX11(Perjeta)HER2BC
IND
Worldwide
HLX13(Yervoy)CTLA-4Solid Tumors
IND
Worldwide
HLX14(Xgeva)RANKLOP
IND
Worldwide
HLX15(Darzalex)CD38MM
Pre-clinical
Worldwide

Bio-innovative Portfolio

Product(Reference Drug)TargetIndicationPre-clinicalINDPhase 1Phase 2Phase 3NDALaunchedCommercial RightsPartner
HLX01CD20RA
Phase 3
Worldwide
HXL04VEGFwAMD/DR
IND
Worldwide
HXL07EGFRSolid Tumors
Phase 2
Worldwide
HLX06VEGFR2Solid Tumors
Phase 1
Worldwide
HLX10PD-1Solid Tumors/HBV
Phase 2
Worldwide
HLX20PD-L1Solid Tumors
Phase 1
Worldwide
HLX22HER2BC/GC
Phase 1
Worldwide
HLX55c-METSolid Tumors
Phase 1
Asia
HLX56DRSolid Tumors
Pre-clinical
China
HLX09CTLA-4Solid Tumors
Pre-clinical
Worldwide
HLX23CD73Solid Tumors
Pre-clinical
Worldwide
HLX24CD47Solid Tumors
Pre-clinical
Worldwide
HLX26LAG3Solid Tumors
Pre-clinical
Worldwide
HLX59CD27Solid Tumors
Pre-clinical
Worldwide
HLX51OX40Solid Tumors
Pre-clinical
Worldwide
HLX52TIM-3Solid Tumors
Pre-clinical
Worldwide
HLX53TIGITSolid Tumors
Pre-clinical
Worldwide
HLX58Claudin 18.2Solid Tumors
Pre-clinical
Worldwide
HLX63GPC3Solid Tumors
Pre-clinical
Worldwide

Combo Therapy

Product(Reference Drug)TargetIndicationPre-clinicalINDPhase 1Phase 2Phase 3NDALaunchedCommercial RightsPartner
HLX10+HLX04PD-1+VEGFnsNSCLC
Phase 3
Worldwide
HLX10+HLX04PD-1+VEGFHCC
Phase 2
Worldwide
HLX10+HLX07PD-1+EGFRSCCHN
IND
Worldwide
HLX10+ChemoPD-1mESCC
Phase 3
Worldwide
HLX10+ChemoPD-1sqNSCLC
Phase 3
Worldwide
HLX10+ChemoPD-1SCLC
Phase 3
Worldwide
HLX10+ChemoPD-1GC
Phase 3
Worldwide
Tumor-Specific Targets
Angiogenesis Targets
Immuono-therapeutic Targets
Combo Therapy
Others