Henlius Biotech Wins Health Canada Approval for Denosumab Biosimilars – Bildyos and Tuzemty Expand Organon Partnership to Canada
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced marketing approval from Health Canada for Bildyos (denosumab...
Henlius Biotech
Henlius Biotech’s HLX18 Wins NMPA Approval – Nivolumab Biosimilar Enters Phase I Solid Tumor Trials in China
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX18, a recombinant humanized anti‑PD‑1 monoclonal antibody...
Henlius Biotech Reports 2025 Revenue Growth 16.5% – Ex‑China Business Doubles as Global Expansion Accelerates
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced strong 2025 annual results, with revenue rising 16.5%...
Shanghai Pharmaceuticals and Henlius Forge Strategic Alliance – Hospital Market Expansion and Global Commercial Collaboration Targeted
Shanghai Pharmaceuticals Holding Co., Ltd. (SPH; HKG: 2607, SHA: 601607) and Henlius (HKG: 2696) announced...
Henlius Wins NMPA Approval for HLX07 Combination Trial – Anti-EGFR Biologic Plus Serplulimab Targets Squamous NSCLC
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that subsidiary Shanghai Henlius...
Henlius Biotech’s HLX3901 Wins NMPA Approval – First-in-Class Tetra-Specific Antibody Targets DLL3-Positive Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that HLX3901, a first-in-class tetra-specific antibody targeting DLL3...
Henlius’ HLX11 Wins CHMP Positive Opinion – Perjeta Biosimilar Nears EU Approval for HER2+ Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s (EMA) Committee for Medicinal...
Henlius Licenses Serplulimab to Abbott for Emerging Markets – Expands Anti‑PD‑1 Global Footprint
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced an exclusive license agreement with Abbott for the commercialization...
Henlius Biotech Initiates Phase Ib/II Study for HLX43 ADC Combinations in Colorectal Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced first patient dosing in a Phase Ib/II clinical study...
Henlius Biotech Secures Global Rights to U-mab’s IL-1RAP Antibody in Licensing Deal
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced a licensing agreement with U-mab Biopharma, acquiring exclusive...
Henlius Triple Combo Gets NMPA Nod for Advanced Solid Tumor Trials
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received National Medical Products Administration (NMPA)...
Henlius’s HLX701 Gets NMPA Nod for Phase Ib/II Advanced CRC Combination Study
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Henlius’s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Henlius Serplulimab NDA Wins Priority Review for Gastric Cancer as Adjuvant Therapy
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the NMPA accepted its New Drug Application...
Shanghai Henlius Secures NMPA Approval for Phase II/III HLX22 HER2 Trials, Pioneering Novel Epitope ADC Combination in Breast Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Henlius Fovinaciclib CDK4-6 Breast-Cancer China Commercialization
Henlius Biotech (HKG: 2696) announced a collaboration with Avanc Pharmaceutical Co., Ltd. to advance the...
Henlius HLX14 Denosumab Biosimilar NDA Accepted by China CDE
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the National Medical Products Administration’s Center for...
Henlius HLX37 Bispecific NMPA Approval Targets Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its self-developed investigational new drug, HLX37 (Recombinant...
Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its anti‑PD‑1 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly...
Henlius’ POHERDY (HLX11) Receives Full FDA Approval for All Pertuzumab Indications
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its pertuzumab biosimilar POHERDY (clinical name HLX11)...