Henlius Fovinaciclib CDK4-6 Breast-Cancer China Commercialization
Henlius Biotech (HKG: 2696) announced a collaboration with Avanc Pharmaceutical Co., Ltd. to advance the...
Henlius Biotech
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)...
Suzhou Forlong Biotech, Shanghai Henlius, and Engineered Cytokine Immunotherapy Collaboration Announced
Suzhou Forlong Biotechnology Co., Ltd. today revealed a strategic partnership with Shanghai Henlius Biotech, Inc....
Shanghai Henlius Biotech Secures UK MHRA Approval for Denosumab Biosimilars BILDYOS & BILPREVDA
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products...
Fosun‑Henlius Announces 26.8‑Month Median OS for Hetronifly Plus Chemo in Advanced NSCLC
Fosun Pharma (SHA: 600196) subsidiary Shanghai Henlius Biotech, Inc. (HKG: 2696) unveiled the final Phase III...
Shanghai Henlius Biotech Secures FDA Orphan Drug Designation for HLX43 in Thymic Epithelial Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced today that the U.S. Food and Drug Administration...
Shanghai Henlius Biotech Achieves Primary Endpoint in Phase 3 Trial of Serplulimab for Early‑Stage Gastric Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) today announced that its phase 3, randomized, double‑blind, multi‑center study...
Henlius Organon Secure EU Marketing Approval for BILDYOS and BILPREVDA Denosumab Biosimilars
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission...
Shanghai Henlius Biotech Secures FDA IND Approval for HLX17, a Pembrolizumab Biosimilar
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
Fosun Secures FDA Approval for Two Denosumab Biosimilar Formulations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License...
Henlius, Serplulimab and Abbott Drive Robust 2025 Financials
Shanghai Henlius Biotech, Inc. (HKG: 2696) released its 2025 first‑half financials, reporting a 2.7 % year‑on‑year...
Henlius Partners with GeneQuantum on HER2-Targeted ADC GQ1005 Development
Shanghai Henlius Biotech Inc. (HKG: 2696) announced a strategic collaboration with China-based GeneQuantum Healthcare. The...
Henlius Biotech’s HLX04-O Accepted by NMPA for Wet AMD Treatment
Shanghai Henlius Biotech Inc. (HKG: 2696) announced on August 13, 2025, that the marketing authorization...
Henlius’ HLX43 Approved by FDA for Phase 1 Trial in Thymic Carcinoma Treatment
China’s Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration...
Henlius Biotech’s HLX14 Recommended for EU Approval by EMA’s CHMP
China-based Shanghai Henlius Biotech, Inc. (HKG: 2696) announced on July 28, 2025, that the European...
Shanghai Henlius Biotech Initiates US Patient Dosing in Phase III Trial for HER2-Positive Gastric Cancer
China-based Shanghai Henlius Biotech Inc., (HKG: 2696) announced the first patient dosing in the US...
Shanghai Henlius Biotech Earns GMP Certification for Prolia/Xgeva Biosimilar HLX14 and Perjeta Biosimilar HLX11
China’s Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that it has received Good Manufacturing Practice...