Denosumab biosimilar (Henlius)

地舒单抗生物类似药（复宏汉霖）

Report date: 2025/12/03 14:48:24

Base Information

Drug NameDenosumab biosimilar (Henlius)
Drug Alias NameRecombinant human anti-RANKL antibody(Shanghai Henlius Biotech)重组抗 RANKL 全人单克隆抗体注射液（复宏汉霖）BildyosBilprevdaHLX14 +[6] 
ClassificationBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Monoclonal antibody humanBiologics > Biosimilar
Mechanisms of ActionTumor necrosis factor ligand superfamily member 11 inhibitors
TargetsTumor necrosis factor ligand superfamily member 11
Therapy Area/IndicationsBone metastasesGlucocorticoid-induced osteoporosisFractures, Bone +[16] 
Global Approved IndicationsBone metastasesHypercalcemiaBone Resorption +[8] 
Approved Indications in ChinaN/A
Original Approved Country/TerritoryUnited States
Original Approved Date2025/08/29
Country/TerritoryUnited StatesUnited KingdomEU +[4] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaNDA/BLA
Originator CompaniesShanghai Henlius Biotech Inc
China Registration ClassN/A

Develop Information

Active CompaniesSciencePharma Sp zooFosun Hanlin (Shenzhen) Biotechnology Co LtdHenlius Europe Gmbh +[7] 
Inactive CompaniesN/A
Active IndicationsBone metastasesGlucocorticoid-induced osteoporosisFractures, Bone +[16] 
Inactive IndicationsN/A

Other Information

ATC CodeN/A
Related LinksN/A