Daratumumab/Hyaluronidase-fihj

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Report date: 2025/03/24 16:34:33

Base Information

Drug NameDaratumumab/Hyaluronidase-fihj
Drug Alias Nameダラツムマブ（遺伝子組換え）・ボルヒアルロニダーゼ　アルファ（遺伝子組換え）daratumumab and hyaluronidase-fihjダラツムマブ・ボルヒアルロニダーゼ　アルファRecombinant human hyaluronidase-based subcutaneous daratumumabDaratumumab subcutaneous +[13] 
ClassificationBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Monoclonal antibody humanBiologics > Protein drugs > Enzyme > Recombinant enzymeBiologics > Protein drugs > Recombinant protein > Recombinant enzyme
Mechanisms of ActionAntibody-dependent cell-mediated cytotoxicity (ADCC) effectsComplement dependent cytotoxicity (CDC) effectsAntibody-dependent cellular phagocytosis (ADCP) effects +[5] 
TargetsLymphocyte differentiation antigen CD38Hyaluronic acid
Therapy Area/IndicationsBone marrow transplant rejectionAmyloidosisPrimary Myelofibrosis +[19] 
Global Approved IndicationsMultiple Myeloma
Approved Indications in ChinaN/A
Original Approved Country/TerritoryUnited States
Original Approved Date2020/05/01
Country/TerritoryUnited StatesEUJapan
CombinationsYes Hyaluronidase recombinant humanDaratumumab
Global Highest StatusApproved
Highest Status in ChinaN/A
Originator CompaniesJohnson & Johnson Innovative Medicine
China Registration ClassN/A

Develop Information

Active CompaniesJanssen, LpJanssen Pharmaceutical KkJanssen Biotech Inc +[5] 
Inactive CompaniesGeorgetown University
Active IndicationsBone marrow transplant rejectionAmyloidosisPrimary Myelofibrosis +[17] 
Inactive IndicationsMonoclonal Gammopathy of Undetermined SignificancePeripheral Nervous System Diseases

Other Information

ATC CodeL01XC
Related LinksN/A