Ranicabtagene Autoleucel

雷尼基奥仑赛

Report date: 2025/08/04 14:24:15

Base Information

Drug NameRanicabtagene Autoleucel
Drug Alias Name抗人CD19 T细胞注射液（恒润达生生物）Anti-CD19 CAR-T Cell Therapy (Hrain Biotechnology)润达基奥仑赛恒凯莱HICARA +[8] 
ClassificationCell and gene therapy > Cell therapy > Donor > AutologousCell and gene therapy > Gene therapy > Viral vector-based gene therapy > Retroviral vector > γ-retroviral vectorCell and gene therapy > Cell therapy > Source of cells > PMBC-derived +[4] 
Mechanisms of ActionT lymphocyte replacementsImmunologic cytotoxicityAnti-CD19
TargetsB-lymphocyte antigen CD19
Therapy Area/IndicationsHematologic NeoplasmsMultiple MyelomaLymphoma, Mantle-Cell +[11] 
Global Approved IndicationsLymphoma, B-Cell
Approved Indications in ChinaLymphoma, B-Cell
Original Approved Country/TerritoryMainland China
Original Approved Date2025/07/29
Country/TerritoryMainland China
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaApproved
Originator CompaniesHrain Biotechnology Co Ltd
China Registration ClassClass 1 therapeutic biologic in China

Develop Information

Active CompaniesShanghai Zhongshan HospitalHrain Biotechnology Co Ltd
Inactive CompaniesXuzhou Medical University (Xzmu)
Active IndicationsLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell +[5] 
Inactive IndicationsHematologic NeoplasmsMultiple MyelomaLymphoma, Mantle-Cell +[6] 

Other Information

ATC CodeN/A
Related LinksN/A