Rituximab biosimilar(Shandong New Time Pharmaceutical)

利妥昔单抗生物类似药（山东新时代药业）

Report date: 2025/08/12 14:52:31

Base Information

Drug NameRituximab biosimilar(Shandong New Time Pharmaceutical)

Drug Alias Name益立达H-02F-007

ClassificationBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Chimeric monoclonal antibodyBiologics > Biosimilar

Mechanisms of ActionAntibody-dependent cell-mediated cytotoxicity (ADCC) effectsComplement dependent cytotoxicity (CDC) effectsCD20-directed cytolytic effects +[4]

TargetsB-lymphocyte antigen CD20

Therapy Area/IndicationsLymphoma, Large B-Cell, Diffuse

Global Approved IndicationsLymphoma, Large B-Cell, Diffuse

Approved Indications in ChinaLymphoma, Large B-Cell, Diffuse

Original Approved Country/TerritoryMainland China

Original Approved Date2025/06/17

Country/TerritoryMainland China

CombinationsNo

Global Highest StatusApproved

Highest Status in ChinaApproved

Originator CompaniesShandong New Time Pharmaceutical Co Ltd

China Registration ClassN/A

Develop Information

Active CompaniesShandong New Time Pharmaceutical Co Ltd

Inactive CompaniesN/A

Active IndicationsLymphoma, Large B-Cell, Diffuse

Inactive IndicationsN/A

Other Information

ATC CodeN/A