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H02

Development stage: Phase 3
Lead developer: Shandong New Time Pharmaceutical
Modality: Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Intravenous

Overview

H02 is a rituximab biosimilar developed by Shandong New Time Pharmaceutical Co., Ltd. for the treatment of CD20-positive B-cell malignancies, specifically diffuse large B-cell lymphoma (DLBCL). As a monoclonal antibody, H02 binds to the CD20 transmembrane antigen expressed on pre-B and mature B lymphocytes. This binding triggers B-cell depletion via multiple mechanisms, including antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and the induction of apoptosis. H02 has been evaluated in a Phase 3 clinical trial (NCT05040906) in combination with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) to demonstrate clinical equivalence to the reference product, Rituxan/MabThera, in previously untreated DLBCL patients. The drug's development has reached the NDA/BLA stage.

Other names: rituximab biosimilar H02

Targets

CD20 (B-lymphocyte antigen CD20)

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