China-based Sinocelltech Group Ltd (SHA: 688520) has received New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its biosimilar ripertamab (SCT400), a CD20 monoclonal antibody (mAb) targeting newly diagnosed CD20-positive diffuse large B-cell non-Hodgkin lymphoma (DLBCL).
Drug Profile
Ripertamab is a biosimilar of Roche’s Mabthera (rituximab) and is indicated for use in combination with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) in adult patients with newly diagnosed CD20-positive DLBCL with an International Prognostic Index (IPI) score of 0 to 2.
Clinical Data
Phase III trials demonstrated that ripertamab achieved significant therapeutic effects, showing non-inferiority to rituximab. The drug exhibited good safety, with a profile similar to rituximab, and significantly reduced the incidence of interstitial lung disease and pulmonary inflammation adverse reactions.-Fineline Info & Tech
