Shots:
- The NMPA has accepted the sBLA of Maiweijian (Denosumab; 120mg), a biosimilar version of Xgeva, developed by its subsidiary T-mab, for preventing skeletal-related events in multiple myeloma and bone metastases from solid tumors
- Maiweijian is China’s first approved 120 mg denosumab biosimilar, initially cleared in March 2024 for adults and skeletally mature adolescents with unresectable giant cell tumor of bone or cases where surgery may cause severe morbidity
- Mabwell reported P-I and III results in International Immunopharmacology and JAMA Oncology, showing through head-to-head studies that the product is comparable to the reference in pharmacokinetics, pharmacodynamics, efficacy, and safety
Ref: Mabwell | Image: Mabwell | Press Release
Related News: Mabwell Initiates P-III Trial for 9MW2821 in TNBC
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