Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China
Shots:
- The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment
- Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases
- The P-I & P-III clinical studies results of the denosumab biosimilar were published in the “International Immunopharmacology” in 2022 and the international journal “JAMA Oncology” in 2024, respectively. Additionally, Mabwell is advancing marketing efforts of MAIWEIJIAN for other indications
Ref: Mabwell’s| Image: Mabwell’s | Press Release
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