China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced separate licensing and commercialization agreements with a strategic business partner in Egypt and Pakistan pharmaceutical company Searle Co Ltd. These agreements grant local rights to Mabwell’s denosumab biosimilars, MAILISHU and 9MW0321.
Denosumab Biosimilars and Their Impact on Fracture Risk Reduction
Denosumab, a novel RANKL inhibitor originally developed by Amgen, is currently marketed in China by BeiGene. The drug has been shown to significantly reduce the risk of multiple fractures in patients, including vertebral, non-vertebral, and hip fractures. This makes the biosimilars an important addition to the treatment options for osteoporosis and other bone diseases.
Regulatory Approvals and Market Access
MAILISHU, one of Mabwell’s denosumab biosimilars, received approval from the China National Medical Products Administration (NMPA) in March 2023. The other biosimilar, 9MW0321, has been filed for Marketing Authorization (MA) approval, indicating Mabwell’s commitment to expanding access to these critical therapies.-Fineline Info & Tech
