By Fineline Cube Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its biosimilar product 9MW0321, a version of Amgen’s Xgeva (denosumab). This makes Mabwell the first company to gain approval for a biosimilar version of the drug in China.
Xgeva, originally developed by US pharmaceutical major Amgen and currently marketed in China by BeiGene, is a RANKL inhibitor used for treating patients with giant cell tumors of bone that are not removable by surgery or may result in severe functional impairment. The drug is indicated for adult and adolescent patients with mature bone development.
Denosumab is a fully humanized monoclonal IgG2 antibody with high affinity and specificity for the soluble, transmembrane form of human RANKL. The 120mg dosage form of the product was approved in China in May 2019 for adults and adolescents with mature skeletal development suffering from inoperable giant cell tumor bone. The 60mg dosage form, marketed as Prolia for treating osteoporosis, was approved in China in June 2020.
9MW0321 has undergone comprehensive head-to-head comparisons with the originator drug in terms of pharmacokinetics and clinical efficacy in patients with solid tumor bone metastases, demonstrating its similarity with the original product in all these aspects.
Mabwell has strategically partnered with several overseas companies, including Searle in Pakistan, Legrand in Colombia and Ecuador, and Innobic in Asia, to promote the local commercialization of its products, expanding their global reach.- Flcube.com