Mabwell's two drugs approved for registration in Pakistan

August 31,MabwellMabwell (Shanghai) Biopharmaceutical Co., Ltd. (688062) announced that its two denosumab injection products, 9MW0311 and 9MW0321, have received registration approval from the Drug Regulatory Authority of Pakistan.

9MW0311 is a recombinant humanized anti-RANKL monoclonal antibody injection (60mg), a biosimilar to denosumab Prolia® (Proliade®), intended for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

9MW0321 is a recombinant humanized anti-RANKL monoclonal antibody injection (120mg), a biosimilar to denosumab XGEVA® (Xgeva®), indicated for the treatment of giant cell tumor of bone (GCTB) in adult and skeletally mature adolescent patients where surgical resection is not feasible or would result in severe functional impairment. It is the first Xgeva® biosimilar approved for marketing in China.

In mid-2025, Mabwell achieved revenue of 101 million yuan, with a net profit attributable to shareholders of -551 million yuan.