On 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe), biosimilar to Amgen’s Prolia®, for the treatment of osteoporosis in postmenopausal women at increased fracture risk, osteoporosis in men at high fracture risk, and glucocorticoid-induced osteoporosis. The approval marks Mabpharm’s fourth marketed product in China.
Mabpharm also indicated that its CMAB807X (Leishu®), biosimilar to Amgen’s Xgeva®, targeting oncology indications, such as bone metastases and giant cell tumour of bone, is expected to receive approval in the near future.
Mabpharm’s growing commercial portfolio in China already includes Leiting® (infliximab; July 2021), Aomaishu® (omalizumab; May 2023) and Enlituo® (cetuximab; June 2024).
Mabpharm enters an increasingly competitive denosumab biosimilar landscape in China. Earlier approvals include Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®), and Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®).