Hong Kong – Mabpharm Limited announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for CMAB807 普博力® (denosumab injection). The product is cleared for three indications: 1) osteoporosis in post-menopausal women at increased fracture risk; 2) osteoporosis in men at high fracture risk; and 3) glucocorticoid-induced osteoporosis in patients with elevated fracture risk.

CMAB807 is a human IgG2 monoclonal antibody targeting RANKL, thereby inhibiting osteoclast formation and activity to reduce bone resorption and improve bone mass. The approved presentation is a 60 mg/1.0 ml pre-filled syringe manufactured by Taizhou Mabtech Pharmaceutical Limited under the Chinese drug approval number Guo Yao Zhun Zi S20260037.

This milestone elevates CMAB807 to Mabpharm’s fourth marketed product, following CMAB009 (cetuximab β), CMAB008 (infliximab), and CMAB007 (omalizumab α). Management highlighted plans to:

• pursue rapid inclusion of CMAB807 in China’s national medical insurance catalogue, • broaden domestic distribution channels to accelerate market penetration, and • advance overseas registration to capture international demand.

Mabpharm expects CMAB807 to become a core revenue and profit driver. The company’s in-house antibody R&D platform—supported by more than two decades of experience and participation in multiple national “863” projects—underpins its competitive position for upcoming insurance and centralised procurement negotiations.

Shareholders and investors are advised to exercise caution when dealing in Mabpharm securities, as commercial success of CMAB807 cannot be guaranteed.