Hong Kong-listed Mabpharm Limited announced that China’s National Medical Products Administration has approved the New Drug Application for CMAB807X 類舒® (denosumab injection).

The IgG2 monoclonal antibody targets RANKL to inhibit osteoclast activity, addressing two indications: 1) delaying or reducing skeletal-related events in patients with bone metastases from solid tumors or multiple myeloma; 2) treating inoperable or function-impairing giant cell tumor of bone in skeletally mature adults and adolescents weighing at least 45 kg.

Key product specifications include a 120 mg/1.7 ml vial format manufactured by Taizhou Mabtech Pharmaceutical Limited under approval number Guo Yao Zhun Zi S20260046.

CMAB807X is an alternative specification to CMAB807 普博力®, Mabpharm’s fourth commercial product. Management expects the new formulation to accelerate inclusion in China’s national medical insurance program, broaden market channels and strengthen pharmaceutical revenue and profit growth. Overseas registration and marketing activities have also been initiated to capture international demand.

The group’s monoclonal-antibody portfolio now comprises five NMPA-approved products—CMAB807X, CMAB807 普博力®, CMAB009, CMAB008 and CMAB007—supported by in-house R&D, manufacturing and clinical capabilities. The company notes that while market entry preparations are under way, successful commercialization of CMAB807X remains subject to execution risks.

Shareholders and potential investors are advised to exercise caution when dealing in Mabpharm shares.