Mabpharm-B (HKEX: 02181) has announced that the marketing registration application (NDA) for its pipeline product CMAB807X Leshu® (Denosumab Injection) has been approved by China's National Medical Products Administration.

The approval covers the treatment of (i) patients with bone metastases from solid tumors or multiple myeloma to delay or reduce the risk of skeletal-related events (pathological fractures, spinal cord compression, bone radiotherapy, or bone surgery), and (ii) patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, including adults and skeletally mature adolescents.

CMAB807X Leshu® (Denosumab Injection) is another dosage form of the company's fourth approved product, CMAB807 Puli® (Denosumab Injection).

The company stated it will work closely with partners to swiftly advance the inclusion of CMAB807X Leshu® in China's national medical insurance reimbursement scheme and expand its market channels, aiming for rapid market penetration and sales volume growth. The product is expected to significantly contribute to the company's drug sales and profit growth.

Mabpharm-B has also initiated overseas market promotion and registration activities for CMAB807X Leshu® and anticipates strong sales performance in international markets as well.