Mabpharm-B (02181.HK) CMAB807X Denosumab Injection NDA Approved by NMPA

NewTimeSpace · 2026/06/24 20:50 · By Boyuan Chen

Mabpharm (2181.HK) announced that its pipeline product CMAB807X Leishu® (denosumab injection) has received NMPA approval for its NDA, with indications covering the treatment of solid tumor bone metastasis or multiple myeloma patients to delay or reduce skeletal-related event risks, and giant cell tumor of bone that is unresectable or where surgery would cause severe morbidity, including adults and skeletally mature adolescents.

Mabpharm Limited (2181.HK) announced on June 24, 2026, that the Board is pleased to announce that recently, the new drug application ("NDA") for the Company's pipeline product CMAB807X Leishu® (denosumab injection) has been approved by the National Medical Products Administration ("NMPA") of the People's Republic of China.

The drug is indicated for: (i) the treatment of patients with solid tumor bone metastases 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) the treatment of giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, including adults and adolescents with mature skeletons (defined as at least one mature long bone and body weight≥45kg).

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MABPHARM-B 02181.HK approvement