The National Medical Products Administration (NMPA) of China has approved a supplemental application for Mabwell’s denosumab injection (Maiweijian) for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk of skeletal-related events (pathological fracture, spinal cord compression, bone radiotherapy, or bone surgery).
Developed by Mabwell’s wholly owned subsidiary T-mab, this new clearance specifically covers the use of the drug in reducing severe skeletal-related complications like spinal cord compression, bone surgery, fractures, and radiation.
Head-to-head trials published in JAMA Oncology have confirmed that the generic option matches the original drug’s safety and efficacy profiles, according to a press release by Mabwell.
Beyond its current distribution in China and Pakistan, the drug is now under regulatory review across more than 30 countries globally.
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