China NMPA approves supplemental application for generic denosumab

The National Medical Products Administration (NMPA) of China has approved a supplemental application for Mabwell’s denosumab injection (Maiweijian) to treat multiple myeloma and bone metastases from solid tumors.

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, the manufacturer of the drug. 

Beyond its current distribution in China and Pakistan, the drug is now under regulatory review across more than 30 countries globally.