Biopharmaceutical company Mabwell has announced that Denosumab Injection (trade name- MAIWEIJIAN) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorisation approval by National Medical Products Administration (NMPA). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

MAIWEIJIAN is a fully human recombinant anti-RANKL monoclonal antibody injection, approved to treat giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment, including in adults and adolescents with mature skeletal development.

Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines. Doctors and patients have a high level of recognition for denosumab. 

Apart from MAIWEIJIAN, no other biosimilar drugs are currently on the market in China. In 2022, its sales amounted to 427 million yuan in China.