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Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar

Apr 8, 2024

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Xgeva®) received marketing approval in China.  MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab.  It is approved in China for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment.

Results of Mabwell’s Phase III trials were published in JAMA Oncology in February 2024 .  In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®.