On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab), developed by its wholly-owned subsidiary T-mab. The drug is now approved to help delay or reduce skeletal-related events, including pathological fracture, spinal cord compression, and the need for bone surgery or radiotherapy, in patients with bone metastases from solid tumours or multiple myeloma.
This builds on Maiweijian™’s initial NMPA approval in March 2024, when it became the first denosumab biosimilar (120mg) approved for marketing in China, initially indicated for unresectable giant cell tumour of bone. Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.
Mabwell announced in April 2026 that it entered into a licensing and commercialisation agreement with an unidentified strategic business partner for Maiweijian™ and Mailishu® in Malaysia. Under the terms of the agreement, the partner is responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, while Mabwell is responsible for the development, manufacturing and supply of the biosimilars.
Mabwell completed its first commercial shipment of its denosumab biosimilars outside China in December 2025, although the destination(s) of the shipment was not disclosed in the press release. According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several markets, including Jordan, Egypt, and Brazil.