On 15 April 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved the supplemental Biologics Licence Application for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab). The approval expands the product’s indication to include the treatment of patients with multiple myeloma to prevent skeletal-related events and patients with bone metastases from solid tumours.
Maiweijian™ was initially approved by the NMPA in April 2024 for the treatment of giant cell tumour of the bone that is unresectable or where surgical resection may lead to severe functional impairment. It was developed by Mabwell’s wholly owned subsidiary, T-mab. Mabwell’s Mailishu®, biosimilar to Amgen’s Prolia® (denosumab), was approved by the NMPA in March 2023.
A day after the approval in China, on 16 April 2026, Mabwell announced 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 will be responsible for the registration and commercialisation of the denosumab biosimilars in Malaysia, whilst Mabwell will be responsible for the development, manufacturing and supply of the biosimilars.