Mabwell (Shanghai) Bioscience Co., Ltd. (688062.SH) announced that its wholly-owned subsidiary, Jiangsu Taikang Biological Medicine Co., Ltd., has received approval from the National Medical Products Administration for a supplemental application to expand the indications of Denosumab Injection (brand name: Maiweijian, code: 9MW0321). The approval covers the treatment of bone metastasis in solid tumors and multiple myeloma, aimed at delaying or reducing the risk of skeletal-related events such as pathological fractures, spinal cord compression, radiation to bone, or bone surgery.

The announcement highlights that Maiweijian holds key competitive advantages: firstly, as a biosimilar to Xgeva that was among the first to be launched in China, it benefits from a significant first-mover advantage; secondly, it has demonstrated strong therapeutic efficacy and is recommended in multiple expert consensus documents and treatment guidelines.

Additionally, compared to commonly used clinical treatments like bisphosphonates, Denosumab offers several benefits: 1) It is targeted, specifically binding to RANKL to block the RANKL/RANK/OPG signaling pathway, thereby preventing skeletal-related events in bone metastasis; 2) It shows significantly superior clinical efficacy to bisphosphonates and remains effective even in patients who have not responded to bisphosphonate therapy; 3) It has a favorable safety profile, as it is not cleared by the kidneys, resulting in fewer instances of nephrotoxicity among patients treated with Denosumab.