SHANGHAI, April 15, 2026 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with a full industry chain, announced that the National Medical Products Administration (NMPA) has accepted supplemental Biologics License Application for MAIWEIJIAN (denosumab injection, R&D code: 9MW0321), a product developed by its wholly-owned subsidiary T-mab, for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved to market in China. It was initially approved in March 2024 for the treatment of adults and skeletally mature adolescents (defined as at least 1 mature long bone and weighing ≥ 45 kg) with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In August 2025, the product received approval from the Drug Regulatory Authority of Pakistan as the country's first denosumab biosimilar (120mg), and supply has now commenced. Mabwell has signed formal cooperation agreements for this product in 33 countries, including Brazil, Saudi Arabia, and Indonesia, and has submitted registration applications in 8 countries.

Recommended for you