The World's Second Approved Biosimilars of Denosumab (MAILISHU)

Release time:Mar 31, 2023

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that the Denosumab solution for injection (trade name: MAILISHU, project code: 9MW0311), which is developed by its wholly-owned subsidiary T-mab, has been formally approved for marketing by the National Medical Products Administration (NMPA) (Approval No.: S20233111). 

MAILISHU is the world's second approved Biosimilars of Denosumab for the osteoporosis in postmenopausal women at high risk of fracture. The drug can significantly reduce the risk of vertebral, non-vertebral and hip fractures within this patient segment.

The Marketing Center of Mabwell has mapped MAILISHU’s launched plan since Q4,2022 and optimizing continuously product promotion strategies and resource allocation plans by researching on the treatment field, patient composition, market potential and other aspects. It is expected that more than 200 hospitals will be accessed and sales goal will not be less than 300K units.

Dr. Datao Liu, co-founder & CEO of Mabwell said, "We’re so excited to announce MAILISHU has been approved. It’s our 2nd commercialized. Age related diseases are Mabwell’s priority areas. More than half of the Chinese aged women suffer from osteoporosis, and fragility fractures, a complication of osteoporosis, are a major risk of life quality and life safety for patients. Mabwell has formed a professional marketing & sales team to take efforts to improve domestic patients’ accessibility in China. In addition, We have reached strategic collaborations in global market and hope to work with overseas partners to benefit more osteoporosis patients worldwide.