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


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SHANGHAI, April 3, 2023 /PRNewswire/ — 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.

About Mabwell

Mabwell (688062.SH), an innovation-driven biopharmaceutical company, has the whole industrial chain of R&D, manufacturing, and commercialization. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017, an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation was established. Mabwell has 17 pipeline products in different R&D stages based on a world-class and state-of-the-art R&D engine, including 13 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Of these, 2 products have been approved and commercialized, 1 product has been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for “Significant New Drugs Development”, 2 projects for National Key R&D Programmes, and several provincial and municipal science and technological innovation projects. Mabwell’s Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA, FDA and EMA, and has passed the EU QP Audit. The large-scale manufacturing base located in Shanghai is under construction. Our mission is “Explore Life, Benefit Health” and our vision is “Innovation, from ideas to reality”. For more information, please visit

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