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MAIWEIJIAN Becomes China's Initial Approved Biosimilar for Denosumab (120mg)

Wednesday, April 10, 2024

Mabwell (688062.SH), an innovative biopharmaceutical company with a complete industry chain, has announced that its wholly-owned subsidiary T-mab has received marketing authorization approval from the National Medical Products Administration (NMPA) for Denosumab Injection, marketed under the name MAIWEIJIAN (R&D code: 9MW0321). This approval makes MAIWEIJIAN the first denosumab biosimilar (120mg) approved for marketing in China.

MAIWEIJIAN, a fully human recombinant anti-RANKL monoclonal antibody injection, has been approved for the treatment of unresectable giant cell tumors of the bone or cases where surgical resection might lead to severe functional impairment, in both adults and adolescents with mature skeletal development.

Mabwell has published the results of phase 1 and phase 3 clinical studies for the denosumab biosimilar in various journals. These studies demonstrate the similarity between 9MW0321 (MAIWEIJIAN) and the originator product in terms of pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. Mabwell is also working on marketing efforts for other potential indications of MAIWEIJIAN.

Denosumab has been recommended by multiple expert consensuses and treatment guidelines for its therapeutic effects. It is favored over bisphosphonates due to its targeted action, superior clinical efficacy, and favorable safety profile.

Regarding the originator product of denosumab (XGEVA®), launched in China in 2019, it is approved for various indications including the treatment of bone metastases of solid tumors and multiple myeloma. It is also indicated for unresectable giant cell tumors of the bone. As of 2022, XGEVA® recorded sales of 427 million yuan in China, with MAIWEIJIAN being the only biosimilar available in the market.



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