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Mabwell Announces NMPA Approval of Supplemental Application for Additional Indications of MAIWEIJIAN (Denosumab Injection)

The approval expands MAIWEIJIAN’s use to help delay skeletal-related events in patients with bone metastases and multiple myeloma, Mabwell said.

  • On Wednesday, May 20, 2026, the National Medical Products Administration approved Mabwell's MAIWEIJIAN for treating bone metastases from solid tumors and multiple myeloma.
  • MAIWEIJIAN binds to RANKL to block the RANKL/RANK/OPG pathway, preventing skeletal complications more effectively than bisphosphonates commonly used in clinical practice.
  • Mabwell previously published Phase I and Phase III clinical research findings for the Denosumab Injection in International Immunopharmacology and JAMA Oncology, systematically verifying safety and efficacy.
  • Expanding its global footprint, Mabwell signed formal cooperation agreements for MAIWEIJIAN with 33 countries, while registration applications have been submitted to 8 additional nations including Jordan, Egypt, and Brazil.
  • The company remains committed to its mission to "Explore Life, Benefit Health" as it advances therapies for oncology and aging-related diseases through its integrated industry chain.
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Mabwell Announces NMPA Approval of Supplemental Application for Additional Indications of MAIWEIJIAN (Denosumab Injection)

SHANGHAI, May 20, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the supplemental application for MAIWEIJIAN (Denosumab Injection, R&D code: 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab,…

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PR Newswire broke the news in United States on Thursday, May 21, 2026.
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