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A Multi-center, Randomized, Double-blind, Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection (MW032) and Denosumab (Xgeva®) in Subjects With Bone Metastases From Solid Tumors

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Trial Profile

A Multi-center, Randomized, Double-blind, Parallel Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Anti RANKL Monoclonal Antibody Injection (MW032) and Denosumab (Xgeva®) in Subjects With Bone Metastases From Solid Tumors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2026

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Bone metastases
  • Focus Registrational; Therapeutic Use
  • Sponsors Mabwell (Shanghai) Bioscience

Most Recent Events

  • 15 Apr 2026 According to a Mabwell Therapeutics Media Release, 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.
  • 08 Apr 2024 According to a Mabwell Therapeutics Media Release, T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (NMPA) (Drug Approval Number: [GYZZ]S20240010). MAIWEIJIAN is the denosumab biosimilar (120mg) approved for marketing in China.
  • 21 Feb 2024 According to a Mabwell Therapeutics Media Release, results from this study were published in journal of JAMA Oncology.

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