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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: 10 Jun 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

  • 20 May 2026 According to a Mabwell Therapeutics Media Release, the supplemental application for MAIWEIJIAN (Denosumab Injection, 9MW0321), which was independently developed by its wholly-owned subsidiary T-mab, has been approved by the National Medical Products Administration (NMPA) for additional indications of bone metastases from solid tumors and multiple myeloma (for the treatment of patients with bone metastases from solid tumors or patients with multiple myeloma, to delay or reduce the risk.
  • 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.

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