Biopharmaceutical company Mabwell has announced that Denosumab Injection (trade name- MAIWEIJIAN) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorisation approval by National Medical Products Administration (NMPA). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
SHANGHAI, April 8, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (NMPA) (Drug Approval Number: [GYZZ]S20240010). MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints
Sandoz wins FDA approval for first two biosimilars for Amgen`s bone drug
Sandoz`s Biologic Jubbonti (denosumab-bbdz) Receives Approval in the U.S.
SHANGHAI, Feb. 21, 2024 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, recently published the phase III study results of denosumab biosimilar (MW032) online in the international top journal of JAMA Oncology. This is the first recorded trial to systematically compare the efficacy, population pharmacokinetics, and safety profile of MW032 and reference denosumab in patients with solid tumors with bone metastasis through a 53-week, multicenter, randomized, double-blind, phase 3 equivalence trial.
FDA slaps boxed warning on Amgen`s osteoporosis drug Prolia
Amneal Adds Two Denosumab Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio
Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trialDenosumab is indicated for...
THOUSAND OAKS, Calif., May 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the U.S. medicare program showing Prolia® (denosumab) injection reduced fracture risk in patients versus oral alendronate, a frequently prescribed bisphosphonate treatment. Treatment with Prolia was also associated with greater reductions in fracture risk over time. The data were presented during an oral presentation at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), in Barcelona, May 4-7, 2023.