Qilu Pharmaceutical's Denosumab Biosimilar Ludaxin® Approved in China for Giant Cell Tumor of Bone

May 01, 2024 07:45 CST Updated 07:45

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Mabwell

Innovative Biopharmaceutical Company

April 30,Qilu PharmaceuticalMabwell's targeted anti-tumor drug Rudaxin® (Denosumab Injection) has officially received marketing approval for the treatment of giant cell tumor of bone that is inoperable or where surgical resection may lead to severe functional impairment, including adult and adolescent patients with mature skeletal development (defined as having at least one mature long bone and weighing ≥45kg).

Denosumab is a fully humanized IgG2 monoclonal antibody that prevents the activation of receptor RANK on osteoclasts and their precursors by the receptor activator of nuclear factor κB ligand (RANKL). Blocking the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby reducing bone resorption and increasing bone mass and strength in both cortical and trabecular bones.

Original ResearchLocationShudan AntibodyByAmgenDevelopment and market launch, divided into two different brands according to specifications and indications, respectively: Xgeva (Xgeva, 70 mg/ml) and Prolia (普罗力, 60 mg/ml). Among themXgeVA is used for the treatment of cancer-related bone diseases.Prolia is used to treat osteoporosis.

Currently, there are 15 companies in China developing biosimilars of denosumab.Among themBoan BiotechTheBoyoubiIt was approved for marketing in November 2022 and is the world's first Prolia biosimilar to be launched.MabwellTheMabwell's product was also approved for marketing in March 2023.Is the world's second Prolia biosimilar to be marketed; subsequentlyOctober 2023,Qilu PharmaceuticalProlia BiosimilarLukexinAlso approved for marketing.In April 2024, MabwellMabwell HealthApproved for marketing, it is the first domestically produced biosimilar of Xgeva (denosumab) to be approved in China.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article.For reprint, please leave a message to the WeChat Official Account backend or send a message, and indicate the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.