Amgen's new RANKL inhibitor, ground-shoian-resistant injection, has been approved by the State Drug Administration

osteoblastoma is an extremely rare and rapidly advanced, high-risk primary bone tumor rich in human nuclear factor activation factor receptor ligand (RANKL), which manifests itself as eccentric osteopathic lesions at the dry end of the long bone and in the spine or spine and tibiarecently, the StateDrug(http://Supervision Authority official website said that the conditions have been approved for the approval of Amincompany(http://the development of the new RANKL inhibitor ground shoito-resistant injection (English name: Denosumab Injection) import registration application for bone cytomegaloblast non-surgical removal or surgical removal of adults and adolescents with mature bone development that may cause severe dysfunctionabout the disshodrinresistancea new type of RANKL inhibitor developed by Amgen, is rankL's all-human monoclonal IgG2 antibody, which has a high affinity and specificity to soluble, transmembrane human rankLIn patients with osteocytoblastoma, the inhibition of RANKL secreted by the tumor matrix component can significantly reduce or eliminate bone-breaking cell-like tumor-related megacellsAs a result, bone dissolution decreased, the progressof cytomegalocell tumors slowed down, and the hyperplasia matrix was replaced by dense, non-hyperplasia, differentiated braided new bones, thus improving clinical outcomesdishoedmono can be used as a targeted treatment for osteocytosis and may be an important treatment option to fill the unmet medical needs of the diseaseThe variety is based on overseas clinical data to support the application for clinical-free import registration in China, the main supporting clinical data provided by the applicant are obtained abroadtherefore, the State Drug Administration, in conjunction with the opinions of various technical departments, on May 21st, conditionally approved the listing of this product, and requested the applicant to continue to carry out clinical research in China after the product was approved, and to formulate and strictly implement the risk management planThe State Drug Administration said it had so far approved 14 varieties listed in the first batch of clinically urgently needed foreign medicinesNext, the State Drug Administration will fully implement the relevant requirements for deepening the reform of the drug review and approval system, comprehensive lying, optimizing the review process, and continuously speed up the treatment of rare diseases and the prevention and treatment of serious life-threatening diseases
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