步長製藥(603858.SH):子公司注射用重組人甲狀旁腺素(1-84)獲批臨牀試驗
格隆匯2月11日丨步長製藥(603858.SH)公佈,公司控股子公司四川瀘州步長生物製藥有限公司(“瀘州步長”)近日收到國家藥品監督管理局核准簽發的關於注射用重組人甲狀旁腺素(1-84)的《藥物臨牀試驗批准通知書》。
瀘州步長本次獲得注射用重組人甲狀旁腺素(1-84)的《藥物臨牀試驗批准通知書》為新增適應症臨牀試驗獲批,新增適應症為:用於輔助鈣和維生素D控制甲狀旁腺功能減退患者的低鈣血癥。
注射用重組人甲狀旁腺素(1-84)擬定適應症包括:1、絕經後婦女骨質疏鬆(正在開展Ⅲ期臨牀研究)。2、用於輔助鈣和維生素D控制甲狀旁腺功能減退患者的低鈣血癥(適應症臨牀試驗申請已獲批准)。
甲狀旁腺功能減退症是一種甲狀旁腺激素(PTH)分泌過少和(或)效應不足而引起的一組臨牀綜合徵。臨牀特徵為低鈣血癥、高磷血癥和由此引起的神經肌肉興奮性增高及軟組織的異位鈣化等,同時PTH水平低於正常或處於與血鈣水平不相應的“正常”範圍。
目前,全球已上市的同類藥物為武田公司Natpara®,該品種於2015年獲美國FDA批准上市。2020年Natpara®的全球銷售額為1.26億美元。
截至2021年12月31日,公司在注射用重組人甲狀旁腺素(1-84)項目上投入的研發費用約為1.466億元人民幣。
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