健友股份(603707.SH):度骨化醇注射液獲得臨牀試驗
格隆匯12月26日丨健友股份(603707.SH)發佈公告,公司於近日收到國家藥監局核准簽發的《臨牀試驗通知書》,並將於近期開展臨牀試驗。
該藥品名稱為“度骨化醇注射液”,度骨化醇化學名稱為(1α,3β,5Z,7E,22E)-9,10-開環麥角甾體-5,7,10(19),22-四烯-1,3-二醇,主要用於慢性腎臟疾病透析患者繼發性甲狀旁腺功能亢進症的治療。度骨化醇注射液最早由美國Genzyme Corporation公司開發,於2000年在美國上市。原研商品名為Heterol®,規格是2ml:4μg。公司參照原研藥品度骨化醇注射液進行仿製研究,仿製劑型為注射液,規格為2ml:4μg。目前,國內僅有口服制劑(膠囊劑)上市,尚無注射劑上市。截至目前,該產品項目已投入研發費用約為1,298.79萬元人民幣。
公告表示,根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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