人福醫藥(600079.SH):鹽酸卡利拉嗪膠囊獲得藥物臨牀試驗批准通知書
格隆匯8月30日丨人福醫藥(600079.SH)公佈,公司控股子公司武漢人福藥業有限責任公司(稱“武漢人福”,公司持有其98.33%的股權,公司控股子公司宜昌人福藥業有限責任公司持有其1.67%的股權)近日收到國家藥品監督管理局核准簽發的鹽酸卡利拉嗪膠囊的《藥物臨牀試驗批准通知書》。
鹽酸卡利拉嗪屬於長半衰期第二代抗精神病藥物,本次鹽酸卡利拉嗪膠囊申請的適應症為成人精神分裂症的治療。鹽酸卡利拉嗪膠囊(商品名:Vraylar)的原研廠家為ABBVIEINC,目前國內已有3家企業獲批臨牀。截至目前該項目累計研發投入約為320萬元人民幣。
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