海思科(002653.SZ):獲得創新藥HSK21542片IND申請《受理通知書》
格隆匯6月20日丨海思科(002653.SZ)公佈,公司全資子公司西藏海思科製藥有限公司於近日收到國家藥品監督管理局下發的《受理通知書》。
HSK21542片是公司自主研發的外周阿片受體的選擇性激動劑,臨牀擬用於慢性瘙癢的治療,國內外目前尚無同類型口服產品上市。非臨牀研究數據證實該產品具有高選擇性和高親和性,緩解瘙癢效果確切,兼具良好的安全性和耐受性。
公司本次申請適應症為“慢性瘙癢”,按我國新化學藥品註冊分類規定,其藥品註冊分類為化藥1類。
公司於2020年5月獲得了HSK21542注射液“瘙癢症”適應症《臨牀試驗通知書》(受理號:CXHL2000068/CXHL2000069,公吿編號:2020-062)。本次開發其口服制劑,可拓展覆蓋更廣泛的用藥人羣,提高患者的用藥依從性,增強給藥的便捷性,滿足更多臨牀用藥需求,為患者提供更多的用藥方案。
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