海思科(002653.SZ):獲得創新藥HSK21542注射液新適應症IND申請《受理通知書》
格隆匯7月14日丨海思科(002653.SZ)公佈,公司子公司遼寧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》,藥品名稱HSK21542注射液,擬用於治療術後噁心嘔吐;根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。
術後噁心嘔吐是一種發生於術後的胃腸功能紊亂,主要發生在術後6h或24h內,少數患者可持續到3-5天。PONV在一般外科手術患者中發生率為30%,在高危患者中高達80%。PONV可以導致患者經歷不同程度的痛苦,包括水、電解質平衡紊亂、傷口裂開、切口疝形成、誤吸和吸入性肺炎等。由此可見,PONV是影響患者術後恢復的一個重要因素,從而延長住院時間並增加醫療費用,降低患者的滿意度。
HSK21542是公司自主研發的強效外周kappa阿片受體(κOpioid
Receptor,KOR)選擇性激動劑,其具有高選擇性和親和性,可通過作用於腸壁上迷走神經元,改變中樞系統對於胃腸刺激信號的調節,從而改善胃腸道不適。此前,在HSK21542注射液已完成的腹部手術術後鎮痛臨牀研究中,HSK21542在展現出良好的術後鎮痛效果的同時,還可減少PONV發生率和止吐藥使用量。HSK21542注射液預期止吐效果和總體安全性良好,有望為術後噁心嘔吐患者的治療提供安全有效的新選擇。
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