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海思科(002653.SZ):獲得創新藥HSK31858片新藥申請的受理通知書
格隆匯 11-29 16:09

格隆匯11月29日丨海思科(002653.SZ)公佈,公司於近日收到國家藥品監督管理局下發的《受理通知書》,基本情況如下:

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。

HSK31858 片是公司自主研發的一種口服、強效和高選擇性的二肽基肽酶1(Dipeptidyl Peptidase 1, DPP1)小分子抑制劑,臨牀擬用於治療支氣管擴張症及急性肺損傷/急性呼吸窘迫綜合徵引起的下呼吸道疾病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。

支氣管擴張症的患病率隨年齡增加而增高據不完全統計,我國7省市40歲以上居民患病率約為1.2%目前尚無針對支氣管擴張的治療藥物,均為對症治療以及處理併發症約有170~600萬支氣管擴張患者無法得到適合的治療

經查詢,全球進展最快同靶點化合物INS1007目前正在進行III期臨牀試驗,其II 期試驗結果顯示對支氣管擴張具有確切療效,除此之外,全球尚無同靶點產品臨牀在研。

HSK31858的開發預計可明顯改善支氣管擴張急性肺損傷/急性呼吸窘迫綜合徵患者的生存狀態我國眾多下呼吸道疾病者提供一種全新機制的治療藥物,具有重要的臨牀和社會意義。

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