海思科(002653.SZ):創新藥HSK31858片獲批臨牀,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
格隆匯2月7日丨海思科(002653.SZ)公佈,公司於近日獲得國家藥監局藥品審評中心下發的關於HSK31858片的《藥物臨牀試驗批准通知書》。經審查,2021年11月受理的HSK31858片符合藥品註冊的有關要求,同意該藥品開展用於“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”的臨牀試驗。
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。
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170萬~600萬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片的開發預計可明顯改善支氣管擴張和急性肺損傷/急性呼吸窘迫綜合徵患者的生存狀態,將為我國眾多下呼吸道疾病患者提供一種全新機制的優效治療藥物,具有重要的臨牀和社會意義。
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