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康哲藥業(00867.HK)創新藥地西泮鼻噴霧劑中國註冊性試驗全部受試者完成首次給藥
格隆匯 10-21 09:58

2020年10月21日,康哲藥業(00867.HK)重磅創新藥地西泮鼻噴霧劑的中國註冊性橋接試驗——比較PK研究在湖南省益陽市中心醫院全部受試者完成首次給藥,這是該產品中國註冊上市進程中的重要里程碑事件。

該研究為單中心、隨機、開放、兩製劑、兩週期、雙交叉的比較藥代動力學研究(“比較PK研究”),共入組24位健康受試者,主要目的為考察空腹條件下地西泮鼻噴霧劑與地西泮注射液在健康受試者體內的藥動學特徵及生物利用度。根據中國NMPA簽發的臨牀試驗通知書要求,康哲藥業需開展該項註冊臨牀研究進行橋接以支持上市,並在遞交NDA的同時提交上市後進一步驗證該產品療效及安全性的臨牀研究計劃。

地西泮鼻噴霧劑

居家便捷、快速起效,針對急性反覆性癲癇發作的創新藥

地西泮鼻噴霧劑由康哲藥業參股的美國Neurelis公司研發,且康哲藥業擁有該產品在中國大陸、香港、澳門、和台灣的全部資產。2020年1月,地西泮鼻噴霧劑獲FDA批准以VALTOCO®商品名稱在美國上市,用於治療6歲及以上癲癇患者的間歇性、刻板性癲癇頻繁發作活動(即癲癇叢集性發作、急性反覆性癲癇發作)。該產品配方結合了基於維生素E溶劑和Intravail®吸收增強劑的獨特組合,以期在鼻腔配方中獲得突出的吸收性、耐受性和可靠性;與靜脈注射地西泮相比,其絕對生物利用度高達96%,且變異性低。

中國活動性癲癇患者約600萬,每年新發患者約40萬。得到正規治療的癲癇患者(約200萬)中,仍有20%-30%無法得到有效控制,癲癇反覆發作次數頻繁,平均每年近70次之多。地西泮鼻噴霧劑一旦在中國獲批,將成為急性反覆發作癲癇患者的長期必備、安全有效的藥物,市場前景可期。

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