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海思科(002653.SZ):創新藥FTP-198片獲受理通知書
格隆匯 10-13 16:44

格隆匯 10 月 13日丨海思科(002653.SZ)公佈,公司全資子公司四川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》,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。

FTP-198系公司研發的化學藥品1類創新藥,擬用於治療特發性肺纖維化(IPF)IPF是一種病因不明的慢性、進行性纖維化肺部疾病,可引起周圍肺纖維化重塑,導致呼吸衰竭,發病率隨年齡增長而升高,常見於6070 歲人羣,是最常見的特發性間質性肺炎。IPF確診後的中位生存期為25年,死亡率高,是呼吸系統的難治性疾病之一。迄今為止,IPF尚無肯定顯著有效的治療藥物,因此迫切需要一種有效且耐受性更好的新型治療藥物。

本品靶點作用機制明確,有可擴展適應症的潛力,除纖維化外,有可能拓展腫瘤、血管生成、自身免疫性疾病、炎症、NASH、神經退行性病變等適應症,公司未來將根據該品種的情況或將進行上述擴展適應症的研究開發。

FTP-19820201月通過澳洲倫理審查,2020年第一季度開展健康人單次/多次給藥、隨機、雙盲、安慰劑對照、劑量遞增研究。

國家藥品監督管理局本次受理FTP-198片的申請,標誌該產品可申請開展適應症“特發性肺纖維化”臨牀試驗,如相關臨牀試驗成功將有望進一步驗證本品有效性和安全性,爭取儘快獲批上市造福廣大患者。

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