海思科(002653.SZ)：創新藥FTP-198片獲得臨牀試驗批准通知書
格隆匯 12 月 1日丨海思科(002653.SZ)公佈，公司之全資子公司四川海思科製藥有限公司(“四川海思科”)於近日收到國家藥品監督管理局下發的《藥物臨牀試驗批准通知書》。
藥品名稱：FTP-198片；劑型：片劑；規格：50mg、200mg；申請事項：臨牀試驗；受理號：CXHL2000501、CXHL2000502；通知書編號2020LP00833、2020LP00834。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年9月24日受理的FTP-198片符合藥品註冊的有關要求，同意該品開展用於特發性肺纖維化的臨牀試驗。
FTP-198系我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60～70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2～5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。
該品靶點作用機制明確，有可擴展適應症的潛力，除纖維化和腫瘤外，還包含血管生成，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情況或將進行上述擴展適應症的研究開發。
FTP-198於2020年1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。根據目前結果，有望成為特發性肺纖維化(IPF)的潛在同類最佳(best-in-class)治療藥物。
國家藥品監督管理局此次批准FTP-198片的臨牀試驗申請，標誌該產品可開展適應症“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該品有效性和安全性，爭取儘快獲批上市造福廣大患者。
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