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天士力(600535.SH):子公司產品獲藥物臨牀試驗批准通知書
格隆匯 11-04 15:34

格隆匯11月4日丨天士力(600535.SH)公佈,近日,公司子公司江蘇天士力帝益藥業有限公司(以下簡稱“江蘇帝益”)收到國家藥監局核准簽發用於治療2型糖尿病的化學1類新藥TSL-1806膠囊《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。

TSL-1806是一種全新結構的選擇性GPR40激動劑,具有全新的降血糖作用機制,預期可單獨使用或者聯用治療2型糖尿病。TSL-1806可以通過激活GPR40受體對胰島素進行調節,且其調節具有葡萄糖依賴性(即血糖上升,才促進胰島素釋放,相比傳統促胰島素分泌劑引發低血糖的風險更低),同時促進GLP-1分泌,避免體重增加。前期禮來公司已在美國和新加坡分別完成了I期臨牀試驗各1項,初步確認其安全性和有效性。目前全球尚未有同機製藥物獲批上市,研發進展最快的同類藥物處於臨牀I期階段。該產品研發成功上市後,將填補臨牀市場空白,為中國乃至全球2型糖尿病患者帶來更多的用藥選擇。

江蘇帝益於2020年8月25日首次提交TSL-1806膠囊臨牀試驗申請並獲得受理,日前獲得藥物臨牀試驗批准通知書,後續將按照通知書要求開展本品的臨牀試驗研究相關工作。截至公告日,江蘇帝益對TSL-1806膠囊研發累計投入人民幣4627.47萬元(含已支付的許可費)。

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