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天士力(600535.SH):控股子公司撤回注射用重組人尿激酶原增加急性缺血性腦卒中新適應症註冊申請
格隆匯 05-13 16:08

格隆匯5月13日丨天士力(600535.SH)公佈,公司控股子公司天士力生物醫藥股份有限公司(簡稱“天士力生物”)於日前收到國家藥品監督管理局簽發的審評意見通知,同意撤回注射用重組人尿激酶原增加急性缺血性腦卒中新適應症註冊申請。收件後天士力生物將按相關新註冊法規要求,儘快完善驗證性臨牀方案並開展後續研究,研究完成後會繼續提出增加該新適應症的註冊申請。

注射用重組人尿激酶原(普佑克)用於急性ST段抬高型心肌梗死的溶栓治療已於2011年批准上市並積累了大量臨牀數據。新增用於治療急性缺血性腦卒中適應症的III期臨牀試驗數據顯示該藥與對照組療效相當,且系統性出血風險顯著低於對照組。普佑克用於治療急性缺血性腦卒中適應症註冊申請於2021年2月獲得國家藥監局受理,按照最新的藥品註冊相關法規要求天士力生物撤回該新適應症的註冊申請。後續該子公司將按相關新註冊法規要求,儘快完善驗證性臨牀方案並開展後續研究,研究完成後會繼續提出增加該新適應症的註冊申請,並將根據研究進展和註冊情況及時履行信息披露義務。

截至2022年4月30日,天士力生物針對該適應症累計研發投入約為人民幣16,947萬元(未經審計)。

普佑克是新一代特異性纖溶酶原激活劑(以下簡稱“特異性溶栓藥”),靶向作用於血栓部位的纖維蛋白,本次申報的新適應症為急性缺血性腦卒中的溶栓治療。目前我國在治療急性缺血性腦卒中領域,與普佑克同屬特異性溶栓藥的唯一上市產品為勃林格殷格翰生產的阿替普酶(Alteplase),商品名愛通立,目前未見有其他類似特異性溶栓生物藥該適應症上市。根據弗若斯特沙利文報吿,阿替普酶2020年在國內市場的銷售規模約為13.45億元。

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