天士力(600535.SH):注射用重組人尿激酶原通過藥品生產質量管理規範符合性檢查並獲得藥品補充申請批准通知書
格隆匯2月11日丨天士力(600535.SH)公佈,公司近日獲悉控股子公司天士力生物醫藥股份有限公司(以下簡稱“天士力生物”)關於注射用重組人尿激酶原(商品名“普佑克”)300L發酵規模細胞培養生產線收到上海市藥品監督管理局簽發的《藥品生產現場檢查結果吿知書》和國家藥品監督管理局簽發的《藥品補充申請批准通知書》。
注射用重組人尿激酶原是國內唯一商業化的重組人尿激酶原產品,屬於特異性溶栓藥,目前獲批的適應症為急性ST段抬高性心肌梗死。該產品針對急性缺血性腦卒中適應症和急性肺栓塞適應症的藥品上市許可申請已提交併獲得受理。該藥品2020年度銷售收入21574.92萬元,佔公司2020年度營業收入的1.59%;2021年1-9月銷售收入17826.17萬元,佔公司2021年前三季度營業收入的3.09%。
我國溶栓藥物市場中,除注射用重組人尿激酶原外,另有3款纖維蛋白特異性纖溶酶原激活劑獲批上市,分別是注射用重組組織型纖溶酶原激活劑(阿替普酶)、注射用重組纖溶酶原激活劑(瑞替普酶)和注射用重組人組織型纖溶酶原激活劑TNK突變體(替奈普酶),公司目前無法從公開渠道獲知該3款產品的銷售數據。
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