石藥集團抗癌新藥SYS6010獲突破性治療認定

財中社

01-02

　　財中社1月2日電石藥集團（01093）發佈公告，宣佈其附屬公司巨石生物製藥有限公司開發的SYS6010（抗人EGFR人源化單抗–JS-1偶聯注射劑）獲得中華人民共和國國家藥品監督管理局授予的突破性治療認定。該產品擬定的適應症爲單藥用於經EGFR-TKI和含鉑化療治療失敗的EGFR突變陽性晚期非小細胞肺癌（NSCLC）。肺癌在中國和全球的發病率及死亡率均位居惡性腫瘤之首，嚴重威脅人類健康。

　　公告指出，EGFR突變陽性晚期NSCLC患者的整體預後較差，現有治療手段無法滿足其臨牀需求。SYS6010在多種實體瘤的開發中，已有臨牀數據表明其單藥治療的療效顯著優於標準治療。獲得突破性治療認定將有助於公司進一步與監管機構溝通，加快產品開發進度。

（文章來源：財中社）

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