石藥集團(01093.HK):SYS 6010於中國獲突破性治療認定
格隆匯1月2日丨石藥集團(01093.HK)宣佈,公司附屬公司巨石生物製藥有限公司開發的SYS 6010( 抗人EGFR人源化單抗– JS -1偶聯注射劑 )("該產品")獲中華人民共和國國家藥品監督管理局授予突破性治療認定,擬定適應症為單藥用於經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)。
肺癌是中國和全球發病率和死亡率最高的惡性腫瘤,嚴重威脅人類健康。多數肺癌患者確診時已分期較晚,其中Ⅲ期患者的5年生存率約20 %,Ⅳ期患者的5年生存率低於5 %,中位生存期為7個月。
亞裔和中國NSCLC患者的EGFR基因突變陽性率為40 – 50 %。EGFR突變陽性晚期NSCLC靶向治療的療效與分子分型關係已在臨牀實踐中得到充分證實,EGFR -TKI目前已成為EGFR突變陽性晚期NSCLC的一線標準治療,TKI治療失敗後標準治療為含鉑雙藥化療+ / -貝伐珠單抗。但經EGFR -TKI及化療治療失敗的EGFR突變陽性NSCLC患者,整體預後較差,該人羣仍存在未被滿足的臨牀需求。
目前該產品在多種實體瘤的開發正在進行中,現有臨牀數據證實該產品單藥在該適應症中的療效顯著優於標準治療。該產品獲授予突破性治療認定,將有助於進一步促進與監管機構的溝通,加快開發進度。
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