和黃醫藥(00013.HK):呋喹替尼(fruquintinib)二線治療胃癌的中國新藥上市申請獲受理
格隆匯4月18日丨和黃醫藥(00013.HK)發佈公吿,國家藥監局已受理呋喹替尼聯合紫杉醇用於二線治療晚期胃癌和胃食管結合部腺癌的中國新藥上市申請。
和黃醫藥研發負責人及首席醫學官石明博士表示:“此次新藥上市申請獲國家藥監局受理是呋喹替尼在解決胃癌患者未被滿足的重大醫療需求的道路上邁出的積極一步。胃癌是全球最常見的癌症之一,尤其是在亞洲人羣中發病率和死亡率為最高。 僅中國就佔全球胃癌新發病例的四成以上。儘管最近胃癌在一線治療方面取得了進展,但對於初次治療後疾病進展的患者可用的治療方法非常有限。呋喹替尼在 FRUTIGA III期研究中展現出為患者帶來具有臨牀意義的獲益,我們很高興有機會為中國患者提供一種潛在的新的口服治療選擇。”
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