雲頂新耀-B(01952.HK)治療轉移性三陰性乳腺癌新藥上市申請獲內地受理
雲頂新耀-B(01952.HK)公布,中國國家藥品監督管理局已受理戈沙妥組單抗(sacituzumab govitecan-hziy)的生物製品上市許可申請,這種新藥用於治療至少接受過兩線或以上既往治療的局部不可切除晚期或者轉移性三陰性乳腺癌(至少其中之一為轉移性疾病)成年患者,目前在國內處於研究性階段。
集團指,戈沙妥組單抗的英文商品名為「Trodelvy」,去年4月獲得了美國食品藥物管理局的加速批准,並於今年4月獲得了完全批准,用於治療至少接受過兩線或以上既往治療的局部不可切除晚期或者轉移性三陰性乳腺癌,至少其中之一為轉移性疾病。
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