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雲頂新耀-B(01952.HK)治療三陰性乳腺癌新藥獲台灣小兒或少數嚴重疾病藥品優先審查認定
阿思達克 07-29 17:54
雲頂新耀-B(01952.HK)公布,中國台灣藥品監管部門給予戈沙妥珠單抗(sacituzumab govitecan-hziy)小兒或少數嚴重疾病藥品審查(小少嚴)認定,這是一種用於治療成年病人無法切除的局部晚期或者轉移性三陰性乳腺癌,且之前已接受過兩次或者更多次系統性治療,且其中至少一次是用於治療轉移性疾病的ADC藥物,在中國台灣仍處於研究性階段。

集團指,「小少嚴」藥品優先審查認定由台灣藥品監管部門給予,旨在解決極待滿足的醫療需求和流行病學患病率在萬分之五以下的嚴重疾病。根據台灣藥品監管部門,如果藥物符合此認定標準,則該藥物應通過優先審查程序獲得批准。

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