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\nBosulifR\u5c6c\u7b2c\u4e8c\u4ee3\u916a\u80fa\u9178\u6fc0(\u9149\u6bcf)\u6291\u5236\u5291(TKI)\uff0c\u9069\u7528\u65bc\u6cbb\u7642\u6210\u4eba\u65b0\u8a3a\u65b7\u4e4b\u6162\u6027\u671f(CP)\u8cbb\u57ce\u67d3\u8272\u9ad4\u967d\u6027\u4e4b\u6162\u6027\u9aa8\u9ad3\u6027\u767d\u8840\u75c5(Ph+ CML)\u8005\uff0c\u4ee5\u53ca\u5148\u524d\u66fe\u63a5\u53d7TKI\u6cbb\u7642\u7522\u751f\u6297\u85e5\u6027\u6216\u7f3a\u4e4f\u8010\u53d7\u6027\u7684\u6210\u4eba\u60a3\u8005\u3002<\/p>\n\n\n

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\n\u7f8e\u6642\u65d7\u4e0bLP757(cabozantinib)505(b)(2)\u65b0\u85e5\u67e5\u9a57\u767b\u8a18\u7533\u8acb(NDA)\u5df2\u7372\u7f8e\u570b\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40(US FDA)\u53d7\u7406\uff0c\u4e26\u9032\u5165\u5be6\u8cea\u5be9\u67e5\u3002\u5982\u516c\u53f8\u5148\u524d\u516c\u544a1\uff0c\u7f8e\u6642\u5df2\u65bc2026\u5e742\u670823\u65e5\u63d0\u4ea4NDA\uff0c\u70ba\u7f8e\u6642\u65bc\u7f8e\u570b\u7684\u9996\u9805505(b)(2)\u53e3\u670d\u816b\u7624\u65b0\u85e5\u7533\u8acb\u3002FDA\u53d7\u7406\u4ee3\u8868\u8a72\u7533\u8acb\u8cc7\u6599\u5df2\u7b26\u5408\u5be6\u8cea\u5be9\u67e5\u7684\u53d7\u7406\u8981\u4ef6\uff0c\u5c07\u9032\u5165\u5b8c\u6574\u7684\u6cd5\u898f\u5be9\u67e5\u7a0b\u5e8f\u3002FDA\u5c07LP757\u7684\u8655\u65b9\u85e5\u4f7f\u7528\u8005\u4ed8\u8cbb\u6cd5(PDUFA)\u76ee\u6a19\u5be9\u67e5\u5b8c\u6210\u65e5\u671f\u8a02\u70ba2026\u5e7412\u670823\u65e5\u3002<\/p>\n\n\n

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\n\u64daIQVIA\u622a\u81f32025\u5e7412\u6708(MAT)\u7684\u8cc7\u6599\uff0ccabozantinib \u5728\u7f8e\u570b\u622a\u81f32025\u5e7412\u6708\u6b62\u5341\u4e8c\u500b\u6708\u7684\u92b7\u552e\u984d\u7d04\u70ba20\u5104\u7f8e\u5143\u3002<\/p>\n\n\n

\n<\/p>\n\n\n

\n2026\/07\/15 09:50<\/p>\n\n\n

\n\u8f49\u8f09\u81ea\u4e2d\u6642\u65b0\u805e\u7db2: https:\/\/www.chinatimes.com\/realtimenews\/20260715001525-260410<\/p>\n\n<\/div>\n\n\n

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\u6700\u65b0\u6587\u7ae0<\/span><\/h2><\/div><\/div><\/div>

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