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\u4e0a\u6d77<\/span>2024\u5e7411\u67088\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u8fea\u54f2\u533b\u836f\uff08\u80a1\u7968\u4ee3\u7801\uff1a688192.SH\uff09\u5ba3\u5e03\uff0c\u516c\u53f8\u5df2\u4e8e\u8fd1\u65e5\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u9012\u4ea4\u8212\u6c83\u54f2\u00ae\uff08\u901a\u7528\u540d\uff1a\u8212\u6c83\u66ff\u5c3c\u7247\uff09\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08New Drug Application\uff0cNDA\uff09\uff0c\u7528\u4e8e\u65e2\u5f80\u7ecf\u542b\u94c2\u5316\u7597\u6cbb\u7597\u65f6\u6216\u6cbb\u7597\u540e\u51fa\u73b0\u75be\u75c5\u8fdb\u5c55\uff0c\u5e76\u4e14\u7ecfFDA\u6279\u51c6\u7684\u8bd5\u5242\u76d2\u68c0\u6d4b\u786e\u8ba4\uff0c\u5b58\u5728\u8868\u76ae\u751f\u957f\u56e0\u5b50\u53d7\u4f53\uff08EGFR\uff0920\u53f7\u5916\u663e\u5b50\u63d2\u5165\u7a81\u53d8\uff08exon20ins\uff09\u7684\u5c40\u90e8\u665a\u671f\u6216\u8f6c\u79fb\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\uff08NSCLC\uff09\u7684\u6210\u4eba\u60a3\u8005\u3002\u8212\u6c83\u54f2\u00ae\u6210\u4e3a\u9996\u6b3e\u5411\u7f8e\u56fdFDA\u9012\u4ea4\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\u7684\u4e2d\u56fd\u6e90\u521b\u80ba\u764c\u9776\u5411\u836f\u3002<\/p>\n

\n

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

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

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\u53c2\u8003\u6587\u732e\uff1a
[1] \u4e2d\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08CSCO\uff09\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u8bca\u7597\u6307\u5357\uff082024\u7248\uff09.
[2] James Chih-Hsin Yang,et al. 2024ASCO #8513.
[3] Bazhenova L, et al. Lung Cancer. 2021 Dec,162154-161.<\/p>\n

\u5173\u4e8e\u8212\u6c83\u54f2\u00ae\uff08\u8212\u6c83\u66ff\u5c3c\u7247\uff09<\/p>\n

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\u5173\u4e8e\u8fea\u54f2\u533b\u836f<\/p>\n

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\u6295\u8d44\u8005\u5173\u7cfb\uff1air@dizalpharma.com<\/a>
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exon20ins NSCLC\u60a3\u8005\u771f\u5b9e\u4e16\u754c\u4e00\u5e74\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u7387\u4ec5\u4e3a13%\uff0c\u4e94\u5e74\u603b\u751f\u5b58\u671f\uff08OS\uff09\u7387\u4ec5\u4e3a8%\uff0c\u60a3\u8005\u751f\u5b58\u83b7\u76ca\u6709\u9650\u3002\u4f20\u7edfEGFR TKI\u5bf9EGFR exon20ins\u7684\u7597\u6548\u4e0d\u4f73\uff0c\u76f4\u5230\u8fd1\u51e0\u5e74\u65b0\u836f\u7814\u53d1\u624d\u6709\u6240\u7a81\u7834\u3002 \u53c2\u8003\u6587\u732e\uff1a[1] \u4e2d\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08CSCO\uff09\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u8bca\u7597\u6307\u5357\uff082024\u7248\uff09.[2] James Chih-Hsin Yang,et al. 2024ASCO #8513.[3] Bazhenova L, et al. 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exon20ins NSCLC\u4e8c\/\u540e\u7ebf\u552f\u4e00\u6807\u51c6\u6cbb\u7597\u65b9\u6848\u3002\u51ed\u501f\u4f18\u5f02\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u6570\u636e\uff0c\u8212\u6c83\u54f2\u00ae\u6b64\u524d\u5df2\u83b7FDA\u6388\u4e88\u5168\u7ebf\u6cbb\u7597EGFR exon20ins NSCLC\u7684”\u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a”\uff08Breakthrough Therapy Designation\uff0cBTD\uff09\uff0c\u53ef\u4eab\u6709\u5305\u62ecFDA\u4e13\u5bb6\u5168\u7a0b\u5bc6\u5207\u6307\u5bfc\u4e0e\u652f\u6301\u7b49\u4e00\u7cfb\u5217\u52a0\u5feb\u836f\u7269\u5f00\u53d1\u7684\u653f\u7b56\uff0c\u52a0\u901f\u63a8\u8fdb\u836f\u7269\u4e0a\u5e02\u8fdb\u7a0b\u3002 \u6b64\u6b21\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff0c\u662f\u57fa\u4e8e\u4e00\u9879\u8bc4\u4f30\u8212\u6c83\u54f2\u00ae\u9488\u5bf9\u7ecf\u6cbbEGFR exon20ins NSCLC\u60a3\u8005\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u56fd\u9645\u591a\u4e2d\u5fc3\u6ce8\u518c\u4e34\u5e8a\u7814\u7a76”\u609f\u7a7a1 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exon20ins NSCLC\u60a3\u8005\u771f\u5b9e\u4e16\u754c\u4e00\u5e74\u65e0\u8fdb\u5c55\u751f\u5b58\u671f\uff08PFS\uff09\u7387\u4ec5\u4e3a13%\uff0c\u4e94\u5e74\u603b\u751f\u5b58\u671f\uff08OS\uff09\u7387\u4ec5\u4e3a8%\uff0c\u60a3\u8005\u751f\u5b58\u83b7\u76ca\u6709\u9650\u3002\u4f20\u7edfEGFR TKI\u5bf9EGFR exon20ins\u7684\u7597\u6548\u4e0d\u4f73\uff0c\u76f4\u5230\u8fd1\u51e0\u5e74\u65b0\u836f\u7814\u53d1\u624d\u6709\u6240\u7a81\u7834\u3002 \u53c2\u8003\u6587\u732e\uff1a[1] \u4e2d\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff08CSCO\uff09\u975e\u5c0f\u7ec6\u80de\u80ba\u764c\u8bca\u7597\u6307\u5357\uff082024\u7248\uff09.[2] James Chih-Hsin Yang,et al. 2024ASCO #8513.[3] Bazhenova L, et al. 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