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\u6b64\u6b21\u6279\u51c6\u8fd8\u5305\u62ec\u5e15\u535a\u5229\u73e0\u5355\u6297\u8054\u5408berahyaluronidase alfa-pmph\u7684\u76ae\u4e0b\u7ed9\u836f\u65b0\u5242\u578b\uff0c\u8be5\u5236\u5242\u901a\u8fc7\u76ae\u4e0b\u7ed9\u836f\u65b9\u5f0f\u5b9e\u73b0\u5e15\u535a\u5229\u73e0\u5355\u6297\u7684\u9012\u9001\uff0c\u4e3a\u60a3\u8005\u63d0\u4f9b\u4e86\u9664\u9759\u8109\u8f93\u6ce8\u4e4b\u5916\u7684\u53e6\u4e00\u79cd\u6cbb\u7597\u9014\u5f84\uff0c\u6709\u671b\u63d0\u9ad8\u6cbb\u7597\u4fbf\u5229\u6027\u548c\u4f9d\u4ece\u6027\u3002<\/p>\n\n\n\n

\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u8be5\u9002\u5e94\u75c7\u9002\u7528\u4e8e\u4ee5\u4e0b\u60a3\u8005\u4eba\u7fa4\uff1a<\/strong><\/strong><\/p>\n\n\n\n

\u2022 \u80bf\u7624\u7ecfFDA\u6279\u51c6\u7684\u68c0\u6d4b\u65b9\u6cd5\u786e\u8ba4PD-L1\u8868\u8fbe\u9633\u6027\uff08\u8054\u5408\u9633\u6027\u8bc4\u5206 CPS \u2265 1\uff09
\u2022 \u65e2\u5f80\u63a5\u53d7\u8fc7\u4e00\u81f3\u4e24\u79cd\u5168\u8eab\u6cbb\u7597\u65b9\u6848
\u2022 \u5bf9\u542b\u94c2\u5316\u7597\u4ea7\u751f\u8010\u836f\u7684\u60a3\u8005<\/p>\n\n\n\n

\u540c\u65f6\uff0cFDA\u6279\u51c6\u4e86PD-L1 IHC 22C3 pharmDx\u4f5c\u4e3a\u914d\u5957\u8bca\u65ad\u5de5\u5177\uff0c\u7528\u4e8e\u68c0\u6d4b\u80bf\u7624PD-L1\u8868\u8fbe\u6c34\u5e73\uff0c\u4ece\u800c\u7b5b\u9009\u9002\u5408\u63a5\u53d7\u5e15\u535a\u5229\u73e0\u5355\u6297\u6cbb\u7597\u7684\u60a3\u8005\uff0c\u5b9e\u73b0\u66f4\u52a0\u7cbe\u51c6\u7684\u4e2a\u4f53\u5316\u6cbb\u7597\u3002<\/p>\n\n\n\n

1. <\/strong>\u4e34\u5e8a\u7814\u7a76\u4f9d\u636e<\/strong><\/strong><\/p>\n\n\n\n

\u672c\u6b21\u6279\u51c6\u4e3b\u8981\u57fa\u4e8eKEYNOTE-B96\u7814\u7a76\uff08NCT05116189\uff09\u7684\u7ed3\u679c\u3002\u8fd9\u662f\u4e00\u9879\u591a\u4e2d\u5fc3\u3001\u968f\u673a\u3001\u53cc\u76f2\u3001\u5b89\u6170\u5242\u5bf9\u7167\u7684III\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5171\u7eb3\u5165643\u540d\u94c2\u7c7b\u8010\u836f\u7684\u4e0a\u76ae\u6027\u5375\u5de2\u764c\u3001\u8f93\u5375\u7ba1\u764c\u6216\u539f\u53d1\u6027\u8179\u819c\u764c\u60a3\u8005\u3002<\/p>\n\n\n\n

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\u65e2\u5f80\u63a5\u53d7\u8fc71\u20132\u7ebf\u7cfb\u7edf\u6cbb\u7597<\/p>\n\n\n\n

\u81f3\u5c11\u63a5\u53d7\u8fc7\u4e00\u6b21\u542b\u94c2\u5316\u7597<\/p>\n\n\n\n

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2. <\/strong>\u7814\u7a76\u7ed3\u679c<\/strong><\/strong><\/p>\n\n\n\n

\u5728PD-L1 CPS \u22651\u7684466\u540d\u60a3\u8005\u4e2d\uff0c\u7814\u7a76\u663e\u793a\u5e15\u535a\u5229\u73e0\u5355\u6297\u8054\u5408\u6cbb\u7597\u65b9\u6848\u5728\u7597\u6548\u65b9\u9762\u4f18\u4e8e\u5bf9\u7167\u7ec4\uff1a<\/p>\n\n\n\n

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\u5bf9\u7167\u7ec4\uff1a7.2\u4e2a\u6708<\/p>\n\n\n\n

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3. <\/strong>\u5b89\u5168\u6027<\/strong><\/strong><\/p>\n\n\n\n

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\u2022 \u80da\u80ce-\u80ce\u513f\u6bd2\u6027\u98ce\u9669<\/p>\n\n\n\n

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\u603b\u7ed3<\/strong><\/strong><\/p>\n\n\n\n

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