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9\u670827\u65e5\uff0c\u4e00\u4efd\u7531\u505a\u7a7a\u673a\u6784\u960e\u706b\u7814\u7a76\u53d1\u5e03\u7684\u62a5\u544a\u8ba9\u4e1a\u5185\u77e5\u540d\u7684CRO\u516c\u53f8\u2014\u2014\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280\u9677\u5165\u80a1\u4ef7\u66b4\u8dcc\u7684\u72b6\u51b5\u3002\u62a5\u544a\u79f0\uff0c\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280\u63a7\u80a1\u5b50\u516c\u53f8\u4f20\u5947\u751f\u7269CAR-T\u6280\u672f\u7684\u6765\u6e90\u6251\u6714\u8ff7\u79bb\uff0c\u4e13\u5229\u7533\u8bf7\u5c61\u906d\u78b0\u58c1\uff0c\u4e34\u5e8a\u6570\u636e\u6d89\u5acc\u9020\u5047\u2026\u20269\u670828\u65e5\uff0c\u91d1\u65af\u745e\u7ed9\u51fa\u6f84\u6e05\u516c\u544a\uff0c\u5c31\u4ea7\u54c1\u7814\u53d1\u3001\u4e13\u5229\u3001\u4e34\u5e8a\u7b49\u95ee\u9898\u8fdb\u884c\u4e86\u4e00\u4e00\u56de\u5e94\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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2017\u5e74\uff0c\u91d1\u65af\u745e\u5e02\u503c\u6da8\u5e45\u8d85450%\uff0c\u88ab\u4e1a\u5185\u79f0\u4e3a\u201c\u5996\u80a1\u201d\u3002\u73b0\u5728\uff0c\u8fd9\u4e00\u4efd\u8d28\u7591\u62a5\u544a\u8ba9\u5176\u80a1\u4ef7\u66b4\u8dcc\u8d8545%\u3002\u91d1\u65af\u745e\u65d7\u4e0b\u5b50\u516c\u53f8\u5357\u4eac\u4f20\u5947\u7684CAR-T\u4ea7\u54c1LCAR-B38M<\/strong>\u5728\u6cbb\u7597\u590d\u53d1\u3001\u96be\u6cbb\u6027\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u4e2d\u8868\u73b0\u51fa\u79ef\u6781\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u5e76\u4e8e\u4eca\u5e74\u62ff\u5230\u4e34\u5e8a\u6279\u4ef6\uff0c\u6210\u4e3a\u56fd\u5185\u7387\u5148\u83b7\u6279\u8fdb\u5165\u4e34\u5e8a\u7684\u7ec6\u80de\u7597\u6cd5\u4ea7\u54c1\u3002<\/strong><\/span><\/p>\n


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\u7136\u800c\uff0c\u960e\u706b\u7814\u7a76\u6307\u51fa\uff0c<\/strong>\u4f20\u5947\u751f\u7269\u7684CAR-T\u7597\u6cd5\u5546\u4e1a\u4ef7\u503c\u6709\u9650\uff0c\u73b0\u6709\u4ea7\u54c1\u7ba1\u7ebf\u65e0\u6cd5\u652f\u6491\u76ee\u524d\u4f30\u503c\u3002\u8be5\u673a\u6784\u6000\u7591\uff0c\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280CAR-T\u6570\u636e\u6d89\u5acc\u9020\u5047\uff0c\u4e34\u5e8a\u5b9e\u9a8c\u6570\u636e\u5ba2\u89c2\u6027\u5b58\u7591\u3002\u4f20\u5947\u751f\u7269\u7684\u4e13\u5229\u7533\u8bf7\u5c61\u906d\u78b0\u58c1\uff0c\u76ee\u524d\u6765\u770b\u51e0\u4e4e\u65e0\u6cd5\u5f62\u6210\u5b8c\u6210\u7684\u4e13\u5229\u4fdd\u62a4\u4f53\u7cfb\u3002<\/span><\/p>\n


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\u62a5\u544a\u4e2d\u8fd8\u63d0\u5230\uff0c\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280\u7ba1\u7406\u5c42\u6d89\u5acc\u9ad8\u4f4d\u5957\u73b0\uff0c\u5e76\u4e14\u901a\u8fc7\u590d\u6742\u4ea4\u6613\u7ed3\u6784\uff0c\u89c4\u907f\u4e86\u5de8\u989d\u80a1\u4efd\u652f\u4ed8\uff0c\u7b79\u5212\u5c06\u4f20\u5947\u751f\u7269\u5206\u62c6\u4e0a\u5e02\uff0c\u7a83\u53d6\u516c\u4f17\u80a1\u4e1c\u5229\u76ca\u3002<\/span><\/p>\n


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9\u670828\u65e5\uff0c\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280\u9488\u5bf9\u8fd9\u4e00\u62a5\u544a\u4f5c\u51fa\u6f84\u6e05\u516c\u544a<\/strong>\uff0c\u5426\u8ba4\u4e86\u960e\u706b\u7814\u7a76\u7684\u6240\u6709\u6307\u63a7\uff0c\u6307\u660e\u62a5\u544a\u5305\u62ec\u8bef\u5bfc\u6027\u3001\u5177\u504f\u89c1\u3001\u6709\u9009\u62e9\u6027\u3001\u4e0d\u51c6\u786e\u3001\u4e0d\u5b8c\u6574\u7684\u58f0\u660e\u53ca\u6beb\u65e0\u6839\u636e\u7684\u6307\u63a7\u4ee5\u53ca\u4e0d\u8d1f\u8d23\u4efb\u7684\u63e3\u6d4b\u3002<\/span><\/p>\n


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\u6307\u63a7\u4e00\uff1a\u6f84\u6e05\u5173\u4e8e\u516c\u53f8\u4e34\u5e8a\u6570\u636e\u62ab\u9732\u7684\u8bf4\u660e<\/span><\/strong><\/p>\n


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\u516c\u53f8\u6240\u6709\u62ab\u9732\u7684\u4e34\u5e8a\u6570\u636e\u5747\u4e3a\u771f\u5b9e\u53ef\u5faa\u7684\uff0c\u4ece\u672a\u9020\u5047\u4e5f\u672a\u300c\u9009\u62e9\u6027\u62ab\u9732\u300d\u3002\u516c\u53f8\u672c\u7740\u79d1\u5b66\u3001\u6c42\u5b9e\u7684\u6001\u5ea6\uff0c\u6309\u7167\u4e34\u5e8a\u7814\u7a76\u7684\u5177\u4f53\u8fdb\u7a0b\u9010\u6b65\u8fdb\u884c\u62ab\u9732\u3002\u4f20\u5947 \u5728IND \u524d\u6240\u505a\u4e34\u5e8a\u8bd5\u9a8c\u7686 \u4e3a\u300c\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u8bd5 \u9a8c\u300d\u3002\u516c\u53f8 \u81ea2016 \u5e74\u4e0e\u897f\u5b89\u4ea4\u901a\u5927\u5b66\u7b2c\u4e8c\u9644\u5c5e\u533b\u9662\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u5408 \u4f5c\uff0c\u8be5\u533b\u9662\u4e3a\u56fd\u5bb6\u4e09\u7ea7\u7532\u7b49\u533b\u9662\uff0c\u5177\u6709\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d44\u8d28\u3002<\/span><\/p>\n


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2017 \u5e74ASCO\uff08American Society of Clinical Oncology\uff0c\u7f8e\u56fd\u4e34\u5e8a\u80bf\u7624\u5b66\u4f1a\uff09\u4f1a\u8bae\u4e8e6 \u6708\u4e3e\u884c\uff0c\u4f46\u5927\u4f1a\u8bba\u6587\u622a\u6b62\u65e5\u4e3a2017 \u5e742 \u6708\u4efd\uff0c\u56e0\u6b64\u516c\u53f8\u5411\u5927\u4f1a\u63d0\u4ea4\u7684\u4e0e\u897f\u5b89\u4ea4\u901a\u5927\u5b66\u7b2c\u4e8c\u9644\u5c5e\u533b\u9662\u5408\u4f5c\u7684\u4e34\u5e8a\u6570\u636e\u4e5f\u662f\u622a\u6b62\u81f32017 \u5e742 \u6708\u3002\u8be5\u4e9b\u6570\u636e \u57282017 \u5e746 \u6708 \u4efdASCO \u5927\u4f1a\u4e0a\u88ab\u53d1 \u5e03\u3002\u4f20\u5947\u4e0e\u4e0a\u6d77\u745e\u91d1\u533b \u9662\u3001\u4e0a\u6d77\u957f\u5f81\u533b\u9662\u548c\u6c5f\u82cf\u7701\u4eba\u6c11\u533b\u9662\u7684\u5408\u4f5c\u5747\u662f\u5728\u63d0\u4ea42017 \u5e74ASCO \u8bba\u6587\u63d0\u4ea4\u622a \u6b62 \u65e5 \u671f\uff08\u53732017 \u5e742 \u6708 \u4efd\uff09\u540e \u624d \u5c55 \u5f00\uff0c\u56e0 \u6b64 \u8fd9 \u4e9b \u6570 \u636e \u672a \u80fd \u57282017 \u5e746 \u6708 \u4efdASCO \u5927\u4f1a\u4e0a\u53d1\u5e03\u3002<\/span><\/p>\n


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2017 \u5e7412 \u67083 \u65e5\u4e0a\u6d77\u745e\u91d1\u533b\u9662\u3001\u4e0a\u6d77\u957f\u5f81\u533b\u9662\u53ca\u6c5f\u82cf\u7701\u4eba\u6c11\u533b\u9662\u4e09\u5bb6\u533b\u9662\u5728ASH\uff08\u7f8e\u56fd\u8840\u6db2\u5e74 \u4f1a\uff09\u4e0a\u8054\u5408\u516c\u5e03\u4e86\u5171\u8ba111 \u4f8b\u590d\u53d1\u96be\u6cbb\u6027\u9aa8\u9ad3\u7624\u75c5\u4f8b\u7684\u4e34\u5e8a\u7814\u7a76\u7ed3\u679c\uff0c8\u4f8b\u8fbe\u5230sCR(stringent complete response)(73%)\uff0c2 \u4f8bVGPR (very good partial response)\uff0c1\u4f8bPR (partial response), ORR (overall response rate) \u8fbe100%\uff0c\u7597\u6548\u4f18\u5f02\u3002<\/span><\/p>\n


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\u622a\u81f32018 \u5e74\u5171\u670974 \u4f4d\u75c5\u4eba\u63a5\u53d7\u6cbb\u7597\u3002\u4e34\u5e8a\u7597\u6548\u53ca\u5b89\u5168\u6027\u4e0e\u524d\u671f\u4e34\u5e8a\u7ed3\u679c\u9ad8\u5ea6\u4e00\u81f4\u3002<\/span><\/p>\n

\u4f20\u5947\u7684\u6240\u6709\u5df2\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5df2\u9001\u4ea4\u7ed9\u4e2d \u56fdCFDA\u548c\u7f8e\u56fdFDA\uff0c\u5e76\u4e8e2018 \u5e743\u6708\u83b7\u5f97CDA\u7684\u6ce8\u518c\u4e34\u5e8a\u6279\u4ef6\uff0c\u83b7\u6279\u5728\u4e2d\u56fd\u8fdb\u884c\u591a\u4e2d\u5fc3\u7684\u786e\u8bc1\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff1b\u5e76\u4e14\u57282018 \u5e745 \u6708\u5df2\u83b7\u5f97\u5728\u7f8e\u56fdFDA \u6279\u51c6\u5f00\u5c551b\/2 \u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6279\u51c6\uff0c\u76ee\u524d\u5165\u7ec4\u60a3\u8005\u62db\u52df\u987a\u5229\uff0c\u5df2\u7ecf\u6b63\u5f0f\u5f00\u59cb\u6cbb\u7597\u3002<\/span><\/p>\n


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\u6307\u63a7\u4e8c\uff1a\u5173\u4e8e\u4f20\u5947\u751f\u7269\u7684CAR-T \u8bbe\u8ba1\uff0c\u751f\u4ea7\u5de5\u827a\u548c\u5546\u4e1a\u5316\u8fdb\u7a0b<\/span><\/strong><\/p>\n


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\u960e\u706b\u53f7\u79f0\u4f20\u5947\u4f7f\u7528\u201cCD28 \u5171\u523a\u6fc0\u7ed3\u6784\u57df\uff0c\u6709Juno\u5931\u8d25\u7684JCAR015 \u524d\u8f66\u4e4b\u9274\uff0c \u662f\u5f88\u591aCAR-T \u516c\u53f8\u5c3d\u91cf\u907f\u5f00\u7684\u8bbe\u8ba1\u201d\uff0c\u8fd9\u662f\u5b8c\u5168\u7684\u6076\u610f\u9020 \u8c23\u3002\u4f20\u5947\u7684CAR\u5e76\u672a\u4f7f\u7528CD28\u5171\u523a\u6fc0\u7ed3\u6784\u57df\uff0c\u800c\u662f\u4f7f\u7528\u76844-1BB\u5171\u523a\u6fc0\u7ed3\u6784\u57df\uff0c\u4e0d\u5b58\u5728\u62a5\u544a\u4e2d\u81c6\u65ad\u7684\u98ce\u9669\u3002<\/span><\/p>\n


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\u4f20\u5947\u4f7f\u7528\u7684\u53cc\u7279\u5f02\u6027\u6297\u4f53\u662f\u57fa\u4e8e\u4f20\u5947\u516c\u53f8\u72ec\u7279\u7814\u53d1\u5e73\u53f0\u5f00\u53d1\uff0c\u4e5f\u662f\u4f20\u5947CAR-T \u4ea7\u54c1\u53d6\u5f97\u826f\u597d\u836f\u6548\u7684\u91cd\u8981\u539f\u56e0\u4e4b\u4e00\u3002\u53cc\u7279\u5f02\u6027\u6297\u4f53\u80fd\u591f\u66f4\u52a0\u7d27\u5bc6\u5730\u4e0e\u6297\u539f\u7ed3\u5408\uff0c\u4f7f\u764c\u75c7\u6297\u539f\u4e0d\u6613\u9003\u9038\u3002<\/span><\/p>\n


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\u4f20\u5947\u638c\u63e1\u4e86\u7a33\u5b9a\u5236\u5907\u81ea\u4e3b\u7814\u53d1\u7684\u53cc\u7279\u5f02\u6027\u6297\u4f53\u7684CAR-T\u4ea7\u54c1\u7684\u5de5\u827a\u6280\u672f\uff0c\u5df2\u6210\u529f\u5236\u5907\u4e8674 \u4f8b\u4ea7\u54c1\u5e76\u5728\u4e2d\u56fd\u7528\u4e8e\u60a3\u8005\u6cbb\u7597\u3002\u4f20\u5947\u516c\u53f8\u4e5f\u4f9d\u6258\u81ea\u5df1\u7684\u7ecf\u9a8c\u5728\u7f8e\u56fd\u6210\u529f\u5236\u5907\u4e86CAR-T \u4ea7\u54c1\u5e76\u5f00\u59cb\u7528\u4e8e\u60a3\u8005\u6cbb\u7597\u3002<\/span><\/p>\n


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\u4f20\u5947 \u7684CAR-T \u4ea7\u54c1 \u4e8e2018 \u5e743 \u6708\u5728\u4e2d\u56fd\u83b7\u5f97\u6b63\u5f0f\u4e34\u5e8a\u8bd5\u9a8c\u6279\u51c6\u5f00\u5c55\u786e\u8bc1\u6027\u4e34\u5e8a\uff0c\u5e76\u4e8e2018 \u5e745\u6708\u5728\u7f8e\u56fd\u83b7\u5f97\u6b63\u5f0f\u4e34\u5e8a\u6279\u51c6\uff0c\u672c\u516c\u53f8\u76f8\u4fe1\uff0c\u5546\u4e1a\u5316\u8fdb\u7a0b\u6b63\u7a33\u6b65\u63a8\u8fdb\u3002<\/span><\/p>\n


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\u672c\u516c\u53f8\u4e4b\u56de\u5e94<\/span><\/strong><\/p>\n


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\u91d1\u65af\u745e\u751f\u7269\u79d1\u6280(Genscript Biotech Corporation) \u662f\u5168\u7403\u751f\u7269\u8bd5\u5242\u5b9a\u5236\u5316\u670d\u52a1\u9886\u57df\u7684\u9886\u5bfc\u8005\uff0c\u7ecf\u8fc7\u591a\u5e74\u7684\u9ad8\u901f\u53d1\u5c55\uff0c\u76ee\u524d\u4e1a\u52a1\u5df2\u7ecf\u62d3\u5c55\u5230\u7cbe\u51c6\u514d\u75ab\u6cbb\u7597\u3001\u751f\u7269\u836f\u5b9a\u5236\u5f00\u53d1(CDMO)\u3001\u751f\u7269\u8bd5\u5242\u4ea7\u54c1\u548c\u4eea\u5668\uff0c\u4ee5\u53ca\u5408\u6210\u751f\u7269\u5b66\u5728\u5de5\u4e1a\u5fae\u751f\u7269\u7684\u5e94\u7528\u9886\u57df\u3002\u91d1\u65af\u745e\u81ea2008 \u5e74\u5f00\u59cb\u5f00\u53d1\u57fa\u4e8e\u7eb3\u7c73\u6297\u4f53\u7684\u836f\u7269\u5e73\u53f0\uff0c\u5e76\u4e3a\u5ba2\u6237\u63d0\u4f9b\u53cc\u7279\u5f02\u6027\u7eb3\u7c73\u6297\u4f53\u7684CRO \u670d\u52a1\uff0c\u5177\u6709\u591a\u5e74\u7684\u6297\u4f53\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u65b9\u9762\u7684\u6280\u672f\u79ef\u7d2f\u3002<\/span><\/p>\n


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\u8303\u535a\u58eb\uff0c\u4f20\u5947\u7684\u9996\u5e2d\u79d1\u5b66\u5b98\uff0c\u66fe\u7ecf\u4e3a\u91d1\u65af\u745e\u6297\u4f53\u5f00\u53d1\u90e8\u603b\u76d1\uff0c\u4e3b\u5bfc\u7eb3\u7c73\u6297\u4f53\u5f00\u53d1\u5e73\u53f0\u3002\u8303\u535a\u58eb\u672c\u79d1\u6bd5\u4e1a\u4e8e\u897f\u5b89\u4ea4\u901a\u5927\u5b66\u533b\u5b66\u9662\uff0c\u5e76\u4e8e\u897f\u5b89\u4ea4\u901a\u5927\u5b66\u7b2c\u4e00\u9644\u5c5e\u533b\u9662\u80be\u79fb\u690d\u4e2d\u5fc3\u4efb\u4f4f\u9662\u533b\u5e08\uff0c\u6b64\u540e\u5728\u65e5\u672c\u5e7f\u5c9b\u5927\u5b66\u83b7\u5f97\u79fb\u690d\u514d\u75ab\u5b66\u535a\u58eb\uff0c\u535a\u58eb\u6bd5\u4e1a\u540e\u8303\u535a\u58eb\u5728\u591a\u4f26\u591a\u5927\u5b66\u75c5\u7ae5\u533b\u9662\u7814\u7a76\u6240\u8fdb\u884c\u514d\u75ab\u76f8\u5173\u7814\u7a76\uff0c\u5e76\u4e8e2014 \u5e74\u52a0\u5165\u91d1\u65af\u745e\u3002\u8303\u535a\u58eb\u5177\u6709\u591a\u5e74\u5e94\u7528\u514d\u75ab\u5b66\u3001\u57fa\u56e0\u6cbb\u7597\u7684\u79d1\u7814\u80cc\u666f\uff0c\u66fe\u5728\u5668\u5b98\u79fb\u690d\u9886\u57df\u53d6\u5f97\u56fd\u9645\u91cd\u5927\u7a81\u7834\u3002<\/span><\/p>\n


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CAR-T \u6280\u672f\u5b9e\u9645\u662f\u7531\u5b66\u672f\u754c\u53d1\u6e90\uff0c\u5c06\u5e94\u7528\u514d\u75ab\u5b66\u3001\u57fa\u56e0\u6cbb\u7597\u4e0e\u4e34\u5e8a\u533b\u5b66\u76f8\u7ed3\u5408\u7684\u65b0\u5174\u6280\u672f\u30022004 \u5e74\u8303\u535a\u58eb\u5728\u5c0f\u513f\u8840\u578b\u4e0d\u914d\u5408\u5fc3\u810f\u79fb\u690d\u7684\u673a\u5236\u57fa\u7840\u7814\u7a76\u65b9\u9762\u53d6\u5f97\u4e16\u754c\u7ea7\u91cd\u5927\u7a81\u7834\uff0c\u5176\u4f5c\u4e3a\u7b2c\u4e00\u4f5c\u8005\u7684\u8bba\u6587\u5728\u4e16\u754c\u9876\u5c16\u7ea7\u5b66\u672f\u520a\u7269\u81ea\u7136\u533b\u5b66\u6742\u5fd7(Nature Medicine) \u4e0a\u53d1\u8868\uff0c\u5f15\u8d77\u56fd\u9645\u5a92\u4f53\u5e7f\u6cdb\u5173\u6ce8\u62a5\u9053\u3002\u4ece\u6b64\u6539\u53d8\u4e86\u5668\u5b98\u79fb\u690d\u9886\u57df\u7ec4\u7ec7\u914d\u578b\u7684\u4e34\u5e8a\u6307\u9488\u3002\u8fd9\u4e00\u53d1\u73b0\u5f7b\u5e95\u6539\u53d8\u4e86\u8be5\u75be\u75c5\u7684\u4e34\u5e8a\u6807\u51c6\uff0c\u6253\u7834\u4e86\u540c\u8840\u578b\u5668\u5b98\u79fb\u690d\u9650\u5236\uff0c\u63d0\u9ad8\u4e86\u60a3\u75c5\u5c0f\u513f\u83b7\u5f97\u5668\u5b98\u79fb\u690d\u7684\u6982\u7387\u3002\u8303\u535a\u58eb\u5728\u57fa\u56e0\u6cbb\u7597\u548c\u4eba\u7c7b\u514d\u75ab\u6cbb\u7597\u9886\u57df\u5148\u540e\u5df2\u53d1\u8868\u8d21\u732e40 \u4f59\u7bc7\u91cd\u8981\u5b66\u672f\u8bba\u6587\u3002\u5176\u4e2d\uff0c\u4ee5\u7b2c\u4e00\u4f5c\u8005\u8eab\u4efd\u53d1\u8868\u7684\u5b66\u672f\u8bba\u6587\u8fbe15 \u7bc7\u3002<\/span><\/p>\n


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\u4ee5\u8303\u535a\u58eb\u4e3a\u9996\u7684\u79d1\u5b66\u5bb6\u56e2\u961f\u7ecf\u8fc7\u6f5c\u5fc3\u7814\u53d1\uff0c\u5728CAR-T \u9886\u57df\u53d6\u5f97\u7a81\u7834\u6027\u7684\u8fdb\u5c55\u3002\u76ee\u524d\u4f20\u5947\u516c\u53f8\u662f\u5728\u4e2d\u56fd\u62e5\u67092\u4e2a\u7814\u53d1\u56e2\u961f\uff0c\u5171140 \u4f59\u4eba\uff0c\u53e6\u5916\u5728\u7f8e\u56fd\u548c\u6b27\u6d32\u5404\u7ec4\u5efa\u4e86\u4e00\u4e2a\u56e2\u961f\uff0c\u5171\u540c\u63a8\u8fdb\u4f20\u5947\u5404\u6761\u7814\u53d1\u7ba1\u7ebf\u7684\u5f00\u53d1\u53ca\u5546\u4e1a\u5316\u3002<\/span><\/p>\n


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\u6307\u63a7\u56db\uff1a\u5173\u4e8e\u516c\u53f8\u4e13\u5229\u7684\u4fdd\u62a4\u5e03\u5c40\u548c\u6388\u6743\u524d\u666f\u7684\u8bf4\u660e<\/span><\/strong><\/p>\n


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\u672c\u516c\u53f8\u4e4b\u56de\u5e94<\/span><\/strong><\/p>\n


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\u516c\u53f8\u5bf9\u4f20\u5947\u81ea\u6709\u6280\u672f\u8fdb\u884c\u4e86\u5b8c\u5584\u7684\u4e13\u5229\u5e03\u5c40\uff0c\u5176\u4e13\u5229\u6388\u6743\u524d\u666f\u660e\u6717\u3002<\/span><\/p>\n


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\u76ee\u524d\u4f20\u5947\u62e5 \u67093 \u9879\u6388\u6743\u4e13\u5229 \u548c70 \u9879\u4e13\u5229\u7533 \u8bf7\uff08PCT \u4e13\u5229\u7533 \u8bf727 \u9879\uff0c\u4e2d\u56fd\u4e13\u5229\u7533\u8bf77 \u9879\uff0c\u6d77\u5916\u4e13\u5229\u7533\u8bf736\u9879\uff09\uff0c\u5176\u4e2d\u4e0e\u7ec6\u80de\u6cbb\u7597\u76f4\u63a5\u76f8\u5173\u7684\u4e13\u5229\u7533\u8bf7 \u5171 \u8ba148 \u9879\uff0c \u4e0eLCARB38M\u76f8\u5173\u7684\u6838\u5fc3\u4e13\u5229PCT\/CN2016\/094408\u5df2\u8fdb\u5165\u4e8629\u4e2a\u56fd\u5bb6\u2571\u5730\u533a\uff0c\u53e6\u4e00\u6838\u5fc3\u4e13\u5229PCT\/CN2017\/096938 \u6b63\u5728\u51c6\u5907\u8fdb\u5165\u56fd\u5bb6\u9636\u6bb5\uff0c \u8ba1\u5212\u4e5f\u8fdb\u5165\u4e0a\u8ff0\u56fd\u5bb6\u548c\u5730\u533a\uff0c\u9884\u8ba1\u5747\u6709\u5f88\u597d\u7684\u6388\u6743\u524d\u666f\u3002<\/span><\/p>\n


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\u960e\u706b\u62a5\u544a\u4e2d \u7684\u300c\u51b2\u7a81\u4e13 \u5229\u300d\uff08\u88683. \u4f20\u5947\u751f\u7269\u4e3a\u4e13\u5229\u6743\u4eba\u7684\u6709 \u5173CAR-T \u4e13\u5229\u7533 \u8bf7 \u60c5 \u51b5\uff09\u4e2d \u5b58 \u5728 \u5077 \u6362 \u6982 \u5ff5\u3001\u6076 \u610f \u8bef \u5bfc\u3002WIPO(World Intellectual Property Organization) \u7684\u51c6\u786e\u7528\u8bcd\u5e94 \u4e3a\u300c\u56fd\u9645\u68c0\u7d22\u62a5 \u544a\u300d(International Search Report) \u4e2d\u6307 \u51fa \u7684\u300c\u76f8 \u5173 \u6587 \u4ef6\u300d(Documents Considered to be relevant) \u800c \u975e\u300c\u51b2 \u7a81 \u4e13 \u5229\u300d\u3002<\/span><\/p>\n


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\u8fd9\u4e9b\u76f8\u5173\u6587\u4ef6\u4ec5\u662f\u53c2\u8003\u6027\u7684\u3001\u65e0\u7ea6\u675f\u529b\u7684\u610f \u89c1\uff08\u53c2\u89c1\u4e13\u5229\u5408\u4f5c\u6761\u7ea6 \u7b2c33 \u6761\uff09\uff0c\u4ec5\u7531\u56fd\u9645\u68c0\u7d22\u62a5\u544a\u7684\u53c2\u8003\u6027\u610f\u89c1\u6765\u8bf4\u4e13\u5229\u6388\u6743\u53ef\u80fd\u6027\u4e3a\u96f6\u662f\u6beb\u65e0\u4f9d\u636e\u3002\u4ee5\u9ed8\u6c99\u4e1c\u7684PD-1 \u6297 \u4f53\uff08K \u836f\uff09\u548c\u65bd\u8d35\u5b9d\u7684PD-1 \u6297 \u4f53\uff08O \u836f\uff09\u4e3a\u4f8b\uff0cK\u836f\u7684\u5316\u5408\u7269\u4e13\u5229WO2008156712\uff0c\u5728\u300c\u56fd\u9645\u68c0\u7d22\u62a5\u544a\u300d\u4e2d\u5f15\u7528\u4e86O \u836f\u7684\u5316\u5408\u7269\u4e13 \u5229\u300cWO2006121168\u300d\uff0c\u4f46K \u836f\u7684\u5316\u5408\u7269\u4e13\u5229\u76ee\u524d\u5728\u6fb3\u5927\u5229\u4e9a\u3001\u4e2d\u56fd\u3001\u52a0\u62ff\u5927\u3001\u6b27\u6d32\u3001\u65e5\u672c\u3001\u97e9\u56fd\u3001\u7f8e\u56fd\u7b49\u56fd\u5bb6\u5747\u83b7\u5f97\u4e86\u6388\u6743\uff0c\u53ef\u89c1\u300c\u56fd\u9645\u68c0\u7d22\u300d\u62a5\u544a\u4e2d\u5217\u51fa\u7684\u300c\u76f8\u5173\u6587 \u4ef6\u300d\u5bf9\u5177\u4f53\u56fd\u5bb6\u7684\u5ba1\u67e5\u65e0\u7ea6\u675f\u529b\u3002<\/span><\/p>\n


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\u6307\u63a7\u4e94\uff1a\u5173\u4e8e\u75c5\u60a3\u6b7b\u4ea1\u62ab\u9732\u7684\u8bf4\u660e<\/span><\/strong><\/p>\n


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\u672c\u516c\u53f8\u4e4b\u56de\u5e94<\/span><\/strong><\/p>\n


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2017 \u5e749 \u670816 \u65e5\uff0c\u6b7b\u4ea1\u75c5\u4f8b\u53d1\u751f\u540e\uff0c\u516c\u53f8\u7b2c\u4e00\u65f6\u95f4\u4ee5\u7814\u7a76\u8005\u4fe1\u7684\u5f62\u5f0f\u901a\u77e5\u4e86\u6240\u6709\u7814\u7a76\u8005\uff0c\u516c\u53f8\u57282017 \u5e749 \u670819 \u65e5\u5411\u516c\u4f17\u62ab\u9732\u4e86\u6b64\u4fe1\u606f\uff0c\u5e76\u672a\u5982\u8be5\u62a5\u544a\u6240\u8a00\u9690\u7792\u3002\u8be5\u75c5\u60a3\u7684\u6240\u6709\u4e13\u4e1a\u533b\u7597\u8d44\u6599\u62a5\u544a\u4e5f\u5747\u5df2\u4e0a\u62a5\u7ed9\u4e2d\u56fdCDE \u53ca\u7f8e\u56fdFDA\uff0c\u7531\u4e13\u4e1a\u4eba\u58eb\u8bc4\u4f30\u53ca\u5224\u65ad\uff0c\u65e0\u4efb\u4f55\u9690\u7792\u3002\u4f20\u5947\u5206\u522b\u4e8e2018\u5e743\u6708\u53ca2018\u5e745\u6708\u83b7\u5f97\u4e86\u4e2d\u56fdCDE \u53ca\u7f8e\u56fdFDA \u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u6279\u4ef6\u3002<\/span><\/p>\n


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\u6307\u63a7\u516d\uff1a\u5173\u4e8e\u7ba1\u7406\u5c42\u6301\u80a1\u53d8\u52a8\u53ca\u4f20\u5947\u516c\u53f8\u80a1\u6743\u6295\u8d44\u7684\u60c5\u51b5\u8bf4\u660e<\/span><\/strong><\/p>\n


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\u672c\u516c\u53f8\u4e4b\u56de\u5e94<\/span><\/strong><\/p>\n


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\u516c\u53f8\u521b\u59cb\u4eba\u4e5f\u662f\u516c\u53f8\u91cd\u8981\u80a1\u4e1c\u4e4b\u4e00 \uff0cGenscript Corporation\u51cf\u5c11\u7684\u80a1\u4efd\u4ec5\u5360\u53d1\u884c\u603b\u80a1\u672c\u76841.15%\uff0c\u76ee\u524d\u4ecd\u6301\u6709\u516c\u53f848.4% \u7684\u80a1\u4efd\u3002<\/span><\/p>\n


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\u738b\u70e8\u5973\u58eb\u51cf\u6301\u80a1\u4efd\u662f\u7531\u4e8e\u5176\u5bf9\u5373\u5c06\u8fc7\u671f\u7684\u671f\u6743\u8fdb\u884c\u884c\u6743\u548c\u4f5c\u4e3a\u7f8e\u56fd\u7eb3\u7a0e\u4e49\u52a1\u4eba\u7684\u7a0e\u52a1\u5b89\u6392\u3002\u738b\u70e8\u5973\u58eb\u5e76\u672a\u51cf\u6301\u901a\u8fc7Genscript Corporation \u6240\u6301\u6709\u7684\u4e0a\u5e02\u516c\u53f8\u80a1\u4efd\u3002<\/span><\/p>\n


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\u4f20\u5947\u516c\u53f8\u662f\u4e00\u5bb6\u521b\u65b0\u578b\u751f\u7269\u9ad8\u79d1\u6280\u4f01 \u4e1a\uff0c\u79d1\u5b66\u5bb6\u53ca\u7ba1\u7406\u56e2\u961f\u662f\u516c\u53f8\u6700\u91cd\u8981\u7684\u6838\u5fc3\u8d44 \u4ea7\uff0c\u6545\u8bda\u5982\u672c\u516c \u53f82017 \u5e7410 \u670820 \u65e5\u516c\u544a\u6240\u62ab \u9732\uff0c\u79d1\u5b66\u5bb6\u548c\u7ba1\u7406\u56e2\u961f\u53c2\u4e0e\u516c\u53f8\u7684\u80a1\u6743\u6295\u8d44\u53ca\u671f\u6743\u6fc0\u52b1\u8ba1 \u5212\uff0c\u8fd9\u662f\u521b\u4e1a\u578b\u79d1\u6280\u4f01\u4e1a\u7684\u60ef \u4f8b\uff0c\u4e5f\u662f\u786e\u4fdd\u516c\u53f8\u80fd\u591f\u6301\u7eed\u4fdd\u6301\u521b\u65b0\u52a8\u529b\u4ee5\u63a8\u52a8\u516c\u53f8\u4ef7\u503c\u5b9e\u73b0\u7684\u91cd\u8981\u9014 \u5f84\u3002\u6b64\u80a1\u6743\u6295\u8d44\u53ca\u671f\u6743\u6fc0\u52b1\u662f\u7ecf\u8463\u4e8b\u4f1a\u614e\u91cd\u8003\u8651\u5e76\u6279\u51c6\u540e\u624d\u4e88\u4ee5\u6267 \u884c\uff0c\u5177\u4f53\u60c5\u51b5\u8bf7\u53c2\u89c1\u516c\u53f8 \u4e8e2017\u5e746\u670828\u65e5\u30012017\u5e747\u670817 \u65e5\u30012017\u5e74<\/span>8\u670828\u65e5\u53ca2017\u5e7410\u670820\u65e5\u53d1\u5e03\u7684\u516c\u544a\u3002<\/span><\/p>\n


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\u6307\u63a7\u4e03\uff1a\u5173\u4e8eCAR-T \u4ea7\u54c1\u5e02\u573a\u6f5c\u529b\u7684\u5206\u6790<\/span><\/strong><\/p>\n


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\u672c\u516c\u53f8\u4e4b\u56de\u5e94<\/span><\/strong><\/p>\n


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\u7f8e \u56fd \u5973 \u5b69Emily Whitehead \u662f\u4e16\u754c\u4e0a\u7b2c\u4e00\u4e2a\u6210\u529f\u63a5\u53d7CAR-T \u7cbe\u51c6\u7ec6\u80de\u7597\u6cd5\u7684\u60a3\u8005\uff0c\u5e76\u4e14\u5df2\u7ecf6\u5e74\u672a\u68c0\u6d4b\u51fa\u764c\u7ec6 \u80de\u3002\u4ece\u533b\u5b66\u7684\u5b9a\u4e49\u4e0a\u6765\u770b\u4e94\u5e74\u5185\u6ca1\u6709\u590d\u53d1\u53ef\u4ee5\u8ba4\u5b9a\u662f\u5df2\u7ecf\u6cbb\u6108\uff0c\u8fd9\u662fCAR-T\u76ee\u524d\u5728\u5168\u4e16\u754c\u5e7f\u53d7\u5173\u6ce8\u7684\u539f\u56e0\u4e4b\u4e00\u3002<\/span><\/p>\n


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

\u6839\u636e\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684\u5e02\u573a\u7814\u7a76\u62a5\u544a\u7f8e\u56fd\u6bcf\u5e74\u7684\u65b0\u53d1\u75c5\u4f8b\u76ee\u524d\u7ea6\u4e3a25,000\u4eba\uff0c\u73b0\u6709\u7684\u60a3\u8005\u7ea6\u4e3a125,000\u4eba\u3002\u6839\u636e\u516c\u5f00\u8d44\u6599\uff0c\u5982\u679cCAR-T \u5b9a\u4ef7\u4e3a$350,000\uff08Novatis\u7684CAR-T\u4ea7 \u54c1Kymriah \u7684CAR-T\u4ea7\u54c1\u5b9a\u4ef7\u4e3a$475,000\uff0cKite Pharma \u7684CAR-T\u4ea7\u54c1\u5b9a\u4ef7\u4e3a$373,000\uff09\uff0c\u90a3\u4e48\u7f8e\u56fd\u5730\u533a\u7684\u6f5c\u5728\u5e02\u573a\u7ea6\u4e3a\u6bcf\u5e7487\u4ebf\u7f8e\u91d1\u2571\u5e74\uff0c\u8fd9\u4e2a\u5e02\u573a\u9884\u6d4b\u8fd8\u6ca1\u6709\u5305\u62ec\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u3002<\/span><\/p>\n


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

\u4f20\u5947\u751f\u7269\u9664\u4e86\u7814\u53d1\u9488\u5bf9\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684CAR-T \u7ec6\u80de\u6cbb\u7597\u6280\u672f\u4ee5\u5916\uff0c\u8fd8\u5728\u7814\u7a76\u5305\u62ec\u6dcb\u5df4\u7624\u3001\u80c3\u764c\u3001\u8111\u80f6\u8d28\u7624 \u7b49\u591a\u79cd\u764c\u75c7\u3002\u516c\u53f8\u76f8\u4fe1CAR-T\u7684\u5e02\u573a\u524d\u666f\u662f\u975e\u5e38\u5de8\u5927\u7684\u3002<\/span><\/p>\n


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

\u6062\u590d\u4e70\u5356<\/span><\/strong><\/p>\n


<\/span><\/strong><\/p>\n

\u5e94\u672c\u516c\u53f8\u8981\u6c42\uff0c\u672c\u516c\u53f8\u80a1\u4efd\u5df2\u81ea\u4e8c\u96f6\u4e00\u516b\u5e74\u4e5d\u6708\u4e8c\u5341\u4e03 \u65e5\uff08\u661f\u671f\u56db\uff09\u4e0a\u5348\u5341\u4e00\u65f6\u4e09\u5341\u4e8c\u5206\u8d77\u4e8e\u8054\u4ea4\u6240\u77ed\u6682\u505c\u724c\uff0c\u4ee5\u5f85\u520a\u53d1\u672c\u516c\u544a\u3002\u672c\u516c\u53f8\u5df2\u5411\u8054\u4ea4\u6240\u7533\u8bf7\u5176\u80a1\u4efd\u81ea\u4e8c\u96f6\u4e00\u516b\u5e74\u4e5d\u6708\u4e8c\u5341\u516b\u65e5\uff08\u661f\u671f\u4e94\uff09\u4e0a\u5348\u4e5d\u65f6\u6b63\u8d77\u4e8e\u8054\u4ea4\u6240\u6062\u590d\u4e70\u5356\u3002<\/span><\/p>\n


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\u5907\u6ce8\uff1a\u672c\u6587\u7efc\u5408\u81ea\u8bc1\u5238\u65f6\u62a5\u3001\u817e\u8baf\u8bc1\u5238\uff0c\u6f84\u6e05\u516c\u544a\u4ee5\u91d1\u65af\u745e\u5b98\u7f51\u4fe1\u606f\u4e3a\u51c6\u3002<\/span><\/strong><\/span><\/p>\n

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End<\/p>\n<\/section>\n

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