{"id":10295,"date":"2025-04-24T08:57:00","date_gmt":"2025-04-24T08:57:00","guid":{"rendered":"https:\/\/moneycompass.com.my\/cn\/%e5%90%88%e6%ba%90%e7%94%9f%e7%89%a9%e8%87%aa%e5%85%8d%e9%a2%86%e5%9f%9f%e7%ac%ac%e4%b8%89%e5%bc%a0%e6%89%b9%e4%bb%b6%ef%bc%81%e7%ba%b3%e5%9f%ba%e5%a5%a5%e4%bb%91%e8%b5%9b%e6%b3%a8%e5%b0%84%e6%b6%b2\/"},"modified":"2025-04-24T08:57:00","modified_gmt":"2025-04-24T08:57:00","slug":"%e5%90%88%e6%ba%90%e7%94%9f%e7%89%a9%e8%87%aa%e5%85%8d%e9%a2%86%e5%9f%9f%e7%ac%ac%e4%b8%89%e5%bc%a0%e6%89%b9%e4%bb%b6%ef%bc%81%e7%ba%b3%e5%9f%ba%e5%a5%a5%e4%bb%91%e8%b5%9b%e6%b3%a8%e5%b0%84%e6%b6%b2","status":"publish","type":"post","link":"https:\/\/moneycompass.com.my\/cn\/%e5%90%88%e6%ba%90%e7%94%9f%e7%89%a9%e8%87%aa%e5%85%8d%e9%a2%86%e5%9f%9f%e7%ac%ac%e4%b8%89%e5%bc%a0%e6%89%b9%e4%bb%b6%ef%bc%81%e7%ba%b3%e5%9f%ba%e5%a5%a5%e4%bb%91%e8%b5%9b%e6%b3%a8%e5%b0%84%e6%b6%b2\/","title":{"rendered":"\u5408\u6e90\u751f\u7269\u81ea\u514d\u9886\u57df\u7b2c\u4e09\u5f20\u6279\u4ef6\uff01\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\uff08LN\uff09\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\uff08IND\uff09\u7533\u8bf7\u83b7\u9ed8\u793a\u8bb8\u53ef"},"content":{"rendered":"

\u5929\u6d25<\/span>2025\u5e744\u670824\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u7f51\u7ad9\u516c\u793a\u4fe1\u606f\u663e\u793a\uff1a\u5408\u6e90\u751f\u7269\u81ea\u4e3b\u7814\u53d1\u7684\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff08\u5546\u54c1\u540d\uff1a\u6e90\u745e\u8fbe\u00ae\uff09\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\uff09\u5df2\u83b7\u5f97\u9ed8\u793a\u8bb8\u53ef\uff08\u53d7\u7406\u53f7\uff1aCXSL2500076\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\uff08Lupus Nephritis, LN\uff09\u3002<\/p>\n

\u622a\u81f3\u76ee\u524d\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u9002\u5e94\u75c7\u6cbb\u7597\u9886\u57df\u4e2d\u5df2\u7ecf\u83b7\u5f973\u5f20IND\u6279\u4ef6\uff0c\u5206\u522b\u9488\u5bf9\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u76f8\u5173\u7684\u514d\u75ab\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\uff08SLE-ITP\uff09\u3001\u81ea\u8eab\u514d\u75ab\u6027\u6eb6\u8840\u6027\u8d2b\u8840(Autoimmune hemolytic anemia, AIHA)\uff0c\u4ee5\u53ca\u6b64\u6b21\u83b7\u6279\u7684\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u80be\u708e\uff08Lupus Nephritis, LN\uff09\u3002\u540c\u65f6\uff0c\u8fd9\u4e5f\u662f\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u5168\u7403\u8303\u56f4\u5185\u83b7\u5f97\u7684\u7b2c7\u5f20\u4e34\u5e8a\u6279\u4ef6\u3002<\/p>\n

\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08systemic lupus erythematosus, SLE\uff09\u662f\u4e00\u79cd\u7cfb\u7edf\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5168\u8eab\u591a\u7cfb\u7edf\u591a\u810f\u5668\u53d7\u7d2f\uff0c\u75be\u75c5\u672c\u8eab\u7684\u7f13\u89e3\u4e0e\u6025\u6027\u53d1\u4f5c\u4ea4\u66ff\u3001\u4f53\u5185\u5b58\u5728\u5927\u91cf\u81ea\u8eab\u6297\u4f53\u4e3a\u4e3b\u8981\u4e34\u5e8a\u7279\u70b9\uff0c\u5982\u4e0d\u53ca\u65f6\u6cbb\u7597\uff0c\u4f1a\u9020\u6210\u53d7\u7d2f\u810f\u5668\u7684\u4e0d\u53ef\u9006\u7684\u635f\u4f24\uff0c\u6700\u7ec8\u5bfc\u81f4\u60a3\u8005\u6b7b\u4ea1\u3002SLE\u75c5\u56e0\u590d\u6742\uff0c\u4e0e\u9057\u4f20\u3001\u6027\u6fc0\u7d20\u3001\u73af\u5883\uff08\u5982\u75c5\u6bd2\u4e0e\u7ec6\u83cc\u611f\u67d3\uff09\u7b49\u591a\u79cd\u56e0\u7d20\u6709\u5173\u3002\u636e\u4f30\u8ba1\uff0c\u5168\u7403SLE\u53d1\u75c5\u7387\u4e3a\u6bcf\u5e745.14\uff081.4-15.13\uff09\/10\u4e07\u4eba\uff0c\u4e2d\u56fd\u7684SLE\u53d1\u75c5\u7387\u4f4d\u5c45\u5168\u7403\u7b2c\u56db\uff0c\u4e3a\u6bcf\u5e7414.09\/10\u4e07\u4eba\u3002<\/p>\n

\u72fc\u75ae\u80be\u708e\uff08LN\uff09\u662f\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08SLE\uff09\u5f15\u8d77\u7684\u80be\u810f\u635f\u5bb3\uff0c\u662f\u6700\u5e38\u89c1\u7684\u5185\u810f\u53d7\u7d2f\u8868\u73b0\u4e4b\u4e00\uff0c\u4e5f\u662f\u5f71\u54cd\u60a3\u8005\u9884\u540e\u7684\u91cd\u8981\u56e0\u7d20\u3002\u5728\u6211\u56fd\uff0c\u8fd1\u534a\u6570SLE\u60a3\u8005\u5e76\u53d1LN\uff0c\u9ad8\u4e8e\u767d\u79cd\u4eba\uff0c\u662f\u6211\u56fd\u6700\u5e38\u89c1\u7684\u7ee7\u53d1\u6027\u514d\u75ab\u80be\u5c0f\u7403\u75be\u75c5\uff0c\u662f\u7ec8\u672b\u671f\u80be\u810f\u75c5\uff08ESRD\uff09\u7684\u5e38\u89c1\u75c5\u56e0\u4e4b\u4e00\uff0c\u4e5f\u662f\u5bfc\u81f4SLE\u60a3\u8005\u6b7b\u4ea1\u7684\u91cd\u8981\u539f\u56e0\u3002\u76ee\u524d\uff0cSLE-LN\u7684\u6cbb\u7597\u4ecd\u9762\u4e34\u8bf8\u591a\u6311\u6218\uff0c\u90e8\u5206\u60a3\u8005\u5bf9\u4f20\u7edf\u6cbb\u7597\u65b9\u6848\u53cd\u5e94\u4e0d\u4f73\uff0c\u5b58\u5728\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u3002<\/p>\n

\u5317\u4eac\u534f\u548c\u533b\u9662\u98ce\u6e7f\u514d\u75ab\u79d1\u66fe\u5c0f\u5cf0\u6559\u6388\uff1a<\/p>\n

\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08SLE\uff09\u662f\u7531\u9057\u4f20\u3001\u73af\u5883\u548c\u6fc0\u7d20\u7b49\u591a\u79cd\u56e0\u7d20\u5f15\u8d77\u7684\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u56e0\u6b64\u75c5\u60c5\u5f02\u8d28\u6027\u5f3a\uff0c\u4e2a\u4f53\u5316\u8bca\u7597\u8981\u6c42\u9ad8\u3002\u6b8b\u9177\u7684\u73b0\u5b9e\u662f\uff0c\u6211\u56fd\u53d1\u75c5\u5e74\u9f84\u572830\u5c81\u5de6\u53f3\u7684\u60a3\u8005\uff0c\u81f355~60\u5c81\u65f6\uff0c\u8d85\u8fc7\u4e00\u534a\u6b7b\u4ea1\u3002\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u662f\u4e00\u4e2a\u5168\u8eab\u6027\u7684\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u4f1a\u5f15\u8d77\u5f88\u591a\u80be\u810f\u95ee\u9898\uff0c\u5305\u62ec\u80be\u810f\u3001\u795e\u7ecf\u7cfb\u7edf\u3001\u8840\u6db2\u7cfb\u7edf\u7684\u95ee\u9898\u7b49\uff0c\u8fd9\u4e9b\u7cfb\u7edf\u7684\u635f\u4f24\u90fd\u4f1a\u5bfc\u81f4\u751f\u547d\u5371\u9669\u3002\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u6b64\u6b21\u5728SLE-LN\u7684\u65b0\u836f\u4e34\u5e8a\u9ed8\u793a\u8bb8\u53ef\uff0c\u518d\u4e00\u6b21\u663e\u793a\u51faCAR-T\u7ec6\u80de\u6cbb\u7597\u7684\u6f5c\u529b\uff0c\u66f4\u8868\u660eSLE\u6cbb\u7597\u6b63\u671d\u7740\u591a\u6837\u5316\u65b9\u5411\u53d1\u5c55\uff0c\u6cbb\u7597\u7684\u524d\u666f\u5341\u5206\u5e7f\u9614\u3002<\/p>\n

\u5317\u4eac\u534f\u548c\u533b\u9662\u98ce\u6e7f\u514d\u75ab\u79d1 \u674e\u68a6\u6d9b\u6559\u6388\uff1a<\/p>\n

\u6211\u56fd\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u60a3\u8005\u5448\u73b0\u4eba\u53e3\u4f17\u591a\u3001\u75c5\u60c5\u91cd\u3001\u75be\u75c5\u8d1f\u62c5\u91cd\u3001\u5408\u5e76\u75c7\u53d1\u751f\u7387\u9ad8\u3001\u5bf9\u751f\u80b2\u9020\u6210\u7684\u5f71\u54cd\u4e25\u91cd\u7684\u7279\u70b9\u3002\u6211\u4eec\u975e\u5e38\u9ad8\u5174\u770b\u5230\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u83b7\u6279\uff0c\u534f\u548c\u591a\u5b66\u79d1\u56e2\u961f\u5c06\u4e0d\u65ad\u63a2\u7d22\u6df1\u5316CAR-T\u7ec6\u80de\u7597\u6cd5\u5728\u8fd9\u4e00\u75be\u75c5\u4e2d\u7684\u5e94\u7528\uff0c\u63a8\u52a8\u81ea\u8eab\u514d\u75ab\u75be\u75c5\u6cbb\u7597\u9886\u57df\u7684\u8fdb\u6b65\uff0c\u60e0\u53ca\u66f4\u591a\u60a3\u8005\u3002<\/p>\n

\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u8840\u6db2\u75c5\u533b\u9662(\u4e2d\u56fd\u533b\u5b66\u79d1\u5b66\u9662\u8840\u6db2\u5b66\u7814\u7a76\u6240)\u4e34\u5e8a\u9996\u5e2d\u4e13\u5bb6\u3001\u56fd\u5bb6\u8840\u6db2\u7cfb\u7edf\u75be\u75c5\u4e34\u5e8a\u533b\u5b66\u7814\u7a76\u4e2d\u5fc3\u4e3b\u4efb\u738b\u5efa\u7965\u6559\u6388\uff1a<\/p>\n

\u8877\u5fc3\u795d\u8d3a\u6211\u56fd\u539f\u7814CD19 CAR-T\u836f\u7269\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u83b7\u5f97\u9ed8\u793a\u8bb8\u53ef\uff01\u4f5c\u4e3a\u6211\u56fd\u5168\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743CAR-T\u7597\u6cd5\u7684\u4ee3\u8868\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5df2\u5728\u767d\u8840\u75c5\u3001\u6dcb\u5df4\u7624\u7b49\u8840\u6db2\u80bf\u7624\u9886\u57df\u5c55\u73b0\u4e86\u4f18\u5f02\u7597\u6548\uff0c\u5e76\u5728\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u4e2d\u5c55\u73b0\u4e86\u7a81\u7834\u6027\u7684\u6f5c\u529b\u3002\u671f\u5f85\u8fd9\u4e00\u521b\u65b0\u7597\u6cd5\u5728\u4e34\u5e8a\u7814\u7a76\u4e2d\u53d6\u5f97\u66f4\u591a\u8fdb\u5c55\u4e0e\u4f73\u7ee9\uff0c\u63a8\u52a8CAR-T\u7597\u6cd5\u5728\u66f4\u5e7f\u6cdb\u7684\u75be\u75c5\u9886\u57df\u53d1\u6325\u4f5c\u7528\u3002<\/p>\n

\u5408\u6e90\u751f\u7269\u9996\u5e2d\u6267\u884c\u5b98 \u5415\u7490\u7490\u535a\u58eb\uff1a<\/p>\n

\u4e00\u4e2a\u6708\u5185\uff0c\u5408\u6e90\u751f\u7269\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff08\u5546\u54c1\u540d\uff1a\u6e90\u745e\u8fbe\u00ae\uff09\u6536\u83b7\u4e24\u5f20\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u9886\u57df\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\uff08IND\uff09\u6279\u4ef6\uff0c\u518d\u6b21\u663e\u793a\u51fa\u4ea7\u54c1\u7684\u6cbb\u7597\u6f5c\u529b\u4e0e\u4e34\u5e8a\u4ef7\u503c\u3002\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u662f\u5408\u6e90\u751f\u7269\u5e03\u5c40\u7684\u5173\u952e\u4e00\u57ce\uff0c\u76ee\u524d\uff0c\u516c\u53f8\u5df2\u7ecf\u5728SLE-ITP\u3001AIHA\u3001SLE-LN\u7b49\u591a\u4e2a\u9002\u5e94\u75c7\u5efa\u7acb\u8d77\u79d1\u7814\u7ba1\u7ebf\u5019\u9009\u4ea7\u54c1\u961f\u5217\u3002\u671f\u5f85\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u80fd\u591f\u5728\u66f4\u591a\u75be\u75c5\u9886\u57df\u6ee1\u8db3\u66f4\u591a\u60a3\u8005\u5c1a\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u5de8\u5927\u9700\u6c42\uff0c\u4e3a\u60a3\u8005\u5e26\u6765\u66f4\u591a\u521b\u65b0\u7ec6\u80de\u7597\u6cd5\u9009\u62e9\u3002<\/p>\n

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

###<\/p>\n

\u5173\u4e8e\u5408\u6e90\u751f\u7269\uff1a<\/p>\n

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\u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff0cCNCT19\uff0cInaticabtagene Autoleucel Injection\uff09\u662f\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u9776\u5411CD19\u7684CAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff0c\u62e5\u6709\u5168\u7403\u72ec\u7279\u7684CD19 scFv\uff08HI19a\uff09\u7ed3\u6784\u548c\u56fd\u9645\u9886\u5148\u7684\u751f\u4ea7\u5236\u9020\u5de5\u827a\uff0c\u5148\u540e\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u4e09\u9879\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bb8\u53ef\uff08IND\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u590d\u53d1\u6216\u96be\u6cbb\u6027\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u3001\u6cbb\u7597\u590d\u53d1\u6216\u96be\u6cbb\u6027\u4fb5\u88ad\u6027B\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u548c\u6cbb\u7597\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u590d\u53d1\u6216\u96be\u6cbbB\u7ec6\u80de\u578b\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\uff0c\u5e76\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3”\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269”\u8ba4\u5b9a\u548c\u7f8e\u56fdFDA\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff08Orphan Drug Designation, ODD\uff09\u30022022\u5e7412\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6b63\u5f0f\u53d7\u7406\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u6cbb\u7597\u6210\u4ebar\/r B-ALL\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5e76\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u30022023\u5e743\u6708\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u6210\u4ebar\/r B-ALL IND\u7533\u8bf7\u4e5f\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08U.S.FDA\uff09\u8bb8\u53ef\u30022023\u5e7411\u6708\uff0c\u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff09\u6b63\u5f0f\u83b7\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u4e0a\u5e02\u3002<\/p>\n

\n<\/div>\n

SOURCE \u5408\u6e90\u751f\u7269\u79d1\u6280\uff08\u5929\u6d25\uff09\u6709\u9650\u516c\u53f8<\/p>","protected":false},"excerpt":{"rendered":"

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\u622a\u81f3\u76ee\u524d\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u9002\u5e94\u75c7\u6cbb\u7597\u9886\u57df\u4e2d\u5df2\u7ecf\u83b7\u5f973\u5f20IND\u6279\u4ef6\uff0c\u5206\u522b\u9488\u5bf9\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u76f8\u5173\u7684\u514d\u75ab\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\uff08SLE-ITP\uff09\u3001\u81ea\u8eab\u514d\u75ab\u6027\u6eb6\u8840\u6027\u8d2b\u8840(Autoimmune hemolytic anemia, AIHA)\uff0c\u4ee5\u53ca\u6b64\u6b21\u83b7\u6279\u7684\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u80be\u708e\uff08Lupus Nephritis, LN\uff09\u3002\u540c\u65f6\uff0c\u8fd9\u4e5f\u662f\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u5168\u7403\u8303\u56f4\u5185\u83b7\u5f97\u7684\u7b2c7\u5f20\u4e34\u5e8a\u6279\u4ef6\u3002 \u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08systemic lupus erythematosus, SLE\uff09\u662f\u4e00\u79cd\u7cfb\u7edf\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5168\u8eab\u591a\u7cfb\u7edf\u591a\u810f\u5668\u53d7\u7d2f\uff0c\u75be\u75c5\u672c\u8eab\u7684\u7f13\u89e3\u4e0e\u6025\u6027\u53d1\u4f5c\u4ea4\u66ff\u3001\u4f53\u5185\u5b58\u5728\u5927\u91cf\u81ea\u8eab\u6297\u4f53\u4e3a\u4e3b\u8981\u4e34\u5e8a\u7279\u70b9\uff0c\u5982\u4e0d\u53ca\u65f6\u6cbb\u7597\uff0c\u4f1a\u9020\u6210\u53d7\u7d2f\u810f\u5668\u7684\u4e0d\u53ef\u9006\u7684\u635f\u4f24\uff0c\u6700\u7ec8\u5bfc\u81f4\u60a3\u8005\u6b7b\u4ea1\u3002SLE\u75c5\u56e0\u590d\u6742\uff0c\u4e0e\u9057\u4f20\u3001\u6027\u6fc0\u7d20\u3001\u73af\u5883\uff08\u5982\u75c5\u6bd2\u4e0e\u7ec6\u83cc\u611f\u67d3\uff09\u7b49\u591a\u79cd\u56e0\u7d20\u6709\u5173\u3002\u636e\u4f30\u8ba1\uff0c\u5168\u7403SLE\u53d1\u75c5\u7387\u4e3a\u6bcf\u5e745.14\uff081.4-15.13\uff09\/10\u4e07\u4eba\uff0c\u4e2d\u56fd\u7684SLE\u53d1\u75c5\u7387\u4f4d\u5c45\u5168\u7403\u7b2c\u56db\uff0c\u4e3a\u6bcf\u5e7414.09\/10\u4e07\u4eba\u3002 \u72fc\u75ae\u80be\u708e\uff08LN\uff09\u662f\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08SLE\uff09\u5f15\u8d77\u7684\u80be\u810f\u635f\u5bb3\uff0c\u662f\u6700\u5e38\u89c1\u7684\u5185\u810f\u53d7\u7d2f\u8868\u73b0\u4e4b\u4e00\uff0c\u4e5f\u662f\u5f71\u54cd\u60a3\u8005\u9884\u540e\u7684\u91cd\u8981\u56e0\u7d20\u3002\u5728\u6211\u56fd\uff0c\u8fd1\u534a\u6570SLE\u60a3\u8005\u5e76\u53d1LN\uff0c\u9ad8\u4e8e\u767d\u79cd\u4eba\uff0c\u662f\u6211\u56fd\u6700\u5e38\u89c1\u7684\u7ee7\u53d1\u6027\u514d\u75ab\u80be\u5c0f\u7403\u75be\u75c5\uff0c\u662f\u7ec8\u672b\u671f\u80be\u810f\u75c5\uff08ESRD\uff09\u7684\u5e38\u89c1\u75c5\u56e0\u4e4b\u4e00\uff0c\u4e5f\u662f\u5bfc\u81f4SLE\u60a3\u8005\u6b7b\u4ea1\u7684\u91cd\u8981\u539f\u56e0\u3002\u76ee\u524d\uff0cSLE-LN\u7684\u6cbb\u7597\u4ecd\u9762\u4e34\u8bf8\u591a\u6311\u6218\uff0c\u90e8\u5206\u60a3\u8005\u5bf9\u4f20\u7edf\u6cbb\u7597\u65b9\u6848\u53cd\u5e94\u4e0d\u4f73\uff0c\u5b58\u5728\u672a\u88ab\u6ee1\u8db3\u7684\u4e34\u5e8a\u9700\u6c42\u3002 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### \u5173\u4e8e\u5408\u6e90\u751f\u7269\uff1a \u5408\u6e90\u751f\u7269\u521b\u7acb\u4e8e2018\u5e746\u6708\uff0c\u5df2\u6210\u957f\u4e3a\u4e2d\u56fd\u7ec6\u80de\u836f\u7269\u4ea7\u4e1a\u81ea\u4e3b\u521b\u65b0\u7684\u5f15\u9886\u8005\uff0c\u81f4\u529b\u4e8e\u6210\u4e3a\u5168\u7403\u9886\u5148\u7684\u7ec6\u80de\u4e0e\u57fa\u56e0\u521b\u65b0\u6280\u672f\u9a71\u52a8\u7684\u65b0\u4e00\u4ee3\u751f\u7269\u533b\u836f\u4f01\u4e1a\u3002\u516c\u53f8\u9996\u4e2a\u6838\u5fc3\u4ea7\u54c1\u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff0cCNCT19\uff09\u4e8e2023\u5e7411\u6708\u6b63\u5f0f\u83b7\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u6279\u51c6\u4e0a\u5e02\u3002\u8be5\u4ea7\u54c1\u662f\u4e2d\u56fd\u767d\u8840\u75c5\u6cbb\u7597\u9886\u57df\u9996\u4e2aCAR-T\u836f\u7269\uff0c\u4e5f\u662f\u4e2d\u56fd\u5168\u81ea\u4e3b\u521b\u65b0\u7684\u9996\u4e2aCD19 CAR-T\u836f\u7269\u3002\u516c\u53f8\u6df1\u5ea6\u5408\u4f5c\u56fd\u5bb6\u4e00\u6d41\u9662\u6240\uff0c\u6784\u5efa\u4e86\u4ee5CAR\u6280\u672f\u5e73\u53f0\u4ee5\u53ca\u57fa\u56e0\u7f16\u8f91\u6280\u672f\u5e73\u53f0\u7b49\u4e3a\u6838\u5fc3\u7684\u56fd\u9645\u5316\u65b0\u836f\u7814\u53d1\u4f53\u7cfb\uff0c\u62e5\u6709\u8986\u76d6\u8840\u6db2\u80bf\u7624\u3001\u5b9e\u4f53\u80bf\u7624\u53ca\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u7b49\u75be\u75c5\u9886\u57df\u768410\u4f59\u79cd\u7ba1\u7ebf\u4ea7\u54c1\u5728\u7814\u3002\u66f4\u591a\u4fe1\u606f\u8bf7\u8bbf\u95eehttp:\/\/www.juventas.cn\/\u00a0 \u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff0cCNCT19\uff0cInaticabtagene Autoleucel Injection\uff09\u662f\u5177\u6709\u81ea\u4e3b\u77e5\u8bc6\u4ea7\u6743\u7684\u9776\u5411CD19\u7684CAR-T\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\uff0c\u62e5\u6709\u5168\u7403\u72ec\u7279\u7684CD19 scFv\uff08HI19a\uff09\u7ed3\u6784\u548c\u56fd\u9645\u9886\u5148\u7684\u751f\u4ea7\u5236\u9020\u5de5\u827a\uff0c\u5148\u540e\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u4e09\u9879\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u8bb8\u53ef\uff08IND\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u590d\u53d1\u6216\u96be\u6cbb\u6027\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u3001\u6cbb\u7597\u590d\u53d1\u6216\u96be\u6cbb\u6027\u4fb5\u88ad\u6027B\u7ec6\u80de\u975e\u970d\u5947\u91d1\u6dcb\u5df4\u7624\u548c\u6cbb\u7597\u513f\u7ae5\u548c\u9752\u5c11\u5e74\u590d\u53d1\u6216\u96be\u6cbbB\u7ec6\u80de\u578b\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\uff0c\u5e76\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3”\u7a81\u7834\u6027\u6cbb\u7597\u836f\u7269”\u8ba4\u5b9a\u548c\u7f8e\u56fdFDA\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff08Orphan Drug Designation, ODD\uff09\u30022022\u5e7412\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6b63\u5f0f\u53d7\u7406\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u6cbb\u7597\u6210\u4ebar\/r B-ALL\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5e76\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u30022023\u5e743\u6708\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u6210\u4ebar\/r B-ALL IND\u7533\u8bf7\u4e5f\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08U.S.FDA\uff09\u8bb8\u53ef\u30022023\u5e7411\u6708\uff0c\u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff09\u6b63\u5f0f\u83b7\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u4e0a\u5e02\u3002 SOURCE \u5408\u6e90\u751f\u7269\u79d1\u6280\uff08\u5929\u6d25\uff09\u6709\u9650\u516c\u53f8<\/p>\n","protected":false},"author":0,"featured_media":10296,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25],"tags":[],"class_list":["post-10295","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"\n\u5408\u6e90\u751f\u7269\u81ea\u514d\u9886\u57df\u7b2c\u4e09\u5f20\u6279\u4ef6\uff01\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\uff08LN\uff09\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\uff08IND\uff09\u7533\u8bf7\u83b7\u9ed8\u793a\u8bb8\u53ef - Money Compass CN<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/moneycompass.com.my\/cn\/\u5408\u6e90\u751f\u7269\u81ea\u514d\u9886\u57df\u7b2c\u4e09\u5f20\u6279\u4ef6\uff01\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u5408\u6e90\u751f\u7269\u81ea\u514d\u9886\u57df\u7b2c\u4e09\u5f20\u6279\u4ef6\uff01\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\uff08LN\uff09\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\uff08IND\uff09\u7533\u8bf7\u83b7\u9ed8\u793a\u8bb8\u53ef - Money Compass CN\" \/>\n<meta property=\"og:description\" content=\"\u5929\u6d252025\u5e744\u670824\u65e5 \/\u7f8e\u901a\u793e\/ — \u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08CDE\uff09\u7f51\u7ad9\u516c\u793a\u4fe1\u606f\u663e\u793a\uff1a\u5408\u6e90\u751f\u7269\u81ea\u4e3b\u7814\u53d1\u7684\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff08\u5546\u54c1\u540d\uff1a\u6e90\u745e\u8fbe\u00ae\uff09\u7684\u65b0\u836f\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\uff08IND\uff09\u5df2\u83b7\u5f97\u9ed8\u793a\u8bb8\u53ef\uff08\u53d7\u7406\u53f7\uff1aCXSL2500076\uff09\uff0c\u7528\u4e8e\u6cbb\u7597\u96be\u6cbb\u6027\u72fc\u75ae\u80be\u708e\uff08Lupus Nephritis, LN\uff09\u3002 \u622a\u81f3\u76ee\u524d\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\u9002\u5e94\u75c7\u6cbb\u7597\u9886\u57df\u4e2d\u5df2\u7ecf\u83b7\u5f973\u5f20IND\u6279\u4ef6\uff0c\u5206\u522b\u9488\u5bf9\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u76f8\u5173\u7684\u514d\u75ab\u6027\u8840\u5c0f\u677f\u51cf\u5c11\u75c7\uff08SLE-ITP\uff09\u3001\u81ea\u8eab\u514d\u75ab\u6027\u6eb6\u8840\u6027\u8d2b\u8840(Autoimmune hemolytic anemia, AIHA)\uff0c\u4ee5\u53ca\u6b64\u6b21\u83b7\u6279\u7684\u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\u80be\u708e\uff08Lupus Nephritis, LN\uff09\u3002\u540c\u65f6\uff0c\u8fd9\u4e5f\u662f\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u5728\u5168\u7403\u8303\u56f4\u5185\u83b7\u5f97\u7684\u7b2c7\u5f20\u4e34\u5e8a\u6279\u4ef6\u3002 \u7cfb\u7edf\u6027\u7ea2\u6591\u72fc\u75ae\uff08systemic lupus erythematosus, SLE\uff09\u662f\u4e00\u79cd\u7cfb\u7edf\u6027\u81ea\u8eab\u514d\u75ab\u6027\u75be\u75c5\uff0c\u5168\u8eab\u591a\u7cfb\u7edf\u591a\u810f\u5668\u53d7\u7d2f\uff0c\u75be\u75c5\u672c\u8eab\u7684\u7f13\u89e3\u4e0e\u6025\u6027\u53d1\u4f5c\u4ea4\u66ff\u3001\u4f53\u5185\u5b58\u5728\u5927\u91cf\u81ea\u8eab\u6297\u4f53\u4e3a\u4e3b\u8981\u4e34\u5e8a\u7279\u70b9\uff0c\u5982\u4e0d\u53ca\u65f6\u6cbb\u7597\uff0c\u4f1a\u9020\u6210\u53d7\u7d2f\u810f\u5668\u7684\u4e0d\u53ef\u9006\u7684\u635f\u4f24\uff0c\u6700\u7ec8\u5bfc\u81f4\u60a3\u8005\u6b7b\u4ea1\u3002SLE\u75c5\u56e0\u590d\u6742\uff0c\u4e0e\u9057\u4f20\u3001\u6027\u6fc0\u7d20\u3001\u73af\u5883\uff08\u5982\u75c5\u6bd2\u4e0e\u7ec6\u83cc\u611f\u67d3\uff09\u7b49\u591a\u79cd\u56e0\u7d20\u6709\u5173\u3002\u636e\u4f30\u8ba1\uff0c\u5168\u7403SLE\u53d1\u75c5\u7387\u4e3a\u6bcf\u5e745.14\uff081.4-15.13\uff09\/10\u4e07\u4eba\uff0c\u4e2d\u56fd\u7684SLE\u53d1\u75c5\u7387\u4f4d\u5c45\u5168\u7403\u7b2c\u56db\uff0c\u4e3a\u6bcf\u5e7414.09\/10\u4e07\u4eba\u3002 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ODD\uff09\u30022022\u5e7412\u6708\uff0c\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6b63\u5f0f\u53d7\u7406\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u6cbb\u7597\u6210\u4ebar\/r B-ALL\u7684\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7\uff08NDA\uff09\u5e76\u7eb3\u5165\u4f18\u5148\u5ba1\u8bc4\u30022023\u5e743\u6708\uff0c\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\u7528\u4e8e\u6cbb\u7597\u6210\u4ebar\/r B-ALL IND\u7533\u8bf7\u4e5f\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08U.S.FDA\uff09\u8bb8\u53ef\u30022023\u5e7411\u6708\uff0c\u6e90\u745e\u8fbe\u00ae\uff08\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\uff09\u6b63\u5f0f\u83b7\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6279\u51c6\u4e0a\u5e02\u3002 SOURCE \u5408\u6e90\u751f\u7269\u79d1\u6280\uff08\u5929\u6d25\uff09\u6709\u9650\u516c\u53f8\" \/>\n<meta property=\"og:url\" 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\u5408\u6e90\u751f\u7269\u79d1\u6280\uff08\u5929\u6d25\uff09\u6709\u9650\u516c\u53f8","og_url":"https:\/\/moneycompass.com.my\/cn\/\u5408\u6e90\u751f\u7269\u81ea\u514d\u9886\u57df\u7b2c\u4e09\u5f20\u6279\u4ef6\uff01\u7eb3\u57fa\u5965\u4ed1\u8d5b\u6ce8\u5c04\u6db2\/","og_site_name":"Money Compass 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