{"id":9479,"date":"2022-11-07T12:30:00","date_gmt":"2022-11-07T04:30:00","guid":{"rendered":"https:\/\/www.franchise.com.hk\/%e5%b8%95%e6%af%8d%e9%86%ab%e7%99%82%e5%ae%8c%e6%88%90%e6%96%b0%e4%b8%80%e8%bc%aa%e6%95%b8%e5%8d%83%e8%90%ac%e7%be%8e%e9%87%91%e8%9e%8d%e8%b3%87%ef%bc%8c%e5%8a%a0%e9%80%9f%e5%85%a8%e7%90%83%e5%8c%96\/9479"},"modified":"2022-11-07T12:30:00","modified_gmt":"2022-11-07T04:30:00","slug":"%e5%b8%95%e6%af%8d%e9%86%ab%e7%99%82%e5%ae%8c%e6%88%90%e6%96%b0%e4%b8%80%e8%bc%aa%e6%95%b8%e5%8d%83%e8%90%ac%e7%be%8e%e9%87%91%e8%9e%8d%e8%b3%87%ef%bc%8c%e5%8a%a0%e9%80%9f%e5%85%a8%e7%90%83%e5%8c%96","status":"publish","type":"post","link":"https:\/\/www.franchise.com.hk\/zh-hans\/%e5%b8%95%e6%af%8d%e9%86%ab%e7%99%82%e5%ae%8c%e6%88%90%e6%96%b0%e4%b8%80%e8%bc%aa%e6%95%b8%e5%8d%83%e8%90%ac%e7%be%8e%e9%87%91%e8%9e%8d%e8%b3%87%ef%bc%8c%e5%8a%a0%e9%80%9f%e5%85%a8%e7%90%83%e5%8c%96\/9479","title":{"rendered":"\u5e15\u6bcd\u91ab\u7642\u5b8c\u6210\u65b0\u4e00\u8f2a\u6578\u5343\u842c\u7f8e\u91d1\u878d\u8cc7\uff0c\u52a0\u901f\u5168\u7403\u5316\u6230\u7565\u4f48\u5c40"},"content":{"rendered":"<p><span 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Breakthrough\u8cc7\u8cea\u8a8d\u8b49\uff0c\u4e26\u65bc2021\u5e7412\u6708PADN\u5b8c\u6210PADN-NMPA\u8a3b\u518a\u81e8\u5e8a\u8a66\u9a57\u6240\u6709\u60a3\u8005\u96a8\u8a2a\u3002<\/p>\n<p>\u6b64\u5916\uff0cPADN\u4f5c\u70ba\u4e00\u6b3e\u539f\u5275\u7522\u54c1\uff0c\u5e15\u6bcd\u91ab\u7642\u770b\u597dPADN\u5728\u5168\u7403\u5e02\u5834\u7684\u7af6\u722d\u529b\uff0c\u9328\u5b9a\u5168\u7403\u5e02\u5834\u4e26\u57282022\u5e74\u7372\u5f97\u591a\u9805\u5be6\u8cea\u9032\u5c55\u3002\u5728PADN\u81e8\u5e8a\u8a66\u9a57\u65b9\u9762\uff0c\u5e15\u6bcd\u91ab\u7642\u5728\u4eca\u5e747\u6708\u8207\u7f8e\u570bFDA\u6210\u529f\u53ec\u958b\u4e86\u95dc\u65bcPADN\u5168\u7403\u591a\u4e2d\u5fc3\u81e8\u5e8a\u8a66\u9a57\u7684Pre-Sub\u6703\u8b70(\u9810\u5be9\u8a08\u5283\u6703\u8b70)\uff0c\u6a19\u8a8c\u8457\u516c\u53f8\u6b63\u5f0f\u9032\u5165FDA PMA\uff08\u4e0a\u5e02\u524d\u5be9\u6279\uff09\u6d41\u7a0b\u3002<\/p>\n<p>2022\u5e748\u6708\uff0cPADN\u9996\u6b21\u8f09\u5165\u570b\u969b\u300a2022 ESC\/ERS \u80ba\u9ad8\u8840\u58d3\u8a3a\u65b7\u548c\u6cbb\u7642\u6307\u5357\u300b\uff1b2022\u5e749\u6708\uff0c\u5e15\u6bcd\u91ab\u7642\u53d7\u9080\u5728\u5168\u7403\u8840\u7ba1\u4ecb\u5165\u9802\u7d1a\u5cf0\u6703TCT\uff08\u7f8e\u570b\u7d93\u5c0e\u7ba1\u5fc3\u8840\u7ba1\u6cbb\u7642\u5b78\u8853\u6703\u8b70\uff09\u4e0a\u516c\u4f48\u4e86PADN-NMPA\u7684\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\uff0c\u5176\u7a4d\u6975\u7684\u7814\u7a76\u6210\u679c\u6210\u529f\u5438\u5f15\u5168\u4e16\u754c\u7684\u95dc\u6ce8\u3002\u76ee\u524d\uff0cPADN\u5168\u7403\u591a\u4e2d\u5fc3\u81e8\u5e8a\u7814\u7a76\u4e5f\u5728\u7a4d\u6975\u63a8\u52d5\u4e2d\uff0c\u5c07\u70ba\u8a72\u9818\u57df\u9818\u5148\u7684\u5668\u68b0\u7642\u6cd5\u53ca\u7522\u54c1\u7684\u5168\u7403\u5546\u696d\u5316\u5960\u5b9a\u66f4\u7d2e\u5be6\u7684\u81e8\u5e8a\u57fa\u790e\u3002<\/p>\n<p>\u7372\u5f97\u591a\u5bb6\u9802\u5c16\u6a5f\u69cb\u6295\u8cc7<br 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