{"id":26507,"date":"2021-12-06T10:00:50","date_gmt":"2021-12-08T03:39:02","guid":{"rendered":"https:\/\/www.abesmoke.com\/?p=26507"},"modified":"2021-12-08T11:39:03","modified_gmt":"2021-12-08T03:39:03","slug":"0c0acae61f","status":"publish","type":"post","link":"https:\/\/www.abesmoke.com\/en\/a\/26507","title":{"rendered":"\u8d44\u8baf | \u7535\u5b50\u70df\u4ea7\u4e1a\u91cd\u6784 HNB\u5e02\u573a\u4f1a\u8fce\u6765\u4e0b\u4e00\u4e2aFEELM\u65f6\u523b\u5417"},"content":{"rendered":"
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\u5bf9\u4ece\u4e1a\u8005\u6765\u8bf4\uff0c\u4e5f\u6709\u5229\u597d\u7684\u4e00\u9762\uff0c\u56e0\u4e3a\u76ee\u524d\u4e0d\u5141\u8bb8\u5728\u7f51\u7edc\u4e0a\u9500\u552e\u7535\u5b50\u70df\uff0c\u7f51\u4e0a\u5e02\u573a\u88ab\u4e00\u4e9b\u5fae\u5546\u548c\u975e\u6cd5\u5546\u8d29\u5360\u636e\uff0c\u6270\u4e71\u54c1\u724c\u5546\u6e20\u9053\u5e03\u5c40\uff0c\u54c1\u724c\u5546\u5f62\u8c61\u53d7\u5230\u5f71\u54cd\u3002\u6b64\u524d\u662f\u54c1\u724c\u5546\u6253\u51fb\u6b64\u7c7b\u884c\u4e3a\uff0c\u73b0\u5728\u6709\u56fd\u5bb6\u5f3a\u529b\u4ecb\u5165\uff0c\u653f\u5e9c\u53ef\u4ee5\u505a\u8fd9\u4ef6\u4e8b\u3002<\/span><\/p>\n


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\u4e0d\u5229\u7684\u65b9\u9762\u4e5f\u5f88\u660e\u663e\u3002\u6309\u7167\u65b0\u7684\u6e20\u9053\u8bbe\u7f6e\uff0c<\/span>\u54c1\u724c\u65b9\u548c\u6279\u53d1\u5546\u5fc5\u987b\u5728\u7ba1\u7406\u90e8\u95e8\u4e3b\u5bfc\u7684\u7edf\u4e00\u4ea4\u6613\u5e02\u573a\u5185\u8fdb\u884c\u4ea4\u6613<\/span>\uff0c\u5730\u65b9\u96f6\u552e\u5546\u5728\u5730\u65b9\u6279\u53d1\u5546\u90a3\u91cc\u8fdb\u8d27\uff0c\u5176\u4ed6\u6e20\u9053\u4e3a\u975e\u6cd5\u3002\u54c1\u724c\u5546\u539f\u6709\u7684\u6e20\u9053\u88ab\u62c6\u89e3\uff0c\u5982\u679c\u4e0d\u80fd\u5728\u65b0\u6e20\u9053\u5efa\u7acb\u7ba1\u63a7\u4f18\u52bf\uff0c\u54c1\u724c\u4ef7\u503c\u5c31\u6253\u4e86\u6298\u6263\u3002<\/span><\/p>\n


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

\u7535\u5b50\u70df\u4f5c\u4e3a\u65b0\u5174\u95e8\u7c7b\uff0c\u6b64\u524d\u662f\u4e00\u4e2a\u81ea\u7531\u7ade\u4e89\u7684\u4ea7\u54c1\uff0c\u884c\u4e1a\u4f18\u80dc\u8005\u9886\u5148\u4f18\u52bf\u5de8\u5927\u3002\u800c\u4eca\uff0c\u5728\u653f\u5e9c\u90e8\u95e8\u5f3a\u529b\u76d1\u7ba1\u4e4b\u4e0b\uff0c\u7535\u5b50\u70df\u8981\u5f00\u59cb\u65b0\u79e9\u5e8f\uff0c\u7ade\u4e89\u6709\u53ef\u80fd\u6ca1\u6709\u90a3\u4e48\u6fc0\u70c8\uff0c\u7ba1\u63a7\u4e0b\u4f01\u4e1a\u7ade\u4e89\u7684\u65b9\u5f0f\u53d1\u751f\u6539\u53d8\uff0c\u884c\u4e1a\u6709\u53ef\u80fd\u5f62\u6210\u65b0\u683c\u5c40\u3002\u5728\u65b0\u683c\u5c40\u4e0b\uff0c\u56e0\u4e3a\u548c\u70df\u8349\u4e00\u6837\u4e0d\u5141\u8bb8\u5ba3\u4f20\uff0c\u6e20\u9053\u91cd\u8981\u6027\u51f8\u663e\uff0c\u600e\u4e48\u80fd\u5728\u6e20\u9053\u4e2d\u5360\u636e\u4f18\u52bf\uff0c\u54ea\u4e9b\u7980\u8d4b\u5c06\u8d77\u51b3\u5b9a\u4f5c\u7528\uff0c\u73b0\u5728\u8fd8\u662f\u672a\u77e5\u3002<\/span><\/p>\n


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

\u76ee\u524d\u5bf9\u7535\u5b50\u70df\u7684\u7a0e\u6536\u653f\u7b56\u8fd8\u672a\u660e\u4e86\uff0c\u8fd8\u4e0d\u77e5\u9053\u7535\u5b50\u70df\u662f\u5426\u4f1a\u7531\u6b64\u6da8\u4ef7\uff0c\u4f46\u663e\u7136\u4e0d\u53ef\u80fd\u6309\u7167\u539f\u6765\u7684\u7a0e\u7387\u3002\u7535\u5b50\u70df\u7684\u53d1\u5c55\u901f\u5ea6\u5c06\u6162\u4e0b\u6765\uff0c\u884c\u4e1a\u5229\u6da6\u4e5f\u5c06\u4e0b\u964d\uff0c\u6574\u4e2a\u884c\u4e1a\u5bf9\u8d44\u672c\u7684\u5438\u5f15\u529b\u5c06\u51cf\u5c11\uff0c\u8fd9\u4e5f\u662f\u5f88\u591a\u8d44\u91d1\u6b64\u524d\u4e0d\u6295\u7535\u5b50\u70df\u7684\u539f\u56e0\uff0c\u5de8\u5927\u653f\u7b56\u4e0d\u786e\u5b9a\u6027\u8ba9\u884c\u4e1a\u524d\u666f\u8499\u4e0a\u9634\u5f71\u3002<\/span><\/p>\n


<\/p>\n

3 <\/span> <\/span>Respira\u516c\u53f8\u63d0\u4ea4\u9996\u4e2a\u53ef\u5438\u5165\u5c3c\u53e4\u4e01\u66ff\u4ee3\u7597\u6cd5\u836f\u7269\u7533\u8bf7<\/span><\/p>\n


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

<\/span>\u5916\u7535\u62a5\u9053\uff0cRespira Technologies \u8ba1\u5212\u4e8e 2022 \u5e74\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u63d0\u4ea4\u7814\u7a76\u6027\u65b0\u836f\u7533\u8bf7\uff08IND\uff09\uff0c\u7528\u4e8e\u4e16\u754c\u9996\u4e2a\u53ef\u5438\u5165\u5c3c\u53e4\u4e01\u66ff\u4ee3\u7597\u6cd5\u3002<\/span><\/p>\n


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

\u300c<\/span>\u4f20\u7edf\u533b\u7597\u4fdd\u5065\u516c\u53f8\u5728\u89e3\u51b3\u5438\u70df\u5371\u673a\u65b9\u9762\u7f3a\u4e4f\u521b\u65b0\uff0c\u56e0\u6b64\uff0c\u5927\u70df\u8349\u516c\u53f8\u6b63\u8bd5\u56fe\u5c06\u81ea\u5df1\u5b9a\u4f4d\u4e3a\u89e3\u51b3\u4ed6\u4eec\u6240\u9020\u6210\u95ee\u9898\u7684\u89e3\u51b3\u65b9\u6848\u3002<\/span>\u5728 Respira\uff0c\u6211\u4eec\u76f8\u4fe1\u53ea\u6709\u6211\u4eec\u7684\u6280\u672f\u624d\u80fd\u6709\u6548\u5e2e\u52a9\u7ec8\u7ed3\u5438\u70df\u5f15\u8d77\u7684\u6b7b\u4ea1\u548c\u75be\u75c5\uff0c\u540c\u65f6\u6ee1\u8db3 CDER [\u836f\u7269\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3] \u5bf9\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u7684\u9ad8\u6807\u51c6\u3002<\/span>\u300dRespira Technologies \u9996\u5e2d\u6267\u884c\u5b98\u517c\u521b\u59cb\u4eba Mario Danek \u8bf4\u3002<\/span><\/p>\n


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

\u300c\u6211\u4eec\u5bf9\u4e0e FDA \u7684\u5bcc\u6709\u6210\u6548\u7684\u5408\u4f5c\u8ba8\u8bba\u611f\u5230\u975e\u5e38\u9ad8\u5174\uff0c\u5e76\u76f8\u4fe1 FDA \u7684\u6307\u5bfc\u5c06\u5e2e\u52a9\u6211\u4eec\u5b9e\u73b0\u7ed3\u675f\u5438\u70df\u5f15\u8d77\u7684\u6b7b\u4ea1\u548c\u75be\u75c5\u7684\u76ee\u6807\u3002<\/span>\u300dDanek \u8bf4\u3002<\/span>\u300cPre-IND \u53ea\u662f Respira \u5c06\u5b9e\u73b0\u7684\u8bb8\u591a\u91cd\u8981\u91cc\u7a0b\u7891\u4e2d\u7684\u7b2c\u4e00\u4e2a\uff0c\u6211\u4eec\u5f88\u9ad8\u5174\u63a8\u8fdb\u6211\u4eec\u63d0\u4ea4 IND \u4ee5\u5f00\u59cb\u4eba\u4f53\u4e34\u5e8a\u7814\u7a76\u7684\u8ba1\u5212\u3002<\/span>\u300d<\/span><\/p>\n


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

\u8be5\u516c\u53f8\u8868\u793a\uff0c\u76ee\u6807\u662f\u98a0\u8986\u4e00\u4e2a\u4ef7\u503c 6180 \u4ebf\u7f8e\u5143\u7684\u5e02\u573a\uff0c<\/span>\u8be5\u5e02\u573a\u7531\u6765\u81ea\u5236\u836f\u516c\u53f8\u7684\u6570\u5341\u5e74\u5386\u53f2\u7684\u53e3\u9999\u7cd6\u548c\u8d34\u5242\u4ee5\u53ca\u70df\u8349\u516c\u53f8\u7684\u7535\u5b50\u5c3c\u53e4\u4e01\u8f93\u9001\u8bbe\u5907\u4e3b\u5bfc<\/span>\uff0c\u8be5\u8bbe\u5907\u5e26\u6709\u5c06\u5c3c\u53e4\u4e01\u8f6c\u5316\u4e3a\u6c14\u96fe\u5242\u7684\u96fe\u5316\u5668\u3002<\/span><\/p>\n


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

Respira \u7684\u9ad8\u7ea7\u7ba1\u7406\u4eba\u5458\u5305\u62ec\u9996\u5e2d\u8fd0\u8425\u5b98Brian Quigley\uff0c\u4ed6\u5728\u5965\u9a70\u4e9a\u96c6\u56e2\u5de5\u4f5c\u4e86 16 \u5e74\uff0c\u4ece 2012 \u5e74\u5230 2018 \u5e74\u62c5\u4efb\u65e0\u70df\u70df\u8349\u4e1a\u52a1\u7684\u9996\u5e2d\u6267\u884c\u5b98\u3002<\/span><\/p>\n

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

\"\u8d44\u8baf<\/p>\n


<\/p>\n

\"\u8d44\u8baf<\/p>\n


<\/p>\n

\u8d44\u8baf |FDA\u9996\u6b21\u6388\u6743\u7535\u5b50\u70df\u4ea7\u54c1\u7684\u4e0a\u5e02\u9500\u552e\uff0c\u6807\u6746\u4f5c\u7528\u610f\u4e49\u91cd\u5927<\/span><\/a>
<\/p>\n

\u8d44\u8baf | \u52a0\u70ed\u5377\u70df\u54c1\u724cNUSO\u56fd\u5185\u9996\u63a8\u56db\u5927\u53e3\u5473\u65b0\u54c1<\/span><\/a>
<\/p>\n

\u8d44\u8baf |\u56db\u5ddd\u4e2d\u70dfHNB\u8fdb\u5165\u6b27\u6d32\uff0c\u8fdb\u4e00\u6b65\u5f00\u62d3\u56fd\u9645\u5e02\u573a<\/a>
<\/p>\n

\u8d44\u8baf |\u82f1\u7f8e\u70df\u8349\uff1a\u7814\u7a76\u663e\u793a\u52a0\u70ed\u70df\u8349\u4ea7\u54c1\u5438\u70df\u8005\u51cf\u5c11\u63a5\u89e6\u6709\u6bd2\u5316\u5b66\u7269\u8d28<\/a>
<\/p>\n

\u8d44\u8baf |\u97e9\u56fd\u70df\u8349\u7b2c\u4e8c\u4ee3HNB\u4ea7\u54c1\u65b0\u8fdb\u56db\u4e2a\u6b27\u4e9a\u56fd\u5bb6\u5e02\u573a<\/a>
<\/p>\n

\u8d44\u8baf |\u65e5\u672c\u4e1c\u4e9a\u4ea7\u4e1a\u682a\u5f0f\u4f1a\u793e\uff1aCBD\u70df\u5f39\u6a2a\u7a7a\u51fa\u4e16<\/span><\/a><\/p>\n

\u8d44\u8baf |\u52a0\u62ff\u5927\u5e1d\u56fd\u70df\u8349\u63a8\u51fa\u65b0\u6218\u7565\uff1a\u805a\u7126\u964d\u4f4e\u98ce\u9669\u4ea7\u54c1<\/a>
<\/p>\n

\u8d44\u8baf |\u83f2\u83ab\u56fd\u9645\uff1a10\u5e74\u5185\u5c06\u505c\u6b62\u5728\u65e5\u672c\u9500\u552e\u5377\u70df<\/a>
<\/p>\n

\u8d44\u8baf |\u4e2d\u70df\u516c\u53f8HNB\u4e1a\u52a1\u4e00\u5e74\u52a8\u6001<\/a>
<\/p>\n

\u8d44\u8baf |PMI\u97e9\u56fd:\u5730\u65b9\u6cd5\u5f8b\u5e94\u53cd\u6620FDA\u5c06IQOS\u4f5c\u4e3a\u4e00\u79cd\u6539\u8fdb\u7684\u98ce\u9669\u4ea7\u54c1\u7684\u5206\u7c7b<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u83f2\u83ab\u56fd\u9645\u97e9\u56fd\u516c\u53f8\u547c\u5401\u5bf9\u52a0\u70ed\u4e0d\u71c3\u70e7\u5236\u5b9a\u5355\u72ec\u76d1\u7ba1\u89c4\u5b9a<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |Ploom TECH\u53d1\u5e03\u80fd\u91cf\u8584\u8377\u65b0\u53e3\u5473\u70df\u5f39<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u52a0\u70ed\u4e0d\u71c3\u70e7\u975e\u70df\u70df\u5f39\u5e02\u573a\u8fce\u6765\u5c0f\u9ad8\u6f6e<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |FreeM\u52a0\u70ed\u4e0d\u71c3\u70e7\u673a\u5668\uff1a\u81ea\u52a8\u611f\u5e94\u52a0\u70ed\uff0c\u5373\u63d2\u5373\u7528<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u56db\u5ddd\u4e2d\u70df\u65b0\u578b\u70df\u8349\u201c\u6d88\u8d39\u7fa4\u610f\u89c1\u9886\u8896\u63a8\u5e7f\u9879\u76ee\u201d\u542f\u52a8<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u963f\u91cc\u5df4\u5df4\u6682\u505c\u5411\u7f8e\u56fd\u9500\u552e\u7535\u5b50\u70df<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u65b0\u5c3c\u53e4\u4e01\u8054\u76df\uff1a\u4e16\u536b\u7ec4\u7ec7\u7684\u62a5\u544a\u53ea\u4f1a\u4f7f\u5438\u70df\u6c38\u4e45\u5316<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |2019\u5e74\u7535\u5b50\u70df\u884c\u4e1a\u89c4\u8303\u53d1\u5c55\u5ba3\u8d2f\u4f1a\u6210\u529f\u4e3e\u529e<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u6052\u4fe1\u6280\u672f\u878d\u5165COV story \u201c\u4e3a\u5c3c\u53e4\u4e01\u5e26\u76d0\u201d<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |FDA\u5df2\u6279\u51c6IQOS\u4e0a\u5e02\u7533\u8bf7, \u6709\u671b\u590d\u5236\u65e5\u672c\u52a0\u70ed\u4e0d\u71c3\u70e7\u5e02\u573a\u7684\u6210\u529f<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u5c0f\u7c73\u6216\u6709\u610f\u5165\u5c40\u7535\u5b50\u70df\uff1f\u8fd9\u6b21\u662f\u5c0f\u7c73TOP25\u5458\u5de5\u64cd\u76d8<\/a>
<\/p>\n

\u4e00\u5468\u8d44\u8baf |\u4e16\u754c\u9996\u6b3e\u53ef\u81ea\u52a8\u9000\u70df\u7684\u52a0\u70ed\u4e0d\u71c3\u70e7\u7535\u5b50\u70df\u95ee\u4e16<\/a><\/span><\/p>\n


<\/p>\n

<\/mpprofile><\/section>\n<\/p><\/div>","protected":false},"excerpt":{"rendered":"

1  HNB\u5e02\u573a\u4f1a\u8fce\u6765\u4e0b\u4e00\u4e2aFEELM\u65f6\u523b\u5417\uff1f \u56de\u671b\u7535\u5b50\u96fe\u5316\u884c\u4e1a\u7684\u8349\u83bd\u65f6\u4ee3\uff0c\u4e00\u53e5\u8bdd\u66fe\u5e7f\u4e3a\u6d41\u4f20\uff0c\u201c\u4f60\u522b\u7ba1\u5b83\u597d\u4e0d\u597d\u62bd\uff0c\u53ea\u8981\u80fd\u5192\u70df\u5c31\u884c\u3002\u201d\u5728\u90a3\u4e2a\u65f6\u5019\uff0c\u5168\u884c\u4e1a\u6280\u672f\u843d\u540e\uff0c\u4ea7\u54c1\u7c97\u7cd9\uff0c\u7ade\u4e89\u6df7\u4e71\u3002\u4f60\u82e5\u5f53\u65f6\u7ad9\u5728\u6df1\u5733\u6c99\u4e95 …<\/p>","protected":false},"author":2,"featured_media":26508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2}},"categories":[1],"tags":[],"class_list":["post-26507","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"jetpack_publicize_connections":[],"_links":{"self":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts\/26507","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/comments?post=26507"}],"version-history":[{"count":0,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts\/26507\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/media\/26508"}],"wp:attachment":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/media?parent=26507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/categories?post=26507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/tags?post=26507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}