{"id":47314,"date":"2026-07-16T09:30:17","date_gmt":"2026-07-16T07:30:17","guid":{"rendered":"https:\/\/kymos.com\/news\/oindp-%e6%b5%8b%e8%af%95%ef%bc%9a%e6%bb%a1%e8%b6%b3-ema-%e7%9a%84%e6%9c%80%e6%96%b0%e9%a2%84%e6%9c%9f\/"},"modified":"2026-07-16T10:06:45","modified_gmt":"2026-07-16T08:06:45","slug":"oindp-%e6%b5%8b%e8%af%95%ef%bc%9a%e6%bb%a1%e8%b6%b3-ema-%e7%9a%84%e6%9c%80%e6%96%b0%e9%a2%84%e6%9c%9f","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/oindp-%e6%b5%8b%e8%af%95%ef%bc%9a%e6%bb%a1%e8%b6%b3-ema-%e7%9a%84%e6%9c%80%e6%96%b0%e9%a2%84%e6%9c%9f\/","title":{"rendered":"OINDP \u6d4b\u8bd5\uff1a\u6ee1\u8db3 EMA \u7684\u6700\u65b0\u9884\u671f"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:calc( 1170px + 20px );margin-left: calc(-20px \/ 2 );margin-right: calc(-20px \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-size: 14pt;\">\u7ecf\u53e3\u5438\u5165\u548c\u9f3b\u7528\u5236\u5242 (OINDPs) \u662f\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u6700\u590d\u6742\u7684\u836f\u7269\u5242\u578b\u4e4b\u4e00\u3002\u5176\u6027\u80fd\u4e0d\u4ec5\u53d6\u51b3\u4e8e\u5236\u5242\u672c\u8eab\uff0c\u8fd8\u53d6\u51b3\u4e8e\u7ed9\u836f\u88c5\u7f6e\u3001\u5236\u9020\u5de5\u827a\u4ee5\u53ca\u5411\u60a3\u8005\u6301\u7eed\u63d0\u4f9b\u9884\u671f\u5242\u91cf\u7684\u80fd\u529b\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8003\u8651\u5230\u8fd9\u79cd\u590d\u6742\u6027\uff0c\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40 (EMA) \u4fee\u8ba2\u4e86\u4e24\u4efd\u4e92\u8865\u7684\u6307\u5357\uff0c\u6db5\u76d6\u4e86\u5438\u5165\u548c\u9f3b\u7528\u836f\u54c1\u7684\u836f\u7269\u8d28\u91cf\uff08<a href=\"https:\/\/www.ema.europa.eu\/en\/pharmaceutical-quality-inhalation-nasal-products-scientific-guideline\" data-wpel-link=\"external\"><em>\u300a\u5438\u5165\u548c\u9f3b\u7528\u836f\u54c1\u836f\u7269\u8d28\u91cf\u6307\u5357\u300b<\/em><\/a>\uff09\u548c\u6cbb\u7597\u7b49\u6548\u6027\uff08<a href=\"https:\/\/www.ema.europa.eu\/en\/requirements-demonstrating-therapeutic-equivalence-between-orally-inhaled-products-oip-asthma-chronic-obstructive-pulmonary-disease-copd-scientific-guideline\" data-wpel-link=\"external\"><em>\u300a\u54ee\u5598\u548c\u6162\u6027\u963b\u585e\u6027\u80ba\u75be\u75c5\u7ecf\u53e3\u5438\u5165\u4ea7\u54c1 (OIP) \u6cbb\u7597\u7b49\u6548\u6027\u8bc1\u660e\u8981\u6c42\u6307\u5357\u300b<\/em><\/a>\uff09\u3002\u8fd9\u4e9b\u6587\u4ef6\u5171\u540c\u7efc\u5408\u4e86\u5f53\u524d\u7684\u79d1\u5b66\u77e5\u8bc6\u3001\u5438\u5165\u6280\u672f\u7684\u8fdb\u6b65\u4ee5\u53ca\u836f\u68b0\u7ec4\u5408\u4ea7\u54c1\u7684\u76d1\u7ba1\u6846\u67b6\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5c3d\u7ba1\u8bb8\u591a\u57fa\u7840\u79d1\u5b66\u539f\u5219\u5e76\u672a\u6539\u53d8\uff0c\u4f46\u65b0\u4fee\u8ba2\u7684\u6307\u5357\u66f4\u52a0\u5f3a\u8c03\u5728\u6574\u4e2a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5bf9\u4ea7\u54c1\u7684\u7406\u89e3\u3001\u5206\u6790\u8868\u5f81\u4ee5\u53ca\u7a33\u5065\u7684\u4f53\u5916\u6570\u636e\u7684\u751f\u6210\u3002\u5bf9\u4e8e\u5236\u836f\u516c\u53f8\u800c\u8a00\uff0c\u8fd9\u4ee3\u8868\u4e86\u4e00\u4e2a\u52a0\u5f3a\u5f00\u53d1\u7b56\u7565\u7684\u673a\u4f1a\uff0c\u540c\u65f6\u4f7f\u5206\u6790\u8ba1\u5212\u4e0e\u5f53\u524d\u7684\u76d1\u7ba1\u9884\u671f\u4fdd\u6301\u4e00\u81f4\u3002 <\/span><\/p>\n<h2><strong>\u8d85\u8d8a\u76d1\u7ba1\u5408\u89c4<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u4fee\u8ba2\u540e\u7684 OINDPs \u8d28\u91cf\u6307\u5357\u4e0d\u4ec5\u66f4\u65b0\u4e86\u6280\u672f\u8981\u6c42\uff0c\u8fd8\u5f3a\u5316\u4e86\u4e00\u79cd\u66f4\u5e7f\u6cdb\u7684\u4ea7\u54c1\u5f00\u53d1\u65b9\u6cd5\uff0c\u5373\u5c06\u5236\u5242\u3001\u7ed9\u836f\u88c5\u7f6e\u3001\u5236\u9020\u5de5\u827a\u548c\u60a3\u8005\u4f7f\u7528\u4f5c\u4e3a\u4e00\u4e2a\u6574\u4f53\u800c\u975e\u72ec\u7acb\u7684\u5143\u7d20\u6765\u8003\u8651\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u79cd\u7efc\u5408\u89c6\u89d2\u6db5\u76d6\u4e86\u6574\u4e2a\u4ea7\u54c1\u751f\u547d\u5468\u671f\uff1a\u4ece\u836f\u7269\u5f00\u53d1\u548c\u6279\u6b21\u8868\u5f81\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u548c\u4e0a\u5e02\u540e\u53d8\u66f4\u3002\u9f13\u52b1\u5f00\u53d1\u4eba\u5458\u5168\u9762\u4e86\u89e3\u4e0d\u540c\u53d8\u91cf\u5982\u4f55\u5f71\u54cd\u4ea7\u54c1\u6027\u80fd\uff0c\u5e76\u751f\u6210\u652f\u6301\u4ea7\u54c1\u957f\u671f\u4e00\u81f4\u6027\u7684\u5206\u6790\u8bc1\u636e\u3002 <\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5bf9\u4e8e\u5438\u5165\u836f\u54c1\uff0c\u8fd9\u5305\u62ec\u8bc1\u660e\u5173\u952e\u8d28\u91cf\u5c5e\u6027 (CQAs) \u5728\u6574\u4e2a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u4e00\u81f4\u3002\u7a7a\u6c14\u52a8\u529b\u5b66\u7c92\u5f84\u5206\u5e03 (APSD)\u3001\u9012\u9001\u5242\u91cf\u548c\u88c5\u7f6e\u6027\u80fd\u7b49\u53c2\u6570\u76f4\u63a5\u5f71\u54cd\u836f\u7269\u5728\u547c\u5438\u9053\u4e2d\u7684\u6c89\u79ef\u4f4d\u7f6e\uff0c\u5e76\u6700\u7ec8\u5f71\u54cd\u5176\u4e34\u5e8a\u8868\u73b0\u3002\u540c\u6837\uff0c\u9f3b\u7528\u836f\u54c1\u9700\u8981\u5bf9\u5236\u5242\u548c\u88c5\u7f6e\u5c5e\u6027\u8fdb\u884c\u8be6\u7ec6\u8868\u5f81\uff0c\u4ee5\u786e\u4fdd\u4e00\u81f4\u5730\u9012\u9001\u5230\u9884\u671f\u7684\u4f5c\u7528\u90e8\u4f4d\u3002  <\/span><\/p>\n<h2><strong>\u5206\u6790\u8868\u5f81\u53d1\u6325\u7740\u65e5\u76ca\u91cd\u8981\u7684\u4f5c\u7528<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u8fd9\u4e24\u4efd\u6307\u5357\u7684\u4e00\u4e2a\u5171\u540c\u4e3b\u9898\u662f\u5206\u6790\u6570\u636e\u5728\u652f\u6301\u4ea7\u54c1\u8d28\u91cf\u548c\u76d1\u7ba1\u51b3\u7b56\u65b9\u9762\u7684\u91cd\u8981\u6027\u65e5\u76ca\u589e\u52a0\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u5f00\u53d1\u4eba\u5458\u4e0d\u5e94\u4ec5\u4f9d\u8d56\u6700\u7ec8\u4ea7\u54c1\u89c4\u683c\uff0c\u800c\u5e94\u5728\u6574\u4e2a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u5bf9\u4ea7\u54c1\u4ea7\u751f\u7a33\u5065\u7684\u7406\u89e3\u3002\u8fd9\u5305\u62ec\u8868\u5f81\u5236\u5242\u548c\u7ed9\u836f\u88c5\u7f6e\u3001\u5728\u4ee3\u8868\u6027\u6761\u4ef6\u4e0b\u8bc4\u4f30\u4ea7\u54c1\u6027\u80fd\u4ee5\u53ca\u8bc1\u660e\u5236\u9020\u7684\u4e00\u81f4\u6027\uff08\u5982\u4e0b\u9762\u56fe 1 \u6240\u793a\uff09\u3002 <\/span><\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-margin-bottom:35px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1774\" height=\"887\" title=\"OINDP Guideline figure 1\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1.png\" alt class=\"lazyload img-responsive wp-image-47269\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271774%27%20height%3D%27887%27%20viewBox%3D%270%200%201774%20887%27%3E%3Crect%20width%3D%271774%27%20height%3D%27887%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1-200x100.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1-400x200.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1-600x300.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1-800x400.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1-1200x600.png 1200w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-1.png 1774w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 850px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p><span style=\"background-color: rgba(0, 0, 0, 0); font-size: 14pt;\">\u6839\u636e\u4ea7\u54c1\u548c\u5f00\u53d1\u9636\u6bb5\u7684\u4e0d\u540c\uff0c\u5206\u6790\u65b9\u6848\u53ef\u80fd\u5305\u62ec\u4ee5\u4e0b\u7814\u7a76\uff1a<\/span><\/p>\n<ul>\n<li><span style=\"font-size: 14pt;\">\u7406\u5316\u8868\u5f81<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u7c92\u5f84\u8868\u5f81<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u7a7a\u6c14\u52a8\u529b\u5b66\u7c92\u5f84\u5206\u5e03 (APSD)<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u9012\u9001\u5242\u91cf\u548c\u5242\u91cf\u5747\u4e00\u6027<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u88c5\u7f6e\u6027\u80fd\u8bc4\u4f30<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u7a33\u5b9a\u6027\u7814\u7a76<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u53ef\u63d0\u53d6\u7269\u548c\u6d78\u51fa\u7269 (E&#038;L) \u7814\u7a76<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">\u4f53\u5916\u6027\u80fd\u5bf9\u6bd4\u7814\u7a76<\/span><\/li>\n<\/ul>\n<p><span style=\"font-size: 14pt;\">\u5176\u4e2d\u8bb8\u591a\u7814\u7a76\u5728 OINDP \u5f00\u53d1\u4e2d\u5df2\u7ecf\u975e\u5e38\u6210\u719f\u3002\u7136\u800c\uff0c\u4fee\u8ba2\u540e\u7684\u6307\u5357\u66f4\u52a0\u5f3a\u8c03\u5b83\u4eec\u5728\u5efa\u7acb\u5bf9\u4ea7\u54c1\u7684\u79d1\u5b66\u7406\u89e3\u4ee5\u53ca\u652f\u6301\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u76d1\u7ba1\u63d0\u4ea4\u65b9\u9762\u7684\u4f5c\u7528\u3002 <\/span><\/p>\n<h2><strong>\u6cbb\u7597\u7b49\u6548\u6027\u59cb\u4e8e\u4f53\u5916\u8bc1\u636e<\/strong><\/h2>\n<p><span style=\"font-size: 14pt;\">\u4fee\u8ba2\u540e\u7684\u6cbb\u7597\u7b49\u6548\u6027\u6307\u5357\u901a\u8fc7\u63cf\u8ff0\u8bc1\u660e\u7ecf\u53e3\u5438\u5165\u4ea7\u54c1\u4e4b\u95f4\u7b49\u6548\u6027\u7684\u9010\u6b65\u65b9\u6cd5\uff0c\u5bf9\u836f\u7269\u8d28\u91cf\u6307\u5357\u8fdb\u884c\u4e86\u8865\u5145\u3002<\/span><\/p>\n<p><span style=\"font-size: 14pt;\">\u8be5\u8fc7\u7a0b\u59cb\u4e8e\u5168\u9762\u7684\u4f53\u5916\u6bd4\u8f83\u3002\u5f53\u8fd9\u4e9b\u6570\u636e\u8db3\u4ee5\u8bc1\u660e\u6cbb\u7597\u7b49\u6548\u6027\u65f6\uff0c\u53ef\u80fd\u4e0d\u9700\u8981\u989d\u5916\u7684\u7814\u7a76\u3002\u5982\u679c\u4ec5\u51ed\u4f53\u5916\u8bc1\u636e\u4e0d\u8db3\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u5c06\u6210\u4e3a\u9996\u9009\u7684\u4e0b\u4e00\u6b65\uff0c\u800c\u5bf9\u6bd4\u4e34\u5e8a\u7ec8\u70b9\u7814\u7a76\u901a\u5e38\u4ec5\u4fdd\u7559\u7528\u4e8e\u5148\u524d\u6c34\u5e73\u7684\u8bc1\u636e\u65e0\u6cd5\u5145\u5206\u8bc1\u660e\u7b49\u6548\u6027\u7684\u60c5\u51b5\uff08\u5982\u4e0b\u9762\u56fe 2 \u6240\u793a\uff09\u3002  <\/span><\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-margin-bottom:35px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-2 hover-type-none\"><img decoding=\"async\" width=\"1774\" height=\"887\" title=\"OINDP Guideline figure 2\" src=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2.png\" data-orig-src=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2.png\" alt class=\"lazyload img-responsive wp-image-47278\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271774%27%20height%3D%27887%27%20viewBox%3D%270%200%201774%20887%27%3E%3Crect%20width%3D%271774%27%20height%3D%27887%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2-200x100.png 200w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2-400x200.png 400w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2-600x300.png 600w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2-800x400.png 800w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2-1200x600.png 1200w, https:\/\/kymos.com\/wp-content\/uploads\/2026\/07\/OINDP-Guideline-figure-2.png 1774w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 850px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0px;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0px;--awb-width-medium:100%;--awb-spacing-right-medium:0px;--awb-spacing-left-medium:0px;--awb-width-small:100%;--awb-spacing-right-small:10px;--awb-spacing-left-small:10px;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-3\"><p><span style=\"font-size: 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14pt;\">\u5176\u7ed3\u679c\u4e0d\u4ec5\u662f\u66f4\u597d\u7684\u76d1\u7ba1\u6587\u4ef6\uff0c\u800c\u4e14\u662f\u66f4\u6709\u4fe1\u5fc3\u786e\u4fdd\u4ea7\u54c1\u5728\u5176\u6574\u4e2a\u5546\u4e1a\u751f\u547d\u5468\u671f\u5185\u59cb\u7ec8\u5982\u9884\u671f\u822c\u8868\u73b0\u3002\u91c7\u7528\u8fd9\u79cd\u5de5\u4f5c\u6d41\u7a0b\u4e0d\u4ec5\u80fd\u786e\u4fdd\u76d1\u7ba1\u5408\u89c4\uff0c\u8fd8\u80fd\u964d\u4f4e\u5f00\u53d1\u6210\u672c\u5e76\u7f29\u77ed\u4e0a\u5e02\u65f6\u95f4\uff0c\u8fd9\u662f\u6bcf\u4e2a\u836f\u7269\u5f00\u53d1\u5546\u548c\u5236\u9020\u5546\u7684\u4e3b\u8981\u76ee\u6807\u3002 <\/span><\/p>\n<h2><strong>\u4ee5\u5206\u6790\u4e13\u4e1a\u77e5\u8bc6\u652f\u6301 OINDP \u5f00\u53d1<\/strong><\/h2>\n<p><span style=\"font-size: 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