{"id":96465,"date":"2023-10-02T07:30:00","date_gmt":"2023-10-02T00:30:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2023100207300096465"},"modified":"2023-10-02T15:38:03","modified_gmt":"2023-10-02T07:38:03","slug":"%e8%8d%af%e6%98%8e%e7%94%9f%e7%89%a9%e7%a5%9d%e8%b4%ba%e5%90%88%e4%bd%9c%e4%bc%99%e4%bc%b4amicus-therapeutics%e5%ba%9e%e8%b4%9d%e7%97%85%e5%88%9b%e6%96%b0%e7%96%97%e6%b3%95%e8%8e%b7%e7%be%8e%e5%9b%bdf","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2023100207300096465","title":{"rendered":"\u836f\u660e\u751f\u7269\u795d\u8d3a\u5408\u4f5c\u4f19\u4f34Amicus Therapeutics\u5e9e\u8d1d\u75c5\u521b\u65b0\u7597\u6cd5\u83b7\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02"},"content":{"rendered":"

\u65e0\u9521<\/span>2023\u5e7410\u67082\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u5168\u7403\u9886\u5148\u7684\u5408\u540c\u7814\u7a76\u3001\u5f00\u53d1\u548c\u751f\u4ea7\uff08CRDMO\uff09\u670d\u52a1\u516c\u53f8\u836f\u660e\u751f\u7269\uff08WuXi Biologics, 2269.HK\uff09\u795d\u8d3a\u5408\u4f5c\u4f19\u4f34Amicus Therapeutics\uff08\u4ee5\u4e0b\u7b80\u79f0Amicus\uff0c\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aFOLD\uff09Pombiliti™\uff08cipaglucosidase alfa\uff09+ Opfolda™\uff08miglustat\uff0965 mg\u80f6\u56ca\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\u3002\u8be5\u53cc\u6210\u5206\u7597\u6cd5\u7528\u4e8e\u6cbb\u7597\u4f53\u91cd\u8d85\u8fc740\u5343\u514b\uff0c\u5df2\u63a5\u53d7\u73b0\u6709\u9176\u66ff\u4ee3\u7597\u6cd5\uff08ERT\uff09\u540e\u75c5\u60c5\u672a\u5f97\u5230\u6539\u5584\u7684\u665a\u53d1\u578b\u5e9e\u8d1d\u75c5\uff08LOPD\uff09\u6210\u4eba\u60a3\u8005\u3002<\/p>\n

Pombiliti™\u662f\u4e00\u79cd\u5929\u7136\u9ad8\u8868\u8fbe\u7518\u9732\u7cd6-6<\/span>-\u78f7\u9178\u7684\u91cd\u7ec4\u4ebaGAA\u9176\uff08rhGAA\uff09\uff0c\u4e8e2012\u5e74\u5728\u836f\u660e\u751f\u7269\u5e73\u53f0\u4e0a\u4ece\u4e00\u4e2a"\u4e3b\u610f"\uff08idea\uff09\u8bde\u751f\uff0c\u5728\u516c\u53f8\u9886\u5148\u7684\u4e00\u4f53\u5316\u6280\u672f\u5e73\u53f0\u53ca\u5f3a\u52b2\u4ea7\u80fd\u5b9e\u529b\u7684\u8d4b\u80fd\u4e0b\u6210\u529f\u5b9e\u73b0\u5546\u4e1a\u5316\u3002\u4f5c\u4e3aPombiliti™\u5546\u4e1a\u5316\u9636\u6bb5\u539f\u6db2\u751f\u4ea7\u72ec\u5bb6\u5408\u4f5c\u4f19\u4f34\u548c\u5236\u5242\u751f\u4ea7\u4e3b\u8981\u5408\u4f5c\u4f19\u4f34\uff0c\u836f\u660e\u751f\u7269\u5728"\u5168\u7403\u53cc\u5382\u6218\u7565"\u7684\u5f15\u9886\u4e0b\uff0c\u6b63\u5728\u901a\u8fc7\u4e94\u4e2a\u751f\u4ea7\u5382\u4e3aPombiliti™\u63d0\u4f9b\u5546\u4e1a\u5316\u751f\u4ea7\u670d\u52a1\u3002<\/p>\n

Amicus Therapeutics<\/b>\u603b\u88c1\u517c\u9996\u5e2d\u6267\u884c\u5b98<\/b>Bradley Campbell<\/span><\/b>\u5148\u751f<\/b>\u8868\u793a\uff1a"\u6b64\u6b21FDA\u7684\u6279\u51c6\u5bf9\u4e8e\u7f8e\u56fd\u5e9e\u8d1d\u75c5\u60a3\u8005\u7fa4\u4f53\u610f\u4e49\u975e\u51e1\u3002\u8fd9\u6b3e\u521b\u65b0\u7597\u6cd5\u6210\u529f\u4e0a\u5e02\u4e0d\u4ec5\u51dd\u805a\u4e86\u836f\u660e\u751f\u7269\u56e2\u961f\u548cAmicus\u56e2\u961f\u4e4b\u95f4\u7684\u65e0\u79c1\u5949\u732e\u7cbe\u795e\uff0c\u66f4\u89c1\u8bc1\u4e86\u53cc\u65b9\u5f3a\u5927\u7684\u5408\u4f5c\u4f19\u4f34\u5173\u7cfb\u3002\u5b83\u79bb\u4e0d\u5f00\u6211\u4eec\u5fc3\u7cfb\u60a3\u8005\uff0c\u7518\u4e8e\u5949\u732e\u7684\u5fd7\u540c\u9053\u5408\uff0c\u66f4\u79bb\u4e0d\u5f00\u6211\u4eec\u628a’\u4e3a\u7f55\u89c1\u75c5\u7fa4\u4f53\u5e26\u6765\u9ad8\u8d28\u91cf\u7597\u6cd5’\u8fd9\u4e00\u613f\u666f\u8f6c\u53d8\u4e3a\u884c\u52a8\u7684\u5f3a\u5927\u6267\u884c\u529b\u3002\u7ecf\u8fc7\u591a\u5e74\u7825\u783a\u524d\u884c\uff0c\u53cc\u65b9\u5171\u540c\u643a\u624b\u5c06\u4e00\u7eb8\u521b\u60f3\uff0c\u4e00\u4e2a\u5206\u5b50\uff0c\u63a8\u8fdb\u81f3\u4e34\u5e8a\u751f\u4ea7\u548c\u5546\u4e1a\u5316\u4e0a\u5e02\u9636\u6bb5\uff0c\u8df5\u884c\u60e0\u53ca\u665a\u53d1\u578b\u5e9e\u8d1d\u75c5\u60a3\u8005\u7684\u8a93\u8a00\u3002"<\/p>\n

\u836f\u660e\u751f\u7269\u9996\u5e2d\u6267\u884c\u5b98\u9648\u667a\u80dc\u535a\u58eb<\/b>\u8868\u793a\uff1a"\u5341\u4e00\u8f7d\u78e8\u4e00\u5251\uff0c\u6211\u4eec\u975e\u5e38\u8363\u5e78\u8d4b\u80fdAmicus\u5b9e\u73b0\u8fd9\u4e00\u91cd\u8981\u91cc\u7a0b\u7891\u3002Amicus\u4e0e\u836f\u660e\u751f\u7269\u4e4b\u95f4\u7d27\u5bc6\u7684\u5408\u4f5c\u5173\u7cfb\u4e0d\u4ec5\u5370\u8bc1\u4e86\u6211\u4eec’\u8ddf\u968f\u5206\u5b50’\uff08follow the molecule\uff09\u5546\u4e1a\u6a21\u5f0f\u7684\u6210\u529f\uff0c\u4e5f\u6fc0\u52b1\u7740\u6211\u4eec\u4e0d\u65ad\u4e3a\u5168\u7403\u5408\u4f5c\u4f19\u4f34\u52a0\u5feb\u53d1\u73b0\u3001\u5f00\u53d1\u548c\u751f\u4ea7\u66f4\u591a\u7528\u4e8e\u6cbb\u7597\u7f55\u89c1\u75c5\u7684\u751f\u7269\u836f\u3002\u540c\u5fc3\u800c\u5171\u6d4e\uff0c\u53cc\u65b9\u7acb\u5fd7\u4e8e\u4e3a\u60a3\u8005\u8c0b\u798f\u7949\u7684\u521d\u5fc3\u5982\u78d0\u3002\u6211\u575a\u4fe1\u53cc\u65b9\u7684\u901a\u529b\u5408\u4f5c\u4e5f\u5c06\u7eed\u5199\u66f4\u591a\u4f20\u5947\uff0c\u9020\u798f\u5168\u7403\u7f55\u89c1\u75c5\u60a3\u8005\u3002"<\/p>\n

\u5173\u4e8e\u5e9e\u8d1d\u75c5<\/b><\/p>\n

\u5e9e\u8d1d\u75c5\u662f\u4e00\u79cd\u7531\u9178\u6027\u03b1-\u8461\u8404\u7cd6\u82f7\u9176\uff08GAA\uff09\u7f3a\u4e4f\u5f15\u8d77\u7684\u9057\u4f20\u6027\u6eb6\u9176\u4f53\u75be\u75c5\uff0c\u4e34\u5e8a\u8868\u73b0\u4e3aGAA\u6c34\u5e73\u7684\u964d\u4f4e\u6216\u7f3a\u5931\u5e76\u5bfc\u81f4\u7ec6\u80de\u4e2d\u7cd6\u539f\u7684\u79ef\u7d2f\u3002\u5e9e\u8d1d\u75c5\u6db5\u76d6\u5a74\u513f\u578b\u5230\u665a\u53d1\u578b\uff0c\u524d\u8005\u5bf9\u5fc3\u810f\u529f\u80fd\u6709\u663e\u8457\u5f71\u54cd\uff0c\u75be\u75c5\u8fc5\u901f\u8fdb\u5c55\u81f3\u6b7b\u4ea1\uff0c\u540e\u8005\u4e3b\u8981\u5f71\u54cd\u9aa8\u9abc\u808c\u548c\u547c\u5438\u808c\uff0c\u75be\u75c5\u8fdb\u5c55\u76f8\u5bf9\u7f13\u6162\u3002\u665a\u53d1\u578b\u5e9e\u8d1d\u75c5\u60a3\u8005\u75c7\u72b6\u53ef\u80fd\u4f1a\u5f88\u4e25\u91cd\uff0c\u865a\u5f31\u65e0\u529b\uff0c\u4e34\u5e8a\u8868\u73b0\u5305\u62ec\u6e10\u8fdb\u6027\u5168\u8eab\u808c\u65e0\u529b\uff0c\u5c24\u5176\u662f\u9aa8\u9abc\u808c\u548c\u547c\u5438\u808c\u4f1a\u968f\u7740\u75be\u75c5\u8fdb\u5c55\u800c\u6076\u5316\u3002<\/p>\n

\u5173\u4e8e<\/b>Pombiliti + Opfolda<\/b><\/p>\n

Pombiliti + Opfolda\u662f\u4e00\u79cd\u53cc\u6210\u5206\u7597\u6cd5\uff0c\u7531\u5bcc\u542b\u7518\u9732\u7cd6<\/span>-6<\/span>-\u78f7\u9178\u7684\u91cd\u7ec4\u4ebaGAA\u9176\u548c\u53e3\u670d\u9176\u7a33\u5b9a\u5242miglustat\u7ec4\u6210\u3002Pombiliti\u901a\u8fc7M6P\u53d7\u4f53\u8fdb\u884c\u9ad8\u4eb2\u548c\u529b\u6444\u53d6\uff0c\u540c\u65f6\u4fdd\u6301\u5176\u751f\u6210\u6700\u9ad8\u6d3b\u6027\u9176\u7684\u529f\u80fd\uff0cOpfolda\u65e8\u5728\u51cf\u5c11\u8840\u6db2\u4e2d\u9176\u6d3b\u6027\u7684\u635f\u5931\u3002<\/p>\n

\u5173\u4e8e\u836f\u660e\u751f\u7269<\/b><\/p>\n

\u836f\u660e\u751f\u7269\uff08\u80a1\u7968\u4ee3\u7801\uff1a2269.HK\uff09\u662f\u4e00\u5bb6\u5168\u7403\u9886\u5148\u7684\u5408\u540c\u7814\u7a76\u3001\u5f00\u53d1\u548c\u751f\u4ea7\uff08CRDMO\uff09\u516c\u53f8\u3002\u516c\u53f8\u901a\u8fc7\u5f00\u653e\u5f0f\u3001\u4e00\u4f53\u5316\u751f\u7269\u5236\u836f\u80fd\u529b\u548c\u6280\u672f\u8d4b\u80fd\u5e73\u53f0\uff0c\u63d0\u4f9b\u5168\u65b9\u4f4d\u7684\u7aef\u5230\u7aef\u670d\u52a1\uff0c\u5e2e\u52a9\u5408\u4f5c\u4f19\u4f34\u53d1\u73b0\u3001\u5f00\u53d1\u53ca\u751f\u4ea7\u751f\u7269\u836f\uff0c\u5b9e\u73b0\u4ece\u6982\u5ff5\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\uff0c\u52a0\u901f\u5168\u7403\u751f\u7269\u836f\u7814\u53d1\u8fdb\u7a0b\uff0c\u964d\u4f4e\u7814\u53d1\u6210\u672c\uff0c\u9020\u798f\u75c5\u60a3\u3002<\/p>\n

\u836f\u660e\u751f\u7269\u5728\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u7231\u5c14\u5170\u3001\u5fb7\u56fd\u548c\u65b0\u52a0\u5761\u62e5\u6709\u8d85\u8fc712000\u540d\u5458\u5de5\u3002\u51ed\u501f\u8fd9\u4e9b\u5458\u5de5\u7ec4\u6210\u7684\u4e13\u4e1a\u670d\u52a1\u56e2\u961f\uff0c\u4ee5\u53ca\u5353\u8d8a\u7684\u6280\u672f\u548c\u6d1e\u89c1\uff0c\u516c\u53f8\u4e3a\u5ba2\u6237\u63d0\u4f9b\u9ad8\u6548\u7ecf\u6d4e\u7684\u751f\u7269\u836f\u89e3\u51b3\u65b9\u6848\u3002\u622a\u81f32023\u5e746\u6708\u5e95\uff0c\u836f\u660e\u751f\u7269\u5e2e\u52a9\u5ba2\u6237\u7814\u53d1\u548c\u751f\u4ea7\u7684\u7efc\u5408\u9879\u76ee\u9ad8\u8fbe621\u4e2a\uff0c\u5176\u4e2d\u5305\u62ec22\u4e2a\u5546\u4e1a\u5316\u751f\u4ea7\u9879\u76ee\u3002<\/p>\n

\u836f\u660e\u751f\u7269\u5c06\u73af\u5883\u3001\u793e\u4f1a\u548c\u6cbb\u7406\uff08ESG\uff09\u89c6\u4e3a\u4e1a\u52a1\u53d1\u5c55\u548c\u4f01\u4e1a\u7cbe\u795e\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\uff0c\u5e76\u81f4\u529b\u4e8e\u6210\u4e3a\u5168\u7403\u751f\u7269\u836fCRDMO\u9886\u57df\u7684ESG\u9886\u5bfc\u8005\uff0c\u4f8b\u5982\u5e94\u7528\u66f4\u7eff\u8272\u73af\u4fdd\u7684\u65b0\u4e00\u4ee3\u751f\u7269\u5236\u836f\u6280\u672f\u548c\u80fd\u6e90\u7b49\u5f15\u9886\u884c\u4e1a\u53d1\u5c55\u3002\u516c\u53f8\u6210\u7acb\u4e86\u7531\u9996\u5e2d\u6267\u884c\u5b98\u9886\u5bfc\u7684ESG\u59d4\u5458\u4f1a\uff0c\u5168\u9762\u843d\u5b9eESG\u6218\u7565\u5e76\u8df5\u884c\u53ef\u6301\u7eed\u6027\u53d1\u5c55\u627f\u8bfa\u3002\u5982\u9700\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u6d4f\u89c8\uff1awww.wuxibiologics.com<\/a>\u3002<\/p>\n

\u66f4\u591a\u4fe1\u606f\uff0c\u656c\u8bf7\u8054\u7cfb<\/b><\/p>\n

\u4e1a\u52a1\u5782\u8be2
Info@wuxibiologics.com<\/a><\/p>\n

\u5a92\u4f53\u5173\u7cfb
PR@wuxibiologics.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u65e0\u95212023\u5e7410\u67082\u65e5 \/\u7f8e\u901a\u793e\/ — \u5168\u7403\u9886\u5148\u7684\u5408\u540c\u7814\u7a76\u3001\u5f00\u53d1\u548c\u751f\u4ea7\uff08CRDMO\uff09\u670d\u52a1\u516c\u53f8\u836f\u660e\u751f\u7269\uff08WuXi Biologics, 2269.HK\uff09\u795d\u8d3a\u5408\u4f5c\u4f19\u4f34Amicus Therapeutics\uff08\u4ee5\u4e0b\u7b80\u79f0Amicus\uff0c\u7eb3\u65af\u8fbe\u514b\u80a1\u7968\u4ee3\u7801\uff1aFOLD\uff09Pombiliti™\uff08cipaglucosidase alfa\uff09+ Opfolda™\uff08miglustat\uff0965 mg\u80f6\u56ca\u83b7\u5f97\u7f8e\u56fdFDA\u6279\u51c6\u4e0a\u5e02\u3002\u8be5\u53cc\u6210\u5206\u7597\u6cd5\u7528\u4e8e\u6cbb\u7597\u4f53\u91cd\u8d85\u8fc740\u5343\u514b\uff0c\u5df2\u63a5\u53d7\u73b0\u6709\u9176\u66ff\u4ee3\u7597\u6cd5\uff08ERT\uff09\u540e\u75c5\u60c5\u672a\u5f97\u5230\u6539\u5584\u7684\u665a\u53d1\u578b\u5e9e\u8d1d\u75c5\uff08LOPD\uff09\u6210\u4eba\u60a3\u8005\u3002 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