{"id":30546,"date":"2021-05-19T15:51:00","date_gmt":"2021-05-19T08:51:00","guid":{"rendered":"https:\/\/www.xinwengao.com\/cn\/pr\/2021051915510030546"},"modified":"2021-05-19T21:42:28","modified_gmt":"2021-05-19T13:42:28","slug":"%e6%b0%b8%e6%98%95%e7%94%9f%e5%8c%bb%e4%b8%ba%e5%8f%b0%e6%b9%be%e9%a6%96%e5%ae%b6%e9%87%87%e7%94%a8beaconr%e6%8f%90%e4%be%9b%e7%bb%86%e8%83%9e%e6%a0%aa%e5%bc%80%e5%8f%91%e6%9c%8d%e5%8a%a1%e7%9a%84cd","status":"publish","type":"post","link":"https:\/\/www.xinwengao.com\/cn\/pr\/2021051915510030546","title":{"rendered":"\u6c38\u6615\u751f\u533b\u4e3a\u53f0\u6e7e\u9996\u5bb6\u91c7\u7528Beacon(R)\u63d0\u4f9b\u7ec6\u80de\u682a\u5f00\u53d1\u670d\u52a1\u7684CDMO\u516c\u53f8"},"content":{"rendered":"

\u53f0\u53172021\u5e745\u670819\u65e5 \/\u7f8e\u901a\u793e\/ — \u6c38\u6615\u751f\u7269\u533b\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8(Mycenax) (TWSE: 4726) \u6210\u4e3a\u4e9a\u6d32\u5c11\u6570\u91c7\u7528Beacon Optofluidic\uff08Beacon\u5355\u7ec6\u80de\u5149\u5bfc\uff09\u7cfb\u7edf\u63d0\u4f9b\u7ec6\u80de\u682a\u5f00\u53d1\u670d\u52a1\u7684CDMO\u516c\u53f8\u3002<\/p>\n

2020\u5e74\uff0c\u6c38\u6615\u751f\u533b\u4e3a\u5176\u7ec6\u80de\u682a\u5f00\u53d1\u670d\u52a1\u91c7\u7528\u9ad8\u901a\u91cf\u9009\u62e9\u7cfb\u7edfBeaconR\u5355\u7ec6\u80de\u5149\u5bfc\u7cfb\u7edf\uff0c\u8be5\u7cfb\u7edf\u65e8\u5728\u7528\u4e8e\u5355\u7ec6\u80de\u514b\u9686\u548c\u5b9a\u91cf\uff0c\u63d0\u4f9b\u56fe\u50cf\u8bc1\u636e\u652f\u6301\u5355\u514b\u9686\u6027\u3002<\/p>\n

\u5728\u7ec6\u80de\u682a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u9700\u5148\u7b5b\u9009\u6210\u5343\u4e0a\u4e07\u4e2a\u7ec6\u80de\uff0c\u627e\u51fa\u7f55\u89c1\u800c\u9ad8\u6548\u7684\u514b\u9686\u3002\u6709\u4e86BeaconR\u5355\u7ec6\u80de\u5149\u5bfc\u7cfb\u7edf\uff0c\u6c38\u6615\u751f\u533b\u80fd\u591f\u83b7\u5f97\u5177\u6709\u9ad8\u4ea7\u91cf\u548c\u5408\u89c4\u7684\u7ec6\u80de\u514b\u9686\uff0c\u4ece\u800c\u5c06\u6574\u4f53\u7ec6\u80de\u682a\u5f00\u53d1\u65f6\u95f4\u7f29\u77ed\u9ad8\u8fbe50%\u3002<\/p>\n

\u968f\u7740<\/b>CDMO<\/b>\u670d\u52a1\u9700\u6c42\u4e0d\u65ad\u6269\u5927\uff0c\u6c38\u6615\u751f\u533b\u7b79\u96c6\u8d44\u91d1\u4ee5\u6269\u5927\u751f\u4ea7<\/b> <\/p>\n

\u5c55\u671b\u672a\u6765\uff0c2021\u5e743\u6708\u6210\u529f\u589e\u8d442670\u4e07\u7f8e\u5143\u4e4b\u540e\uff0c\u6c38\u6615\u751f\u533b\u8ba1\u5212\u8fdb\u4e00\u6b65\u6269\u5927\u73b0\u6709\u751f\u4ea7\u7ebf\u7684\u4ea7\u80fd\u3002<\/p>\n

2020\u5e74\u7684\u5168\u7403\u751f\u7269\u5236\u836fCDMO\u5e02\u573a\u89c4\u6a21\u4e3a99.3\u4ebf\u7f8e\u5143\u3002\u9884\u4f302026\u5e74\uff0c\u5168\u7403\u5e02\u573a\u89c4\u6a21\u6709\u671b\u8fbe\u5230186.3\u4ebf\u7f8e\u5143\uff0c\u5176\u4e2d\u7ea635%\u7684CDMO\u5e02\u573a\u589e\u957f\u9884\u8ba1\u5c06\u6765\u81ea\u4e9a\u592a\u533a\uff0c\u8fd9\u4e3b\u8981\u5f52\u56e0\u4e8e\u4e00\u7ad9\u5f0fCDMO\u9700\u6c42\u4e0d\u65ad\u6269\u5927\u3002<\/p>\n

\u6c38\u6615\u751f\u533b\u9884\u8ba1CDMO\u9500\u552e\u673a\u4f1a\u5c06\u8fdb\u4e00\u6b65\u6269\u5927\u3002\u4f5c\u4e3a\u5b8c\u5168\u4e00\u7ad9\u5f0f\u7684CDMO\u516c\u53f8\uff0c\u6c38\u6615\u751f\u533b\u8ba1\u5212\u4e8e\u4e0d\u4e45\u540e\u63a8\u51fa\u7ec6\u80de\u7597\u6cd5\u3001\u8fde\u7eed\u5f0f\u751f\u4ea7\u7684\u5de5\u827a\u548cADC\uff08\u6297\u4f53\u5076\u8054\u836f\u7269\uff09\u670d\u52a1\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u5404\u79cd\u751f\u7269\u5236\u836f\u5f00\u53d1\u751f\u4ea7\u7684\u670d\u52a1\u3002<\/p>\n

\u6c38\u6615\u751f\u533b\u7684\u7b2c\u4e8cGMP\u5de5\u5382\u5c06\u4e8e2023\u5e74\u6295\u5165\u751f\u4ea7<\/b><\/p>\n

\u76ee\u524d\uff0c\u6c38\u6615\u751f\u533b\u5df2\u6709\u4e00\u4e2a\u901a\u8fc7PIC\/S\u8ba4\u8bc1\u7684\u5de5\u5382\uff0c\u8d1f\u8d23\u4e34\u5e8a\u524d\u5230\u65e9\u671f\u5546\u4e1a\u91cf\u4ea7\u7684\u751f\u4ea7\u3002\u9274\u4e8e\u4e0d\u65ad\u6269\u5927\u7684CDMO\u670d\u52a1\u9700\u6c42\u4ee5\u53ca\u5927\u89c4\u6a21\u5546\u4e1a\u751f\u4ea7\u9700\u6c42\uff0c2020\u5e74\u6c38\u6615\u751f\u533b\u5f00\u59cb\u5efa\u8bbe\u7b2c\u4e8c\u4e2aGMP\u5de5\u5382\uff08\u4e8c\u5382\uff09\u5e76\u9884\u8ba1\u57282023\u5e74\u6295\u5165\u751f\u4ea7\u3002<\/p>\n

\u4e8c\u5382\u7684\u8bbe\u8ba1\u7b26\u5408\u65e5\u672cPMDA\u3001\u6b27\u76df<\/span>EMA\u548c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08US FDA\uff09\u7684\u6cd5\u89c4\u89c4\u8303\uff0c\u603b\u9762\u79ef\u4e3a12750\u5e73\u65b9\u7c73\u3002\u8be5\u5382\u5c06\u8bbe\u7f6e\u4e24\u6761\u54fa\u4e73\u52a8\u7269\u7ec6\u80de\u751f\u4ea7\u7ebf\uff0c\u6bcf\u6761\u751f\u4ea7\u7ebf\u7684\u6700\u5927\u4ea7\u80fd\u4e3a6000\u5347<\/span>\uff0c\u9884\u8ba1\u6bcf\u5e74\u4ea7\u80fd\u53ef\u8fbe60\u6279\u3002<\/p>\n

\u6c38\u6615\u751f\u533b\u4ea6\u5c06\u5728\u4e8c\u5382\u5efa\u7acb\u4e00\u6761\u65b0\u7684\u9694\u79bb\u64cd\u4f5c\uff08Isolator\uff09\u65e0\u83cc\u5145\u586b\u7ebf\uff0c\u53ef\u5145\u586b\u74f6\u5145(Vial)\u3001\u9884\u5145\u6db2\u5f0f\u6ce8\u5c04\u5668\uff08Pre-filled Syringe\uff09\u53ca\u51bb\u5e72\u5f0f\u5145\u586b\uff08Lyophilization\uff09\uff0c\u8fdb\u4e00\u6b65\u6269\u5927\u5145\u586b\u7684\u4ea7\u80fd\u4e0e\u6279\u91cf\u6570\uff0c\u6ee1\u8db3\u6cd5\u89c4\u4e0e\u5ba2\u6237\u7684\u8981\u6c42<\/span>\u3002<\/p>\n

\u6b64\u65b0\u5382\u5c06\u534f\u52a9\u6c38\u6615\u751f\u533b\u6ee1\u8db3\u5ba2\u6237\u5bf9\u751f\u7269\u5236\u836f\u5546\u4e1a\u91cf\u4ea7\u7684\u9700\u6c42\u3002<\/p>\n

\u6c38\u6615\u751f\u7269\u533b\u836f\u7b80\u4ecb<\/b> <\/p>\n

\u6c38\u6615\u751f\u533b\u6210\u7acb\u4e8e2001\u5e749\u6708\uff0c\u4e3a\u53f0\u6e7e\u751f\u7269\u5236\u836fCMC\u5f00\u53d1\u548cGMP\u751f\u4ea7\u9886\u57df\u7684\u5148\u9a71\u3002\u8be5\u516c\u53f8\u62e5\u6709\u4ece\u7ec6\u80de\u682a\u5f00\u53d1\u3001\u4ea7\u7a0b\u5f00\u53d1\u3001\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u3001\u914d\u65b9\u5f00\u53d1\u5230GMP\u751f\u4ea7\u548c\u65e0\u83cc\u5145\u586b\u4e00\u7ad9\u5f0f\u7684\u751f\u7269\u836f\u5f00\u53d1\u751f\u4ea7\u670d\u52a1\u94fe\u3002\u4ee5\u53f0\u6e7e\u4e3a\u5f00\u53d1\u5236\u9020\u4e2d\u5fc3\uff0c\u6c38\u6615\u751f\u533b\u5782\u76f4\u6574\u5408\u884c\u4e86\u751f\u7269\u5236\u836f\u4e0a\u4e0b\u6e38\u9886\u57df\uff0c\u4e3a\u5168\u7403\u5ba2\u6237\u63d0\u4f9b\u5b8c\u6574\u7684\u5f00\u53d1\u548c\u5236\u9020\u670d\u52a1\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u53f0\u53172021\u5e745\u670819\u65e5 \/\u7f8e\u901a\u793e\/ — \u6c38\u6615\u751f\u7269\u533b\u836f\u80a1\u4efd\u6709\u9650\u516c\u53f8(Mycenax) (TWSE: 4726) \u6210\u4e3a\u4e9a\u6d32\u5c11\u6570\u91c7\u7528Beacon Optofluidic\uff08Beacon\u5355\u7ec6\u80de\u5149\u5bfc\uff09\u7cfb\u7edf\u63d0\u4f9b\u7ec6\u80de\u682a\u5f00\u53d1\u670d\u52a1\u7684CDMO\u516c\u53f8\u3002 2020\u5e74\uff0c\u6c38\u6615\u751f\u533b\u4e3a\u5176\u7ec6\u80de\u682a\u5f00\u53d1\u670d\u52a1\u91c7\u7528\u9ad8\u901a\u91cf\u9009\u62e9\u7cfb\u7edfBeaconR\u5355\u7ec6\u80de\u5149\u5bfc\u7cfb\u7edf\uff0c\u8be5\u7cfb\u7edf\u65e8\u5728\u7528\u4e8e\u5355\u7ec6\u80de\u514b\u9686\u548c\u5b9a\u91cf\uff0c\u63d0\u4f9b\u56fe\u50cf\u8bc1\u636e\u652f\u6301\u5355\u514b\u9686\u6027\u3002 \u5728\u7ec6\u80de\u682a\u5f00\u53d1\u8fc7\u7a0b\u4e2d\uff0c\u9700\u5148\u7b5b\u9009\u6210\u5343\u4e0a\u4e07\u4e2a\u7ec6\u80de\uff0c\u627e\u51fa\u7f55\u89c1\u800c\u9ad8\u6548\u7684\u514b\u9686\u3002\u6709\u4e86BeaconR\u5355\u7ec6\u80de\u5149\u5bfc\u7cfb\u7edf\uff0c\u6c38\u6615\u751f\u533b\u80fd\u591f\u83b7\u5f97\u5177\u6709\u9ad8\u4ea7\u91cf\u548c\u5408\u89c4\u7684\u7ec6\u80de\u514b\u9686\uff0c\u4ece\u800c\u5c06\u6574\u4f53\u7ec6\u80de\u682a\u5f00\u53d1\u65f6\u95f4\u7f29\u77ed\u9ad8\u8fbe50%\u3002 \u968f\u7740CDMO\u670d\u52a1\u9700\u6c42\u4e0d\u65ad\u6269\u5927\uff0c\u6c38\u6615\u751f\u533b\u7b79\u96c6\u8d44\u91d1\u4ee5\u6269\u5927\u751f\u4ea7  \u5c55\u671b\u672a\u6765\uff0c2021\u5e743\u6708\u6210\u529f\u589e\u8d442670\u4e07\u7f8e\u5143\u4e4b\u540e\uff0c\u6c38\u6615\u751f\u533b\u8ba1\u5212\u8fdb\u4e00\u6b65\u6269\u5927\u73b0\u6709\u751f\u4ea7\u7ebf\u7684\u4ea7\u80fd\u3002 2020\u5e74\u7684\u5168\u7403\u751f\u7269\u5236\u836fCDMO\u5e02\u573a\u89c4\u6a21\u4e3a99.3\u4ebf\u7f8e\u5143\u3002\u9884\u4f302026\u5e74\uff0c\u5168\u7403\u5e02\u573a\u89c4\u6a21\u6709\u671b\u8fbe\u5230186.3\u4ebf\u7f8e\u5143\uff0c\u5176\u4e2d\u7ea635%\u7684CDMO\u5e02\u573a\u589e\u957f\u9884\u8ba1\u5c06\u6765\u81ea\u4e9a\u592a\u533a\uff0c\u8fd9\u4e3b\u8981\u5f52\u56e0\u4e8e\u4e00\u7ad9\u5f0fCDMO\u9700\u6c42\u4e0d\u65ad\u6269\u5927\u3002 \u6c38\u6615\u751f\u533b\u9884\u8ba1CDMO\u9500\u552e\u673a\u4f1a\u5c06\u8fdb\u4e00\u6b65\u6269\u5927\u3002\u4f5c\u4e3a\u5b8c\u5168\u4e00\u7ad9\u5f0f\u7684CDMO\u516c\u53f8\uff0c\u6c38\u6615\u751f\u533b\u8ba1\u5212\u4e8e\u4e0d\u4e45\u540e\u63a8\u51fa\u7ec6\u80de\u7597\u6cd5\u3001\u8fde\u7eed\u5f0f\u751f\u4ea7\u7684\u5de5\u827a\u548cADC\uff08\u6297\u4f53\u5076\u8054\u836f\u7269\uff09\u670d\u52a1\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u5404\u79cd\u751f\u7269\u5236\u836f\u5f00\u53d1\u751f\u4ea7\u7684\u670d\u52a1\u3002 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