{"id":9537,"date":"2018-06-14T01:00:00","date_gmt":"2018-07-27T09:39:33","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/27\/%e8%81%8c%e8%be%be%e9%ab%98%e7%ae%a1%e4%b8%a8%e8%8b%b1%e5%88%9b%e8%bf%9c%e8%be%be%e5%a4%9a%e9%ab%98%e7%ae%a1%e8%81%8c%e4%bd%8d%e8%99%9a%e4%bd%8d%e4%bb%a5%e5%be%85\/"},"modified":"2018-07-27T17:39:34","modified_gmt":"2018-07-27T09:39:34","slug":"%e8%81%8c%e8%be%be%e9%ab%98%e7%ae%a1%e4%b8%a8%e8%8b%b1%e5%88%9b%e8%bf%9c%e8%be%be%e5%a4%9a%e9%ab%98%e7%ae%a1%e8%81%8c%e4%bd%8d%e8%99%9a%e4%bd%8d%e4%bb%a5%e5%be%85","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/9537\/","title":{"rendered":"\u804c\u8fbe\u9ad8\u7ba1\u4e28\u82f1\u521b\u8fdc\u8fbe\u591a\u9ad8\u7ba1\u804c\u4f4d\u865a\u4f4d\u4ee5\u5f85"},"content":{"rendered":"
\n
\u82f1\u521b\u8fdc\u8fbe\uff08\u5317\u4eac\uff09\u751f\u7269\u533b\u836f\u79d1\u6280\u6709\u9650\u516c\u53f8\u6210\u7acb\u4e8e2012\u5e748\u6708\uff0c\u662fCASI Pharmaceuticals\uff08\u80a1\u7968\u4ee3\u7801\uff1aCASI\uff09\u5728\u4e2d\u56fd\u8bbe\u7acb\u7684\u5168\u8d44\u516c\u53f8\uff0c\u5df2\u7ecf\u5728\u7f8e\u56fdNASDAQ\u4e0a\u5e02\u3002\u516c\u53f8\u4e13\u6ce8\u4e8e\u6297\u80bf\u7624\u836f\u53ca\u5176\u4ed6\u672a\u88ab\u6ee1\u8db3\u7684\u6cbb\u7597\u9886\u57df\u65b0\u836f\u5f00\u53d1\u53ca\u9ad8\u7aef\u4eff\u5236\u836f\u5f15\u8fdb\uff0c\u805a\u96c6\u4e2d\u56fd\u6297\u80bf\u7624\u521b\u65b0\u836f\u5e02\u573a\u4e0e\u56fd\u9645\u6297\u80bf\u7624\u5b64\u513f\u836f\u5e02\u573a\u4ee5\u53ca\u9ad8\u54c1\u8d28\u4eff\u5236\u836f\u54c1\u5e02\u573a\uff0c\u529b\u4e89\u6210\u4e3a\u4e2d\u56fd\u6297\u80bf\u7624\u884c\u4e1a\u589e\u957f\u6700\u5feb\u3001\u7ade\u4e89\u529b\u6700\u5f3a\u3001\u6700\u5177\u53d1\u5c55\u524d\u666f\u7684\u516c\u53f8\u30022014\u5e74\u4ece\u7f8e\u56fd\u9891\u8c31\u516c\u53f8\u83b7\u5f973\u4e2aFDA\u5df2\u6279\u51c6\u7684\u6297\u80bf\u7624\u4e13\u5229\u65b0\u836f\u7684\u5927\u4e2d\u534e\u5730\u533a\u5e02\u573a\u6743\u5229\uff0c\u6b63\u7533\u62a5\u4e2d\u56fd\u836f\u76d1\u5c40\u8fdb\u53e3\u6ce8\u518c\uff0c\u9884\u8ba1\u7b2c\u4e00\u4e2a\u4ea7\u54c12018\u5e74\u56fd\u5185\u4e0a\u5e02\u3002\u516c\u53f8\u4e8e2018\u5e741\u6708\u6210\u529f\u6536\u8d2d\u8bfa\u534e\u516c\u53f8\u7f8e\u56fd\u5c71\u5fb7\u58eb\u836f\u5382\u768425\u4e2a\u7f8e\u56fdFDA\u5df2\u6279\u51c6\u4e0a\u5e02\u7684ANDA\u836f\u54c1\u4ee5\u53ca4\u4e2a\u5f85\u6279\u51c6ANDA\u5728\u7814\u836f\u7269\u3002\u516c\u53f8\u4e3b\u8981\u80a1\u4e1c\u6709\uff1a IDG\u4e2d\u56fd\u57fa\u91d1\uff08\u63a7\u80a1\u80a1\u4e1c\uff09\u3001\u51ef\u9e4f\u534e\u76c8KPCB\u4e2d\u56fd\u57fa\u91d1\u7b49\u3002\u4e2d\u56fd\u529e\u516c\u5730\u70b9\u4e3a\u5317\u4eac\u5e02\u671d\u9633\u533a\u4e1c\u4e8c\u73af\uff0c\u53e6\u5916\u5728\u5317\u4eac\u5e02\u660c\u5e73\u533a\u8bbe\u6709\u5168\u8d44\u5b50\u516c\u53f8\uff0c\u4e3b\u8981\u8fdb\u884c\u8fdb\u884c\u65b0\u836f\u7814\u53d1\u3001\u514d\u75ab\u6cbb\u7597\u7b49\u9879\u76ee\u3002<\/span><\/section>\n

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

\n
><\/span>><\/span>><\/span>><\/span><\/section>\n
\n

\u8054\u7cfb\u65b9\u5f0f<\/span><\/p>\n<\/section>\n<\/section>\n

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

\u8054\u7cfb\u4eba\uff1a\u5f20\u5973\u58eb <\/span><\/p>\n

\u5ea7\u673a\uff1a010-6508 6067<\/span><\/p>\n

\u624b\u673a\uff1a15255563494<\/span><\/p>\n

\u6295\u9012\u90ae\u7bb1\uff1asummerz@casipharmaceuticals.com.cn <\/span><\/p>\n

\u516c\u53f8\u5730\u5740: \u5317\u4eac\u5e02\u671d\u9633\u533a\u671d\u9633\u95e8\u5916\u5927\u885718\u53f7\u4e30\u8054\u5e7f\u573aB\u5ea7 1214-1215<\/span><\/p>\n

\u516c\u53f8\u7f51\u5740: www.casihpharma.com.cn<\/span><\/p>\n

\u6295\u9012\u4e3b\u9898\uff1a\u5e94\u8058\u5c97\u4f4d+\u59d3\u540d+\u82f1\u521b\u8fdc\u8fbe<\/span><\/p>\n


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><\/span>><\/span>><\/span>><\/span><\/section>\n
\n

\u516c\u53f8\u798f\u5229<\/span><\/p>\n<\/section>\n

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-\u8865\u5145\u533b\u7597\u4fdd\u9669<\/span><\/p>\n

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–\u5e74\u5ea6\u4f53\u68c0<\/span><\/p>\n

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\n
><\/span>><\/span><\/section>\n
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><\/span>><\/span><\/section>\n
\n

\u804c\u4f4d\u8be6\u60c5<\/span><\/p>\n<\/section>\n<\/section>\n

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\n
\n
\n
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\n
1<\/section>\n<\/section>\n<\/section>\n
\u4e34\u5e8a\u533b\u5b66\u603b\u76d1<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

\u5c97\u4f4d\u804c\u8d23\uff1a<\/span><\/strong><\/p>\n

    \n
  1. \n

    \u627f\u62c5\u65b0\u836f\u4e34\u5e8a\u7814\u7a76\u65b9\u6848\u53ca\u76f8\u5173\u6587\u4ef6\u7684\u8bbe\u8ba1\u548c\u5236\u5b9a\uff0c\u5e76\u4e0e\u4e34\u5e8a\u4e13\u5bb6\u4ea4\u6d41\u4fee\u6539\u5b8c\u5584;<\/span><\/p>\n<\/li>\n

  2. \n

    \u8d1f\u8d23\u7b5b\u9009\u4e34\u5e8a\u8bd5\u9a8c\u673a\u6784\uff0c\u5bf9\u8bd5\u9a8c\u673a\u6784\u3001\u8d39\u7528\u3001\u65f6\u95f4\u7b49\u8fdb\u884c\u8bc4\u4f30\uff1b\u8054\u7edc\u7814\u7a76\u57fa\u5730\uff0c\u7ec4\u7ec7\u4e34\u5e8a\u65b9\u6848\u5728\u7814\u7a76\u57fa\u5730\u7684\u5b9e\u65bd\uff1b<\/span><\/p>\n<\/li>\n

  3. \n

    \u9886\u5bfc\u534f\u8c03\u63ed\u76f2\u524d\u8bd5\u9a8c\u6570\u636e\u7684\u4ea4\u53c9\u6838\u67e5\uff0c\u786e\u4fdd\u83b7\u5f97\u51c6\u786e\u7ed3\u679c\uff1b\u5206\u6790\u8bd5\u9a8c\u6570\u636e\uff0c\u64b0\u5199\u4e34\u5e8a\u8bd5\u9a8c\u62a5\u544a\u548c\u7814\u7a76\u7ed3\u8bba\uff1b<\/span><\/p>\n<\/li>\n

  4. \n

    \u6307\u5bfcCRA\uff0c\u8d1f\u8d23\u7ba1\u7406\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5404\u79cd\u6750\u6599\uff0c\u5305\u62ec\u836f\u7269\u4f9b\u5e94\u53caCRF\u8868\u7ba1\u7406\uff1b\u8d1f\u8d23\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u6587\u6863\u7684\u5efa\u7acb\u548c\u7ba1\u7406\uff0c\u6709\u89c4\u5f8b\u66f4\u65b0\u6240\u6709\u7684\u8bd5\u9a8c\u6570\u636e\u5e93\uff0c\u4ee5\u4fdd\u8bc1\u4fe1\u606f\u51c6\u786e\uff1b<\/span><\/p>\n<\/li>\n

  5. \n

    \u8d1f\u8d23\u6ce8\u518c\u3001\u7533\u62a5\uff0c\u5efa\u7acb\u4e34\u5e8a\u7814\u7a76\u7684\u8d28\u91cf\u4f53\u7cfb\uff1b\u5728\u6267\u884c\u548c\u63a8\u8fdb\u516c\u53f8\u7684\u4ea7\u54c1\u7ebf\u7684\u6218\u7565\u8ba1\u5212\u65f6\uff0c\u5e94\u786e\u4fdd\u53d1\u5c55\u8ba1\u5212\u6ee1\u8db3\u60a3\u8005\u3001\u536b\u751f\u4fdd\u5065\u63d0\u4f9b\u8005\u4ee5\u53ca\u76d1\u7ba1\u673a\u6784\u6240\u9700\u8981\u7684\u8d28\u91cf\u548c\u5b89\u5168\u6807\u51c6\uff1b<\/span><\/p>\n<\/li>\n

  6. \n

    \u8d1f\u8d23\u5c5e\u4e0b\u5458\u5de5\u7684\u62db\u8058\u3001\u57f9\u8bad\u53ca\u7ba1\u7406\u7b49\u5de5\u4f5c\uff1b\u9886\u5bfc\u7814\u7a76\u56e2\u961f\u786e\u4fdd\u8bd5\u9a8c\u6309\u7167\u65f6\u95f4\u9884\u671f\u53ca\u9884\u7b97\u8d39\u7528\u9ad8\u8d28\u91cf\u5b8c\u6210\uff1b<\/span><\/p>\n<\/li>\n

  7. \n

    \u5b9a\u671f\u4e3b\u6301\u56e2\u961f\u5185\u90e8\u4f1a\u8bae\uff0c\u901a\u62a5\u8bd5\u9a8c\u8fdb\u5c55\u53ca\u5b58\u5728\u95ee\u9898\uff0c\u5e76\u5411\u4e0a\u7ea7\u9886\u5bfc\u6c47\u62a5\uff1b<\/span><\/p>\n<\/li>\n

  8. \n

    \u5efa\u7acb\u548c\u7ef4\u6301\u5173\u952e\u4e13\u5bb6\u3001\u5b66\u79d1\u9886\u57df\u9886\u8896\u4eba\u7269\u7684\u5173\u7cfb\uff0c\u5e76\u4fdd\u6301\u4e0e\u516c\u53f8\u7684\u5546\u4e1a\u8ba1\u5212\u4ee5\u53ca\u5f00\u53d1\u76ee\u6807\u76f8\u4e00\u81f4\uff1b<\/span><\/p>\n<\/li>\n

  9. \n

    \u5b9a\u671f\u6536\u96c6\u56fd\u5185\u5916\u6700\u65b0\u65b0\u836f\u7684\u7814\u7a76\u4fe1\u606f\uff0c\u534f\u52a9\u516c\u53f8\u8fdb\u884c\u533b\u836f\u9879\u76ee\u7684\u6218\u7565\u6295\u8d44\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


    <\/p>\n

    \u4efb\u804c\u8d44\u683c\uff1a<\/span><\/strong><\/p>\n

      \n
    1. \n

      \u62e5\u6709\u533b\u5b66\u80cc\u666f\uff0c\u4e34\u5e8a\u533b\u5b66\u7b49\u76f8\u5173\u4e13\u4e1a\u7855\u58eb\u4ee5\u4e0a\u5b66\u5386\uff1b<\/span><\/p>\n<\/li>\n

    2. \n

      5\u5e74\u4ee5\u4e0a\u4e34\u5e8a\u533b\u5b66\u4e13\u4e1a\u7ecf\u9a8c\uff0c\u8d1f\u8d23\u8fc7\u5b8c\u6574\u7684\u4e34\u5e8a\u7814\u7a76\u9879\u76ee\u7ecf\u9a8c\uff08\u4eba\u5458\u3001\u9879\u76ee\u3001\u9884\u7b97\u3001\u8d22\u52a1\u7b49\uff09 \uff0c\u6709\u80bf\u7624\u79d1\u6216\u5185\u79d1\u7ecf\u9a8c\u8005\u4f18\u5148\u8003\u8651\uff1b<\/span><\/p>\n<\/li>\n

    3. \n

      \u4e34\u5e8a\u4e13\u4e1a\uff0c\u5305\u62ec\u4e2d\u533b\u3001\u897f\u533b\u3001\u4e2d\u897f\u533b\u7ed3\u5408\u4e13\u4e1a\uff0c\u719f\u6089\u4e34\u5e8a\u8bd5\u9a8c\u7684\u76f8\u5173\u6cd5\u89c4\uff1b <\/span><\/p>\n<\/li>\n

    4. \n

      \u719f\u7ec3\u8fd0\u7528office\u8f6f\u4ef6\uff0c\u80fd\u591f\u719f\u7ec3\u4f7f\u7528\u82f1\u8bed\uff1b<\/span><\/p>\n<\/li>\n

    5. \n

      \u5177\u6709\u79d1\u7814\u8ba1\u5212\u548c\u6267\u884c\u80fd\u529b\uff1b\u5177\u5907\u826f\u597d\u7684\u65e5\u5e38\u4e8b\u52a1\u4e0e\u7d27\u6025\u4e8b\u52a1\u7684\u5904\u7406\u80fd\u529b\uff0c\u4ee5\u53ca\u56e2\u961f\u9886\u5bfc\u80fd\u529b\uff1b <\/span><\/p>\n<\/li>\n

    6. \n

      \u5177\u6709\u6781\u5f3a\u7684\u8d23\u4efb\u5fc3\uff0c\u52a8\u624b\u80fd\u529b\u5f3a\uff0c\u601d\u7ef4\u6d3b\u8dc3\uff0c\u6709\u5f88\u597d\u7684\u521b\u65b0\u601d\u7ef4\u80fd\u529b\u548c\u56e2\u961f\u5408\u4f5c\u7cbe\u795e\uff1b<\/span><\/p>\n<\/li>\n

    7. \n

      \u6709\u826f\u597d\u7684\u6c9f\u901a\u80fd\u529b\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


      <\/p>\n

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

      \n
      \n
      \n
      \n
      \n
      2<\/section>\n<\/section>\n<\/section>\n
      \uff08\u56fd\u9645\uff09BD\u9879\u76ee\u7ecf\u7406<\/section>\n<\/section>\n<\/section>\n<\/section>\n

      \u5e74\u85aa\uff1a30W<\/span><\/p>\n

      \u62db\u8058\u4eba\u6570\uff1a1\u4eba<\/span><\/p>\n


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

      \u5c97\u4f4d\u804c\u8d23\uff1a<\/span><\/strong><\/p>\n

        \n
      1. \n

        \u534f\u52a9\u603b\u76d1\u53caVP\u8bc4\u4f30\u5f85\u5f15\u8fdb\u65b0\u836f\u9879\u76ee\uff0c\u719f\u6089\u80bf\u7624\u3001\u809d\u75c5\u9886\u57df\u3002<\/span><\/p>\n<\/li>\n

      2. \n

        \u719f\u6089\u65b0\u836f\u7684\u975e\u4e34\u5e8a\u836f\u6548\u5b66\u8bc4\u4f30\u53ca\u4e34\u5e8a\u8bc4\u4f30\u3002<\/span><\/p>\n<\/li>\n

      3. \n

        \u719f\u6089\u56fd\u5185\u533b\u836f\u5e02\u573a\u53ca\u6ce8\u518c\u6cd5\u89c4\uff0c\u534f\u8c03\u76f8\u5173\u90e8\u95e8\u5bf9\u76ee\u6807\u4ea7\u54c1\u7684\u6280\u672f\u3001\u4e13\u5229\u3001\u5e02\u573a\u524d\u666f\u548c\u53ef\u884c\u6027\u8fdb\u884c\u6df1\u5165\u8c03\u7814\u8bc4\u4ef7\uff0c\u64b0\u5199\u8bc4\u4f30\u62a5\u544a\u3002<\/span><\/p>\n<\/li>\n

      4. \n

        \u719f\u7ec3\u5e94\u7528\u56fd\u5185\u5916\u836f\u54c1\u7814\u53d1\u8fdb\u5c55\u68c0\u7d22\u5de5\u5177\u5e76\u80fd\u7efc\u5408\u5f52\u7eb3\u3001\u5206\u6790\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


        <\/p>\n

        \u4efb\u804c\u8981\u6c42\uff1a<\/span><\/strong><\/p>\n

          \n
        1. \n

          \u533b\u836f\u76f8\u5173\u4e13\u4e1a\u80cc\u666f\uff08\u836f\u7406\u5b66\u4f18\u5148\uff09\uff0c\u7814\u7a76\u751f\u5b66\u5386\uff1b\u4e09\u5e74\u4ee5\u4e0a\u533b\u836f\u884c\u4e1aBD\u9879\u76ee\u8bc4\u4f30\u7ecf\u9a8c\uff1b<\/span><\/p>\n<\/li>\n

        2. \n

          \u6027\u683c\u5916\u5411\u3001\u79ef\u6781\uff0c\u80fd\u627f\u53d7\u4e00\u5b9a\u7684\u538b\u529b\uff1b\u5177\u5907\u72ec\u7acb\u5de5\u4f5c\u80fd\u529b\u3001\u8de8\u90e8\u95e8\u534f\u8c03\u5408\u4f5c\u7684\u80fd\u529b\uff1b<\/span><\/p>\n<\/li>\n

        3. \n

          \u719f\u7ec3\u7684\u82f1\u8bed\u542c\u8bf4\u8bfb\u5199\u80fd\u529b\uff1b<\/span><\/p>\n<\/li>\n<\/ol>\n


          <\/p>\n

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

          \n
          \n
          \n
          \n
          \n
          3<\/section>\n<\/section>\n<\/section>\n
          ANDA\u9879\u76ee\u7ecf\u7406\/\u603b\u76d1<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

          \u5e74\u85aa\uff1a\u9762\u8bae<\/span><\/p>\n

          \u62db\u8058\u4eba\u6570\uff1a1\u4eba<\/span><\/p>\n


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

          \u5c97\u4f4d\u804c\u8d23\uff1a<\/span><\/strong><\/p>\n

            \n
          1. \n

            \u8d1f\u8d23\u5728\u7814\u9879\u76ee\u7684\u65e5\u5e38\u7ba1\u7406\u5de5\u4f5c\uff0c\u5bf9\u836f\u7269\u7814\u53d1\u8fc7\u7a0b\u8fdb\u884c\u6709\u6548\u7684\u76d1\u7763\u3001\u63a7\u5236\u548c\u534f\u8c03\uff1b\u8d1f\u8d23\u9879\u76ee\u6574\u4f53\u89c4\u5212\u53ca\u6210\u672c\u9884\u7b97\uff0c\u53c2\u4e0e\u9879\u76ee\u7acb\u9879\u8bba\u8bc1\uff1b<\/span><\/p>\n<\/li>\n

          2. \n

            \u8d1f\u8d23\u5bf9\u5f00\u5c55\u9879\u76ee\u7684CRO\/CMO\u53ca\u4f9b\u5e94\u5546\u7684\u8054\u7edc\u6c9f\u901a\u3001\u7763\u4fc3\u534f\u8c03\u3001\u8fdb\u5ea6\u8ffd\u8e2a\u7b49\uff0c\u968f\u65f6\u628a\u63e1\u65f6\u95f4\u8fdb\u5ea6\uff0c\u786e\u4fdd\u6309\u65f6\u9ad8\u8d28\u91cf\u5b8c\u6210\u4efb\u52a1\uff1b<\/span><\/p>\n<\/li>\n

          3. \n

            \u5236\u5b9a\u9879\u76ee\u8ba1\u5212\u3001\u91cf\u5316\u4efb\u52a1\uff0c\u5206\u914d\u4efb\u52a1\u5e76\u76d1\u7763\u548c\u63a8\u52a8\u9879\u76ee\u8fdb\u7a0b\uff0c\u534f\u8c03\u9879\u76ee\u7ec4\u4e4b\u95f4\u7684\u5408\u4f5c\uff0c\u5bf9\u9879\u76ee\u8d28\u91cf\u8fdb\u884c\u63a7\u5236\u3002<\/span><\/p>\n<\/li>\n

          4. \n

            \u6839\u636e\u9879\u76ee\u8fdb\u5c55\u60c5\u51b5\uff0c\u5408\u7406\u5236\u5b9a\u8d28\u91cf\u7814\u7a76\u8ba1\u5212\u3001\u5e76\u5bf9\u9879\u76ee\u7814\u53d1\u8fdb\u5ea6\u3001\u7814\u53d1\u8d28\u91cf\u3001\u7814\u53d1\u98ce\u9669\u7684\u63a7\u5236\u548c\u7ba1\u7406\uff1b<\/span><\/p>\n<\/li>\n

          5. \n

            \u8d1f\u8d23\u9879\u76ee\u7684\u5bf9\u5185\u3001\u5bf9\u5916\u5173\u7cfb\u7684\u534f\u8c03\uff0c\u9879\u76ee\u8fdb\u5ea6\u7684\u76d1\u63a7\u53ca\u638c\u63e1\uff0c\u786e\u4fdd\u9879\u76ee\u5982\u671f\u4fdd\u8d28\u5b8c\u6210\uff1b<\/span><\/p>\n<\/li>\n

          6. \n

            \u914d\u5408\u5176\u4ed6\u90e8\u95e8\u8fdb\u884c\u9879\u76ee\u8c03\u7814\u548c\u54a8\u8be2\u3002<\/span><\/p>\n<\/li>\n

          7. \n

            \u8d1f\u8d23\u6536\u96c6\u653f\u7b56\u6cd5\u89c4\u3001\u6280\u672f\u8981\u6c42\u7684\u52a8\u6001\u4fe1\u606f\uff0c\u638c\u63e1\u65b0\u836f\u4e34\u5e8a\u524d\u7814\u7a76\u53ca\u4e34\u5e8a\u7814\u7a76\u65b9\u9762\u7684\u6cd5\u5f8b\u3001\u6cd5\u89c4\u7b49\u4fe1\u606f\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


            <\/p>\n

            \u4efb\u804c\u8d44\u683c\uff1a<\/span><\/strong><\/p>\n

              \n
            1. \n

              \u5b66\u5386\u8981\u6c42\uff1a\u672c\u79d1\u53ca\u4ee5\u4e0a\u5b66\u5386\uff0c\u6709\u6d77\u5916\u80cc\u666f\u4f18\u5148\u3002<\/span><\/p>\n<\/li>\n

            2. \n

              \u4e13\u4e1a\u8981\u6c42\uff1a\u836f\u5b66\u53ca\u76f8\u5173\u4e13\u4e1a\u80cc\u666f<\/span><\/p>\n<\/li>\n

            3. \n

              \u5916\u8bed\u8981\u6c42\uff1a\u82f1\u8bed\u6c34\u5e73\u81f3\u5c11\u8fbe\u5230CET6\uff0c\u540c\u65f6\u5177\u5907\u8f83\u5f3a\u7684\u4e13\u4e1a\u82f1\u8bed\u80fd\u529b\u3002<\/span><\/p>\n<\/li>\n

            4. \n

              \u5de5\u4f5c\u7ecf\u9a8c\uff1a\u5236\u836f\u4f01\u4e1a\u6216CRO\u516c\u53f8\u76f8\u5173\u5de5\u4f5c\u7ecf\u9a8c\u8005\u4f18\u5148\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


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

              \u80fd\u529b\u8981\u6c42\uff1a<\/span><\/strong><\/p>\n

                \n
              1. \n

                \u5177\u6709\u9ad8\u5ea6\u7684\u8d23\u4efb\u5fc3\u53ca\u6c9f\u901a\u3001\u534f\u8c03\u7ec4\u7ec7\u80fd\u529b\uff1b \u5177\u6709\u8f83\u5f3a\u7684\u72ec\u7acb\u5de5\u4f5c\u80fd\u529b\u548c\u56e2\u961f\u534f\u4f5c\u7cbe\u795e\u3002<\/span><\/p>\n<\/li>\n

              2. \n

                \u5177\u6709\u4e30\u5bcc\u7684\u9879\u76ee\u7ba1\u7406\u548c\u534f\u8c03\u7684\u7ecf\u9a8c\uff1b<\/span><\/p>\n<\/li>\n

              3. \n

                \u5177\u6709\u6e05\u6670\u5730\u4e66\u9762\u548c\u53e3\u5934\u8868\u8fbe\u80fd\u529b\uff0c\u5584\u4e8e\u8fdb\u884c\u6d3b\u8dc3\u800c\u79ef\u6781\u5730\u6c9f\u901a\uff1b<\/span><\/p>\n<\/li>\n

              4. \n

                \u5177\u6709\u72ec\u7acb\u5de5\u4f5c\u80fd\u529b\uff0c\u4f46\u540c\u65f6\u53c8\u5177\u6709\u8f83\u5f3a\u7684\u96c6\u4f53\u610f\u8bc6\u548c\u826f\u597d\u7684\u56e2\u961f\u5408\u4f5c\u7cbe\u795e\uff1b<\/span><\/p>\n<\/li>\n

              5. \n

                \u5177\u6709\u4f18\u79c0\u7684\u95ee\u9898\u89e3\u51b3\u80fd\u529b\u53ca\u5e94\u6025\u9884\u6848\u7ba1\u7406\u80fd\u529b\uff1b<\/span><\/p>\n<\/li>\n

              6. \n

                \u5177\u6709\u826f\u597d\u7684\u9002\u5e94\u80fd\u529b\uff0c\u80fd\u5728\u65f6\u95f4\u9650\u5236\u548c\u4efb\u52a1\u538b\u529b\u4e0b\u5de5\u4f5c\uff1b<\/span><\/p>\n<\/li>\n

              7. \n

                \u5728\u672c\u884c\u4e1a\u6709\u4e00\u5b9a\u7684\u4eba\u8109\u5173\u7cfb\u57fa\u7840\uff0c\u5177\u6709\u826f\u597d\u7684\u4eba\u9645\u5173\u7cfb\uff1b<\/span><\/p>\n<\/li>\n

              8. \n

                \u5177\u6709\u4e30\u5bcc\u7684cGMP\u4e13\u4e1a\u77e5\u8bc6\uff0c\u719f\u6089ICH \u3001FDA\u6cd5\u89c4\u53ca\u6307\u5bfc\u539f\u5219\uff08\u5305\u62ec\u6280\u672f\u8f6c\u79fb\u3001\u751f\u4ea7\u548cANDA\u62a5\u6279\u7684\u76f8\u5173\u77e5\u8bc6\uff09<\/span><\/p>\n<\/li>\n<\/ol>\n


                <\/p>\n

                \u6280\u80fd\u8981\u6c42\uff1a<\/span><\/strong><\/p>\n

                  \n
                1. \n

                  \u5177\u6709\u4e30\u5bcc\u7684\u533b\u836f\u884c\u4e1a\u76f8\u5173\u77e5\u8bc6\u548c\u7ba1\u7406\u7ecf\u9a8c\uff1b<\/span><\/p>\n<\/li>\n

                2. \n

                  \u719f\u6089\u836f\u7269\u4e34\u5e8a\u524d\u7814\u53d1\u7684\u5168\u8fc7\u7a0b\uff0c\u719f\u6089\u56fd\u5185\u5916\u4e34\u5e8a\u524d\u7814\u7a76\u53d1\u5c55\u4e0e\u73b0\u72b6\uff1b<\/span><\/p>\n<\/li>\n

                3. \n

                  \u80fd\u72ec\u7acb\u67e5\u9605\u6709\u5173\u6587\u732e\u8d44\u6599\uff0c\u64b0\u5199\u5404\u7c7b\u62a5\u544a\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


                  <\/p>\n

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

                  \n
                  \n
                  \n
                  \n
                  \n
                  4<\/section>\n<\/section>\n<\/section>\n
                  \u836f\u54c1\u6ce8\u518c\u7ecf\u7406<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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

                  \u5e74\u85aa\uff1a\u9762\u8bae<\/span><\/p>\n

                  \u62db\u8058\u4eba\u6570\uff1a1\u4eba<\/span><\/p>\n


                  <\/p>\n

                  \u804c\u4f4d\u63cf\u8ff0:<\/span><\/strong><\/p>\n

                    \n
                  1. \n

                    \u8d1f\u8d23\u516c\u53f8\u6297\u80bf\u7624\u65b0\u836f\u7533\u62a5\u8d44\u6599\u7684\u64b0\u5199\u3001\u6536\u96c6\u3001\u6574\u7406\u3001\u5ba1\u6838\u53ca\u7533\u62a5\u5de5\u4f5c\uff1b<\/span><\/p>\n<\/li>\n

                  2. \n

                    \u786e\u4fdd\u7533\u62a5\u8d44\u6599\u51c6\u786e\u6027\u4e0e\u53ca\u65f6\u6027\uff1b\u8ddf\u8e2a\u6ce8\u518c\u5ba1\u6279\u8fdb\u5ea6\uff0c\u53ca\u65f6\u89e3\u51b3IND\/NDA\u6ce8\u518c\u7533\u62a5\u8fc7\u7a0b\u4e2d\u9047\u5230\u7684\u95ee\u9898\uff1b\u7ef4\u62a4\u516c\u53f8\u4e0eCFDA\u7b49\u836f\u76d1\u90e8\u95e8\u53ca\u5176\u4ed6\u76f8\u5173\u653f\u5e9c\u90e8\u95e8\u7684\u826f\u597d\u5173\u7cfb\uff1b <\/span><\/p>\n<\/li>\n

                  3. \n

                    \u603b\u7ed3\u5236\u5b9aIND\/NDA\u6ce8\u518c\u7533\u62a5\u7ba1\u7406\u7684\u5236\u5ea6\u3001\u539f\u5219\u53caSOP\uff1b\u6536\u96c6\u56fd\u5185\u5916\u836f\u76d1\u7684\u653f\u7b56\u6cd5\u89c4\uff0c\u5efa\u7acb\u5e76\u53ca\u65f6\u66f4\u65b0\u56fd\u5185\u5916\u6ce8\u518c\u76f8\u5173\u653f\u7b56\u4fe1\u606f\u5e93\uff1b<\/span><\/p>\n<\/li>\n

                  4. \n

                    \u4e0e\u516c\u53f8\u5176\u4ed6\u90e8\u95e8\u4fdd\u6301\u826f\u597d\u7684\u6c9f\u901a\uff1b\u5b8c\u6210\u4e0a\u7ea7\u4ea4\u4ee3\u7684\u5176\u4ed6\u5de5\u4f5c\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


                    <\/p>\n

                    \u4efb\u804c\u8d44\u683c\uff1a<\/span><\/strong><\/p>\n

                      \n
                    1. \n

                      \u5177\u6709\u56e2\u961f\u5408\u4f5c\u53ca\u5f00\u62d3\u521b\u65b0\u7cbe\u795e\u3001\u6709\u826f\u597d\u7684\u4eba\u9645\u6c9f\u901a\u548c\u7ec4\u7ec7\u534f\u8c03\u53ca\u8868\u8fbe\u80fd\u529b\uff1b<\/span><\/p>\n<\/li>\n

                    2. \n

                      \u719f\u6089\u836f\u54c1\u6ce8\u518c\u6cd5\u89c4\u53ca\u7533\u62a5\u6d41\u7a0b\uff1b\u719f\u6089\u6ce8\u518c\u7533\u62a5\u5404\u4e2a\u73af\u8282\u7684\u5bf9\u63a5\u7a0b\u5e8f\uff1b<\/span><\/p>\n<\/li>\n

                    3. \n

                      \u6709\u4e09\u5e74\u4ee5\u4e0a\u7684\u836f\u54c1\u6ce8\u518c\u7533\u62a5\u7ecf\u9a8c\uff1b\u6709\u591a\u6b21\u53bb\u56fd\u5bb6\u5c40\u6216\u5e02\u5c40\u7533\u62a5\u9879\u76ee\u7684\u7ecf\u9a8c\uff1b\u5bf9\u56fd\u5185\u5916\u7684\u533b\u836f\u5e02\u573a\u53ca\u76f8\u5173\u653f\u7b56\u6709\u4e00\u5b9a\u7684\u8ba4\u8bc6\uff1b\u6709\u6297\u80bf\u7624\u65b0\u836f\u56fd\u5185\u6ce8\u518c\u7533\u62a5\u7ecf\u9a8c\u8005\u4f18\u5148\u8003\u8651\uff1b<\/span><\/p>\n<\/li>\n

                    4. \n

                      \u751f\u7269\u533b\u836f\u76f8\u5173\u4e13\u4e1a\u672c\u79d1\u4ee5\u4e0a\u5b66\u5386\uff1b <\/span><\/p>\n<\/li>\n

                    5. \n

                      \u82f1\u8bed\u516d\u7ea7\u4ee5\u4e0a\uff08\u542b\uff09\uff1b<\/span><\/p>\n<\/li>\n

                    6. \n

                      \u6709\u836f\u54c1\u8fdb\u53e3\u6ce8\u518c\u7ecf\u9a8c\u8005\u4f18\u5148\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


                      <\/p>\n

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

                      \n
                      \n
                      \n
                      \n
                      \n
                      5<\/section>\n<\/section>\n<\/section>\n
                      Finance BP<\/section>\n<\/section>\n<\/section>\n<\/section>\n

                      \u85aa\u6c34\uff1a10-15K\/M<\/span><\/p>\n

                        \n
                      • \n

                        \u652f\u6301\u9500\u552e\u56e2\u961f\uff0c\u9500\u552e\u8d39\u7528\u7684\u5f52\u96c6\uff0c\u8d22\u52a1\u6570\u636e\u7edf\u8ba1\uff0c\u9884\u7b97\u6267\u884c\u60c5\u51b5\u5206\u6790\u5de5\u4f5c\u3002<\/span><\/p>\n<\/li>\n

                      • \n

                        \u533b\u836f\u5546\u4e1a\u884c\u4e1a\uff0c\u67091-2\u5e74BP\u80cc\u666f\u4f18\u5148\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


                        <\/p>\n

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

                        \n
                        \n
                        \n
                        \n
                        \n
                        6<\/section>\n<\/section>\n<\/section>\n
                        \u6cd5\u52a1\u7ecf\u7406\/\u603b\u76d1 <\/section>\n<\/section>\n<\/section>\n<\/section>\n

                        \u5e74\u85aa60-80\u4e07<\/span><\/p>\n

                          \n
                        • \n

                          \u72ec\u7acb\u8fdb\u884c\u6d77\u5916\u533b\u836f\u5546\u52a1\u5408\u4f5c\u9879\u76ee\u7684\u6cd5\u52a1\u652f\u6301\uff0c\u719f\u6089\u4ea7\u54c1\u5f15\u8fdb\u8fc7\u7a0b\u4e2d\u7684\u76f8\u5173\u6cd5\u5f8b\u6cd5\u89c4\uff0c\u5173\u6ce8\u6280\u672f\u8f6c\u79fb\u8d44\u6599\u7684\u5b8c\u6574\u6027\uff1b<\/span><\/p>\n<\/li>\n

                        • \n

                          \u65e5\u5e38\u56fd\u5185\u5546\u4e1a\u5408\u4f5c\u5408\u540c\u7684\u5ba1\u7406\u3002<\/span><\/p>\n<\/li>\n

                        • \n

                          \u82f1\u6587\u597d\uff0c\u6709\u4e00\u5b9a\u7684\u533b\u836f\u4e13\u4e1a\u80cc\u666f\uff0c\u5728\u884c\u4e1a\u5185\u67095\u5e74\u5de6\u53f3\u76f8\u5173\u5de5\u4f5c\u7ecf\u9a8c\u3002<\/span><\/p>\n<\/li>\n<\/ul>\n


                          <\/p>\n

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

                          \n
                          \n
                          \n
                          \n
                          \n
                          7<\/section>\n<\/section>\n<\/section>\n
                          \u5176\u4ed6\u9ad8\u7ba1\u804c\u4f4d<\/section>\n<\/section>\n<\/section>\n<\/section>\n
                            \n
                          • \n

                            \u809d\u75c5\u4e8b\u4e1a\u90e8\u603b\u7ecf\u7406120-150W<\/span><\/p>\n<\/li>\n

                          • \n

                            \u5fc3\u8840\u7ba1\u53ca\u7cd6\u5c3f\u75c5\u603b\u7ecf\u7406120-150W<\/span><\/p>\n<\/li>\n

                          • \n

                            \u4e2d\u67a2\u795e\u7ecf\u7cfb\u7edf\u603b\u7ecf\u7406120-150W<\/span><\/p>\n<\/li>\n

                          • \n

                            ANDA\u526f\u603b70-80W<\/span><\/p>\n<\/li>\n

                          • \n

                            \u6218\u7565\u6295\u8d44\u603b\u76d170-80w<\/span><\/p>\n<\/li>\n

                          • \n

                            \u6cd5\u52a1\u7ecf\u7406\/\u603b\u76d160-80w<\/span><\/p>\n

                            <\/span><\/p>\n<\/li>\n<\/ul>\n

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

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

                            \n
                            \n
                            \n
                            \n
                            \n

                            \u3010\u804c\u8fbe\u9ad8\u7ba1\u3011<\/span><\/strong>\u4e3a\u533b\u836f\u9b54\u65b9\u9ad8\u7aef\u76f4\u8058\u5e73\u53f0\uff0c\u4e3a\u533b\u836f\u884c\u4e1a\u8f93\u9001\u4f18\u8d28\u4eba\u624d\uff0c\u672c\u680f\u76ee\u804c\u4f4d\u4e3a\u4e2d\u9ad8\u7aef<\/strong>\u804c\u4f4d\uff0c\u4e3a\u533b\u836f\u9b54\u65b9\u4ee3\u4f18\u79c0\u533b\u836f\u4f01\u4e1a\u514d\u8d39<\/strong>\u53d1\u5e03\uff0c\u4fe1\u606f\u771f\u5b9e\u53ef\u9760\u3002\u6709\u6c42\u804c\u610f\u5411\u8005\uff0c\u53ef\u76f4\u63a5\u4e0e\u4f01\u4e1a\u8054\u7cfb\u3002\u5176\u4ed6\u4f01\u4e1a\u5982\u6709\u8be5\u7c7b\u804c\u4f4d\u9700\u8981\u53d1\u5e03\uff0c\u53ef\u4e0e\u6211\u4eec\u5de5\u4f5c\u4eba\u5458\u8054\u7cfb\uff08\u5fae\u4fe1\u53f7\uff1amedicube\uff09<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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                            \u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u533b\u836f\u9b54\u65b9 <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

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