{"id":607243,"date":"2025-12-02T05:14:34","date_gmt":"2025-12-02T13:14:34","guid":{"rendered":"https:\/\/nai500.com\/?p=607243"},"modified":"2025-12-02T05:14:34","modified_gmt":"2025-12-02T13:14:34","slug":"%e4%b8%8b%e4%b8%80%e4%b8%aa%e9%87%8d%e7%a3%85%e8%8d%af%e7%89%a9%e4%bc%9a%e6%9d%a5%e8%87%aa%e4%b8%ad%e5%9b%bd%e5%90%97%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/nai500.com\/zh-hans\/blog\/2025\/12\/%e4%b8%8b%e4%b8%80%e4%b8%aa%e9%87%8d%e7%a3%85%e8%8d%af%e7%89%a9%e4%bc%9a%e6%9d%a5%e8%87%aa%e4%b8%ad%e5%9b%bd%e5%90%97%ef%bc%9f\/","title":{"rendered":"\u4e0b\u4e00\u4e2a\u91cd\u78c5\u836f\u7269\u4f1a\u6765\u81ea\u4e2d\u56fd\u5417\uff1f"},"content":{"rendered":"

\u4e00\u6ce2\u65b0\u7684\u4e2d\u56fd\u5236\u836f\u4f01\u4e1a\u6b63\u4ece\u5feb\u901f\u8ddf\u968f\u8005\u8f6c\u5411\u9996\u521b\u8005\u3002\u7ecf\u8fc7\u591a\u5e74\u7684\u6295\u8d44\u5468\u671f\u3001\u76d1\u7ba1\u5347\u7ea7\u4ee5\u53ca\u4f9b\u5e94\u94fe\u7684\u5e38\u6001\u5316\uff0c\u4e2d\u56fd\u7684\u751f\u7269\u5236\u836f\u673a\u5668\u5df2\u5177\u5907\u5168\u7403\u5316\u8fd0\u4f5c\u80fd\u529b\u3002\u95ee\u9898\u4e0d\u518d\u770b\u8d77\u6765\u662f\u5047\u8bbe\u6027\u7684\uff1a\u4e0b\u4e00\u6b3e\u91cd\u78c5\u836f\u7269\u53ef\u80fd\u5728\u4e0a\u6d77\u88ab\u53d1\u73b0\uff0c\u5728\u4e9a\u6d32\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5728\u82cf\u5dde\u751f\u4ea7\uff0c\u5e76\u4ee5 FDA \u548c EMA \u6807\u7b7e\u4e0a\u5e02\u3002\u5982\u679c\u4f60\u662f\u5173\u6ce8\u53ef\u6301\u7eed\u589e\u957f\u548c\u73b0\u91d1\u6d41\u62a4\u57ce\u6cb3\u7684\u6295\u8d44\u8005\uff0c\u8fd9\u4e0d\u662f\u5c0f\u4f17\u6545\u4e8b\u3002\u8fd9\u662f\u4e00\u79cd\u6db5\u76d6\u53d1\u73b0\u3001\u4e34\u5e8a\u548c CDMO \u7684\u53ef\u5e7f\u6cdb\u51fa\u53e3\u7684\u80fd\u529b\uff0c\u5bf9\u5b9a\u4ef7\u6743\u548c\u65b0\u5174\u5e02\u573a\u53ef\u53ca\u6027\u5177\u6709\u6df1\u8fdc\u5f71\u54cd\u3002<\/p>\n

\u4e2d\u56fd\u751f\u7269\u79d1\u6280\u7684\u89c4\u6a21\u9047\u4e0a\u901f\u5ea6<\/h3>\n

\u5317\u4eac\u7684\u653f\u7b56\u6846\u67b6\u73b0\u5728\u5956\u52b1\u201c\u5feb\u901f\u8fbe\u6210\u8d28\u91cf\u201d\u3002NMPA \u7684\u6539\u9769\u3001\u4e0e ICH \u7684\u5bf9\u9f50\u4ee5\u53ca Marketing Authorization Holder \u5236\u5ea6\u538b\u7f29\u4e86\u65f6\u95f4\u7ebf\uff0c\u63a8\u52a8\u516c\u53f8\u65e9\u671f\u8fbe\u5230 FDA \u548c EMA \u6807\u51c6\u3002\u8fd9\u52a0\u901f\u4e86\u8de8\u5883\u5ba1\u6279\u548c\u5bf9\u5916\u6388\u6743\u3002\u5728\u57fa\u5c42\uff0c\u4e16\u754c\u7ea7\u7684\u5de5\u7a0b\u80fd\u529b\u5df2\u8f6c\u5316\u4e3a\u4ea7\u51fa\u80fd\u529b\u3002WuXi AppTec (SSE: 603259; HKEX: 2359) \u6784\u5efa\u4e86\u8d2f\u7a7f\u53d1\u73b0\u3001\u5f00\u53d1\u548c\u5236\u9020\u7684\u7aef\u5230\u7aef\u5e73\u53f0\u3002\u5176\u7ea6 39,000 \u540d\u5458\u5de5\u30016,000 \u4e2a\u5ba2\u6237\u4ee5\u53ca\u8986\u76d6\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u5fb7\u56fd\u3001\u745e\u58eb\u548c\u65b0\u52a0\u5761\u7684\u7f51\u7edc\uff0c\u4e3a\u4efb\u4f55\u751f\u7269\u6280\u672f\u516c\u53f8\u63d0\u4f9b\u4e86\u5373\u65f6\u7684\u5168\u7403\u8db3\u8ff9\u3002\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u4e5f\u5728\u8d76\u4e0a\uff0c\u5f97\u76ca\u4e8e\u4e0a\u6d77\u3001\u82cf\u5dde\u3001\u5e7f\u5dde\u548c\u5317\u4eac\u7684\u533b\u9662\u7f51\u7edc\uff0c\u4ee5\u53ca\u964d\u4f4e\u4e0a\u5e02\u540e\u7814\u7a76\u98ce\u9669\u7684\u771f\u5b9e\u4e16\u754c\u6570\u636e\u8bd5\u70b9\u3002\u6700\u7ec8\u6548\u679c\u662f\u5f62\u6210\u4e86\u4e00\u4e2a\u80fd\u591f\u5728\u4e0d\u8d70\u6377\u5f84\u7684\u60c5\u51b5\u4e0b\u538b\u7f29\u7814\u53d1\u5468\u671f\u7684\u56fd\u5185\u751f\u6001\u7cfb\u7edf\uff0c\u4ee5\u53ca\u4e00\u4e2a\u73b0\u5728\u6210\u4e3a\u7ade\u4e89\u4f18\u52bf\u800c\u975e\u75ab\u60c5\u65f6\u4ee3\u74f6\u9888\u7684\u4f9b\u5e94\u94fe\u3002<\/p>\n

\u653f\u7b56\u987a\u98ce\u4e0e FDA \u52a8\u80fd<\/h3>\n

\u7814\u53d1\u7ba1\u7ebf\u5f00\u59cb\u83b7\u5f97\u897f\u65b9\u6807\u7b7e\u3002BeiGene \u7684 Brukinsa \u83b7\u5f97\u591a\u6b21 FDA \u6279\u51c6\uff0c\u6700\u7ec8\u5728 2023 \u5e74\u56e0\u5728\u6162\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u4e2d\u7684\u5ba1\u6279\u83b7\u6279\uff1b\u5176\u5728\u4e0e ibrutinib \u7684\u6b63\u9762\u6bd4\u8f83\u7814\u7a76\u4e2d\u663e\u793a\u66f4\u4f18\u7597\u6548\uff0c\u4ece\u800c\u6539\u53d8\u4e86\u4e34\u5e8a\u533b\u751f\u7684\u5904\u65b9\u884c\u4e3a\u3002Legend Biotech \u4e0e Janssen \u5171\u540c\u5f00\u53d1\u7684 CAR-T \u7597\u6cd5 Carvykti \u83b7\u5f97\u7f8e\u56fd\u6279\u51c6\u5e76\u6b63\u5728\u6269\u5927\u5728\u6b27\u6d32\u7684\u53ef\u53ca\u6027\uff0c\u8fd9\u662f\u4e2d\u56fd\u539f\u521b\u79d1\u5b66\u8f6c\u5316\u4e3a\u7f8e\u56fd\u9500\u91cf\u7684\u91cd\u8981\u91cc\u7a0b\u7891\u3002\u4e0e\u6b64\u540c\u65f6\uff0c\u5bf9\u5916\u6388\u6743\u5df2\u6210\u719f\u4e3a\u53ef\u91cd\u590d\u7684\u878d\u8d44\u5f15\u64ce\uff1a\u672c\u571f\u9886\u5148\u8005\u65e9\u671f\u5c06\u8d44\u4ea7\u8d27\u5e01\u5316\u7ed9\u5168\u7403\u5236\u836f\u516c\u53f8\uff0c\u540c\u65f6\u5728\u56fd\u5185\u6784\u5efa\u81ea\u5df1\u7684\u5546\u4e1a\u5316\u4f53\u7cfb\u3002\u8fd9\u4e0d\u4ec5\u5173\u4e4e\u836f\u7269\uff0c\u8fd8\u5173\u4e4e\u57fa\u7840\u8bbe\u65bd\u548c\u6570\u5b57\u6760\u6746\u3002\u201c\u4e00\u5e26\u4e00\u8def\u201d\u7269\u6d41\u548c China Communications Construction Company \u7684\u5168\u7403\u8d70\u5eca\u9879\u76ee\u4f7f\u751f\u7269\u5236\u5242\u51b7\u94fe\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u8fd0\u8f93\u5728\u4e9a\u6d32\u3001\u975e\u6d32\u548c\u4e2d\u4e1c\u66f4\u53ef\u9760\uff0c\u6253\u5f00\u4e86\u9ad8\u589e\u957f\u5e02\u573a\u3002\u56fd\u5bb6\u7ea7\u7684 AI \u4e0e\u4e91\u8ba1\u7b97\u80fd\u529b\u4e3a\u7814\u53d1\u56e2\u961f\u63d0\u4f9b\u66f4\u5f3a\u7684\u8fed\u4ee3\u52a8\u529b\u3002Alibaba Group \u7684\u8d85\u5927\u89c4\u6a21\u4e91\u652f\u6301\u57fa\u56e0\u7ec4\u5b66\u548c\u5316\u5b66\u9886\u57df\u7684\u6a21\u578b\u8bad\u7ec3\u4e0e\u4eff\u771f\u8ba1\u7b97\uff0c\u800c Tencent \u7684\u6570\u5b57\u5065\u5eb7\u89e6\u8fbe\u4e0e\u4e91\u5de5\u5177\u5219\u7b80\u5316\u4e86 eClinical \u5de5\u4f5c\u6d41\u3002\u89c4\u6a21\u3001\u653f\u7b56\u3001AI \u4e0e\u5206\u9500\u5f7c\u6b64\u5f3a\u5316\u3002<\/p>\n

\u5f53\u524d\u503c\u5f97\u5173\u6ce8\u7684 10 \u53ea\u4e2d\u56fd\u751f\u7269\u5236\u836f\u80a1<\/h3>\n

1) BeiGene (NASDAQ: BGNE) \u2013 \u91cc\u7a0b\u7891\uff1aBrukinsa \u5728 2023 \u5e74\u56e0\u5728 CLL \u7684 FDA \u6279\u51c6\u800c\u53d6\u5f97\u91cd\u8981\u7a81\u7834\uff0c\u5176\u4e0e ibrutinib \u7684\u5934\u5bf9\u5934\u7814\u7a76\u663e\u793a\u51fa\u66f4\u4f18\u7684\u7597\u6548\u3002\u5168\u7403\u5f71\u54cd\uff1a\u5728 BTK \u6291\u5236\u5242\u9886\u57df\u6269\u5927\u7f8e\u6b27\u5e02\u573a\u4efd\u989d\uff0c\u51f8\u663e\u4e2d\u56fd\u5728\u91cd\u5927\u80bf\u7624\u5b66\u54c1\u7c7b\u4e2d\u9886\u5148\u7684\u80fd\u529b\u3002<\/p>\n

2) WuXi AppTec (SSE: 603259; HKEX: 2359) \u2013 \u91cc\u7a0b\u7891\uff1a\u6784\u5efa\u4e86\u7531 20 \u4e2a\u7ad9\u70b9\u7ec4\u6210\u7684\u5168\u7403\u7f51\u7edc\uff0c\u4e3a 6,000 \u4e2a\u5ba2\u6237\u63d0\u4f9b\u8d2f\u7a7f\u836f\u7269\u751f\u547d\u5468\u671f\u7684\u670d\u52a1\u3002\u5168\u7403\u5f71\u54cd\uff1a\u6210\u4e3a\u5168\u7403\u751f\u7269\u6280\u672f\u521b\u65b0\u7684\u4e8b\u5b9e\u6027\u652f\u67f1\uff0c\u964d\u4f4e\u4e86\u6210\u5343\u4e0a\u4e07\u9879\u76ee\u7684\u6210\u672c\u548c\u4e34\u5e8a\u542f\u52a8\u65f6\u95f4\u3002<\/p>\n

3) WuXi Biologics (HKEX: 2269) \u2013 \u91cc\u7a0b\u7891\uff1a\u4e2d\u56fd\u3001\u7231\u5c14\u5170\u4e0e\u5fb7\u56fd\u62e5\u6709\u591a\u5ea7\u901a\u8fc7 FDA \u4e0e EMA \u68c0\u67e5\u7684\u751f\u7269\u5236\u836f\u5382\u5e76\u5df2\u6295\u5165\u8fd0\u8425\u3002\u5168\u7403\u5f71\u54cd\uff1a\u6210\u4e3a\u5168\u7403\u6700\u5927\u7684\u4e00\u6b21\u6027\u8017\u6750\u751f\u7269\u5236\u9020\u4ea7\u80fd\u4e4b\u4e00\uff0c\u652f\u6301\u5168\u7403\u4e0a\u5e02\u7684\u5feb\u901f\u653e\u91cf\u3002<\/p>\n

4) Innovent Biologics (HKEX: 1801) \u2013 \u91cc\u7a0b\u7891\uff1a\u5176\u4e0e Eli Lilly \u5171\u540c\u5f00\u53d1\u7684 PD-1 \u6291\u5236\u5242 Tyvyt \u5df2\u5165\u9009\u4e2d\u56fd\u56fd\u5bb6\u533b\u4fdd\u76ee\u5f55\u5e76\u5728\u6269\u5927\u9002\u5e94\u75c7\u3002\u5168\u7403\u5f71\u54cd\uff1a\u5c55\u793a\u4e86\u4e2d\u56fd\u4e0e\u897f\u65b9\u4f19\u4f34\u5171\u5efa\u514d\u75ab\u80bf\u7624\u5b66\u54c1\u724c\u7684\u80fd\u529b\u3002<\/p>\n

5) Zai Lab (NASDAQ: ZLAB) \u2013 \u91cc\u7a0b\u7891\uff1a\u901a\u8fc7\u5408\u4f5c\u5728\u4e2d\u56fd\u63a8\u51fa\u591a\u6b3e\u9996\u521b\/\u5148\u4e0a\u5e02\u7597\u6cd5\uff0c\u5305\u62ec\u7528\u4e8e\u5375\u5de2\u764c\u7684 niraparib\u3002\u5168\u7403\u5f71\u54cd\uff1a\u4f5c\u4e3a\u5168\u7403\u751f\u7269\u79d1\u6280\u8fdb\u5165\u4e2d\u56fd\u7684\u53ef\u9760\u5546\u4e1a\u5316\u6865\u6881\uff0c\u52a0\u901f\u4e86\u4e16\u754c\u7b2c\u4e8c\u5927\u836f\u54c1\u5e02\u573a\u7684\u60a3\u8005\u7528\u836f\u53ef\u53ca\u6027\u3002<\/p>\n

6) Jiangsu Hengrui (SSE: 600276) \u2013 \u91cc\u7a0b\u7891\uff1a\u5728\u4e2d\u56fd\u5236\u836f\u4f01\u4e1a\u4e2d\u7814\u53d1\u6295\u5165\u540d\u5217\u524d\u8305\uff0c\u62e5\u6709\u5e7f\u6cdb\u7684\u6297\u80bf\u7624\u4e0e ADC \u7ba1\u7ebf\uff0c\u5e76\u5728\u7f8e\u56fd\u6709 IND \u53d7\u7406\u4e2d\u3002\u5168\u7403\u5f71\u54cd\uff1a\u4f5c\u4e3a\u9886\u5148\u7684\u672c\u571f\u521b\u65b0\u8005\uff0c\u65e5\u76ca\u901a\u8fc7\u8de8\u5883\u4ea4\u6613\u9a8c\u8bc1\u5176\u7ba1\u7ebf\u8d28\u91cf\u3002<\/p>\n

7) Legend Biotech (NASDAQ: LEGN) \u2013 \u91cc\u7a0b\u7891\uff1aCarvykti \u5728\u591a\u53d1\u6027\u9aa8\u9ad3\u7624\u7684 FDA \u6279\u51c6\uff0c\u5e76\u5728\u4e3b\u8981\u5e02\u573a\u6269\u5927\u9002\u5e94\u8bc1\u3002\u5168\u7403\u5f71\u54cd\uff1a\u5c06\u4e2d\u56fd\u8d77\u6e90\u7684\u7ec6\u80de\u6cbb\u7597\u63a8\u5411\u5168\u7403\u821e\u53f0\uff0c\u5236\u9020\u4e0e\u4f9b\u5e94\u89c4\u6a21\u5df2\u80fd\u6ee1\u8db3\u7f8e\u6b27\u9700\u6c42\u3002<\/p>\n

8) CSPC Pharmaceutical Group (HKEX: 1093) \u2013 \u91cc\u7a0b\u7891\uff1a2023 \u5e74\u83b7\u6279\u4e2d\u56fd\u672c\u571f\u7814\u53d1\u7684 mRNA COVID-19 \u8ffd\u52a0\u9488\u3002\u5168\u7403\u5f71\u54cd\uff1a\u5728\u65b0\u578b\u6280\u672f\u5e73\u53f0\u4e0a\u7684\u80fd\u529b\u6269\u5c55\u4e86\u4e2d\u56fd\u5728\u75ab\u82d7\u4e0e mRNA \u5e73\u53f0\u4e0a\u7684\u5b58\u5728\uff0c\u4e3a\u672a\u6765\u4f20\u67d3\u75c5\u4e0e\u80bf\u7624\u5b66\u5e94\u7528\u505a\u51c6\u5907\u3002<\/p>\n

9) Pharmaron (SZSE: 300759; HKEX: 3759) \u2013 \u91cc\u7a0b\u7891\uff1a\u5c06\u4e00\u4f53\u5316 CRO \u4e0e CDMO \u670d\u52a1\u6269\u5c55\u5230\u7ec6\u80de\u4e0e\u57fa\u56e0\u6cbb\u7597\uff0c\u7ad9\u70b9\u8986\u76d6\u4e2d\u56fd\u3001\u7f8e\u56fd\u4e0e\u82f1\u56fd\u3002\u5168\u7403\u5f71\u54cd\uff1a\u4f5c\u4e3a\u8de8\u5883\u5f00\u53d1\u5f15\u64ce\uff0c\u964d\u4f4e CMC \u98ce\u9669\u5e76\u52a0\u901f\u5148\u8fdb\u7597\u6cd5\u7684\u65f6\u95f4\u8868\u3002<\/p>\n

10) Tigermed (SZSE: 300347; HKEX: 3347) \u2013 \u91cc\u7a0b\u7891\uff1a\u5efa\u7acb\u4e86\u652f\u6301\u8de8\u5730\u533a\u591a\u4e2d\u5fc3\u80bf\u7624\u4e0e\u7f55\u89c1\u75c5\u8bd5\u9a8c\u7684\u5168\u7403\u4e34\u5e8a\u8fd0\u8425\u8db3\u8ff9\u3002\u5168\u7403\u5f71\u54cd\uff1a\u63d0\u5347\u4e86\u4e2d\u56fd\u5728\u5173\u952e\u6027\u8bd5\u9a8c\u6267\u884c\u4e2d\u7684\u89d2\u8272\uff0c\u63d0\u9ad8\u4e86\u5168\u7403\u6570\u636e\u96c6\u7684\u901f\u5ea6\u4e0e\u591a\u6837\u6027\u3002<\/p>\n

AI\u3001\u4e91\u4e0e\u57fa\u7840\u8bbe\u65bd\u653e\u5927\u4f18\u52bf<\/h3>\n

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