{"id":607244,"date":"2025-12-02T05:19:34","date_gmt":"2025-12-02T13:19:34","guid":{"rendered":"https:\/\/nai500.com\/?p=607244"},"modified":"2025-12-02T05:19:34","modified_gmt":"2025-12-02T13:19:34","slug":"%e4%b8%8b%e4%b8%80%e5%80%8b%e9%87%8d%e7%a3%85%e8%97%a5%e6%9c%83%e4%be%86%e8%87%aa%e4%b8%ad%e5%9c%8b%e5%97%8e%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/nai500.com\/zh-hant\/blog\/2025\/12\/%e4%b8%8b%e4%b8%80%e5%80%8b%e9%87%8d%e7%a3%85%e8%97%a5%e6%9c%83%e4%be%86%e8%87%aa%e4%b8%ad%e5%9c%8b%e5%97%8e%ef%bc%9f\/","title":{"rendered":"\u4e0b\u4e00\u500b\u91cd\u78c5\u85e5\u6703\u4f86\u81ea\u4e2d\u570b\u55ce\uff1f"},"content":{"rendered":"

\u65b0\u4e00\u6ce2\u4e2d\u570b\u85e5\u5ee0\u6b63\u5f9e\u5feb\u901f\u8ddf\u96a8\u8005\u8f49\u5411\u5148\u884c\u8005\u3002\u7d93\u904e\u591a\u5e74\u6295\u8cc7\u9031\u671f\u3001\u76e3\u7ba1\u5347\u7d1a\u8207\u4f9b\u61c9\u93c8\u56de\u6b78\u5e38\u614b\uff0c\u4e2d\u570b\u7684\u751f\u7269\u88fd\u85e5\u6a5f\u5668\u5df2\u9054\u5230\u5168\u7403\u898f\u6a21\u3002\u554f\u984c\u4e0d\u518d\u53ea\u662f\u5047\u8a2d\uff1a\u4e0b\u4e00\u500b\u91cd\u78c5\u85e5\u53ef\u80fd\u5728\u4e0a\u6d77\u88ab\u767c\u73fe\u3001\u5728\u4e9e\u6d32\u591a\u570b\u9032\u884c\u8a66\u9a57\u3001\u5728\u8607\u5dde\u751f\u7522\uff0c\u4e26\u4ee5 FDA \u8207 EMA \u6a19\u7c64\u4e0a\u5e02\u3002\u82e5\u4f60\u662f\u8ffd\u8e64\u8010\u4e45\u6210\u9577\u8207\u73fe\u91d1\u7522\u751f\u8b77\u57ce\u6cb3\u7684\u6295\u8cc7\u8005\uff0c\u9019\u4e0d\u662f\u5c0f\u773e\u6545\u4e8b\uff0c\u800c\u662f\u4e00\u9805\u6db5\u84cb\u767c\u73fe\u3001\u81e8\u5e8a\u8207 CDMO \u7684\u5ee3\u6cdb\u4e14\u53ef\u51fa\u53e3\u80fd\u529b\uff0c\u5c0d\u65b0\u8208\u5e02\u5834\u7684\u5b9a\u50f9\u529b\u8207\u53ef\u53ca\u6027\u5177\u6709\u6df1\u9060\u5f71\u97ff\u3002<\/p>\n

\u4e2d\u570b\u751f\u6280\u7684\u898f\u6a21\u9047\u4e0a\u901f\u5ea6<\/h3>\n

\u5317\u4eac\u7684\u653f\u7b56\u67b6\u69cb\u5982\u4eca\u734e\u52f5\u5411\u54c1\u8cea\u8fc5\u901f\u9081\u9032\u3002NMPA \u7684\u6539\u9769\u3001\u8207 ICH \u7684\u5c0d\u9f4a\uff0c\u4ee5\u53ca Marketing Authorization Holder \u5236\u5ea6\u58d3\u7e2e\u4e86\u6642\u9593\u7dda\uff0c\u4e26\u8feb\u4f7f\u516c\u53f8\u65e9\u671f\u5c31\u9054\u5230 FDA \u8207 EMA \u6a19\u6e96\u3002\u9019\u52a0\u901f\u4e86\u8de8\u5883\u6838\u51c6\u8207\u6388\u6b0a\u6388\u51fa\u3002\u5be6\u52d9\u5c64\u9762\u4e0a\uff0c\u4e16\u754c\u7d1a\u5de5\u7a0b\u80fd\u529b\u5df2\u8f49\u5316\u70ba\u541e\u5410\u91cf\u3002WuXi AppTec (SSE: 603259; HKEX: 2359) \u652f\u6490\u8d77\u4e00\u500b\u6db5\u84cb\u767c\u73fe\u3001\u958b\u767c\u8207\u88fd\u9020\u7684\u7aef\u5230\u7aef\u5e73\u53f0\u3002\u64c1\u6709\u7d04 3.9 \u842c\u540d\u54e1\u5de5\u30016,000 \u500b\u5ba2\u6236\uff0c\u4ee5\u53ca\u904d\u53ca\u4e2d\u570b\u3001\u7f8e\u570b\u3001\u5fb7\u570b\u3001\u745e\u58eb\u8207\u65b0\u52a0\u5761\u7684\u7db2\u7d61\uff0c\u5b83\u70ba\u4efb\u4f55\u751f\u6280\u516c\u53f8\u5373\u523b\u63d0\u4f9b\u5168\u7403\u8db3\u8de1\u3002\u81e8\u5e8a\u8a66\u9a57\u54c1\u8cea\u4e5f\u6b63\u5728\u8fce\u982d\u8d95\u4e0a\uff0c\u5f97\u76ca\u65bc\u4e0a\u6d77\u3001\u8607\u5dde\u3001\u5ee3\u5dde\u8207\u5317\u4eac\u7684\u91ab\u9662\u7db2\u7d61\uff0c\u4ee5\u53ca\u964d\u4f4e\u4e0a\u5e02\u5f8c\u7814\u7a76\u98a8\u96aa\u7684\u5be6\u52d9\u6578\u64da\u8a66\u9ede\u3002\u6574\u9ad4\u6548\u61c9\u662f\uff1a\u4e00\u500b\u53ef\u58d3\u7e2e\u958b\u767c\u9031\u671f\u800c\u4e0d\u5077\u5de5\u6e1b\u6599\u7684\u570b\u5167\u751f\u614b\u7cfb\uff0c\u8207\u73fe\u5df2\u6210\u70ba\u7af6\u722d\u512a\u52e2\u800c\u975e COVID \u671f\u9593\u74f6\u9838\u7684\u4f9b\u61c9\u93c8\u3002<\/p>\n

\u653f\u7b56\u9806\u98a8\u8207 FDA \u52d5\u80fd<\/h3>\n

\u7ba1\u7dda\u958b\u59cb\u53d6\u5f97\u897f\u65b9\u6a19\u7c64\u3002BeiGene \u7684 Brukinsa \u5728\u5c0d\u6bd4 ibrutinib \u7684\u982d\u5c0d\u982d\u7814\u7a76\u5c55\u73fe\u512a\u8d8a\u7642\u6548\u5f8c\uff0c\u65bc 2023 \u5e74\u7372\u5f97 FDA \u5c0d\u6162\u6027\u6dcb\u5df4\u7403\u767d\u8840\u75c5\u7684\u6838\u51c6\uff0c\u4e26\u6539\u8b8a\u4e86\u91ab\u5e2b\u4f7f\u7528\u7fd2\u6163\u3002Legend Biotech \u8207 Janssen \u5171\u540c\u958b\u767c\u7684 CAR-T \u7642\u6cd5 Carvykti \u7372\u5f97\u7f8e\u570b\u6838\u51c6\uff0c\u4e26\u5728\u6b50\u6d32\u64f4\u5927\u53ef\u53ca\u6027\uff0c\u9019\u5c0d\u4e2d\u570b\u8d77\u6e90\u79d1\u5b78\u8f49\u5316\u70ba\u7f8e\u570b\u92b7\u552e\u662f\u500b\u91cc\u7a0b\u7891\u3002\u8207\u6b64\u540c\u6642\uff0c\u6388\u6b0a\u51fa\u8b93\u5df2\u6210\u719f\u70ba\u53ef\u8907\u88fd\u7684\u8cc7\u91d1\u4f86\u6e90\uff1a\u570b\u5167\u9f8d\u982d\u65e9\u671f\u5c07\u8cc7\u7522\u8b8a\u73fe\u7d66\u5168\u7403\u85e5\u5ee0\uff0c\u540c\u6642\u5728\u570b\u5167\u69cb\u5efa\u81ea\u5df1\u7684\u5546\u696d\u67b6\u69cb\u3002\u9019\u4e0d\u50c5\u95dc\u4e4e\u85e5\u7269\uff0c\u4e5f\u95dc\u4e4e\u57fa\u790e\u8a2d\u65bd\u8207\u6578\u4f4d\u69d3\u687f\u3002\u300c\u4e00\u5e36\u4e00\u8def\u300d\u7269\u6d41\u8207 China Communications Construction Company \u7684\u5168\u7403\u8d70\u5eca\u9805\u76ee\u4f7f\u751f\u7269\u88fd\u5291\u51b7\u93c8\u8207\u81e8\u5e8a\u8a66\u9a57\u904b\u8f38\u5728\u4e9e\u6d32\u3001\u975e\u6d32\u8207\u4e2d\u6771\u66f4\u70ba\u53ef\u9760\uff0c\u958b\u555f\u9ad8\u6210\u9577\u5e02\u5834\u3002\u570b\u5bb6\u7d1a AI \u8207\u96f2\u7aef\u904b\u7b97\u70ba\u7814\u767c\u5718\u968a\u63d0\u4f9b\u66f4\u5feb\u8fed\u4ee3\u7684\u7b97\u529b\u3002Alibaba Group \u7684\u8d85\u5927\u898f\u6a21\u96f2\u7aef\u652f\u63f4\u57fa\u56e0\u9ad4\u5b78\u8207\u5316\u5b78\u9818\u57df\u7684\u6a21\u578b\u8a13\u7df4\u8207\u6a21\u64ec\u5de5\u4f5c\u8ca0\u8f09\uff0c\u800c Tencent \u7684\u6578\u4f4d\u5065\u5eb7\u8986\u84cb\u8207\u96f2\u7aef\u5de5\u5177\u7c21\u5316\u4e86 eClinical \u5de5\u4f5c\u6d41\u7a0b\u3002\u898f\u6a21\u3001\u653f\u7b56\u3001AI \u8207\u5206\u92b7\u76f8\u4e92\u5f37\u5316\u3002<\/p>\n

\u73fe\u5728\u503c\u5f97\u95dc\u6ce8\u7684 10 \u6a94\u4e2d\u570b\u751f\u7269\u88fd\u85e5\u80a1\u7968<\/h3>\n

1) BeiGene (NASDAQ: BGNE) \u2013 \u91cc\u7a0b\u7891\uff1aBrukinsa \u5728 2023 \u5e74\u7372 FDA \u627f\u8a8d\u7528\u65bc CLL\uff0c\u4e4b\u524d\u5728\u982d\u5c0d\u982d\u7814\u7a76\u4e2d\u5c0d ibrutinib \u986f\u793a\u51fa\u66f4\u597d\u7684\u7642\u6548\u3002\u5168\u7403\u5f71\u97ff\uff1a\u5728 BTK \u6291\u5236\u5291\u9818\u57df\u64f4\u5927\u7f8e\u570b\u8207\u6b50\u76df\u5e02\u5360\uff0c\u5f70\u986f\u4e2d\u570b\u5728\u91cd\u8981\u816b\u7624\u7642\u6cd5\u985e\u5225\u4e2d\u7684\u9818\u5c0e\u80fd\u529b\u3002<\/p>\n

2) WuXi AppTec (SSE: 603259; HKEX: 2359) \u2013 \u91cc\u7a0b\u7891\uff1a\u5efa\u69cb\u4e86\u6db5\u84cb\u85e5\u7269\u751f\u547d\u9031\u671f\u3001\u670d\u52d9 6,000 \u540d\u5ba2\u6236\u7684 20 \u7ad9\u5168\u7403\u7db2\u7d61\u3002\u5168\u7403\u5f71\u97ff\uff1a\u6210\u70ba\u5168\u7403\u751f\u6280\u5275\u65b0\u7684\u4e8b\u5be6\u4e0a\u9aa8\u5e79\uff0c\u70ba\u6578\u5343\u500b\u8a08\u756b\u964d\u4f4e\u6210\u672c\u8207\u5230\u81e8\u5e8a\u7684\u6642\u9593\u3002<\/p>\n

3) WuXi Biologics (HKEX: 2269) \u2013 \u91cc\u7a0b\u7891\uff1a\u4e2d\u570b\u3001\u611b\u723e\u862d\u8207\u5fb7\u570b\u7684\u591a\u500b\u751f\u7269\u88fd\u5291\u5ee0\u5df2\u901a\u904e FDA \u8207 EMA \u8996\u5bdf\u4e26\u4e0a\u7dda\u3002\u5168\u7403\u5f71\u97ff\uff1a\u6210\u70ba\u5168\u7403\u6700\u5927\u4e4b\u4e00\u7684\u4e00\u6b21\u6027\u751f\u7269\u88fd\u5291\u88fd\u9020\u9ad4\u7cfb\uff0c\u80fd\u70ba\u5168\u7403\u4e0a\u5e02\u63d0\u4f9b\u5feb\u901f\u64f4\u7522\u80fd\u529b\u3002<\/p>\n

4) Innovent Biologics (HKEX: 1801) \u2013 \u91cc\u7a0b\u7891\uff1a\u5176\u8207 Eli Lilly \u5171\u540c\u958b\u767c\u7684 PD-1 \u6291\u5236\u5291 Tyvyt \u5df2\u5165\u5217\u4e2d\u570b\u570b\u5bb6\u91ab\u4fdd\u76ee\u9304\u4e26\u64f4\u5927\u9069\u61c9\u75c7\u3002\u5168\u7403\u5f71\u97ff\uff1a\u5c55\u793a\u4e2d\u570b\u8207\u897f\u65b9\u5925\u4f34\u5171\u540c\u6253\u9020\u514d\u75ab\u816b\u7624\u5b78\u7cfb\u5217\u7522\u54c1\u7684\u80fd\u529b\u3002<\/p>\n

5) Zai Lab (NASDAQ: ZLAB) \u2013 \u91cc\u7a0b\u7891\uff1a\u900f\u904e\u5408\u4f5c\u5728\u4e2d\u570b\u63a8\u51fa\u591a\u9805\u9996\u5275\u7642\u6cd5\uff0c\u5305\u62ec\u7528\u65bc\u5375\u5de2\u764c\u7684 niraparib\u3002\u5168\u7403\u5f71\u97ff\uff1a\u4f5c\u70ba\u5168\u7403\u751f\u6280\u9032\u5165\u4e2d\u570b\u5546\u696d\u5316\u7684\u6a4b\u6a11\uff0c\u4fc3\u9032\u4e16\u754c\u7b2c\u4e8c\u5927\u85e5\u54c1\u5e02\u5834\u7684\u75c5\u60a3\u53ef\u53ca\u6027\u3002<\/p>\n

6) Jiangsu Hengrui (SSE: 600276) \u2013 \u91cc\u7a0b\u7891\uff1a\u70ba\u4e2d\u570b\u85e5\u4f01\u4e2d\u7814\u767c\u652f\u51fa\u6700\u9ad8\u8005\u4e4b\u4e00\uff0c\u64c1\u6709\u5ee3\u6cdb\u7684\u816b\u7624\u8207 ADC \u7ba1\u7dda\uff0c\u4e26\u6709\u7f8e\u570b IND \u7533\u8acb\u5728\u9032\u884c\u4e2d\u3002\u5168\u7403\u5f71\u97ff\uff1a\u4f5c\u70ba\u570b\u5167\u9802\u5c16\u5275\u65b0\u8005\uff0c\u65e5\u76ca\u7de0\u7d50\u8de8\u5883\u4ea4\u6613\u4ee5\u9a57\u8b49\u5176\u7ba1\u7dda\u54c1\u8cea\u3002<\/p>\n

7) Legend Biotech (NASDAQ: LEGN) \u2013 \u91cc\u7a0b\u7891\uff1aCarvykti \u7372 FDA \u6838\u51c6\u7528\u65bc\u591a\u767c\u6027\u9aa8\u9ad3\u7624\uff0c\u4e14\u5728\u4e3b\u8981\u5e02\u5834\u6301\u7e8c\u64f4\u5927\u9069\u61c9\u75c7\u3002\u5168\u7403\u5f71\u97ff\uff1a\u5c07\u4e2d\u570b\u8d77\u6e90\u7684\u7d30\u80de\u7642\u6cd5\u63a8\u5411\u5168\u7403\u821e\u53f0\uff0c\u88fd\u9020\u8207\u4f9b\u61c9\u5df2\u64f4\u5145\u4ee5\u6eff\u8db3\u7f8e\u570b\u8207\u6b50\u76df\u9700\u6c42\u3002<\/p>\n

8) CSPC Pharmaceutical Group (HKEX: 1093) \u2013 \u91cc\u7a0b\u7891\uff1a\u5728 2023 \u5e74\u7372\u6279\u4e2d\u570b\u570b\u5167\u958b\u767c\u7684 mRNA COVID-19 \u52a9\u63a8\u5291\u3002\u5168\u7403\u5f71\u97ff\uff1a\u5728\u65b0\u578b\u85e5\u5291\u578b\u614b\u4e0a\u7684\u80fd\u529b\u64f4\u5c55\u4e86\u4e2d\u570b\u5728\u75ab\u82d7\u8207 mRNA \u5e73\u53f0\u7684\u4f48\u5c40\uff0c\u5c0d\u672a\u4f86\u50b3\u67d3\u75c5\u8207\u816b\u7624\u61c9\u7528\u5177\u6709\u610f\u7fa9\u3002<\/p>\n

9) Pharmaron (SZSE: 300759; HKEX: 3759) \u2013 \u91cc\u7a0b\u7891\uff1a\u5c07\u6574\u5408\u5f0f CRO \u8207 CDMO \u670d\u52d9\u64f4\u5c55\u5230\u7d30\u80de\u8207\u57fa\u56e0\u7642\u6cd5\uff0c\u4e26\u5728\u4e2d\u570b\u3001\u7f8e\u570b\u8207\u82f1\u570b\u8a2d\u9ede\u3002\u5168\u7403\u5f71\u97ff\uff1a\u4f5c\u70ba\u8de8\u5883\u958b\u767c\u5f15\u64ce\uff0c\u964d\u4f4e CMC \u98a8\u96aa\u4e26\u52a0\u901f\u5148\u9032\u7642\u6cd5\u6642\u9593\u8868\u3002<\/p>\n

10) Tigermed (SZSE: 300347; HKEX: 3347) \u2013 \u91cc\u7a0b\u7891\uff1a\u5efa\u7acb\u4e86\u652f\u63f4\u6db5\u84cb\u816b\u7624\u8207\u7f55\u898b\u75be\u75c5\u7684\u591a\u5340\u57df\u8a66\u9a57\u7684\u5168\u7403\u81e8\u5e8a\u904b\u71df\u8db3\u8de1\u3002\u5168\u7403\u5f71\u97ff\uff1a\u63d0\u5347\u4e2d\u570b\u5728\u95dc\u9375\u8a66\u9a57\u57f7\u884c\u4e2d\u7684\u89d2\u8272\uff0c\u6539\u5584\u5168\u7403\u8cc7\u6599\u96c6\u7684\u901f\u5ea6\u8207\u591a\u6a23\u6027\u3002<\/p>\n

AI\u3001\u96f2\u7aef\u8207\u57fa\u790e\u8a2d\u65bd\u653e\u5927\u512a\u52e2<\/h3>\n

\u4ee5 AI \u70ba\u5148\u7684\u85e5\u7269\u8a2d\u8a08\u5df2\u5f9e\u627f\u8afe\u8d70\u5411\u751f\u7522\u529b\u3002\u4e2d\u570b\u5718\u968a\u90e8\u7f72\u57fa\u790e\u6a21\u578b\u65bc\u76ee\u6a19\u767c\u73fe\u3001\u7d50\u69cb\u9810\u6e2c\u8207 de novo \u8a2d\u8a08\uff0c\u58d3\u7e2e hit-to-lead \u9031\u671f\u3002\u5f97\u76ca\u65bc\u570b\u5167\u8d85\u5927\u898f\u6a21\u96f2\u7aef\u7d93\u6fdf\uff0c\u7b97\u529b\u65e2\u4fbf\u5b9c\u53c8\u5feb\u901f\u3002Alibaba \u7684\u96f2\u7aef\u5806\u758a\u7a4d\u6975\u6436\u653b\u751f\u547d\u79d1\u5b78\u5e02\u5834\uff0c\u63d0\u4f9b\u7b26\u5408\u5408\u898f\u7684\u57fa\u56e0\u7d44\u5b78\u8207\u5efa\u6a21\u89e3\u6c7a\u65b9\u6848\uff1bTencent \u7684\u751f\u614b\u7cfb\u5c07\u75c5\u60a3\u4e92\u52d5\u3001\u5f71\u50cf\u8207\u8a66\u9a57\u7ba1\u7406\u4e32\u6210\u4e00\u500b\u9589\u74b0\u3002\u5be6\u9ad4\u57fa\u790e\u8a2d\u65bd\u540c\u6a23\u5438\u5f15\u4eba\uff1a\u4e0a\u6d77\u3001\u8607\u5dde\u5468\u908a\u7684\u88fd\u9020\u5712\u5340\u64c1\u6709\u7b26\u5408\u5168\u7403 GMP \u6a19\u6e96\u7684\u5148\u9032\u4e00\u6b21\u6027\u751f\u7269\u53cd\u61c9\u5668\u8207\u5145\u586b\u5b8c\u5de5\u7dda\u3002\u9019\u4e9b\u5ee0\u5340\u63a5\u5165\u5347\u7d1a\u5f8c\u7684\u6e2f\u53e3\u3001\u516c\u8def\u8207\u51b7\u93c8\u914d\u9001\u4e2d\u5fc3\uff0c\u78ba\u4fdd\u751f\u7269\u88fd\u5291\u6301\u7e8c\u6d41\u901a\u3002\u82e5\u8981\u627e\u5c0b\u898f\u6a21\u8207\u54c1\u8cea\u5171\u5b58\u7684\u7bc4\u672c\uff0c\u53ef\u53c3\u8003\u8a72\u570b\u7684\u96fb\u52d5\u8eca\u7522\u696d\uff1aBYD \u5411\u4e16\u754c\u5c55\u793a\u4e86\u4e2d\u570b\u5982\u4f55\u5feb\u901f\u64f4\u5c55\u8907\u96dc\u88fd\u9020\u4e26\u5728\u5730\u5316\u4f9b\u61c9\u3002\u751f\u7269\u88fd\u85e5\u6b63\u6cbf\u7528\u76f8\u540c\u6253\u6cd5\uff0c\u5de5\u7a0b\u6df1\u5ea6\u8207\u6d41\u7a0b\u63a7\u5236\u5982\u4eca\u6210\u70ba\u751f\u7269\u88fd\u5291\u7522\u7387\u8207\u6210\u672c\u7684\u5dee\u7570\u5316\u56e0\u7d20\u3002<\/p>\n

\u98a8\u96aa\u8207\u6295\u8cc7\u7d50\u8ad6<\/h3>\n

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