Views on China–Europe healthcare cross-border — EU market access, regulation, deals and clinical development. Written by Gordon Chen (高登哥), based in Paris.
聚焦中欧医疗健康跨境——市场准入、欧盟法规、交易与临床开发。由常驻巴黎的高登哥（陈刚）撰写。
FDA 是产品准入，欧盟才是企业准入。为什么第一站该选欧盟而不是美国？一份关于 CE、全球通行证与商业化路径的判断。
FDA is product access; the EU is company access. Why the EU — not the US — should be the first stop for Chinese pharma and device companies: CE, the global passport, and the commercial path.
我们正站在第五康波清算尾声与第六康波爆发口。AI 制药、精密医疗与全球合规，是中国医疗企业的机会窗口与四个抓手。
At the tail of the Fifth wave and the breakout of the Sixth. AI pharma, precision medicine and global compliance — the opportunity window and four levers for Chinese healthcare firms.
法国 ANSM 第 3 份 GLP-1 药物警戒报告：84 万人用药、2801 起不良反应。中国出海企业最该补的，是上市后这一课。
France ANSM's 3rd GLP-1 pharmacovigilance report: 840k users, 2,801 adverse events. The post-marketing lesson every Chinese company going global must learn.
中国创新药在 ESMO 2026 占了近 1/3 的压轴席位。从跟随到首创，license-out 爆发，学术舞台成为信任锚。
Chinese innovative drugs took nearly one-third of ESMO 2026 late-breaking abstracts. From follower to originator, the license-out boom, and the academic stage as a trust anchor.