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中国FIC新药管线位居全球第二

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所属报告：

医药生物行业深度：聚焦创新药产业链静待消费医疗改善-250108（28页）.pdf

打包全文图表

国产创新药国际地位领先，创新质量不断提高。根据医药魔方的数据，截至 2024 年8 月，中国在研创新药管线数量达 5380 项，占全球在研新药管线的比重约为 36.00%，仅略低于美国（5397 项）；中国新药批准上市数量达 910 项，处于全球第二水平。中国创新药的在研管线数量、批准上市数量处于国际领先水平。与此同时，中国创新药的创新质量在不断提高，主要体现在：（1）截至 2024 年 8 月，中国 FIC 新药管线数量为 1762 项，仅次于美国。根据医药魔方对全球不同靶点、不同药理类型的6800多条赛道的梳理排名，中国研发进度处于全球 TOP3 的在研管线数量比重约为 43.00%，未显著低于美国水平（66.00%）。（2）中国对外授权的创新药管线数量、交易金额明显增多，处于历史高位水平，表明国内创新管线质量获得国际大药企认可。在 ADC、双抗等领域，中国创新药已处于国际领先水平，诞生多起金额巨大的对外授权以及频繁产生对外授权。以双抗为例，自 2024 年下半年以来，国内共产生了 16 笔对外授权项目。（3）中国诞生了多个原创的、具有突破性治疗效果的新药。比如，在泽布替尼对伊布替尼用于治疗复发/难治性（R/R）慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）的全球 3 期临床试验，泽布替尼取得了 PFS 优效性结果，并体现出安全性优势。又如，2024 年 9 月，康方生物 PD-1/VEGF双特异性抗体新药依沃西单药在头对头帕博利珠单抗单药一线治疗 PD-L1 表达阳性（PD-L1 TPS≥1%）的局部晚期或转移性非小细胞肺癌（NSCLC）的注册性 III 期临床研究中取得显著阳性结果。

行业数据原图定位