石药HER2单抗报产，华润三九拿下罕见病创新药，国产CAR-T超8.6亿美元出海

医药经济报11-11

石药集团帕妥珠单抗上市申请获受理11月11日，CDE官网显示，石药集团递交的帕妥珠单抗注射液上市申请获受理，用于治疗HER2阳性乳腺癌。值得一提的是，这是国内第5款申报上市的帕妥珠单抗生物类似药。帕妥珠单抗是由罗氏原研的一款HER2单抗，通过靶向HER2的细胞外二聚体化结构域（亚结构域Ⅱ），阻断HER2与其他HER2家族成员（包括EGFR、HER3和HER4）生成配体依赖型异源二聚体，从而阻断信号...

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CAR-T超8.6亿美元出海11月10日，Lyell Immunopharma宣布，已获得斯丹赛生物开发的LYL273（前身为GCC19CART）在大中华区以外的全球权利，进一步强化其在实体瘤CAR-T领域的研发布局。斯丹赛生物将获得4000万美元预付款及190万股Lyell普通股，并有资格在未来获得额外现金和股权对价，以及基于净销售额的分层特许权使用费。其中，额外现金包括潜在3000万美元的临床里程金、最高1.15亿美元的后期监管里程金，以及最高6.75亿美元的商业销售里程金；股权对价则包括在实现特定临床或监管里程时最多185万股Lyell普通股。LYL273是一款针对鸟苷酸环化酶-C（GCC）的新型自体CAR-T细胞候选产品，主要用于治疗转移性结直肠癌（mCRC）及其他表达GCC的实体瘤。该产品通过CD19-CAR表达与受控的细胞因子释放技术优化设计，旨在增强CAR-T细胞在不利实体瘤微环境中的扩增能力、免疫浸润及抗癌效果。目前，LYL273已获得美国FDA授予的mCRC快速通道指定。编辑：李咏诗版式编辑：张松审校：马飞、张松\n\n\n海量资讯、精准解读，尽在新浪财经APP","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; 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