重磅|益普生和昱言公司官宣FS001的全球独家许可协议

　　益普生获得 FS001 的开发、生产和商业化的独家全球权利，完成此首创新药的临床前开发的最后阶段

　　FS001 靶向⼀种在多种实体肿瘤中高度表达的新型肿瘤相关抗原，该靶标由昱言公司的专有蛋白质组学平台发现

　　FS001 在多种肿瘤模型中展示出强大的临床前疗效，并显示出良好的临床前安全性

　　巴黎，法国，2024 年 7 月 11 日 ——益普生 (Euronext: IPN； ADR: IPSEY) 和昱言公司今天宣布了 FS001 的独家全球许可协议。FS001 是⼀种具有首创新药（FIC）潜力的抗体-药物偶联物 (ADC)，靶向⼀种全新的肿瘤相关抗原，该抗原在许多实体肿瘤中过表达，并在肿瘤增殖和转移中起关键作用。这种新型肿瘤抗原是由昱言公司专属的高通量、整合性转化蛋白质组学和人工智能 (AI) 驱动的筛选平台，通过分析所收集到的大量具有明确特征的临床肿瘤样本发现 。FS001 利用了⼀种创新的、稳定的、可切割的连接体，与⼀种非常有效的拓扑异构酶I抑制剂偶联。FS001 在多种耐药癌症模型中也显示了良好的临床前疗效。该协议赋予益普生在全球范围内开发、制造和商业化FS001 的独家权利。

　　“我们很高兴将 FS001 添加到我们不断增长的产品线中，这是益普生今年获得授权的第⼆个 ADC。通过使用尖端的蛋白质组学技术和人工智能筛选平台，昱言团队发现了⼀个全新的治疗相关靶点，进⼀步释放 ADC 的潜力，治疗更多的患有难治性癌症的患者。” 益普生高级副总裁兼早期开发主管 Mary Jane Hinrichs 表示：“随着我们准备启动 I 期临床试验，我们将在选定的实体肿瘤类型中评估 FS001，我们希望这将为世界各地的癌症患者提供关键的新疗法。”

　　“我们与益普生的战略合作伙伴关系为我们用高通量、整合性转化蛋白质组学平台，发现和开发具有完全创新的治疗产品的方法流程，提供了强有力的认可，” 昱言公司的创始人兼董事长Catherine Wong（黄超兰）说。“我们很高兴与益普生合作，在全球范围内推进 FS001。益普生在加速创新疗法的临床开发和商业化方面有着良好的记录。我们相信 FS001 有潜力作为单⼀药物或与标准治疗联用治疗多种癌症。

　　昱言公司将获得高达 10.3 亿美元的资金，包括首付款、开发、监管和商业化重要节点的付款，以及成功的开发和监管批准后的全球销售分级特许权使用费。根据协议条款，益普生将负责 I 期准备工作，包括提交新药临床试验 (IND) 申请以及所有后续临床开发、生产和全球商业化活动。

　　关于益普生

　　我们是⼀家全球性的生物制药公司，专注于在肿瘤、罕见病和神经三个治疗领域为患者提供革新药物。

　　我们的产品线以外部创新为动力，以近 100 年的开发经验和在美国、法国和英国的全球中心为支持。我们遍布在 40 多个国家的团队，和我们在世界各地的合作伙伴，使我们能够为80多个国家的患者提供药物。

　　益普生通过美国存托凭证计划 (ADR: IPSEY) 的⼀级赞助，在巴黎 (Euronext: IPN) 和美国上市。欲了解更多信息，请访问 ipsen.com。

　　关于昱言

　　我们是⼀家新兴的生物技术公司，开创了高通量、整合性转化蛋白质组学平台，由基于人工智能的数据分析系统支持，以加速发现临床相关治疗和诊断的全新靶点。我们正在建立用于诊断和治疗癌症、炎症/自身免疫性疾病和神经系统疾病的新候选产品管道。昱言由巢生公司孵化成立。

　　关于抗体-药物偶联物（ADC）

　　ADC 由三个主要成分组成: 抗体、有效载荷和连接体。该抗体选择性地靶向已识别的肿瘤抗原。有效载荷是治疗癌症的药物活性成分，通过化学连接剂附着在抗体上。该连接体连接抗体和有效载荷，并减少到达非肿瘤组织的有效载荷的数量1。

　　关于 FS001

　　FS001 是⼀种潜在的首创新药 ADC，在多种实体肿瘤中具有临床前疗效，并且在动物研究中具有良好的安全性和优异的治疗窗口。FS001 由(i)昱言的专属抗体，靶向利用公司高通量整合转化蛋白质组学平台所鉴定的新靶点，和 (ii)上海诗健生物技术有限公司开发的，具有优异药物特性的创新连接体和有效载荷组成。FS001 正处于临床前开发的最后阶段。

　　FS001项目昱言核心团队

　　益普生联系方式

　　邮箱: corporate.communications@ipsen.com

　　联系人

　　Craig Marks | + 44 7584 349 1932

　　Nicolas Bogler | +33 (0) 6 52 19 98 92

　　媒体

　　Amy Wolf | +41 7 95 76 07 23

　　Jess Smith | + 44 7557 267 634

　　昱言联系方式

　　Kerry Wang | +86 13611776259

　　邮箱: kerry.wang@foreseenbio.com

　　Ipsen Disclaimers and/or Forward-Looking Statements

　　益普生免责声明和/或前瞻性声明

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