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益普生和昱言公司宣布具有首创新药(FIC)潜力的抗体-药物偶联物的全球独家许可协议

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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
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

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