重磅| 益普生和昱言公司官宣FS001的全球獨家許可協(xié)議

2024.7.11

　　益普生獲得 FS001 的開發(fā)、生產(chǎn)和商業(yè)化的獨家全球權(quán)利，完成此首創(chuàng)新藥的臨床前開發(fā)的最后階段

　　FS001 靶向?種在多種實體腫瘤中高度表達的新型腫瘤相關抗原，該靶標由昱言公司的專有蛋白質(zhì)組學平臺發(fā)現(xiàn)

　　FS001 在多種腫瘤模型中展示出強大的臨床前療效，并顯示出良好的臨床前安全性

　　巴黎，法國，2024 年 7 月 11 日 ——益普生 (Euronext: IPN； ADR: IPSEY) 和昱言公司今天宣布了 FS001 的獨家全球許可協(xié)議。FS001 是?種具有首創(chuàng)新藥（FIC）潛力的抗體-藥物偶聯(lián)物 (ADC)，靶向?種全新的腫瘤相關抗原，該抗原在許多實體腫瘤中過表達，并在腫瘤增殖和轉(zhuǎn)移中起關鍵作用。這種新型腫瘤抗原是由昱言公司專屬的高通量、整合性轉(zhuǎn)化蛋白質(zhì)組學和人工智能 (AI) 驅(qū)動的篩選平臺，通過分析所收集到的大量具有明確特征的臨床腫瘤樣本發(fā)現(xiàn) 。FS001 利用了?種創(chuàng)新的、穩(wěn)定的、可切割的連接體，與?種非常有效的拓撲異構(gòu)酶I抑制劑偶聯(lián)。FS001 在多種耐藥癌癥模型中也顯示了良好的臨床前療效。該協(xié)議賦予益普生在全球范圍內(nèi)開發(fā)、制造和商業(yè)化FS001 的獨家權(quán)利。

　　“我們很高興將 FS001 添加到我們不斷增長的產(chǎn)品線中，這是益普生今年獲得授權(quán)的第?個 ADC。通過使用尖端的蛋白質(zhì)組學技術(shù)和人工智能篩選平臺，昱言團隊發(fā)現(xiàn)了?個全新的治療相關靶點，進?步釋放 ADC 的潛力，治療更多的患有難治性癌癥的患者?！?益普生高級副總裁兼早期開發(fā)主管 Mary Jane Hinrichs 表示：“隨著我們準備啟動 I 期臨床試驗，我們將在選定的實體腫瘤類型中評估 FS001，我們希望這將為世界各地的癌癥患者提供關鍵的新療法?！?/p>

　　“我們與益普生的戰(zhàn)略合作伙伴關系為我們用高通量、整合性轉(zhuǎn)化蛋白質(zhì)組學平臺，發(fā)現(xiàn)和開發(fā)具有完全創(chuàng)新的治療產(chǎn)品的方法流程，提供了強有力的認可，” 昱言公司的創(chuàng)始人兼董事長Catherine Wong（黃超蘭）說?！拔覀兒芨吲d與益普生合作，在全球范圍內(nèi)推進 FS001。益普生在加速創(chuàng)新療法的臨床開發(fā)和商業(yè)化方面有著良好的記錄。我們相信 FS001 有潛力作為單?藥物或與標準治療聯(lián)用治療多種癌癥。

　　昱言公司將獲得高達 10.3 億美元的資金，包括首付款、開發(fā)、監(jiān)管和商業(yè)化重要節(jié)點的付款，以及成功的開發(fā)和監(jiān)管批準后的全球銷售分級特許權(quán)使用費。根據(jù)協(xié)議條款，益普生將負責 I 期準備工作，包括提交新藥臨床試驗 (IND) 申請以及所有后續(xù)臨床開發(fā)、生產(chǎn)和全球商業(yè)化活動。

　　關于益普生

　　我們是?家全球性的生物制藥公司，專注于在腫瘤、罕見病和神經(jīng)三個治療領域為患者提供革新藥物。

　　我們的產(chǎn)品線以外部創(chuàng)新為動力，以近 100 年的開發(fā)經(jīng)驗和在美國、法國和英國的全球中心為支持。我們遍布在 40 多個國家的團隊，和我們在世界各地的合作伙伴，使我們能夠為80多個國家的患者提供藥物。

　　益普生通過美國存托憑證計劃 (ADR: IPSEY) 的?級贊助，在巴黎 (Euronext: IPN) 和美國上市。欲了解更多信息，請訪問 ipsen.com。

　　關于昱言

　　我們是?家新興的生物技術(shù)公司，開創(chuàng)了高通量、整合性轉(zhuǎn)化蛋白質(zhì)組學平臺，由基于人工智能的數(shù)據(jù)分析系統(tǒng)支持，以加速發(fā)現(xiàn)臨床相關治療和診斷的全新靶點。我們正在建立用于診斷和治療癌癥、炎癥/自身免疫性疾病和神經(jīng)系統(tǒng)疾病的新候選產(chǎn)品管道。昱言由巢生公司孵化成立。

　　關于抗體-藥物偶聯(lián)物（ADC）

　　ADC 由三個主要成分組成: 抗體、有效載荷和連接體。該抗體選擇性地靶向已識別的腫瘤抗原。有效載荷是治療癌癥的藥物活性成分，通過化學連接劑附著在抗體上。該連接體連接抗體和有效載荷，并減少到達非腫瘤組織的有效載荷的數(shù)量1。

　　關于 FS001

　　FS001 是?種潛在的首創(chuàng)新藥 ADC，在多種實體腫瘤中具有臨床前療效，并且在動物研究中具有良好的安全性和優(yōu)異的治療窗口。FS001 由(i)昱言的專屬抗體，靶向利用公司高通量整合轉(zhuǎn)化蛋白質(zhì)組學平臺所鑒定的新靶點，和 (ii)上海詩健生物技術(shù)有限公司開發(fā)的，具有優(yōu)異藥物特性的創(chuàng)新連接體和有效載荷組成。FS001 正處于臨床前開發(fā)的最后階段。

　　FS001項目昱言核心團隊

　　益普生聯(lián)系方式

　　郵箱: corporate.communications@ipsen.com

　　聯(lián)系人

　　Craig Marks | + 44 7584 349 1932

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

　　媒體

　　Amy Wolf | +41 7 95 76 07 23

　　Jess Smith | + 44 7557 267 634

　　昱言聯(lián)系方式

　　Kerry Wang | +86 13611776259

　　郵箱: kerry.wang@foreseenbio.com

　　Ipsen Disclaimers and/or Forward-Looking Statements

　　益普生免責聲明和/或前瞻性聲明

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