Ipsen gains exclusive global rights, outside of Greater China, for development, manufacturing and commercialization of SIM0613, a LRRC15-targeting antibody-drug conjugate

益普生获得SIM0613的全球独家权利（大中华区除外），用于该LRRC15靶向抗体药物偶联物的开发、生产和商业化。

SIM0613 is optimally designed for superior tumor penetration with robust preclinical efficacy data

SIM0613 的设计旨在实现卓越的肿瘤渗透，并具有强大的临床前疗效数据。

Program expected to enter Phase I clinical development in H2 2026

预计该计划将于2026年下半年进入I期临床开发阶段。

Simcere Zaiming is eligible to receive up to $1.06B in total payments

先声再明总计可获得高达 10.6 亿美元的付款

PARIS, FRANCE; 22 DECEMBER 2025

法国巴黎；2025年12月22日

– Ipsen (Euronext: IPN; ADR: IPSEY) announced today an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs..

– 益普生（Euronext: IPN；ADR: IPSEY）今天宣布了一项独家许可协议，获得抗体药物偶联物（ADC）SIM0613在大中华区以外的全球权利。SIM0613具有同类最佳潜力，靶向LRRC15蛋白，旨在增强对未满足需求最高的实体瘤的肿瘤渗透和差异化的抗肿瘤活性。

“Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology,” said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. “By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally.

“今天的公告强调了我们引领创新和塑造肿瘤学未来的宏伟愿景，”益普生研发执行副总裁兼负责人克里斯特尔·乌戈博士说道。“通过及早推进一流和最佳疗法，我们最大限度地发挥全球患者治疗效果的潜力。”

The addition of the SIM0613 ADC is testament to this ambition—pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020.”.

SIM0613 ADC的加入证明了这一雄心——开创性的科学为最需要的人群开辟了新的可能性，并且进一步拓展了益普生快速发展的研究和早期开发组合，自2020年以来已新增超过20个项目。”

“SIM0613 is developed via Simcere Zaiming’s proprietary antibody-drug conjugate platform,” said Renhong Tang, PhD, CEO of Simcere Zaiming. “We are excited to partner with Ipsen on this novel drug candidate and look forward to working together to advance the clinical development of SIM0613. “

“SIM0613是通过先声再明专有的抗体药物偶联平台开发的，”先声再明首席执行官唐任宏博士表示，“我们很高兴与益普生合作开发这一新型候选药物，并期待共同努力推进SIM0613的临床开发。”

Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications. .

根据协议条款，先声再明有资格获得总计高达10.6亿美元的款项，包括首付款、开发、监管和商业里程碑付款，以及按销售分级计算的特许权使用费，但需以成功开发和获得监管批准为条件。益普生在技术转让流程后将拥有生产权利，并负责大中华区以外的所有活动，包括一期临床准备活动、研究性新药申请及临床试验申请的提交。

About SIM0613

关于SIM0613

SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed on varies tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cell and therefore sparing healthy cells.

SIM0613 靶向富含亮氨酸重复序列的蛋白15（LRRC15），该蛋白在多种肿瘤类型和癌相关成纤维细胞中高表达，但在正常细胞中的表达有限。SIM0613与LRRC15蛋白结合后会被内化，释放出细胞毒性载荷，从而杀死癌细胞，同时保护健康细胞。

SIM0613 is specifically engineered for deep tumor and cancer-associated fibroblast penetration, resulting in robust tumor regressions in multiple in vivo preclinical models..

SIM0613 是专门设计用于深入肿瘤和癌相关成纤维细胞渗透的，这在多个体内临床前模型中显示出强大的肿瘤消退效果。

About Ipsen

关于益普生

We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K.

我们是一家全球生物制药公司，专注于在三个治疗领域为患者带来变革性药物：肿瘤学、罕见病和神经科学。我们的研发管线由内部和外部创新推动，并得到近百年开发经验以及美国、法国和英国的全球中心的支持。

Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries..

我们在40多个国家的团队和世界各地的合作伙伴关系使我们能够将药物带给100多个国家的患者。

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit

益普生在巴黎（泛欧交易所：IPN）和美国通过一级赞助的美国存托凭证计划（ADR：IPSEY）上市。欲了解更多信息，请访问

ipsen.com

易普森公司

.

。

About Simcere Zaiming

关于先声再明

Simcere Zaiming is an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing ground breaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®.

先声再明是一家专注于肿瘤领域的生物制药公司，是先声药业集团有限公司（HKEX: 2096，「先声药业」）的子公司。先声再明成立于2023年，致力于开发突破性疗法，以满足全球癌症患者未被满足的临床需求。凭借强大且创新的研发管线以及多样化的临床资产，先声再明已在中国成功推出了多款创新产品，包括恩泽舒®、科塞拉®、恩维达®、恩度®和恩立妥®。

The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners..

该公司决心通过其内部的研发、制造和商业化能力，辅以与领先合作伙伴的战略合作，为全球癌症患者提供潜在的变革性治疗选择。

About antibody-drug-conjugates

关于抗体药物偶联物

Antibody-Drug Conjugates are comprised of three main components: the antibody, a payload and a linker. The antibody selectively targets an identified tumor antigen. Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches non-tumor tissue..

抗体药物偶联物由三个主要组成部分构成：抗体、有效载荷和连接子。抗体选择性地靶向特定的肿瘤抗原。有效载荷是治疗癌症的药理活性成分，通过化学连接子附着在抗体上。连接子将抗体与有效载荷连接起来，并减少到达非肿瘤组织的有效载荷量。

Ipsen Contacts

益普生联系人

Investors

投资者

Henry Wheeler

亨利·惠勒

henry.wheeler@ipsen.com

henry.wheeler@ipsen.com

+33 7766471149

+33 7766471149

Khalid Deojee

哈利德·德欧吉

khalid.deojee@ipsen.com

khalid.deojee@ipsen.com

+33 666019526

+33 666019526

Media

媒体

Sally Bain

萨莉·贝恩

sally.bain@ipsen.com

sally.bain@ipsen.com

+1 8573200517

+1 8573200517

Anne Liontas

安妮·莱昂塔斯

anne.liontas.ext@ipsen.com

anne.liontas.ext@ipsen.com

+33 0767347296

+33 0767347296

Disclaimers and/or forward-looking statements

免责声明和/或前瞻性声明

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein.

本文包含的前瞻性声明、目标和指标基于益普生的管理战略、当前观点和假设。这些声明涉及已知和未知的风险与不确定性，可能导致实际结果、业绩或事件与此处预期的内容有重大差异。

All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations.

上述所有风险都可能影响益普生未来实现其财务目标的能力，这些目标是在假设合理的宏观经济条件的基础上根据今天可获得的信息制定的。使用“相信”、“预期”和“预计”等词语及其类似表达旨在识别前瞻性陈述，包括益普生对未来事件的预期，包括监管文件提交和决定。

Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data.

此外，本文件中描述的目标是在未考虑外部增长假设和潜在的未来收购的情况下制定的，这些假设和收购可能会改变这些参数。这些目标基于益普生认为合理的数据和假设。这些目标取决于未来可能发生的条件或事实，而不仅仅依赖于历史数据。

Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons.

鉴于某些风险和不确定性的发生，特别是处于早期开发阶段或临床试验中的有希望的药物可能最终无法上市或达到其商业目标，实际结果可能会与这些目标有很大差异，尤其是出于监管或竞争原因。

Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards .

益普生可能面临来自仿制药的竞争，这可能会导致市场份额的损失。此外，研发过程包含多个阶段，每个阶段都存在相当大的风险，益普生可能无法实现其目标，并被迫放弃相关努力。

Attachment

附件

Ipsen PR_Simcere Zaiming_22122025

益普生公关_先声再明_22122025