Elafibranor

在本周（2026年5月11日—5月18日），全球生物医药产业不仅见证了重磅新药的获批与AD（阿尔茨海默病）新药研发的逆袭，在政策改革、本土研发、跨国商业同盟以及国际学术会议等多个维度上，同样涌现出大量极具冲击力的突破。 这些信息如同繁星点缀，共同交织出一幅新药开发、监管审批与商业博弈的宏大图景。为了让大家能一眼看懂这些前沿资讯，我们对本周最受瞩目的“一周创新药快讯”进行了深度的通俗化拆解。 一、 医保与市场准入：政策“暖风”频吹，商保变身“敲门砖”，参照药更趋透明 对于新药而言，研发成功只是第一步，如何让患者买得起、用得上，才是最终的商业闭环。本周，国家医保局在政策端释放了两个极具风向标意义的信息： 1. 商保目录首次与国家医保衔接 5月17日，国家医保局就本年度基本医保药品目录以及商保创新药目录的调整方案进行了深度解读 。 其中最吸睛的改变，是今年在目录外药品申报条件中，首次新增了“纳入2025年商业健康保险创新药品目录的药品” 。 通俗解读：过去，商业健康保险目录和国家基本医保目录是“各过各的桥”。很多高昂的创新药在没进入医保前，只能寄希望于商保报销。而新规打破了这道藩篱，让“商保目录”变成了申报“国家医保”的直接通道。这意味着，一款新药如果先在商保中验证了性价比和临床刚需，就能更快、更顺理成章地切入国家医保这个“基本盘”。 2. 参照药预沟通公示：谈判基准的“明牌化” 5月12日至5月18日，国家医保局对2026年第二批参照药预沟通工作的企业申请名单进行了社会公示 。 通俗解读：所谓“参照药”，就是新药在进行医保价格谈判时，国家用来评估其性价比的“对照物”（比如原研药或标准疗法） 。参照药是谁，直接决定了新药的降价幅度和谈判底价。这一预沟通名单的透明公示，让药企在谈判前就能建立对等的临床对照基准，极大提升了价格测算和国家准入谈判的透明度 。 二、 本土在研突围：第四代EGFR精准攻坚，双靶“减重明星”获批上市 本周，两款极具代表性的国产1类新药分别在临床监管和商业上市上迎来了重要突破，展现了中国原研药在“攻克耐药”与“慢性病管理”上的强劲实力。 1. 豪森药业HS-10504：精准狙击肺癌“三代药耐药” 5月13日，国家药监局药审中心（CDE）公示，豪森药业自主研发的1类新药、第四代EGFR-TKI抑制剂HS-10504片拟纳入突破性治疗药物程序 。其针对的适应症，是经三代EGFR靶向药（如奥希替尼、阿美替尼等）治疗失败后，伴随EGFR C797S突变的局部晚期或转移性非小细胞肺癌 。 攻克痛点：第三代靶向药虽然效果好，但患者在使用后不可避免地会出现耐药，其中最棘手的就是“C797S突变” 。这就像是癌细胞把大门的锁眼给换了，导致三代药这把钥匙再也插不进去，此时患者往往面临无药可用的窘境 。 突破性设计：HS-10504采用了独特的第四代空间位阻解构设计 。不管C797S耐药突变怎么变，它都能精准绕开空间阻碍，强力与突变激酶结合并发挥抑制活性，同时它不伤及正常的野生型EGFR，因此皮疹和腹泻等副作用极低 。 硬核数据：在AACR年会上公布的临床数据显示，在400mg QD推荐剂量下，34例可评估的C797S突变患者客观缓解率（ORR）达到52.9%，中位无进展生存期（PFS）达9.6个月，且脑组织药物浓度可达血浆浓度的60%以上，对极难处理的肺癌脑转移展现出惊人的颅内控制力 。 2. 信达生物玛仕度肽：全球首款GCG/GLP-1双靶点减重降糖药获批 5月8日，国家药监局（NMPA）正式批准信达生物的玛仕度肽预充式多剂量注射笔（2ml:24mg）上市，并在5月11日引发了整个业界的刷屏关注 。 作用机制：传统的减重药（如司美格鲁肽）大多是GLP-1单靶点激动剂，主要通过让人“不想吃”来减肥。而玛仕度肽则是全球首个获批的GCG/GLP-1双受体激动剂 。它在GLP-1介导的食欲抑制和胰岛素分泌之外，协同激活了GCG受体，从而显著增加了外周能量的消耗 。 通俗解释：它不仅能让你“管住嘴”，还能帮你“迈开腿”消耗脂肪，从而在快速降糖、强效减重以及改善脂肪肝方面，建立了比单靶点药物更优的全谱治疗格局 。 三、 跨国商业同盟：正大天晴与GSK强强联手，本土渠道赋能“乙肝治愈”ASO 5月11日，中国生物制药宣布旗下附属公司正大天晴与葛兰素史克（GSK）达成了一项针对乙肝临床功能性治愈药物Bepirovirsen（贝普若韦生）在中国内地的独家战略合作协议 。 Bepirovirsen是什么？ 这是一款同类首创（FIC）的反义核酸（ASO）药物，它的终极目标是实现慢乙肝患者的“临床功能性治愈”（即停药后HBsAg和HBV DNA持续阴性） 。 独特的合作模式：协议约定，正大天晴将全面负责该药在中国内地的进口、分销、医院准入和推广，该药产生的销售收入将全部确认为正大天晴的营业收入，而GSK则作为持证人（MAH）主导全球医学和注册策略 。 商业逻辑：中国是乙肝大国，但乙肝患者群体极度分化，且大量下沉在基层和县域市场。GSK虽然拥有顶尖的产品，但缺乏下沉的销售毛细血管；正大天晴则是国内肝病领域的“销售铁军”。这种“GSK出药，正大天晴出人并合表收入”的深度绑定，能让这款革命性新药在获批后，以最快速度铺向中国庞大的基层医疗网络 。 四、 国际学术会议：AUA、ESTRO、EASL前沿数据齐发，实体瘤迎来“神仙打架” 本周，全球数个高规格专科学术大会（美国泌尿外科协会AUA年会、欧洲放射肿瘤学会ESTRO年会、欧洲肝脏研究学会EASL大会）密集召开，多项改变临床标准的关键在研数据集中释放： 1. 肾脏保护新曙光：Padeliporfin VTP（血管靶向光动力治疗） 在AUA 2026年会上，ImPact Biotech公布了其III期ENLIGHTED研究的最新数据：在72例低级别上尿路尿路上皮癌（UTUC）患者中，实现了70%的完全缓解（CR）率，总客观缓解率达到 88% 。完成维护期治疗的患者中，高达85.7% 成功维持CR状态超过12个月 。 通俗解读：传统的上尿路尿路上皮癌患者，往往需要切除整个肾脏和输尿管，这对患者的生活质量是毁灭性的打击。而Padeliporfin VTP是一种“血管靶向光动力疗法” 。医生将光敏药物注入血管，再用微创尿道镜导入激光局部照射，光能激活药物后会精准“憋死”肿瘤微血管，从而把肿瘤消灭 。这一疗法不伤及正常的肾脏组织，让大量面临保肾危机的患者成功“留住了肾” 。 2. 膀胱癌的新一代免疫疗法：TARA-002 在AUA年会上，Protara Therapeutics公布了TARA-002治疗非肌层浸润性膀胱癌（NMIBC）的Phase II ADVANCED-2研究更新数据 。在未接受过卡介苗（BCG-Naïve）治疗的患者中，该药实现了 72.4% 的任意时间完全缓解（CR）率，且在12个月时的持续CR率仍高达 55.0%。 通俗解读：卡介苗（BCG）是膀胱癌术后防止复发的金标准，但全球常年面临BCG结核杆菌制剂缺货、耐受性差的窘境。TARA-002作为一种新型的免疫激活剂，能激发体内的巨噬细胞和树突状细胞去主动吃掉残留的癌细胞 。它不含活菌，安全性极佳（无3级严重不良事件），未来有望成为BCG的核心替代方案 。 3. “无心脏毒性”的白血病核心骨干化疗：Annamycin 5月15日，Moleculin Biotech公布了其关键Phase IIB/3 MIRACLE试验的最新盲态数据：在45例复发/难治性急性髓系白血病（R/R AML）患者中，观察到了高达 40% 的复合完全缓解（CRc）率 。 通俗解读：阿霉素等“蒽环类化疗药”是血液肿瘤治疗的绝对支柱。然而这类药有一个致命硬伤——严重的累积性心脏毒性。一旦用药总量超过限制，就会造成不可逆的心肌衰竭。Annamycin通过脂质体包裹和结构改造，既保留了强效杀伤白血病细胞的威力，又精妙地避开了心肌积聚，成功攻克了化疗药的“卡脖子”毒性，让高龄、心脏功能不全的白血病患者重新迎来了化疗治愈的机会 。 4. 物理学与医学的跨界：纳米放射增敏剂 JNJ-1900 在ESTRO 2026年会上，Nanobiotix与强生（J&J）公布了JNJ-1900（NBTXR3）治疗不可手术切除的III期非小细胞肺癌（NSCLC）的II期CONVERGE研究数据 。 通俗解读：放疗虽然能杀死癌细胞，但也会“伤敌一千，自损八百”，导致周围健康组织被灼伤。JNJ-1900是一款首创的“纳米放射增敏剂” 。医生先将这些纳米颗粒注射进肿瘤内部 。当外界射线照射时，这些纳米颗粒会像“放大镜”一样，在肿瘤局部物理性地增幅放射能量，而由于周围正常组织没有纳米颗粒，射线能量维持原样。这实现了“靶向精准增幅放疗”，不增加任何健康组织的照射损伤 。 5. 胆管炎患者的“疲劳与瘙痒克星”：IQIRVO（elafibranor） 在EASL年会上，Ipsen与GENFIT公布了IQIRVO治疗原发性胆汁性胆管炎（PBC）的最新临床数据 。数据显示，它不仅能实现极高比例的碱性磷酸酶（ALP，疾病进展指标）完全正常化，更是目前唯一在临床上证实能独立改善患者顽固疲劳和严重瘙痒症状的药物 。 通俗解读：PBC患者往往伴随极其痛苦、抓挠至流血的皮肤瘙痒，以及无法通过休息缓解的深层疲劳，这严重破坏了患者的日常生活。此前获批的奥贝胆酸不仅不能止痒，反而会加重瘙痒，且有肝毒性。IQIRVO作为 alpha \delta 双重激动剂，在强效保护肝脏的同时解决了患者最痛苦的全身症状，建立了不可动摇的二线领导地位 。 五、 海外风向与供应链安全：山德士胰岛素“双子星”获批，欧盟筑牢安全网 最后，本周在海外监管端同样传来了两个重要声音： 1. 山德士胰岛素“双子星”获批，百亿市场引来生物类似药强力替代 5月15日，山德士（Sandoz）确认，欧洲委员会（EC）已正式批准其研发的两款重要胰岛素生物类似药 Bysumlog（赖脯胰岛素）和 Dazparda（门冬胰岛素）上市 。 通俗解读：这标志着糖尿病患者高价进口原研药（优泌乐、诺和锐）将迎来更具性价比的高品质替代方案，有望大幅削减欧洲糖尿病患者的整体医疗支出，拓展生命挽救药物的可及性 。 2. 欧洲议会推动《关键药物法案》 political agreement 5月12日，欧洲药监局（EMA）对欧洲议会和理事会达成的临时政治协议——《关键药物法案》（Critical Medicines Act，CMA）表示热烈欢迎 。 通俗解读：历经新冠疫情和地缘冲突后，欧洲国家深感原料药（API）依赖海外带来的短缺危机。该法案旨在通过建立国家级援助、集中联合采购等制度，对全欧200多种核心关键抗生素和罕见病用药进行供应链脆弱性评估，防范供应链断裂引发的公共卫生危机 。 结语 纵观本周的一周创新药快讯，我们能清晰地感受到一个变革的脉搏：政策正在主动为高价值创新药拓宽准入通道，原研技术正不遗余力地向“最难攻克的耐药突变”发起总攻，商业模式在不断向本土联合下沉演进，而前沿科技更是将光动力、纳米物理、生物学精妙融合。这些星火般的创新汇聚一处，正合力将人类的健康边界推向更远、更安全的未来。

Three late-breaking abstracts accepted, including: Real-world benefit of IQIRVO® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue Real-world benefit of IQIRVO® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue PARIS, FRANCE, 15 MAY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today the latest data on IQIRVO® (elafibranor) demonstrating clinically meaningful improvements in ALP, a surrogate marker of primary biliary cholangitis (PBC) disease progression, and symptom management, achieved in a real-world setting, will be presented at the European Association for the Study of Liver Disease (EASL) 2026 congress in Barcelona. IQIRVO is the only PBC therapy with data on meaningful improvements on Alkaline Phosphatase (ALP) reduction and both fatigue and pruritus symptoms. In a late-breaking presentation, the depth of effect of IQIRVO on ALP normalization in PBC patients with ALP 1-1.67 x upper limit of normal (ULN) in the real-world setting will be presented. Normalization of ALP levels (<1 x ULN) is associated with improved prognosis and increased survival rates. Ipsen is currently conducting a Phase III study, ELSPIRE, which is evaluating IQIRVO in this patient population, in a clinical setting. Additionally, Ipsen will present interim real-world data from the ELFINITY® Phase IV study confirming real-world effectiveness of IQIRVO in both biochemical outcomes and symptom control, including fatigue and pruritus, with a favorable safety profile. Further late-breaking data includes a new post-hoc analysis from the Phase III pivotal ELATIVE® trial, which will provide further evidence of the impact of IQIRVO on fatigue, using the established Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PROMIS PFSF 7a) tool. Fatigue is the most common and debilitating symptom reported by PBC patients. IQIRVO is the only medicine to have demonstrated a positive effect on fatigue in patients with moderate to severe fatigue at baseline and occurring independently of its effect on pruritus.1 With two molecules approved for three different rare cholestatic liver diseases and a pipeline with two additional late-stage indications, Ipsen is leading research and development for treatments where unmet need is high and treatments are often few or do not exist. Ipsen Abstracts About IQIRVO® (elafibranor) IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. Iqirvo was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA, EMA and MHRA approvals are contingent on the further verification of clinical benefit. Iqirvo is currently in regulatory processes with other authorities. Iqirvo (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. About Primary Biliary Cholangitis PBC is a rare, autoimmune liver disease where a build-up of bile and toxins and chronic inflammation cause irreversible fibrosis of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the US and 165,000 people in Europe, the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated and may lead to liver transplant and in some cases, premature death. About Ipsen 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. 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. 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 ipsen.com. Disclaimers and/or forward-looking statementsThe 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. 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. 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. 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. 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 to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. References Attachment Ipsen PR_EASL_15052026 Three late-breaking abstracts accepted, including: Real-world benefit of IQIRVO® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue Real-world benefit of IQIRVO® (elafibranor) in PBC patients with Alkaline Phosphatase (ALP) 1-1.67 x Upper Limit of Normal (ULN) and on fatigue and pruritus symptoms ELATIVE Phase III trial data on the impact of IQIRVO on PBC fatigue PARIS, FRANCE, 15 MAY 2026 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today the latest data on IQIRVO® (elafibranor) demonstrating clinically meaningful improvements in ALP, a surrogate marker of primary biliary cholangitis (PBC) disease progression, and symptom management, achieved in a real-world setting, will be presented at the European Association for the Study of Liver Disease (EASL) 2026 congress in Barcelona. IQIRVO is the only PBC therapy with data on meaningful improvements on Alkaline Phosphatase (ALP) reduction and both fatigue and pruritus symptoms. In a late-breaking presentation, the depth of effect of IQIRVO on ALP normalization in PBC patients with ALP 1-1.67 x upper limit of normal (ULN) in the real-world setting will be presented. Normalization of ALP levels (<1 x ULN) is associated with improved prognosis and increased survival rates. Ipsen is currently conducting a Phase III study, ELSPIRE, which is evaluating IQIRVO in this patient population, in a clinical setting. Additionally, Ipsen will present interim real-world data from the ELFINITY® Phase IV study confirming real-world effectiveness of IQIRVO in both biochemical outcomes and symptom control, including fatigue and pruritus, with a favorable safety profile. Further late-breaking data includes a new post-hoc analysis from the Phase III pivotal ELATIVE® trial, which will provide further evidence of the impact of IQIRVO on fatigue, using the established Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PROMIS PFSF 7a) tool. Fatigue is the most common and debilitating symptom reported by PBC patients. IQIRVO is the only medicine to have demonstrated a positive effect on fatigue in patients with moderate to severe fatigue at baseline and occurring independently of its effect on pruritus.1 With two molecules approved for three different rare cholestatic liver diseases and a pipeline with two additional late-stage indications, Ipsen is leading research and development for treatments where unmet need is high and treatments are often few or do not exist. Ipsen Abstracts About IQIRVO® (elafibranor) IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist, which exerts an effect on PPARα and PPARδ. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. Activation of PPARα and PPARδ also has anti-inflammatory effects by acting on different pathways. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. Iqirvo was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA, EMA and MHRA approvals are contingent on the further verification of clinical benefit. Iqirvo is currently in regulatory processes with other authorities. Iqirvo (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. About Primary Biliary Cholangitis PBC is a rare, autoimmune liver disease where a build-up of bile and toxins and chronic inflammation cause irreversible fibrosis of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the US and 165,000 people in Europe, the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated and may lead to liver transplant and in some cases, premature death. About Ipsen 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. 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. 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 ipsen.com. Disclaimers and/or forward-looking statementsThe 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. 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. 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. 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. 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 to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation and risks arising from unexpected regulatory or political changes such as changes in tax regulation and regulations on trade and tariffs, such as protectionist measures, especially in the United States; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. References Attachment Ipsen PR_EASL_15052026