GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals’ lead asset, efimosfermin alfa.

GSK plc（伦敦证券交易所/纽约证券交易所代码：GSK）与波士顿制药公司（一家领先的临床阶段生物制药公司，专注于为严重肝病患者开发高度针对性的疗法）今天宣布，双方已达成一项协议，根据该协议，GSK将收购波士顿制药公司的主要资产efimosfermin alfa。

Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million..

Efimosfermin 是一种处于三期临床准备阶段的潜在最佳研究性特效药物，用于治疗和预防脂肪肝病（SLD）的进展。根据协议，GSK将支付12亿美元的预付款，并可能追加总额达8亿美元的基于成功的里程碑付款。

Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin’s direct antifibrotic mechanism of action and GSK’s data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK’990, a siRNA therapeutic in development for other subsets of patients with SLD..

Efimosfermin是一种新型的、每月一次的成纤维细胞生长因子21（FGF21）类似物治疗药物，目前正处于临床开发阶段，用于治疗代谢功能障碍相关的脂肪性肝炎（MASH），包括肝硬化，并将进一步开发用于酒精相关性肝病（ALD），这两种均属于SLD（慢性肝病）。鉴于Efimosfermin直接的抗纤维化作用机制以及GSK通过人类遗传学和疾病表型研究获得的数据驱动洞察，该药物有潜力应对更晚期的SLD阶段，并可与GSK’990（一种正在为其他SLD患者亚群开发的siRNA治疗药物）联合使用，带来更多治疗机会。

The acquisition of efimosfermin is highly aligned to GSK’s R&D focus on science related to the immune system and is further evidence of the company’s intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. .

收购efimosfermin高度契合GSK在免疫系统相关科学领域的研发重点，进一步证明了该公司旨在利用其在纤维化和自体炎症方面的深厚理解，开发能够阻止和逆转疾病进展的精准干预措施。

SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients.

SLD代表了一个影响全球约5%人口的重要未满足医疗需求领域，患者治疗选择有限。

SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation..

SLD，包括MASH和ALD，其特征是肝脏中脂肪的积累（脂肪变性），并伴有相关的炎症和纤维化。ALD在全球影响约2600万名患者，并且与MASH一起是美国肝移植的主要原因，对医疗资源利用造成了显著的负担和成本。

Substantial and disproportionate costs are associated with end-stage liver disease. Interventions that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 - 100 billion over the next two decades..

与终末期肝病相关的成本高昂且不成比例。减少中度至重度纤维化的干预措施可以防止肝硬化、肝癌、住院和移植的进展，有望在未来二十年为美国医疗系统节省400亿至1000亿美元。

Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile.

近期来自 efimosfermin 的 II 期试验数据显示，该试验旨在评估每月一次皮下注射剂量在经活检证实为中度至重度（F2 或 F3）MASH 参与者中的疗效和安全性，结果显示 efimosfermin 能够快速且显著逆转肝纤维化并阻止其进展，且具有可控的耐受性。

These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities.

这些数据表明，与其他治疗方式相比，efimosfermin可能带来更显著的纤维化改善，并且其益处预期不受背景胰高血糖素样肽-1（GLP-1）治疗的影响。此外，efimosfermin还可降低甘油三酯水平并改善血糖控制，这对于常伴有心代谢共病的MASH患者而言是重要的考虑因素。

Efimosfermin’s unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024..

Efimosfermin的独特特性，包括较低的免疫原性和延长的半衰期，也为每月一次的给药方案和提高患者便利性提供了可能。该试验的完整数据已在2024年11月的美国肝病研究协会（AASLD）会议上公布。

Tony Wood, Chief Scientific Officer, GSK said:

葛兰素史克首席科学官托尼·伍德表示：

“The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029.

“FGF21类药物在MASH中展现了最令人兴奋的数据，包括首次在疾病中证明肝硬化的逆转，而efimosfermin凭借其每月一次的给药方案和耐受性特征，有潜力定义一种新的护理标准。Efimosfermin将大幅拓展我们的肝病学研发管线，并为我们提供开发潜在的同类最佳新药的机会，预计首次上市将在2029年。”

It complements GSK‘990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes.”.

它补充了同样针对ALD和MASH正在开发的GSK‘990，为GSK提供了开发单药治疗和潜在组合疗法的选择，以改善患者预后。"

Elias Zerhouni MD, Chair of the Board,

医学博士伊莱亚斯·泽尔胡尼，董事会主席，

Boston Pharmaceuticals, said:

波士顿制药公司表示：

“I am very proud of today’s agreement with GSK, a company I know and admire with proven expertise in liver disease, and the outstanding work of the Boston Pharmaceuticals team. This would not have been possible without the impressive, sustained and long-term strategic commitment to leading science and biotechnology ventures from the Bertarelli family, and the expertise of Ernesto Bertarelli, which led to the development of efimosfermin as a potential best-in-class therapy.

“我为今天与GSK达成的协议感到非常自豪，这是一家我了解且钦佩的在肝病领域拥有成熟专业知识的公司，同时我也为Boston Pharmaceuticals团队的出色工作感到骄傲。如果没有Bertarelli家族令人钦佩的、持续的、长期致力于科学和生物技术领域的战略承诺，以及Ernesto Bertarelli的专业知识，efimosfermin作为一种潜在的同类最佳疗法的开发是不可能实现的。”

We are delighted that GSK, a global leader, recognised efimosfermin’s potential to address a growing global public health concern and unmet medical need. Together, we look forward to efimosfermin’s ongoing journey to become a best-in-class treatment for patients with SLD.”.

我们很高兴全球领先的GSK认识到efimosfermin在应对日益严重的全球公共卫生问题和未满足的医疗需求方面的潜力。我们期待与GSK共同推动efimosfermin的发展，使其成为治疗SLD患者的同类最佳疗法。

The addition of efimosfermin further strengthens GSK’s hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases.

Efimosfermin的加入进一步增强了GSK专注于解决病毒性（慢性乙型肝炎）和脂肪变性（SLD）导致的纤维化肝病的专科药物肝病学管线。

Financial considerations

财务方面的考虑

Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG..

根据协议条款，GSK将收购波士顿制药公司的子公司BP Asset IX, Inc.，以获取efimosfermin。GSK将支付总计高达20亿美元的现金对价，其中包括12亿美元的预付款和高达8亿美元的基于成功的里程碑付款。GSK还将负责基于成功的里程碑付款以及向诺华制药公司支付的分级版税。

GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US.

葛兰素史克将把这笔交易作为业务合并入账。该交易需符合惯例条件，包括根据美国《哈特-斯科特-罗迪诺法案》获得适用的监管机构批准。

For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel.

对于GSK，Evercore Partners International LLP担任独家财务顾问，Cleary Gottlieb Steen & Hamilton LLP担任法律顾问。

For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel.

对于波士顿制药公司，Centerview Partners LLC担任独家财务顾问，Sullivan & Cromwell LLP担任法律顾问。

About efimosfermin alfa

关于艾菲莫非阿尔法

Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world..

Efimosfermin 是一种研究性药物，每月一次皮下注射的长效 FGF21 变体，旨在调节关键代谢途径，以减少肝脏脂肪、改善肝脏炎症并逆转 MASH 患者的肝纤维化。Efimosfermin 目前正在进行中度至重度纤维化（包括肝硬化）的临床试验，尚未在全球任何地方获得处方资格。

About Boston Pharmaceuticals

关于波士顿制药公司

Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society..

波士顿制药是一家临床阶段的生物制药公司，利用经验丰富且专注的药物开发团队，推进一系列高度差异化的疗法，这些疗法可能满足严重肝病领域的重要未满足医疗需求。波士顿制药是B-Flexion的投资组合公司，B-Flexion是一家私人创业投资公司，管理与贝塔雷利家族相关的综合基金和投资，同时与精明资本合作，以实现跨代创造卓越价值的共同目标，并为社会作出积极贡献。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。