Seladelpar

2026年步入收官阶段，国内创新药赛道迎来年度终极复盘与冲刺大考。在政策持续鼓励源头创新、临床未满足需求持续释放、全球药企加速本土化布局的多重背景下，一批涵盖自免、罕见病、代谢、神经、抗感染、血液肿瘤、肝胆疾病的重磅新药集中递交上市申请，冲刺年内获批窗口。 不同于往年同质化仿制药扎堆申报的格局，本次冲刺上市的10款核心新药，覆盖全新靶点、首创机制、国产首款、全球唯一剂型四大核心稀缺属性，既有本土药企十年研发攻坚的原创成果，也有跨国巨头与国产企业合作引进的全球标杆品种。 表：10款重磅新药有望在中国获批上市 注：表格数据截止日期为2026年10月12日 一、自身免疫与罕见病破局：从FcRn到EZH1/2的精准打击 自身免疫疾病与罕见肿瘤，是全球新药研发的高壁垒、高刚需赛道。长期以来，国内该领域治疗方案匮乏、传统药物疗效有限、副作用显著，大量患者面临无药可用、用药效果不佳的困境。2026年冲刺上市的多款新药，以全新精准靶点为核心，实现自免慢病与罕见难治肿瘤的治疗破局。 在自身免疫疾病领域，石药集团联合和铂医药开发的巴托利单抗，是本年度最具代表性的突破性品种之一，主打全身型重症肌无力治疗，为国内数千万自免患者带来全新治疗选择。 巴托利单抗为全人源单克隆抗体，核心作用机制精准靶向FcRn-IgG结合通路，通过阻断二者相互结合，快速加速体内致病性IgG清除，从根源上抑制IgG介导的自身免疫损伤，完美适配重症肌无力的发病机制，区别于传统激素、免疫抑制剂的广谱抑制模式，具备疗效精准、副作用可控的核心优势。 该品种最早由韩国HanAll Biopharma研发，2017年和铂医药拿下大中华区权益，2022年携手石药集团联合开发，整体交易总金额超10亿元，依托双方产业、临床、商业化资源，快速推进本土化临床落地。2024年6月，企业重新递交该药生物制品许可申请，补齐临床数据短板，正式冲刺国内上市。10月22日，NMPA官网显示，巴托利单抗在国内获批上市，用于治疗全身型重症肌无力（gMG）。 临床数据层面，该药的核心价值已获得国际权威期刊认可。其针对重症肌无力的关键III期临床研究成果已于2024年3月发表于《JAMA Neurology》，数据证实巴托利单抗可显著改善患者肌力评分，持续降低疾病复发风险，长期治疗安全性、耐受性良好，为上市获批与临床推广提供了顶级循证支撑。作为国内重症肌无力领域稀缺的精准靶向新药，其获批后有望快速纳入临床指南，改写传统治疗方案。 罕见肿瘤赛道，海和药物的艾普美妥司他实现国产技术零的突破。该药是高选择性EZH1/2双重小分子抑制剂，主打不可手术、局部晚期或转移性经治上皮样肉瘤，该疾病属于恶性程度极高、临床药物空白的罕见软组织肉瘤，既往缺乏有效治疗手段，患者预后极差。 相较于单一EZH2抑制剂，艾普美妥司他可同时抑制EZH1的代偿激活效应，彻底阻断肿瘤增殖的表观遗传通路，抑制效果更全面、抗肿瘤活性更强。从全球赛道格局来看，目前仅第一三共的Valemetostat一款EZH1/2双重抑制剂获批上市，而艾普美妥司他是全球临床进展最快的国产同靶点药物，有望成为国内首款获批的EZH1/2抑制剂。 两款新药的精准落地，标志着国内自免疾病、罕见肿瘤治疗正式迈入“靶向精准化”时代，打破了传统药物治疗粗放、疗效有限的僵局，同时填补了国产创新在高端自免、罕见肿瘤靶点领域的技术空白，为后续同类新药研发提供成熟范式。 二、代谢与神经退行性疾病：降脂新靶点与帕金森“长疗效”之争 代谢慢病与神经退行性疾病是国内患者基数最大、临床需求最刚性的赛道，传统治疗药物长期存在疗效不足、给药繁琐、无法控制病情进展的短板。本年度冲刺上市的两款重磅新药，分别卡位降脂新靶点与帕金森长效治疗领域，实现慢病精细化管理的升级突破。 恒瑞医药自主研发的芮弗西拜单抗，是国内首款靶向ANGPTL3的降脂创新药，主打纯合子型家族性高胆固醇血症（HoFH），破解了遗传性重症高血脂的治疗难题。HoFH属于罕见遗传性代谢疾病，患者自幼血脂异常升高，传统他汀类药物治疗效果极差，极易引发早发心梗、脑梗，临床长期缺乏高效治疗药物。 2025年2月，该药上市申请正式获CDE受理，2026年1月其II期临床研究成果登顶《JAMA Cardiology》，核心数据极具突破性：HoFH患者每4周皮下注射600mg芮弗西拜单抗，治疗12周后，患者LDL-C水平较基线平均降幅达59.09%，降脂效果强效且持续稳定，且整体安全性、耐受性优异，无严重不良反应发生。 放眼全球赛道，ANGPTL3靶点仅再生元的依维苏单抗获批上市，但该品种至今未布局中国市场，芮弗西拜单抗凭借本土化研发、成熟的临床数据、完善的商业化体系，抢先锁定国内市场先机，有望成为国产首款、国内唯一可用的ANGPTL3靶向降脂药，彻底填补重症遗传性高血脂的治疗空白。 神经退行性疾病领域，复星医药引进的奥吡卡朋，重构了帕金森病症状波动的治疗标准。该药为第三代COMT抑制剂，也是全球唯一一款每日仅需睡前口服一次的帕金森治疗药物，主打解决左旋多巴治疗后的剂末现象与症状波动难题。 传统帕金森治疗药物给药频次高、药效波动大，患者易出现“关期”僵直、运动障碍，严重影响生活质量。奥吡卡朋凭借长效缓释特性，可平稳控制全天病情，大幅优化患者用药依从性。临床数据显示，50mg剂量奥吡卡朋可有效减少患者绝对“关期”时长120分钟，相较安慰剂可增加有效“开期”71.9分钟。 更具临床价值的是，既往使用恩他卡朋治疗的患者，换用奥吡卡朋后，可进一步实现无异动症“开期”延长45.7分钟、关期缩短39.3分钟，疗效升级优势显著。作为长效、低负担的联合治疗药物，奥吡卡朋的上市将彻底改善帕金森患者的运动与非运动症状，推动国内帕金森病精细化、长效化管理落地。 三、抗感染与血液肿瘤：国产创新药的“爆发”与“内卷” 抗感染与血液肿瘤是国产创新药布局最密集、竞争最激烈的赛道，2025-2026年迎来国产新药集中落地爆发期，呈现出“批量上市、差异化突围、剂型升级”的全新竞争格局，在同质化内卷中跑出特色创新路径。 抗感染领域，先声药业联合安帝康生物开发的玛氘诺沙韦，扛起国产高端抗流感新药的创新大旗。该药为1类创新药，属于cap依赖型核酸内切酶抑制剂，通过阻断流感病毒mRNA转录，抑制病毒自我复制，实现高效抗病毒效果。 相较于传统抗流感药物，玛氘诺沙韦具备颠覆性给药优势，成人患者全病程仅需口服一粒即可完成治疗，24小时内可快速阻断病毒复制，实现“一天转阴”；同时针对性开发儿童颗粒剂型，适配2-11岁儿童流感患者，实现“一袋治愈”的便捷治疗体验，填补儿童精准抗流感的剂型空白。 行业数据显示，2025年国内已有玛帕西沙韦、玛硒洛沙韦、昂拉地韦、玛舒拉沙韦4款国产抗流感新药密集获批，标志着国产抗流感赛道正式进入爆发期。赛道热度飙升的同时，同质化内卷加剧，而玛氘诺沙韦凭借超短疗程、全人群覆盖、双剂型布局的差异化优势，在激烈竞争中站稳脚跟，成为国产抗流感创新的标杆品种。 血液肿瘤赛道，两款国产新药分别从小分子口服药与细胞治疗两个维度实现突破，破解复发难治性肿瘤的治疗困境。徐诺药业的阿贝司他是口服泛HDAC抑制剂，主打复发或难治性滤泡性淋巴瘤，适配多线治疗失败的晚期患者。 其中国注册II期临床数据表现亮眼：患者整体ORR达69.5%，完全缓解率14.6%，疾病控制率高达91.5%，89%的患者实现肿瘤体积缩小；同时具备长效获益优势，中位缓解持续时间13.96个月，中位无进展生存期13.80个月，中位总生存期突破47.18个月，为晚期淋巴瘤患者带来长期生存希望。口服给药的便捷性，也大幅降低了患者院端治疗负担。 细胞治疗领域，艺妙神州的泊基奥仑赛刷新国产CAR-T治疗数据。该药是靶向CD19的自体CAR-T细胞产品，针对复发难治性弥漫大B细胞淋巴瘤，101例大样本中国注册临床数据显示，整体ORR达71%，实现完全缓解患者的中位PFS超24个月，长效获益优势突出。 目前国内已有9款CAR-T产品获批上市，赛道竞争趋于饱和，泊基奥仑赛依托大样本国产临床数据、优异的长期生存获益、本土化制备成本优势，在同质化CAR-T产品中实现差异化突围，为国产血液肿瘤细胞治疗提供全新解决方案。 四、胆汁淤积与血小板减少：新机制药物填补临床空白 肝胆罕见病与自身免疫性血液病，长期存在“症状难治、药物稀缺、机制单一”的临床痛点。本年度冲刺上市的三款新药，以全新作用机制、差异化治疗路径，针对性填补原发性胆汁性胆管炎、免疫性血小板减少症的治疗空白，完善罕见慢病治疗体系。 针对原发性胆汁性胆管炎（PBC），GSK利奈昔巴特与吉利德司拉德帕形成“双机制互补”的创新格局，分别从症状缓解与病因干预两个维度破解临床难题。两款药物均已通过国内临床急需药品政策先行落地，正式获批后将全面提升患者可及性。 GSK的利奈昔巴特是口服IBAT抑制剂，核心作用是抑制胆汁酸肠道再摄取，减少血液循环中的瘙痒致病介质，精准解决PBC患者最核心的胆汁淤积性瘙痒症状。该药2026年3月率先获FDA批准，成为全球首款针对PBC瘙痒的专属治疗药物，目前中欧多国上市申请同步推进，落地后将彻底改变PBC患者瘙痒无特效药的困境。 吉利德的司拉德帕则靶向病因治疗，作为高选择性PPARδ激动剂，可精准调控胆汁淤积、肝脏炎症、肝纤维化三大核心通路，适配对熊去氧胆酸（UDCA）应答不足或无法耐受UDCA的PBC患者，可单药或联合用药，实现对疾病进展的源头干预。相较于传统对症治疗药物，司拉德帕可延缓肝纤维化进展，实现标本兼治。 两款药物机制互补、疗效协同，分别解决PBC患者的症状痛苦与病情进展难题，形成完善的疾病治疗矩阵，填补国内PBC精细化治疗的长期空白。 自身免疫性血液病领域，和黄医药的索乐匹尼布为免疫性血小板减少症（ITP）带来口服新方案。该药是高选择性口服Syk抑制剂，针对一线激素、免疫球蛋白治疗无效或复发的成人慢性ITP患者，精准阻断自身免疫介导的血小板破坏通路。 2025年ASH大会公布的三年长期随访数据显示，索乐匹尼布长期治疗持续应答率达61.5%，中位治疗时长超86周，长期用药安全性可控，胃肠道毒性显著低于同类药物，解决了传统ITP药物副作用大、复发率高的痛点。 目前国内ITP临床主要依赖TPO-R激动剂，存在价格高、长期疗效不稳定的问题。索乐匹尼布凭借口服便捷、长效稳定、安全性优异的优势，可与现有药物形成互补，重塑ITP全程治疗格局，为复发难治患者提供全新治疗选择。 结语 纵观这10款冲刺上市的重磅新药，我们看到的不仅是一份商业化的成绩单，更是中国医药创新生态的缩影。从恒瑞、石药等本土巨头的自研突破，到复星、先声的引进消化，再到GSK、吉利德等跨国药企的全球同步，中国患者正以前所未有的速度享受到全球前沿疗法。然而，获批只是起点，后续的医保谈判、商业化落地、以及真实世界疗效的验证，才是决定这些药物能否真正惠及患者的关键。 2026年的这场“大考”，不仅考验着药企的战略定力，也考验着中国医药市场的支付能力与包容度。无论结果如何，这场创新浪潮都将推动中国医疗健康事业迈向新的高度。 参考来源： 1、 Insight数据库 2、 企业官网 声明：本内容仅用作行业信息传播，为作者独立观点，不代表研界OmniSci立场，也不构成任何投资与医疗建议。如需转载，请务必注明文章作者与来源。 END

- Late-Breaking Phase 3 Data from the IDEAL Study Highlight the Impact of Livdelzi ® on Composite Alkaline Phosphatase (ALP) Normalization and Other Markers of Disease Progression in Primary Biliary Cholangitis (PBC) - - New Long-Term and Real-World Evidence in Hepatitis Delta Virus (HDV) Examine Combined Virologic and Biochemical Response with Hepcludex ® - FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) will present new clinical and real-world evidence across primary biliary cholangitis (PBC) and chronic hepatitis delta virus (HDV) infection at The Liver Meeting ® 2026, hosted by the American Association for the Study of Liver Diseases (AASLD), November 5-9 in Denver, Colorado. The data will examine durability of response, patient-relevant symptoms, and opportunities to better understand long-term disease management across these two rare and serious liver diseases. Key Highlights Gilead’s scientific program includes 21 accepted abstracts, including late-breaking Phase 3 research from the Livdelzi ® (seladelpar) 10 mg development program and new long-term and real-world evidence for Hepcludex ® (bulevirtide-gmod) 2 mg and 8.5 mg in chronic HDV. The portfolio of research reflects Gilead's continued focus on generating evidence that helps broaden understanding of treatment response, patient experience, and long-term management considerations. By combining long-term clinical data, real-world insights, and research in patient-centred outcomes, Gilead continues to drive innovation and progress scientific advancements to inform treatment decisions and enhance understanding of rare liver diseases. Improving Care Across the PBC Journey Gilead will present analyses from the Livdelzi clinical development program and real-world studies, including late-breaking Phase 3 presentation of the IDEAL study results which evaluate the impact of seladelpar on composite alkaline phosphatase (ALP) normalization in a historically understudied population of adults living with PBC with lower levels of ALP elevation (1-1.67x ULN) who were on or intolerant to ursodeoxycholic acid (UCDA). (LB#5007). ALP normalization is an increasingly recognized treatment goal that continues to be studied in relation to long-term outcomes in PBC. Additional data on safety and efficacy of seladelpar up to five years (#1170) and late-breaking data on fatigue (LB#5040) will also be presented. Additional real-world studies will examine persistent gaps in care, including factors affecting eligibility for, and escalation to, second-line treatment (#1170 and #1221). Together, the analyses provide a broader understanding of the diverse experiences, unmet needs and challenges faced by people living with PBC, including those at high risk of disease progression. “As treatment options evolve, our ambitions for people living with rare liver diseases should evolve as well,” said Swati Tole, Senior Vice President, Clinical Development, Inflammation at Gilead. “At The Liver Meeting, we will present late-breaking results from the Phase 3 IDEAL study highlighting composite alkaline phosphatase (ALP) normalization, an important marker of disease activity in people with PBC. We will also share data that look beyond biochemical measures of disease activity to explore durability of response, symptoms and the realities of long-term disease management. Together, these insights can help broaden our understanding of important aspects of care for people living with PBC.” Advancing Long-Term Disease Outcomes in Chronic HDV Gilead will also present new long-term and real-world data that deepens the understanding of Hepcludex for the treatment of chronic HDV. Highlights include 96-week efficacy findings on the combined virologic and biochemical response (#3203) and a 48-week analysis of clinically significant portal hypertension prevalence and impact of Hepcludex in people living with chronic HDV (#3243). U.S. real-world studies will also spotlight low testing rates (#4080) and the burden of advanced liver disease (#3216), underscoring the need for earlier detection and stronger long-term management for people living with HDV. Gilead’s Commitment to Improving Outcomes for People with Liver Diseases For people living with PBC and HDV, delayed diagnosis and treatment can mean more time living with burdensome symptoms or progressive liver damage. Gilead's new data highlight these persistent gaps and showcase opportunities for earlier diagnosis, timely treatment escalation, more patient-centered research, and a better understanding of long-term disease management. Collectively, the data emphasizes the importance of identifying people at risk of progression, optimizing treatment decisions and advancing understanding of long-term outcomes across PBC and HDV. For more information, including a complete list of abstract titles being presented at the meeting, please visit the AASLD website . Key Abstracts at AASLD 2026: ID Abstract Title PBC Abstract #5007 Oral Presentation November 8, 2026 5:00–5:15 PM Seladelpar for Alkaline Phosphatase Normalization in Primary Biliary Cholangitis: Results from the IDEAL Phase III Randomized-Controlled Trial Abstract #5040 Poster Presentation November 8, 2026 1:00–2:00 PM Clinically Meaningful Fatigue Improvement with Seladelpar in Patients with Primary Biliary Cholangitis: Data from the Open-label ASSURE Study Abstract #1170 Poster Session November 5, 2026 12:00-1:00 PM Sustained Biochemical Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis, Including Those at High Risk for Progression, up to 5 years of Treatment from ASSURE Abstract #1137 Poster Session November 5, 2026 12:00-1:00 PM Seladelpar is Associated with Stable Renal Function Over 5 Years of Treatment: Interim Results from the ASSURE Study Abstract #1164 Poster Session November 5, 2026 12:00-1:00 PM Seladelpar Downregulates Inflammatory and Fibrotic Pathways: Insights from Serum Proteomic Analysis Abstract #1157 Poster Session November 5, 2026 12:00-1:00 PM Seladelpar Leads to Rapid and Sustained Alkaline Phosphatase Reduction, Regardless of Baseline Levels, Over 5 Years of Treatment in Patients with Primary Biliary Cholangitis Abstract #1160 Poster Session November 5, 2026 12:00-1:00 PM Seladelpar Leads to Long-Term Efficacy and Safety in Patients with Prior OCA and/or Fibrate Exposure Abstract #1233 Poster Session November 5, 2026 12:00-1:00 PM Seladelpar Leads to Durable and Significant Decrease in the Pruritogenic Cytokine IL-31, Associated with Pruritus Improvement: Long-Term Data from the ASSURE Study Abstract #1221 Poster Session November 5, 2026 12:00-1:00 PM Risk Factors for Progression in Patients with Primary Biliary Cholangitis who are Eligible for Second-line Treatment: Evidence from a Real-world Study Abstract #1171 Poster Session November 5, 2026 12:00-1:00 PM Health-related Quality of Life Among Patients with PBC by Response Status: Analysis of a Real-world Dataset Abstract #1182 Poster Session November 5, 2026 12:00-1:00 PM Healthcare Resource Utilization and Costs in Patients with Primary Biliary Cholangitis in the United States Abstract #1313 Poster Session November 5, 2026 12:00-1:00 PM Association Between Treatment Adherence and Healthcare Utilization Among Individuals with Primary Biliary Cholangitis in the United States Hepatitis Delta Abstract #3200 Poster Session November 7, 2026 1:00–2:00 PM Characteristics and Outcomes of On-Treatment ALT Flares in Patients with Hepatitis Delta Virus Receiving Bulevirtide and Pegylated Interferon Abstract #3203 Poster Session November 7, 2026 1:00–2:00 PM Integrated Efficacy Analysis of Bulevirtide 10 mg Monotherapy in Patients with Chronic Hepatitis Delta Abstract #3243 Poster Session November 7, 2026 1:00–2:00 PM Clinically Significant Portal Hypertension may Improve in Some Patients with Chronic Hepatitis Delta After 48 Weeks of Bulevirtide Treatment - a Pooled Analysis of Phase II/III Clinical Trials Abstract #4080 Poster Session November 8, 2026 1:00–2:00 PM Hepatitis Delta Testing Rates Remain Low Among Individuals with Chronic Hepatitis B: a US Administrative Claims Analysis Abstract #3216 Poster Session November 7, 2026 1:00–2:00 PM Disease Progression Among a Nationally Representative Cohort of Commercially Insured Patients with Hepatitis Delta Virus in the United States Abstract #3215 Poster Session November 7, 2026 1:00–2:00 PM On-Treatment and Posttreatment Patterns of Non-Invasive Tests of Fibrosis with Long-Term Bulevirtide Treatment for Chronic Hepatitis Delta: An Integrated Analysis Abstract #3236 Poster Session November 7, 2026 1:00–2:00 PM Diagnostic Performance of Noninvasive Tests for Hepatic Fibrosis in Patients with Chronic Hepatitis Delta Receiving Bulevirtide Abstract #3202 Poster Session November 7, 2026 1:00–2:00 PM A Systematic Literature Review and Meta-Analysis Evaluating Post-Treatment HDV RNA-Based Surrogate Endpoints for Predicting Long-Term Clinical Outcomes in Hepatitis Delta Virus Infection Hepatitis B Abstract #4089 Poster Session November 8, 2026 1:00–2:00 PM Combining PAGE-B Score with Fibrotest Improves HCC Risk Stratification in Patients Treated with Tenofovir-based Treatment About Livdelzi Livdelzi (seladelpar) is an oral PPAR‑delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR‑delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti‑inflammatory, antipruritic, and antifibrotic effects. Clinical trial data demonstrate that Livdelzi supports meaningful improvements in key markers of disease activity, including biochemical response and alkaline phosphatase (ALP) normalization, with sustained effects observed over long‑term follow‑up in multiple studies. These findings are supported by clinical studies evaluating Livdelzi in participants treated for up to 5 years. Livdelzi has the potential to help address ongoing unmet needs for people living with PBC, including those who remain inadequately controlled on existing therapies. Pruritus is one of the most common and debilitating symptoms of PBC that can significantly impair quality of life. Clinical trial data have demonstrated improvements in pruritus with Livdelzi compared with placebo. U.S. Indication for Livdelzi Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for LIVDELZI Warnings and Precautions Fractures: Fractures occurred in 4% of LIVDELZI-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with LIVDELZI and monitor bone health according to current standards of care. Liver Test Abnormalities: LIVDELZI has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting LIVDELZI and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting LIVDELZI. Biliary Obstruction: Avoid use of LIVDELZI in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LIVDELZI and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with LIVDELZI were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions Potential Increased Exposure of LIVDELZI with: Probenecid: Avoid coadministration with LIVDELZI. Strong CYP2C9 Inhibitors: Monitor for adverse effects during concomitant use. Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors (eg, fluconazole): Monitor for adverse effects during concomitant use. CYP2C9 Poor Metabolizers Using Moderate or Strong CYP3A4 Inhibitors: Monitor for adverse effects during concomitant use of a moderate or strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers. Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP (eg, cyclosporine): Monitor for adverse effects during concomitant use. Potential Reduction in LIVDELZI Exposure with: Rifampin: Concomitant use of LIVDELZI with rifampin, an inducer of metabolizing enzymes, may result in delayed or suboptimal LIVDELZI biochemical response. Monitor biochemical response (eg, ALP and bilirubin) when patients initiate rifampin during LIVDELZI treatment. Bile Acid Sequestrants: Administer LIVDELZI at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to LIVDELZI to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There are no data on the presence of LIVDELZI in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LIVDELZI and any potential adverse effects on the breastfed infant from LIVDELZI. About Hepcludex (bulevirtide-gmod) 8.5 mg in the U.S. Hepcludex (bulevirtide-gmod) is a first-in-class entry inhibitor for the treatment of adults living with chronic hepatitis delta virus (HDV) infection. Chronic HDV infection is a serious liver disease that occurs only as a co-infection in individuals with chronic HBV and is associated with rapid disease progression, liver failure, and increased mortality. Hepcludex is supplied as a vial for once-daily subcutaneous injection. Each vial contains an 8.5 mg dose when prepared according to the Instructions for Use within FDA-approved labeling. Hepcludex works by blocking the entry of both HDV and HBV into liver cells, addressing a key step in the viral lifecycle. The FDA’s accelerated approval of Hepcludex is supported by data from the Phase 3 MYR301 study demonstrating that Hepcludex was an effective and generally well-tolerated treatment option, with efficacy and safety observed at week 48 through long-term treatment of up to 144 weeks. Hepcludex is supplied as a once-daily injectable therapy and represents the first and only treatment option for people living with chronic HDV that received FDA accelerated approval in the United States, addressing a long-standing unmet medical need for this historically underserved patient community. For more information, please visit Hepcludex.com U.S. Access and Hepcludex Approval Across Markets The Gilead Support Path ® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments. Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA), Canada the United Kingdom and other countries globally to treat people living with chronic HDV. Please see below for U.S. Indication and Important Safety Information for Hepcludex. U.S. Indication for Hepcludex Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). U.S. Important Safety Information for HEPCLUDEX IMPORTANT SAFETY INFORMATION BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted. Warnings and Precautions Hypersensitivity reactions including anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment. Adverse Reactions Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus. Dosage and Administration Dosage in adults: 8.5 mg once daily administered by subcutaneous injection HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown. In all patients, manage the underlying HBV infection as clinically appropriate. Pregnancy and Lactation Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. But our commitment doesn’t stop there. Through ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. Gilead remains committed to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. In 2025, Gilead announced a $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Livdelzi/Lyvdelzi (seladelpar) and Hepcludex (bulevirtide) (such as IDEAL); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar and bulevirtide; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Livdelzi, Lyvdelzi, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. U.S. full Prescribing Information for Livdelzi ® and Hepcludex ® is available at . For more information about Gilead, please visit the company’s website at , follow Gilead on X/Twitter(@Gilead Sciences) and LinkedIn(@Gilead-Sciences) Contacts Priscilla White, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com