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Company advances its leadership in MASH with clinical-stage, genetically targeted siRNA asset from Arrowhead Pharmaceuticals Precision approach targets patients who have a mutation in the PNPLA3 gene, which is highly prevalent among Hispanic patients with MASH Phase 1 data published in The New England Journal of Medicine demonstrated a 46% liver fat reduction in homozygous patients and a well-tolerated safety profile Madrigal’s pipeline includes more than 10 programs at multiple stages of development, anchored by Rezdiffra ® (resmetirom) as the foundational treatment CONSHOHOCKEN, Pa., May 05, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced an exclusive global license agreement with Arrowhead Pharmaceuticals for ARO-PNPLA3, a clinical-stage, small interfering RNA (siRNA) asset targeting patatin-like phospholipase domain-containing protein 3 (PNPLA3), a key genetic driver of MASH. The license of ARO-PNPLA3 adds to Madrigal’s pipeline with a precision medicine approach for patients at high risk of MASH. PNPLA3 I148M, a well-established genetic contributor to MASH progression, is associated with increased liver fat, inflammation, fibrosis, cirrhosis and hepatocellular carcinoma. Approximately 30% of patients with MASH with moderate to advanced fibrosis (consistent with stages F2 to F3 fibrosis) carry two identical copies of this variant (known as homozygous patients), and it is highly prevalent in Hispanic populations. “The addition of an siRNA program targeting PNPLA3 to our pipeline reflects Madrigal’s commitment to shaping the future of MASH patient care,” said Bill Sibold, Chief Executive Officer of Madrigal. “MASH is a complex, heterogeneous disease, and we believe patients will benefit from personalized treatment strategies targeting key genetic risk factors that drive disease progression and adverse outcomes. We’re particularly excited about the potential to advance research for members of the Hispanic community, who are disproportionately affected by MASH.” “We are pleased to add ARO-PNPLA3 to our pipeline as we continue to expand Madrigal’s leadership in MASH,” said David Soergel, M.D., Chief Medical Officer of Madrigal. “This licensing agreement advances our R&D strategy of developing therapies that target validated disease mechanisms and may complement Rezdiffra’s broad therapeutic effects, especially in patient populations with specific needs. Encouraging Phase 1 data support continued development of this targeted approach for patients with a well-defined genetic driver of disease, and we will begin planning for combination studies with Rezdiffra.” Phase 1 trials provide proof-of-concept for ARO-PNPLA3 as a potential precision-medicine approach in MASH A Phase 1, first-in-human, double-blind, placebo-controlled trial of ARO-PNPLA3 was conducted in the United States in 55 patients with Metabolic dysfunction-associated fatty liver disease (MAFLD) who were either homozygous or heterozygous carriers of the PNPLA3 I148M variant. Approximately 93% of participants were Hispanic or Latino. Data from this study, published in The New England Journal of Medicine , demonstrated: Reductions in liver fat up to 46% (as measured by MRI-PDFF) at 12 weeks following a single dose at the highest dose level tested in PNPLA3 I148M homozygous patients Rapid onset of effect, with reductions observed at six weeks and sustained through at least 24 weeks No clinically meaningful adverse events were observed No effect on liver fat content was observed in heterozygous participants at any of the doses studied Results from a second Phase 1 trial conducted in Japan (n=9) support these findings siRNA: Potential for an Effective, Genetically Targeted Treatment Approach Small interfering RNAs (siRNAs) offer a precision approach to gene silencing in MASH by selectively reducing the production of disease-driving proteins. When linked to a GalNAc ligand, siRNA molecules are delivered directly into hepatocytes, where they silence genes that have been identified as key risk factors for MASH by breaking down targeted mRNA. By pairing this precise gene-silencing approach with Rezdiffra, the company aims to explore whether reducing drivers of disease at the genetic level can complement Rezdiffra’s therapeutic effects. Madrigal currently has seven siRNA programs in its pipeline. ARO-PNPLA3 is a GalNAc-conjugated siRNA designed to reduce expression of PNPLA3, a genetically validated driver of MASH. Mutations in the PNPLA3 gene have been shown to disrupt the liver’s ability to properly process fat. This leads to increased fat accumulation in hepatocytes, and is strongly associated with MASH progression and a high risk of developing hepatocellular carcinoma (HCC). The results of two Phase 1 trials suggested that a single dose of ARO-PNPLA3 reduced liver fat content in homozygous carriers of the PNPLA3 I148M variant, providing proof-of-concept for ARO-PNPLA3 as a precision-medicine approach in this patient population. Madrigal will consult with the FDA on design of a Phase 2 combination trial with Rezdiffra. Deal Terms Arrowhead has granted Madrigal an exclusive global license to develop, manufacture and commercialize ARO-PNPLA3. Arrowhead will receive an upfront payment of $25 million, additional payments of up to $975M if certain milestones are achieved and royalties on net sales. About MASH Metabolic dysfunction-associated steatohepatitis (MASH is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, the need for liver transplantation and premature mortality. MASH is the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S., and the fastest-growing indication for liver transplantation in Europe. Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10 to 17 times higher risk of liver-related mortality as compared to patients without fibrosis. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients. As disease awareness improves and disease prevalence increases, the number of diagnosed patients F2 to F4c MASH is growing. About Rezdiffra What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. This indication is approved based on improvement of MASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than MASH. have gallbladder problems or have been told you have gallbladder problems, including gallstones. are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby. A pregnancy safety study for women who take Rezdiffra during pregnancy collects information about the health of you and your baby. You or your healthcare provider can report your pregnancy by visiting or calling 1-800-905-0324. are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take,  including prescription and over-the-counter medicines, vitamins and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works. Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, because Rezdiffra is not recommended in patients taking these medicines. Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice) or stomach pain/tenderness. gallbladder problems. Gallbladder problems such as gallstones, or inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with MASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach pain, vomiting, dizziness and constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or  . You may also report side effects to Madrigal at 1-800-905-0324. Please see the full  Prescribing Information , including  Patient Information , for Rezdiffra. About Madrigal Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit and follow us on LinkedIn. Forward-Looking Statements This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to Madrigal’s development goals and timelines for its pipeline candidates, the potential benefit of ARO-PNPLA3 in the treatment of MASH and Madrigal’s ability to advance its leadership position in MASH treatment. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; Madrigal’s ability to successfully commercialize Rezdiffra; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product; Madrigal’s history of operating losses and the possibility that it may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal’s clinical trials, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) or any product candidate’s mechanism of action; market demand for and acceptance of Rezdiffra; Madrigal’s ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; Madrigal’s ability to prevent and/or mitigate cyber-attacks; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; Madrigal’s ability to protect its intellectual property; and changes in laws and regulations applicable to Madrigal’s business and its ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission (“SEC”), for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 19, 2026, and as updated from time to time by Madrigal’s other filings with the SEC. Madrigal may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Madrigal’s website in addition to following its press releases, filings with the SEC, public conference calls, and webcasts. Investor Contact Tina Ventura, IR@madrigalpharma.com Media Contact Christopher Frates, media@madrigalpharma.com

提起中国创新药，恒瑞医药是绕不开的名字。作为行业公认的标杆，它市值稳居前列、管线布局全面、品牌家喻户晓，像站在聚光灯下的“门面担当”，代表着中国创新药的对外形象与发展高度。但很多人不知道，创新药从来不是一家企业的单打独斗，而是横跨研发、生产、临床、商业化、上游供应的超长产业链战争。恒瑞的光芒太盛，让市场常常忽略了产业链深处，那些低调却硬核的“幕后玩家”——它们没有恒瑞的高曝光度，却牢牢掌控着产业链最核心的技术、最刚需的环节，是支撑整个行业从跟跑到并跑、再到局部领跑的真正“里子”，更是中国创新药突破海外垄断、实现自主可控的底层底气。 2026年，创新药行业迎来政策与业绩的双重红利期。五一前夕，生物医药首次被《政府工作报告》明确为“新兴支柱产业”，与集成电路、航空航天等战略产业并列，行业地位实现历史性提升。4月，国务院发布药品价格新政，明确高水平创新药可享受上市初期价格保护，直接解决药企研发投入的后顾之忧。5月1日，《生物医学新技术临床研究和临床转化应用管理条例》正式施行，为创新药临床转化打通关键堵点。多重利好下，创新药产业链迎来价值重估机遇，而真正具备核心壁垒的企业，才会在这轮行情中脱颖而出。今天，抛开市场炒作与股价波动，从产业链本质出发，深度拆解四家藏在恒瑞背后的隐形龙头，看清中国创新药产业的真实骨架与核心竞争力。 一、药明康德：产业链“卖水人”，全球CXO绝对龙头 如果把创新药企业比作“淘金者”，那药明康德就是给所有淘金者提供“水和工具”的人——无论淘金者能否挖到金子，卖水人都能实现稳定盈利，这正是CXO（医药研发生产外包）行业的核心逻辑。作为全球CXO领域的绝对龙头，药明康德是国内唯一覆盖“药物发现→临床前研究→临床试验→CDMO生产”全产业链的一站式平台，业务贯穿创新药研发生产全流程，几乎所有国内外创新药企，都或多或少与它存在合作关系。 成立二十多年来，药明康德始终扎根医药研发服务领域，从早期的小分子化学合成，逐步拓展至生物学、药物分析、临床CRO、大分子CDMO等全领域，构建起难以复制的技术壁垒与规模优势。截至2026年4月底，药明康德总市值达3268.71亿元，稳居全球CXO行业首位，远超国内同行。产能布局上，它在全球拥有12个研发生产基地，员工超6万人，服务客户超4000家，涵盖全球前20大药企及众多新兴Biotech，客户粘性极强。 技术实力方面，药明康德在小分子药物化学、ADC药物中间体、双抗/多抗等前沿领域，均达到全球领先水平。近年来，随着全球创新药研发热潮持续升温，海外药企外包需求不断向中国转移，叠加国内创新药企业研发投入持续加码，药明康德的业绩实现持续高速增长。2025年上半年，公司归母净利润同比增长超100%，核心CDMO业务产能利用率持续饱和，充分受益于行业高景气度。 在整个创新药产业链中，药明康德扮演着“基础设施”的角色——没有它提供的低成本、高效率研发生产服务，国内众多中小创新药企的研发之路将举步维艰。恒瑞虽强，也需依赖CXO企业提供部分研发辅助服务，而药明康德凭借全产业链覆盖能力，成为支撑整个行业发展的“底层基石”，是名副其实的产业链“里子”龙头。 二、百济神州：全球化标杆，创新药出海“先行者” 如果说恒瑞是国内创新药的“龙头”，那百济神州就是中国创新药全球化的“标杆”。作为国内首家实现“研发-商业化-全球销售”全链条闭环的Biotech，百济神州从成立之初就瞄准全球市场，不走仿制药老路，专注于源头创新，是国内少数能与国际顶尖药企同台竞技的企业。 截至2026年4月底，百济神州总市值达3619.64亿元，超过恒瑞医药，位居A股创新药板块首位，充分体现了市场对其全球化价值的认可。与恒瑞侧重国内市场不同，百济神州的核心优势在于“全球化布局+重磅产品出海”。公司核心产品BTK抑制剂泽布替尼，是首个完全由中国药企自主研发、并在美国获批上市的抗癌新药，已在全球80多个国家和地区获批，2025年上半年销售额同比增长超40%，海外收入占比超70%，真正实现了“中国创新，全球受益”。 研发管线方面，百济神州构建起以血液瘤、实体瘤、自免疾病为核心的丰富管线，在研产品超50款，其中10余款处于临床后期，多款产品具备全球首创（First-in-class）潜力。2026年前4个月，在全球创新药临床审批放缓的背景下，百济神州仍有3款产品获得突破性治疗品种认定，研发效率与临床价值得到全球监管机构认可。 商业化能力上，百济神州搭建了覆盖全球的商业化团队，在美国、欧洲、中国等核心市场均建立了完善的销售网络，具备独立开展全球学术推广、市场准入、患者服务的能力。相比之下，国内多数创新药企仍局限于国内市场，商业化能力薄弱，难以支撑产品出海后的市场拓展。 在创新药产业链中，百济神州代表着中国创新药的“最高水平”——它打破了海外药企在高端创新药领域的垄断，证明了中国企业具备源头创新与全球商业化的能力。恒瑞的成功，更多是基于国内市场的深耕细作；而百济神州的价值，在于为中国创新药开辟了全球化道路，是行业从“国内龙头”迈向“全球巨头”的核心力量，更是产业链中不可或缺的“硬核里子”。 三、荣昌生物：ADC赛道王者，技术授权“天花板” 近年来，ADC（抗体偶联药物）成为全球创新药领域最热门的赛道，被誉为“下一代抗癌药”，而荣昌生物正是国内ADC赛道的绝对龙头，也是全球少数掌握ADC核心技术的企业之一。如果说恒瑞是综合型创新药龙头，那荣昌生物就是细分赛道的“隐形冠军”，凭借独家技术壁垒，在ADC领域实现“弯道超车”，成为产业链中技术含金量最高的企业之一。 荣昌生物成立于2008年，专注于抗体药物、ADC药物、双抗药物等生物药的研发与生产，核心团队由海外顶尖药企资深专家组成，具备丰富的新药研发与商业化经验。公司核心产品维迪西妥单抗，是国内首个自主研发的ADC药物，也是全球首个获批用于胃癌治疗的ADC药物，2024年销售额持续高速增长，已成为国内胃癌治疗领域的重磅药物。 最能体现荣昌生物技术实力的，是其全球化授权能力。2021年，荣昌生物将维迪西妥单抗的海外权益授权给国际顶尖药企Seagen，获得26亿美元的首付款+里程碑付款，创下当时中国创新药海外授权的最高纪录。2025年，公司另一款ADC药物RC88，再次与海外药企达成合作，授权金额超10亿美元，充分证明了荣昌生物的ADC技术已达到全球顶尖水平，得到国际市场的高度认可。 研发管线方面，荣昌生物构建起“ADC+双抗”双平台布局，在研产品超20款，其中6款处于临床后期，覆盖胃癌、乳腺癌、肺癌、膀胱癌等多个高发癌种。2026年，公司有3款ADC药物进入III期临床，有望在未来2-3年内陆续获批上市，形成“多款重磅产品同时商业化”的格局，成长空间巨大。 在创新药产业链中，荣昌生物代表着细分赛道的“核心技术壁垒”——ADC药物研发难度极大，涉及抗体、毒素、连接子三大核心技术，全球仅少数企业掌握完整技术体系。恒瑞虽也布局ADC赛道，但起步较晚，目前仍处于临床早期阶段，而荣昌生物已实现技术授权与产品商业化的双重突破，是国内ADC赛道的“拓荒者”与“引领者”。它的成功，不仅带动了国内ADC产业链的发展，更证明了中国企业在高端生物药领域具备自主创新能力，是产业链中技术硬核的“里子”龙头。 四、信立泰：慢病创新药龙头，刚需赛道“压舱石” 如果说恒瑞、百济神州、荣昌生物聚焦于肿瘤、自免等高端创新药赛道，那信立泰则深耕心血管、肾科、代谢等慢病刚需赛道，是国内慢病创新药领域的绝对龙头。慢病具有“患者基数大、用药周期长、刚需性强”的特点，是创新药领域最稳定、最具持续性的赛道，而信立泰凭借二十余年的深耕，在这一领域构建起难以撼动的壁垒，成为产业链的“压舱石”。 信立泰成立于1998年，从仿制药起家，逐步转型为创新药企，专注于心脑血管、肾科、代谢、骨科四大核心治疗领域，核心产品均为临床刚需的重磅药物。公司核心产品包括高血压领域1类创新药信立坦、抗血小板领域标杆产品泰嘉、肾性贫血治疗药物恩那罗等，其中信立坦是国内首个自主研发的ARB类降压药，2024年销售额超20亿元，是国内高血压治疗领域的核心药物。 与肿瘤药相比，慢病创新药具有“研发风险低、商业化成功率高、现金流稳定”的优势。信立泰深耕慢病赛道二十余年，深刻理解临床需求，研发管线聚焦于“未被满足的临床刚需”，避免与头部企业正面竞争，走出了一条差异化发展道路。截至2026年4月底，公司总市值达571.79亿元，虽然不及恒瑞、百济神州，但业绩稳定性极强，2025年前三季度归母净利润同比增长超10%，现金流持续充裕，是创新药板块中少见的“低波动、高确定性”标的。 研发投入方面，信立泰始终保持高强度研发投入，2024年研发费用率超20%，在慢病药企中处于较高水平。公司在研管线丰富，涵盖高血压、心衰、肾病、高血脂、糖尿病等多个慢病领域，其中5款产品处于临床后期，有望在未来3-5年内陆续获批上市，为业绩持续增长提供支撑。 在创新药产业链中，信立泰代表着“刚需赛道的稳定力量”——肿瘤药、高端生物药虽热度高，但研发风险大、竞争激烈、医保谈判压力大；而慢病创新药直接关系到亿万百姓的日常用药需求，市场空间广阔、增长稳定、政策支持力度大。恒瑞虽布局慢病赛道，但重心仍在肿瘤领域，而信立泰是国内唯一专注于慢病创新药的龙头企业，凭借“刚需赛道+稳定业绩+丰富管线”的组合，成为创新药产业链的“基本盘”，是支撑行业长期稳定发展的重要“里子”。 结语：恒瑞是标杆，“里子”企业才是行业底气 综合来看，恒瑞医药作为国内创新药的“门面”，凭借全链条研发能力、丰富管线与强大商业化能力，树立了行业标杆，是中国创新药发展的重要代表。但我们必须清醒认识到，创新药产业的强大，不能只靠一家企业的“单打独斗”，而是需要产业链上不同环节、不同赛道的企业协同发力、共同支撑。 药明康德作为CXO龙头，提供全产业链研发生产服务，是行业的“基础设施”；百济神州作为全球化标杆，实现创新药“中国研发、全球销售”，是行业的“全球化先锋”；荣昌生物作为ADC赛道王者，掌握核心技术壁垒，是行业的“技术硬核”；信立泰作为慢病创新药龙头，深耕刚需赛道、提供稳定现金流，是行业的“压舱石”。这四家企业，虽不如恒瑞那般家喻户晓，却在各自领域做到极致，掌握着产业链最核心的资源、技术与市场，是支撑中国创新药从“大国”迈向“强国”的真正底气。 2026年，在政策红利持续释放、研发创新不断突破、商业化能力逐步提升的背景下，创新药产业链有望迎来新一轮高质量发展周期。恒瑞作为行业标杆，将继续引领行业发展方向；而以药明康德、百济神州、荣昌生物、信立泰为代表的“里子”企业，将凭借核心壁垒持续受益，成为产业链中最具投资价值的核心力量。 中国创新药的发展，既要“面子”光鲜，也要“里子”扎实。只有当越来越多的“里子”企业崛起，掌握核心技术、占据关键赛道、实现自主可控，中国创新药才能真正摆脱对海外的依赖，在全球医药舞台上占据重要一席之地，为中国经济高质量发展注入强劲动力，也为全球患者提供更多高质量、可及性强的创新药物。 #话题讨论#：你认为在创新药产业链中，除了这四家企业，还有哪些细分领域的隐形龙头值得关注？欢迎在评论区留言分享你的观点！ 免责声明：本文仅为个人观点，不涉及任何投资推荐，不构成任何投资建议，大家据此操作风险自担！以上内容纯属政策科普，仅供参考。创作不易，不喜勿喷，感谢理解！记得关注小编，后续持续为大家带来实用干货～