Pozdeutinurad

- Expands Sobi's pipeline with a highly differentiated new Phase 3 asset in Gout - Acquisition expected to be highly accretive to Sobi's mid- to long-term growth and margin trajectory SAN DIEGO, Dec. 15, 2025 /PRNewswire/ -- Arthrosi Therapeutics, Inc., (Arthrosi) has entered into a definitive agreement to be acquired by Sobi® (STO:SOBI). The acquisition strengthens Sobi's gout franchise by adding pozdeutinurad (AR882), an investigational next-generation, once-daily oral URAT1 inhibitor currently being evaluated in two fully recruited global Phase 3 clinical studies for the potential management of progressive and tophaceous gout and expected to read out in 2026. Pozdeutinurad complements Sobi's pipeline by adding a potentially best-in-class URAT1 inhibitor for patients sub-optimally treated with first-line therapies. Today's announcement reflects Sobi's commitment to advancing treatment options for people living with gout. "The acquisition of Arthrosi allows us to expand our gout pipeline with a highly differentiated new asset", said Guido Oelkers, President and CEO of Sobi. "Pozdeutinurad has the potential to become the therapy of choice for patients who have progressive gout with persistent and unresolved symptoms despite first-line therapy. The product has the potential to materially accelerate our growth until the mid 2030s, and beyond. We welcome all members of the talented Arthrosi team and are looking forward to working closely together to be able to offer this therapy to patients as soon as possible." "We are thrilled to join forces with Sobi and look forward to working together to ensure a seamless transition as they advance pozdeutinurad towards pivotal data and potential regulatory filings. We believe that Sobi's global expertise in commercialisation will accelerate our shared mission to deliver pozdeutinurad's potentially transformative benefits for individuals living with gout", stated Litain Yeh, Ph.D., Founder and CEO of Arthrosi Therapeutics. Transaction details Under the terms of the agreement, Sobi will pay USD 950 million (approximately SEK 9.1 billion) upfront in cash to acquire Arthrosi, together with up to USD 550 m (approximately SEK 5.3 billion) in cash in clinical, regulatory and sales milestones. The transaction is subject to the satisfaction of customary closing conditions and is expected to close in H1 2026. Sobi plans to fund the upfront payment mainly through debt in the form of existing credit facilities and a new credit facility provided by Handelsbanken and Danske Bank. The acquisition is expected to be highly accretive to Sobi's mid- to long-term growth and margin trajectory. Barclays Bank PLC is acting as Sobi's financial advisor and McDermott, Will & Schulte is acting as legal advisor to Sobi on this transaction. Centerview Partners LLC is serving as exclusive financial advisor to Arthrosi Therapeutics, and Goodwin Procter LLP is serving as legal counsel to Arthrosi Therapeutics. About Pozdeutinurad Pozdeutinurad (AR882) is an investigational URAT1 inhibitor being developed for the treatment of progressive and tophaceous gout and has completed Phase 2 studies that demonstrated compelling efficacy with a sustained reduction of serum uric acid, dissolution of tophi and a well-tolerated safety profile. It is currently being evaluated in two Phase 3 studies, REDUCE 1 and REDUCE 2, two twelve-month, randomized, double-blind, placebo-controlled studies to assess pozdeutinurad's ability to reduce sUA in patients with progressive and tophaceous gout. Both Phase 3 studies are now fully enrolled, and the pivotal data is expected in 2026. About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing pozdeutinurad, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with progressive gout. The rights to pozdeutinurad in Greater China are held by ApicHope. About Gout Gout is the most common form of inflammatory arthritis. Gout is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. When gout is left untreated, it can become a progressive disease with serious consequences. Over time, frequent flares and persistent uric acid buildup can lead to chronic joint damage, reduced mobility, and the formation of tophi (hard deposits under the skin). While many patients with chronic gout are treated in first line with urate lowering therapy some are sub-optimally treated or do not respond to first line therapies and the disease progresses. In later lines, uncontrolled gout is associated with a higher risk of comorbidities such as kidney disease and cardiovascular complications, making early diagnosis and effective management critical. Despite available treatments, many patients struggle to achieve target uric acid levels, underscoring the need for innovative therapies to prevent long-term disability and improve quality of life. Sobi® Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. Gerard Tobin Head of Investor Relations Arthrosi Contact: Shunqi Yan, PhD Founder & Chief Operating Officer [email protected] Precision AQ Contact: Alex Lobo 212-698-8802 [email protected] SOURCE Arthrosi Therapeutics 21% more press release views with Request a Demo

12月13日，瑞典罕见病制药巨头Sobi（Swedish Orphan Biovitrum）宣布将以最高15亿美元的价格收购美国生物技术公司Arthrosi Therapeutics，其中首付款高达9.5亿美元现金，另外5.5亿美元为临床、监管和销售里程碑付款。这笔交易的核心是Arthrosi公司正在开发的pozdeutinurad（AR882）——一款用于治疗痛风的新型URAT1抑制剂，目前正处于两项全球III期临床研究中。01.Arthrosi：华人创办，聚焦痛风的III期明星biotech成立于2018年的Arthrosi Therapeutics总部位于美国加州圣地亚哥，是一家专注痛风及相关高尿酸血症治疗的临床后期生物技术公司。公司由Litain Yeh博士创立，其研发策略聚焦于一个长期存在却仍未被充分解决的临床问题：在相当比例的痛风患者中，现有降尿酸治疗难以长期、稳定地将血清尿酸（serum uric acid，sUA）控制在治疗目标范围内，进而导致疾病反复发作、关节结构损伤以及皮下痛风石的形成。围绕这一未满足需求，Arthrosi构建了高度集中的产品布局。其核心资产pozdeutinurad（AR882）是一款新一代URAT1抑制剂，通过抑制肾近端小管对尿酸的重吸收、促进尿酸排泄来降低血尿酸水平。从作用机制上看，该药物沿用了已被验证的降尿酸路径，但在药效强度和给药稳定性方面力图实现改进，以提高长期控制的可行性。Arthrosi在研管线情况在已公布的II期临床研究中，AR882显示出稳定而显著的降尿酸效果，血清尿酸水平持续下降。基于前期数据，Arthrosi已完成该产品多项I期和II期临床研究，并将其推进至关键性III期开发阶段。目前，两项全球III期研究均已完成全部患者入组，分别覆盖进展性及结节性痛风患者人群。其关键结果预计将于2026年度公布，为后续注册申报提供核心依据。AR882痛风药物临床2a期数据在疾病结构改善方面，探索性研究还提供了影像学层面的补充证据。相关数据显示，AR882在治疗过程中可伴随皮下痛风石体积的缩小，并在部分患者中通过双能CT（dual-energy computed tomography，DECT）观察到深层组织尿酸结晶负荷的下降。此类影像学改善在口服降尿酸药物中相对少见，也为其在结节性痛风人群中的潜在定位提供了支持。围绕这一核心资产，Arthrosi也吸引了来自中国市场的长期战略投资。2023年7月，一品红药业通过其全资子公司广州瑞腾生物参与 Arthrosi Therapeutics的D轮优先股融资，并与关联主体Guangrun Health Industry（香港）共同认购公司新发股份。根据当时披露的信息，一品红及其关联主体在该轮融资后合计持有Arthrosi超40%的股权，对应公司估值约2亿美元。除股权投资外，一品红与Arthrosi还曾共同设立广州瑞安博医药科技有限公司，用于承载AR882在中国大陆、香港、澳门和台湾地区的研发、注册及商业化布局。随着后续融资推进及股权结构调整，截至2025年底的一品红公告显示，其通过瑞腾生物（香港）持有Arthrosi约13.45%的股权，并向董事会派驻董事参与公司治理。在此背景下，Sobi和Arthrosi发起的并购交易，将直接涉及该部分股权的退出安排及相应的投资回报路径。02.Sobi：罕见病巨头下注痛风赛道Sobi是一家总部位于瑞典的全球性生物制药公司，长期专注于罕见病和专科疾病药物的研发与商业化，重点覆盖血液学、免疫学及部分代谢相关疾病领域。公司在纳斯达克斯德哥尔摩交易所上市，2024年实现营收约260亿瑞典克朗（约合25亿美元），在约30个国家设有据点，已建立起覆盖欧美为主的成熟商业化体系。在过去十余年的发展中，Sobi依托血友病、补体介导疾病等产品构建了稳定的现金流基础，但与此同时，部分核心产品逐步进入专利后期阶段，公司面临中长期增长接续的问题。在这一背景下，通过并购引入具备后期确定性的创新资产，成为其近年战略调整的重要方向。从表面看，痛风并非典型的罕见病适应症，但从Sobi的业务逻辑出发，这一选择并不突兀。痛风属于患者规模相对可控、疾病管理周期长、未满足需求明确的慢性炎症性疾病，在市场结构和商业模式上，与Sobi过往深耕的专科疾病具有相似特征。在这一背景下，Arthrosi的AR882成为Sobi管线布局中的补位型资产。从产品结构看，AR882作为口服小分子药物，与Sobi现有以注射剂和生物制剂为主的产品组合形成互补，有助于拓展其在慢性疾病长期管理场景中的覆盖范围。Sobi总裁兼首席执行官Guido Oelkers在收购公告中指出，AR882有可能成为进行性痛风患者的首选疗法，并有望在2030年代中期及以后为公司贡献新的增长动力。03.痛风创新药进入“安全+适配”竞争时代高尿酸血症早已不再是边缘性代谢异常，而逐渐成为继高血压、高血糖、高血脂之后的“第四高”。随着人口老龄化、肥胖和代谢综合征患病率上升，全球患者基数持续扩容。根据弗若斯特沙利文数据，2020年全球高尿酸血症及痛风患者总数已超过11亿，其中中国患者约1.7亿；预计到2030年，全球患者规模将增至约14.2亿，中国患者人数也有望突破2.4亿。庞大的慢病人群与长期用药需求，构成了痛风创新药持续吸引资本和产业资源投入的底层背景。在治疗实践中，痛风管理仍呈现出明显的“分层结构”：非甾体抗炎药（non-steroidal anti-inflammatory drugs，NSAIDs）、秋水仙碱和糖皮质激素主要用于急性发作期的炎症控制，而别嘌醇、非布司他等传统降尿酸药物则构成长期治疗的基础。然而，在进展性或结节性痛风患者，以及合并肾功能受损等复杂人群中，现有口服方案在长期达标率、耐受性和安全性方面仍存在现实局限，部分药物的使用也受到明确的风险警示限制。这一结构性缺口，为在疗效稳定性和人群适配性上具备优势的新一代口服降尿酸药物，打开了明确的临床空间。在多条创新路径中，URAT1抑制剂成为竞争最集中的赛道之一。除Arthrosi的pozdeutinurad外，日本卫材开发的dotinurad已在日本及部分亚洲市场获批，其欧美地区的开发与商业化权益由Crystalys Therapeutics持有。中国企业也在密集布局：恒瑞医药的SHR4640于今年一月上市申请获受理；通化东宝的XO/URAT1双靶点药物等已推进至后期临床阶段。与此同时，部分企业开始探索更前沿路径，如IL-1β抑制剂、siRNA长效降尿酸方案等，试图在给药频率或炎症控制层面建立差异化。需要警惕的是，URAT1并非低风险靶点，已有在研药物因安全性问题折戟临床。这也意味着，在这一赛道中，单纯比较降尿酸强度已难以构成长期壁垒，真正决定产品竞争力的，是长期用药安全性以及在合并症人群中的适用性与稳定性。从更宏观的视角看，Sobi的出手也折射出行业并购逻辑的变化——资源正持续向临床后期、路径相对确定的资产集中。对中国创新药企业而言，Arthrosi的路径也提供了另一种参考：通过股权投资或全球合作，参与后期资产成长，既分散研发风险，又有机会分享国际市场价值。可以预见，随着AR882等核心候选药物关键III期数据陆续揭晓，痛风赛道的真正分化才刚刚开始。最终能留下来的，或许并非靶点布局最多的玩家，而是那些真正解决了长期用药与复杂人群治疗难题的产品。*封面来源：神笔PRO专题推荐声明：动脉新医药所刊载内容之知识产权为动脉新医药及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。