Rosuvastatin Calcium

接上文：仿制药企业的产品线构建策略与方法（一）随着仿制药投资回报率持续走低，优质可仿资源逐渐走向枯竭，市场竞争白热化，依靠一两个仿制药"爆款"实现快速扩张的时代已成过去。企业亟需转变发展思路，将竞争维度从单一产品升级为整体管线布局。在当前行业加速分化的转型期，构建一个兼具市场吸引力、行业竞争力且能持续迭代创新的产品管线，已成为企业建立并维持竞争优势的核心所在。一、刷新投资品种的选择逻辑在企业发展过程中，唯有确立清晰的战略方向，才能系统性地构建核心竞争力。作为核心竞争力的关键载体，公司资源与能力配置的重要抓手，产品组合的品种选择与管线设计必须严格服务于公司战略目标。否则，不仅无法创造战略价值，反而会挤占宝贵的战略资源，最终阻碍战略落地。这正如一位建筑工人需要购买钢筋钳来完成工作，绝不能因为镰刀促销就放弃专业工具而选择不相关的农具。当前行业环境下，优质仿制药资源日益稀缺，"机会性品种"的发掘空间持续收窄。与此同时，市场竞争加剧导致偶然性机会的回报率显著降低。如果企业仍固守原有思路，不主动扩大品种投资规模，市场份额萎缩将不可避免。而要实现投资规模的扩大，就必须适当降低投资回报预期，放宽产品筛选标准。需要特别指出的是，"机会品种"本质上追求的是短期套利，属于典型的短视经营行为。随着企业规模扩张，其战略定位必须实现从"市场拾遗者"到"行业跟随者"，再到"市场挑战者"，最终迈向"行业领导者"的阶梯式跃升。每个发展阶段都需要匹配差异化的管线设计逻辑和产品选择策略。此外，在投资回报率普遍下滑的背景下，新品种筛选必须更加精准高效，避免宝贵的研发资源被无效消耗。在当前市场环境下，企业要实现高效、精准的产品选择和管线布局，必须建立一套自上而下的系统性决策逻辑——以公司战略为指引，先明确管线设计框架，再据此筛选匹配的产品组合。第一，企业战略规划的首要环节，是立足内外部环境分析，制定科学的发展战略，并据此明确新产品开发需求。具体而言，企业的战略定位（增长型、稳定型或收缩型）、现有销售规模及财务实力，将共同决定其年度品种投资的数量和规模。以年销售额50亿元的仿制药企业A为例，其产品年销售额因价格下行而萎缩3-5亿元。为维持现有业务规模，该企业每年需获取10-20个产品批文，对应研发投入约0.5-1亿元。若企业追求业务增长，则需进一步加大投资力度，扩充产品管线规模。第二，在明确公司战略后，企业需要结合自身业务特性和资源禀赋，选择适配的竞争战略，并据此设计相匹配的产品管线布局方案。具体而言，若采取总成本领先战略，产品管线设计应着重体现规模效应——优先选择市场需求量大、生产工艺协同性强、剂型标准化的品种，以充分发挥规模经济和经验曲线优势。而差异化战略则需聚焦小众细分领域，通过非主流品种布局建立独特竞争优势。在实施层面，企业应综合考虑投资规模、管线设计要求、可获取资源等因素，形成一揽子规划。针对每条管线，需制定详细的布局方案，包括：1）目标品种数量；2）管线总投资预算；3）各产品立项时间节点；4）预期投资回报率等关键指标第三，在完成管线战略设计后，需要运用金字塔模型对管线内各品种进行精准角色定位。成功的产品管线必须围绕"核心品种"进行系统性布局——若无现成核心品种，则应优先选择"市场潜力最大"或"企业优势最突出"的项目作为核心，必要时可通过外部引进明星产品填补这一关键位置。同时，企业需充分重视"战略搅局产品"和"市场陪衬产品"的战术价值。产品管线的评估标准不应局限于单一品种的投资回报率，而应着眼于整体效益最大化。以某钙制剂企业为例：为实现终端市场下沉，该企业将钙剂A作为公益产品免费捐赠给贫困学生，借助其品牌影响力带动钙剂B在普通学生群体的销售，成功实现管线协同效应。金字塔模型（示意图）第四，在管线布局实施阶段，需对每个候选项目进行双重维度的严格评估——既要考量其市场价值，也要评估技术可行性。针对评估结果采取差异化处理方案：1）对评估不达标的项目：优先寻找替代品种若无合适替代方案，需系统分析该品种缺失对管线完整性的影响2） 对同领域多选一的情况：集中采购市场：优选临床证据充分、市场认可度高的品种细分专科市场：重点选择具有独特临床价值、能建立明确差异化的品种由战略到产品，层层递进的立项逻辑（示意图）基于科学规划的产品管线布局，就如同按照施工蓝图建造房屋——目标明确、路径清晰，既能避免"机会主义"选品策略下的决策困境，又可规避"广撒网"式布局导致的资源错配风险。二、新品种选择策略在构建产品管线时，必须重新定义"优质品种"的评判标准。在行业发展初期，业界普遍将"技术门槛低、市场容量大、竞争格局好"视为理想品种的三大特征。然而，在当前高度竞争的市场环境下，同时满足这三个条件的品种已不复存在：1）技术门槛低且市场容量大的品种：必然吸引大量竞争者涌入，导致利润空间被快速挤压；2）市场容量大且竞争较少的品种：往往存在极高的技术壁垒，将多数企业挡在门外；3）竞争较少且技术简单的品种：通常是市场空间有限的小众产品，真正具有商业价值的利基品种实则凤毛麟角。市场大、难度低和竞争小的三角关系在品种选择过程中，"技术难度低"、"市场潜力大"、"竞争压力小"三者构成难以兼顾的三角关系，企业只能寻求折中平衡，难以客观评判品种优劣。为提升可操作性，笔者提出以下三个替代标准：第一，目标品种必须具备明确的临床需求，能够满足客户核心价值或创造额外价值。这包括评估：是否存在确切或未被满足的需求，可替代空间及可开发市场容量。即便某些品种整体需求有限，但只要具备不可替代性（如针对特定患者群体的唯一治疗方案或显著优势方案），仍具较强市场吸引力。第二，企业需具备足够的竞争优势来打造差异化产品，包括但不限于：首仿上市优势、生产成本优势、管线协同效应或特色服务等。第三，目标品种必须符合公司战略定位，有助于培育或强化核心竞争力。例如，差异化品种显然不适合实施总成本领先战略的企业，反之亦然。采用这种"自上而下"逻辑筛选的品种均具备战略价值，即便是"陪衬品种"或"搅局品种"。相比之下，单纯追求"机会品种"的企业虽可获得短期经济利益，但缺乏战略价值，将长期陷入被动应对、疲于奔命的竞争困境。（一）总成本领先战略的品种选择实施总成本领先战略的企业，其产品管线布局必须聚焦于大众化市场（特别是集中带量采购市场），通过最大化规模经济效应和经验曲线效应来建立竞争优势。在具体品种筛选过程中，需要从以下几个关键维度进行系统性评估：（1）以销量为出发点选择品种。销量越大的品种，规模经济效应越强——获批适应证多、适应证发病率较高的普药。尽量舍弃规模而不经济的元素，如差异化、小众化的剂型、包装、规格，尽量使用大包装。虽然这些品种、剂型或规格可以提升产能利用率，但频繁切换产品、频繁清洁验证会大幅增加生产线的维护成本，甚至增加质量风险。如果企业想要布局这些产品、剂型或规格，应整合到差异化战略事业部或差异化战略的产品管线中。（2）以成本优势为出发点选择品种。系统梳理各品种价格，并结合原材料供货价格、加工成本，计算毛利空间，毛利超过40% 的品种几乎都可以立项。（3）以专利失效时间为出发点选择品种。仿制药强调先发效应，上市时间越早，价格越高，产品的生命周期越长，因此，务必要赶上第一次集中带量采购——企业应建立原研药的专利失效时间库，提前4~5 年开始布局，如存在挑战专利的上市机会，布局时间还需进一步提前。（4）以竞争态势或供求状况为出发点，选择竞争不充分，供给不足的品种。系统梳理各品种的供求状况、生产厂家数量，并根据销售额规模和厂家数量制定一定的截取标准，达到标准的产品就可以考虑布局，例如，1 亿元市场规模且销售厂家不超过3 家的品种。（5）基于技术优势的品种选择与升级策略应成为企业的重要考量。企业可依托连续流制造、生物合成等创新工艺技术，通过技术突破实现显著降本，这既适用于新品种立项，也适用于老品种升级改造。在当前可仿资源日益稀缺、行业竞争持续加剧的市场环境下，通过技术创新实现老品种降本增效的战略价值愈发凸显。这类技术驱动型项目一旦成功实施，往往能重塑产品竞争格局，为老产品注入新的市场活力，有效延长其生命周期。（6）从管线的协同性、原料制剂协同性、产能利用率的角度考虑，折中地选择品种，但投资回报率测算不宜为负值（定位为搅局产品和陪衬产品的情况除外）。对于瞄准集中带量采购市场的企业，只要能够显著提升规模经济效应，每年能够创造200 万以上净利润的品种都不应轻易放弃（按照2024 年的行情）。在品种选择时，企业需综合考虑药品的实际应用前景，优先布局增长潜力明确的品种。 以他汀类降脂药为例，尽管集中带量采购推动该品类整体销量因“以价换量”而大幅增长，但不同品种表现分化明显——阿托伐他汀和瑞舒伐他汀销量显著提升，而辛伐他汀反而下滑。究其原因，在带量采购后价格趋同的背景下，患者更倾向于选择疗效更优、安全性更高、市场认可度更强的产品。因此，当同一品类（或靶点）下多个产品面临带量采购时，除非采取全覆盖策略，否则应聚焦临床获益和品牌认知度最高的品种。此外，总成本领先战略要求全价值链的成本优化，而研发协同是降低开发成本的关键路径。 例如，若A公司已成功开发二甲双胍缓释片，则可顺势布局西格列汀二甲双胍缓释片、利格列汀二甲双胍缓释片等同类复方制剂，借助技术相似性分摊研发成本，实现资源的高效复用。鉴于普通仿制药已进入典型的成本效益竞争阶段，且可仿品种资源日益稀缺，企业在品种选择上不应过度挑剔，而应尽可能覆盖符合条件的品种。对于具备条件的企业，更需构建一定规模的品种储备，以增强市场竞争力。（二）差异化战略的品种选择差异化战略的品种选择逻辑与总成本领先战略形成鲜明对比，其核心在于满足非主流、小众化的治疗需求。鉴于我国医院市场对差异化产品的可及性较低，往往需要配套的市场推广投入，因此在产品布局上应当保持治疗领域的相对集中。从技术实现层面考量，差异化路径虽多，但不宜为单个产品频繁开发新技术或新建产线，这就要求在技术路线上也要有所聚焦。结合当前国内医药市场特征，企业可通过以下具体方式实现差异化。（1）从产品管线的层面上与众不同——选择特色的细分市场或特殊渠道建立产品管线（也可理解为一种聚焦战略）。如聚焦于新零售终端，则可考虑系统化布局减肥药、皮肤病（如灰指甲、青春痘、痤疮）用药、隐私疾病（如脱发、痔疮、狐臭、便秘、性功能障碍）护理用药、避孕药、凝胶贴膏等患者自主消费意识较强而又因为隐私原因不希望当面就医买药，或消费体验好却又无法在公立医院满足消费意愿的产品；如聚焦于民营医院终端，则可考虑系统化布局辅助生殖用药、美容药、生长激素等无法在公立医院满足消费意愿或公立医院没有治疗成本优势的产品；如聚焦于诊所（第三终端），则应考虑系统地二次定位抗生素、解热镇痛药、廉价的OTC 品种。我国约有28万家诊所，药品采购和使用过程受医改政策的限制相对较小，如果把市场充分开发出来，有望成为医改风暴的暂时性避风港。（2）通过高技术壁垒实现差异化，即围绕着技术平台打造管线，包括原料技术平台（如性激素、前列腺素、多肽、手性中心繁多或工艺路线极长的系列产品、可生物合成或连续流制造的系列产品）、制剂技术平台（如吸入剂、脂质体、微球等高壁垒制剂）或生产制造平台（生产工艺或生产条件极其苛刻或复杂的品种，高毒、高爆的品种，需要单独生产线制造的品种）。高壁垒的技术平台通常需要较长的技术开发时间和较大的前期投入，所以在赛道选择时必须注重差异化。发展空间较高的赛道，应强调龙头效应，而发展空间较小的赛道，必须强调独家效应。否则，一旦发生同质化竞争，巨额投资将无法收回。（3）通过高法规壁垒实现差异化，包括专利挑战，监管技术挑战，毒、麻、精、放等管制产品。由于管制产品存在很高的法规壁垒，市场机会注定只属于少数企业，它本身就是差异化的。另外，有些特殊的品种在注册、审批和监管过程中需要一事一议——无法形成统一的审批标准，或需要无效他人的专利，布局这些品种也是实现差异化的主要方式。（4）通过布局利基品种实现差异化。常见的利基（niche）品种有三类，第一类是因信息差而未被大众关注到的品种、品规或用法用量，这种品种谁先获得信息谁就有先发性优势；第二类是小众化而拥有确切临床需求的品种，这种品种必须强调临床地位的独特性——是某些特定患者的唯一选择或最佳选择，竞争对手和潜在竞争对手数量不能太多（一般三家以内），且没有恶意的搅局者；第三类是可通过改良提升治疗获益或降低不良反应的、临床需求无法替代的老品种，如左旋双多巴、纳洛酮等。（5）通过布局高初始资金投入的品种实现差异化。常见的类型包括高临床费用投入的3 类药品种（国外上市而国内未上市）或仅生物等效性证据不足以支持获得批准的品种（局部用药），高固定资产投资的品种（单品单线或定制化生产线）。此类品种应能解决未满足的临床需求或显著的治疗获益，具有足够好的市场前景以回收投资，否则不能轻易布局。（6）通过收购因历史原因无法复制的品种实现差异化。某些老品种在当前的法规政策下不可能再获得批准，属于稀缺性资源。然而这些老产品往往具有一定的固定用户群和品牌效应，具有再定位的价值，尤其是独家品种。让加拿大仿制药巨头Valeant 迅速崛起的一大商业模式就是通过收购老品种，二次定位后涨价。差异化产品布局需建立在充分市场调研基础上，企业应通过医生和患者调研，明确差异化产品能否实现预期价值，以及相比主流产品的额外优势。鉴于差异化产品市场规模有限，必须审慎评估现有及潜在竞争者数量，避免陷入同质化竞争困局。医院渠道布局可采取仿创结合策略，重点构建以高壁垒仿制药、特色仿制药和改良型新药为特色的产品管线。其中，改良型新药作为新兴领域，差异化优势显著，机遇远大于挑战，值得企业重点投入。零售渠道布局则可采取多元化策略，通过品牌仿制药、非专利品牌药、OTC产品及消费者保健品的组合，打造差异化产品矩阵。三、降低投资回报预期当行业步入成熟期，最显著的特征在于新产品开发难度加大、新客户获取成本攀升。随着市场竞争日趋白热化，投资回报预期不可避免地呈现下行趋势。在此背景下，企业必须理性调整产品投资回报预期，否则将陷入"无项目可投"的困境。这一调整不仅是应对市场变化的必要举措，更是确保企业可持续发展的关键策略。集中带量采购以后，仿制药的价格和利润水平都被腰斩，而且竞争变得异常激烈，每次中标后可获得的销量越来越少，投资三五个新项目换回的收益可能抵不上集中带量采购实施以前一个项目换回的收益。为此，企业要保障销售额和利润的稳定，必须翻倍地投资新项目，然而由于“机会性品种”的越来越少和“鸟枪法”试错成本的不断升高，企业必须改变新投资项目的选择逻辑。一要降低投资回报预期；二要改变投资项目的决策方式，制定清晰的、自上而下的决策逻辑——公司战略决定业务战略，业务战略决定产品管线设计，产品管线决定投资品种的选择。当前，我国医药行业已进入深度转型期，多数企业的项目选择逻辑亟待根本性变革，可谓"不破不立"。在此特别建议企业决策者：必须摒弃依赖单一爆款产品的传统思维，立项不要再过度强调品种自身的好坏（不要将目光聚焦于产品自身），而是产品管线利益的最大化，企业必须从过去的"单品突破"转向"体系作战"，通过构建具有协同效应的产品集群，形成可持续的竞争优势。这种转变不仅是应对带量采购等政策变革的必然选择，更是企业实现长期稳健发展的关键路径。作者介绍：魏利军，副主任药师，北京药眼信息咨询有限公司，北京慧药实验室科技有限公司，著有《跨国药企成功启示录》、《仿制药企兴衰启示录》、《制药企业的战略与产品管线建设》，《跨国药企的成功基因》（出版中），以上内容来自作者新书《制药企业的战略与产品管线建设》，由于该书尚未上线销售，需要购买的朋友可以添加作者微信Voyager88药事纵横投稿须知：稿费已上调，欢迎投稿

Akebia continues to publish important, clinically relevant data to further physicians’ understanding of Vafseo® (vadadustat)CAMBRIDGE, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Journal of the American Society of Nephrology (JASN) has published pre-specified analyses for the U.S. and non-U.S. patient subgroups from the vadadustat global phase 3 clinical program, which included two trials in patients with dialysis-dependent chronic kidney disease (DD-CKD; INNO2VATE) and two trials in patients with non–dialysis-dependent CKD (NDD-CKD; PRO2TECT). The vadadustat global phase 3 clinical trials were open-label, randomized, noninferiority trials that compared the safety and efficacy of vadadustat with darbepoetin alfa in adult patients with CKD-related anemia. Data from the pre-specified analyses for the U.S. patient subgroup demonstrate that among patients with DD-CKD, safety and efficacy of vadadustat and darbepoetin alfa in the U.S. and outside the U.S. were similar. Among the U.S. patient subgroup with NDD-CKD, safety and efficacy outcomes were similar, but the risk for major adverse cardiovascular event (MACE) with vadadustat was higher than darbepoetin alfa outside the United States. In these analyses, safety was measured by time to first MACE and efficacy was measured by mean change in hemoglobin. The article titled, “Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States,” is available here. Vafseo® (vadadustat) was approved by the U.S. Food and Drug Administration in March 2024 for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. Vafseo has been available in the U.S. since January 2025. “Geographic-specific pre-specified analyses of the vadadustat global phase 3 clinical program are important data as physicians in the U.S. are making care decisions for patients with CKD-related anemia,” said Steven K. Burke, M.D., Senior Vice President, Research & Development and Chief Medical Officer of Akebia. “The analyses reflect how regional differences in clinical trial patient baseline characteristics, hemoglobin targets, and access to health care services and other regional clinical practices can ultimately contribute to differing outcomes in a global trial.” Full results of the vadadustat global clinical phase 3 clinical program were previously published in the New England Journal of Medicine: INNO2VATE, PRO2TECT. The Journal of the American Society of Nephrology, an official publication of the American Society of Nephrology (ASN), publishes high-impact research to advance the understanding and treatment of kidney diseases, including physiology, pathobiology, and person-centered care. JASN publishes original research advancing the understanding and care of kidney diseases through laboratory, translational, and clinical studies. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. About Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATIONVAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS.VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its componentsUncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. Seizures Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on DialysisThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm.Lactation: Breastfeeding not recommended until two days after the final dose.Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s expectations regarding the importance of the vadadustat global phase 3 clinical data, including that the geographic-specific pre-specified analyses are important data as physicians in the U.S. are making care decisions for patients with CKD-related anemia; and Akebia’s ability to continue to publish important, clinically relevant data to further physicians’ understanding of Vafseo. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," “could”, derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the commercial availability of Vafseo; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Vafseo, including generic entrants and the timing thereof; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to achieve and maintain profitability and to maintain operating expenses consistent with its operating plan; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; early termination of any of Akebia's collaborations; and changes in the geopolitical environment and uncertainty surrounding U.S. trade policy on tariffs. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrascomcarrasco@akebia.com