Sivopixant

成立于1878年的日本制药企业盐野义制药集团，拥有超过140年的历史。作为日本历史最悠久的药企之一，成立于日本大阪，创立之初主要贩卖汉方药材。后续研发青霉素，1948年推出首款国产抗生素，1950年开发的广谱抗生素「Keflex」（头孢菌素），全球销售额超10亿美元，成为"日本制药黄金时代"象征。一、2024财年营收情况2025年5月盐野义制药公布了2024财年（2024年4月-2025年3月）营收达4383亿日元（同比+0.7%），营业利润1566亿日元（同比+2.1%），连续三年创新高。关键增长点主要来自HIV业务，来自ViiV Healthcare的特许权收入增长22.8%（446亿日元），主要受益于长效注射剂Cabenuva及口服疗法（如Dovato）的强劲销售。海外业务收入同比增长18.4%（约92亿日元）。从2000年到如今，盐野义经历利润连跌的风波，2009年将整合酶抑制剂dolutegravir授权给GSK，换得ViiV合资公司20%股权。这是一场HIV的“豪赌”，ViiV的HIV药物2024年贡献2404亿日元特许权收入，占盐野义总营收55%。二、营运成本与费用情况2024财年盐野义制药的成本支出情况如下：总成出支出增加1490亿日元，主要来自三个部分，销售成本同比上一个财年增加了62亿日元增幅达10.8%，总金额达到6380亿日元；研发费用增加了60亿日元，增幅5.8%，研发费用总额1086亿日元；销售及行政费用增加了27亿日元，同比增长了2.6%，总额达到1061亿日元。盐野义制药2024财年的销售成本增加主要有三个方面的原因：自2022财年起，为应对抗生素等产品需求增长，持续扩大生产规模并增建生产设施、产品结构变化以及原材料与制造成本上升等。在销售管理与研发费用方面，主要由于新冠产品推广费用、感染药物研发投入以及全球研发布局美国研究中心扩建及后期开发项目的推进等等。尽管成本上升，但其通过严格的费用管控，经营利润仍实现增长。盐野义制药2025财年预计在营收方面较2024财年增长20.9%，目标预测5300亿日元，营业利润1750亿日元，同比增长11.7%的预期，归属母公司的净利润为1800亿日元目标，同比增长5.65%。其2025财年的主要增长引擎为并购了JT制药部门的收入，吞并日本烟草旗下百年药企——（原）田边制药，获得AI药物发现平台。另一个重要举措是其HIV/失眠药Quviviq的尺寸放量以及Zuranolone抗抑郁药的上市、ENDEAVORRIDE数字疗法业务拓展，希望能共同作用于企业的营收。三、研发进度及研发管线布局以下为盐野义制药2025财年的研发里程碑计划，从不同疾病领域来看：* 感染性疾病Ensitrelvir针对新冠治疗，处于提交阶段，2025上半财年（FY2025 1H）向欧盟提交；用于新冠暴露后预防（PEP），提交阶段，2025上半财年向美、欧提交，下半财年（FY2025 2H）争取日本获批；针对12岁以下儿童新冠治疗与预防，处于全球提交准备阶段，2025上半财年向日本提交。* S-268024：新冠JN.1疫苗，处于3期临床，2025上半财年出3期临床初步结果。* Cefiderocol：抗耐药菌（AMR）儿科感染（革兰氏阴性菌感染），3期临床，2025上半财年出3期初步结果，下半财年向美、欧提交。* 其他几项处于2期临床或1期临床阶段。生活质量相关疾病：* Zuranolone：抑郁症，提交阶段，2025上半财年争取日本获批。* Zatolmilast：脆性X综合征，2/3期临床，2025下半财年出2/3期初步结果。* SASS-001（S-600918+DrugX）：中枢性睡眠呼吸暂停，2期临床，2025下半财年出2期初步结果。* S-531011：实体瘤，1b/2期临床，2025下半财年出1b/2期初步结果。* S-606001：庞贝病，1期临床，2025上半财年出1期初步结果。* S-740792：多发性硬化相关步态障碍，1期临床，2025下半财年出1期初步结果。盐野义集团针对新冠药物，其意图或将新冠管线从“应急产品”转型为常态化呼吸感染防控组合。各类药物都在积极布局全球审批和申报，以拓展并布局全球市场。基于盐野义制药在2025财年研发里程碑计划，其管线布局呈现出战略聚焦、风险平衡以及全球化开发效率的三大特点。四、战略布局为了应对新冠冬峰低于预期以及Ensitrelvir美国III期试验未达终点两方面的外部挑战，以及其内部暂停慢性疼痛药S-151128（膝骨关节炎疗效未达标），资源倾斜晚期管线。盐野义为其制定全新的战略目标成为"全球小分子药物研发领导者"，专注感染性疾病和高质量生命（QOL）疾病领域。盐野义制药在最新的STS2030计划中将战略分为以下三部分：* Phase1(2020-2022)：转型基础建设* Phase2(2023-2025)：加速增长与投资* Phase3(2026-2030)：实现全球领导地位针对以上新战略，盐野义制药做出如下核心战略举措调整：-- 业务投资驱动的新增长模式，并购整合JT制药部门，Torii制药以及Akros Pharma，强化日本销售网络，增强研发管线，优化生产。-- 稳固现有的增长引擎：聚焦长效注射剂和口服双药方案，抢占全球长效治疗市场30%的份额为其2031年目标。并积极拓展海外业务，扩大美欧的销售覆盖范围，亚洲板块依托合作伙伴加速市场准入。-- 管线产品的加速开发：感染性疾病领域，Ensitrelvir（新冠药）加速全球申报（美国滚动提交，欧洲准备中）。多项药物积极驱动2/3期临床试验。在QOL疾病领域，2025年在日本上市首个快速抗抑郁药Zuranolone。盐野义聚焦感染病与高社会影响QOL疾病，稳步实现管线推进、海内外协同拓展市场，以研发转化与创新药上市巩固地位，应对行业变化向2030愿景迈进，积极布局突破挑战，重塑集团优势。药事纵横投稿须知：稿费已上调，欢迎投稿

First Patient Dosed in Phase 2A Dose-Finding, Proof-of-Concept RESTEADY Trial Evaluating SASS-001 in a Sub-Population of Patients with Sleep Apnea with a Central Component; Top-line Data Expected in 1H 2026 SASS-001, a Novel Drug Combination of Sivopixant and a second compound, is the first clinical stage asset from Apnimed's Joint Venture with Shionogi Both Phase 3 Trials (SynAIRgy and LunAIRo) evaluating AD109 in Mild, Moderate and Severe Obstructive Sleep Apnea (OSA) patients of all body types remain on track for top-line results expected in Q2 and Q3 2025, respectively CAMBRIDGE, Mass., April 7, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced that the first patient has been dosed in the Phase 2A RESTEADY trial evaluating the novel oral drug combination, SASS-001, in an underserved population of patients suffering from sleep apnea with a central component. Top-line results from the study are expected in the first half of 2026. SASS-001 represents the first clinical stage asset from Shionogi-Apnimed Sleep Science, LLC (SASS), Apnimed's joint venture with Shionogi & Co., Ltd. (Shionogi). "With the first patient dosed in the Phase 2A RESTEADY trial, both Apnimed and SASS have reached an important milestone – the advancement of a scientific hypothesis to clinical development," commented Larry Miller, MD, Chief Executive Officer of Apnimed. "Today's announcement represents the combined efforts of the Apnimed and Shionogi teams, highlighting their respective strengths in sleep medicine drug development and drug discovery." RESTEADY is a Phase 2A, multicenter, double-blind randomized, controlled, dose escalation, parallel-arm, safety and efficacy study evaluating SASS-001 in adult patients suffering from sleep apnea with a central component (NCT06776432). The study is expected to enroll approximately 60 patients from up to 10 U.S. clinical sites. Patients will be randomized in a 3:1 ratio to either dose-escalating SASS-001 or a placebo arm. Patient participation in the study is approximately 10 weeks, with trial measures to include sleep-clinic polysomnography and at-home sleep evaluations. Apnimed's most advanced clinical program, AD109, also continues to progress following the conclusion of enrollment in both Phase 3 clinical trials, LunAIRo and SynAIRgy. The Company continues to anticipate the availability of top-line data from both trials in Q2 and Q3 2025, respectively. AD109 is being studied in obese and non-obese adult patients with mild, moderate and severe OSA. About SASS and SASS-001 SASS is a joint venture of Apnimed and Shionogi focused on accelerating the discovery, preclinical and clinical development of novel pharmacologic solutions designed to address the complex pathology of sleep apnea and other sleep related diseases. SASS-001 is an investigational oral clinical candidate under development by SASS for sleep apnea with a central component. The candidate is a combination of sivopixant, a selective P2X3 receptor antagonist, and a second compound. About Sleep Apnea with a Central Component Sleep apnea with a central component is characterized by the concomitant presence of obstructive and central apneas. In central apneas, breathing temporarily stops due to absence of the signal from the nervous system to respiratory muscles to initiate a breath. This mechanism is different from the neuromuscular dysfunction that is thought to cause OSA, in which a breath is initiated but airflow is prevented by a physical occlusion of the airway despite contraction of respiratory muscles. Central and obstructive apneas often coexist in an individual patient, particularly in those with concomitant cardiovascular diseases such as atrial fibrillation and heart failure. About Obstructive Sleep Apnea Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. It has been demonstrated that OSA affects people of all body types, ages and genders —there is no single "face" of the disease. An estimated 80 million people in the United States and 1 billion people worldwide suffer from OSA. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, such as high blood pressure, cardiovascular disease and type 2 diabetes, along with impacts on quality of life, including daytime fatigue and impaired judgement. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in all people with OSA. About Apnimed Apnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. We believe the introduction of simple, once-nightly oral drugs will dramatically expand diagnosis and the reach of treatment for people with OSA. OSA, like other common chronic diseases such as diabetes or hypertension, would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing its growing pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. Our lead candidate AD109 could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 is currently in two Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is developing several therapies through our joint venture with Shionogi & Co., Ltd., Shionogi Apnimed Sleep Science. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Ramzi Benamar [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED