Bupropion Hydrochloride/Dextromethorphan

一位阿尔茨海默病患者的女儿看着母亲在焦虑中反复徘徊、抗拒进食，甚至对最亲近的家人发出攻击性的言语，她知道母亲的记忆正在被疾病偷走，但眼前这些痛苦的行为症状更让她感到无助和绝望。对全球数千万患者家庭而言，这种被称为“激越”的症状是照护中最具挑战性的难题之一。 2026年1月，上海浦东新区的生物医药企业纽欧申医药（NeuShen Therapeutics）宣布，其自主研发的创新药物NS-136获得美国食品药品监督管理局（FDA）批准，开展治疗阿尔茨海默病激越症状的II期临床试验。 这是中国原创新药在中枢神经系统疾病领域取得的又一重大国际化突破，标志着中国生物医药企业开始跻身全球神经精神疾病治疗研发的第一梯队。 01 破冰之旅 阿尔茨海默病不仅仅是一种导致记忆衰退的疾病，更伴随着一系列精神行为症状。其中，激越症状是影响患者生活质量和增加照护负担的核心因素之一。 激越症状表现为过度运动、言语攻击、易怒、抗拒护理等行为， 约50%的中重度患者会受此困扰 ，但目前临床上缺乏安全有效的针对性疗法。现有治疗方案多为标签外使用的抗精神病药物，效果有限且常伴随严重副作用。 2026年1月，纽欧申医药宣布，其自主研发的NS-136获得美国FDA批准开展II期临床试验。这是该公司获得的首个美国临床试验许可，被视为其全球化管线布局的里程碑事件。 02 精准调节 NS-136的创新之处在于其独特的作用机制。它是一种高选择性毒蕈碱型乙酰胆碱M4受体正向变构调节剂，简称M4 PAM。 与传统的直接激动剂不同，正向变构调节剂只在 内源性乙酰胆碱存在时 才增强受体活性，这种机制被称为“内源性刹车调节”。这意味着它可以更精准地调节大脑中与精神症状相关的神经回路，同时避免非选择性胆碱能激动剂常见的副作用。 临床前研究表明，NS-136在疾病动物模型中对多种精神症状展现出良好治疗效果。相比同靶点竞品，该化合物通过多点修饰规避了剂量限制性代谢产物的生成风险，显著降低了个体间药代动力学变异度。 03 临床试验 根据FDA批准的方案，即将开展的II期临床试验将采用 随机、双盲、安慰剂对照的国际多中心设计 ，旨在评估NS-136治疗阿尔茨海默病激越症状的有效性和安全性。 这项试验标志着NS-136的临床开发进入新阶段。目前该药物在国内的一项针对精神分裂症的II期临床试验正在进行中。 值得一提的是，NS-136的I期临床试验已于中澳两国完成，结果显示其具有良好的安全性和药代动力学特性。这些数据支持其进入下一阶段的临床研究。 纽欧申医药也已同步提交阿尔茨海默病激越症状在中国的II期临床试验申请，展现全球同步开发的战略布局。 04 公司背景 纽欧申医药是一家临床阶段的国际化生物技术公司，成立于三年前，专注于神经与精神疾病领域的创新疗法研发。公司在中国上海和美国波士顿均设有研发中心，聚集了一支国际化的新药研发团队。 公司创始人兼首席执行官申华琼博士表示：“获得美国FDA临床试验许可，是我们发展历程中一座令人振奋的里程碑。这标志着我们自主研发实力获得了国际监管认可与肯定。” 2025年5月，纽欧申医药完成了 数千万美元的A轮融资 ，由上海生物医药基金领投。这笔资金主要用于推进包括NS-136在内的核心研发项目的临床开发。 05 未满足需求 阿尔茨海默病是一种严重的神经退行性疾病，影响患者的记忆、思维和行为，是导致老年痴呆的主要原因。 全球有数千万阿尔茨海默病患者，其中激越症状是导致患者提前入住护理机构及加剧照料者压力的主要因素之一。对于这些患者和家庭而言， 缺乏安全有效的对症疗法 已成为巨大的临床未满足需求。 目前，全球仅有少数几家公司专注于阿尔茨海默病激越症状的药物研发。例如，百时美施贵宝正在进行KarXT治疗该适应症的III期临床试验，而Axsome公司的AXS-05也于2025年底获得了FDA的优先审评资格。 06 行业意义 NS-136获得FDA批准开展II期临床试验，不仅对该药物本身意义重大，也对中国生物医药产业具有深远影响。这标志着中国原创新药在中枢神经系统这一高难度领域开始获得国际主流监管机构的认可。 过去十余年间，中枢神经系统药物研发面临诸多挑战，临床前转化率极低，临床设计与管理难度高，导致新机制靶点探索鲜有重大突破。 纽欧申医药在短短三年内，将多个具有全球竞争力的项目推进到临床阶段，特别是NS-136等项目即将进入验证性临床试验，展现出中国生物医药企业在神经精神疾病领域的研发实力和国际化视野。 上海浦东张江实验室的科研人员正在分析NS-136的最新试验数据，而波士顿研发中心的同事们也在同步推进美国临床试验的筹备工作。随着这项国际多中心II期临床试验的启动，全球数千万阿尔茨海默病激越症状患者将迎来新的希望。 在神经退行性疾病治疗领域，每一次突破都显得尤为珍贵。NS-136的进展不仅代表着一种潜在新疗法的诞生，更象征着中国创新药企开始在国际舞台上展现解决全球性健康难题的能力与决心。

NEW YORK, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced the first patient has been dosed in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia. FORWARD (Fibromyalgia Response with Esreboxetine Evaluated Using a Randomized Withdrawal Research Design) is a Phase 3, double-blind, placebo-controlled, multicenter, randomized withdrawal trial in patients with fibromyalgia consisting of an open-label AXS-14 treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response during the 12-week open-label period will be randomized in a 1:1 ratio to continue AXS-14 (8 mg) once daily or to switch to matching placebo for up to 12 weeks or until a loss of therapeutic response occurs. The primary endpoint will be the time from randomization to loss of therapeutic response. About Fibromyalgia Fibromyalgia is a chronic, debilitating neurological pain disorder that affects approximately 17 million people in the U.S.1,2 Fibromyalgia is considered to be mediated mainly in the central nervous system.2 It is characterized by widespread pain, fatigue, disturbed sleep, depression, cognitive impairment, and hypersensitivity to sensory stimuli.1,2 Other symptoms of this disorder can include tingling in the hands and feet and headaches.2-4 Fibromyalgia has considerable detrimental effects on physical, emotional, social, and day-to-day functioning and is associated with significant economic burden and reduced quality of life.5 Despite its prevalence and impact, current treatment options remain limited. Many patients experience inadequate symptom control or intolerable side effects, with over 50% of fibromyalgia patients discontinuing their treatment within the first year.6 About AXS-14 AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine is the SS-enantiomer of racemic reboxetine. AXS-14 is an investigational drug product not approved by the FDA. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Ashley Dong Director, Investor Relations (929) 687-1614 adong@axsome.com Media: Darren Opland Senior Director, Corporate Communications (929) 837-1065 dopland@axsome.com References: Source: Axsome Therapeutics, Inc.