强生精神分裂症疗法CAPLYTA®向美国FDA提交了补充新药申请-动脉网

Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

强生等信源发布 2025-07-08 03:45

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可切换为仅中文

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Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in adults with schizophrenia compared to placebo

基于长期的第三阶段数据显示，与安慰剂相比，成年人精神分裂症复发风险降低了63％。

CAPLYTA

卡普利塔

is FDA approved to treat schizophrenia and is the first and only approved treatment for bipolar I and II depression as an adjunctive and monotherapy

获得FDA批准用于治疗精神分裂症，并且是首个也是唯一一个被批准用于双相I型和II型抑郁症的辅助治疗和单一疗法。

With the addition of CAPLYTA

随着CAPLYTA的加入

to Johnson & Johnson's robust portfolio of therapies, the Company now offers the broadest range of treatment options for adults with schizophrenia

由于强生公司强大的治疗药物组合，该公司目前为成人精神分裂症患者提供了最广泛的治疗选择。

TITUSVILLE, N.J.

新泽西州泰特斯维尔

，

July 8, 2025

2025年7月8日

/PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布，已向美国食品药品监督管理局（FDA）提交了一份补充新药申请（sNDA），基于评估CAPLYTA安全性和有效性的长期数据。

(lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA

(lumateperone) 用于预防精神分裂症的复发。CAPLYTA

is the newest addition to Johnson & Johnson's portfolio of schizophrenia therapies, which now offers the broadest range of oral and long-acting injectable treatment options to support each patient's individual treatment journey.

是杨森制药精神分裂症治疗产品组合的最新成员，目前该组合已拥有最广泛的口服和长效注射治疗方案选择，可以支持每位患者的个体化治疗过程。

'For people living with schizophrenia, relapses can be devastating as they disrupt lives, undo hard-earned treatment progress toward patients' goals, and increase the risk of hospitalization with each episode,' said Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York..

“对于精神分裂症患者来说，复发可能是毁灭性的，因为它们会扰乱生活，使患者在治疗目标上取得的来之不易的进步付诸东流，并且每次发作都会增加住院的风险，”纽约霍夫斯特拉/诺斯韦尔 Zucker 医学院精神病学临床教授 Christoph U. Correll 医学博士说道。

'CAPLYTA

‘卡普利塔’

substantially lowers the chance of relapse for patients compared to placebo, which is often a major source of anxiety and suffering for them and their families.'

与安慰剂相比，实质上降低了患者复发的几率，这对患者及其家人来说常常是焦虑和痛苦的主要来源。

The submission is supported by positive results from a Phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer in patients receiving CAPLYTA

该申请得到了一项 III 期、双盲、多中心、安慰剂对照、随机撤药试验的积极结果的支持，该试验的主要终点发现，在 26 周双盲治疗阶段，接受 CAPLYTA 的患者复发时间显著延长。

compared to those receiving placebo (p=0.0002). Treatment with CAPLYTA

与接受安慰剂的患者相比（p=0.0002）。使用CAPLYTA治疗

was also associated with a 63 percent reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]). The key secondary endpoint showed a significantly delayed time to all-cause discontinuation, including relapse, compared with placebo during the double-blind phase (p=0.0007).

与安慰剂相比，复发风险降低了63%（风险比 [95% CI] = 0.37，[0.22, 0.65]）。关键次要终点显示，在双盲阶段，所有原因导致的停药时间，包括复发，显著延迟（p=0.0007）。

The safety profile of CAPLYTA.

CAPLYTA的安全性概况。

was consistent with the existing body of clinical data, and no new safety concerns were identified. The most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.

与现有的临床数据一致，没有发现新的安全隐患。观察到的发生率大于或等于5%且为安慰剂组两倍的最常见不良事件是头痛。

我

Schizophrenia affects up to an estimated 2.8 million adults in the United States, yet it remains insufficiently treated, with approximately 40 percent of people not receiving care.

精神分裂症影响着美国多达约280万成年人，但仍有约40%的患者未能接受治疗，这种疾病尚未得到充分关注。

When left untreated, this complex mental health disorder can lead to episodes of psychosis, hallucinations, or other disruptive behaviors, which can damage and interrupt the lives of those living with schizophrenia as well as their loved ones.

如果不及时治疗，这种复杂的精神健康障碍会导致精神病发作、幻觉或其他破坏性行为，这些都会损害并扰乱精神分裂症患者及其亲人生活。

iii

Relapses, or a recurrence of symptoms, are associated with significant functional decline, increased caregiver burden, and a greater likelihood of hospitalization.

复发或症状的再次出现与显著的功能下降、照护者负担加重以及更高的住院可能性相关。

iii

On average, an adult with schizophrenia experiences nine relapses in less than six years.

平均而言，一名成年精神分裂症患者在不到六年的时间里会经历九次复发。

四

'Relapse prevention is a critical goal for the long-term care and management of this debilitating disorder,' said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. 'These Phase 3 results provide compelling evidence of meaningful relapse prevention, which is critical in preserving long-term patient stability, breaking the cycle of hospitalization, and helping to control symptom progression.

“预防复发是这种致残性疾病长期护理和管理的关键目标，”约翰逊 & 约翰逊创新医学部神经科学全球治疗领域负责人比尔·马丁博士表示。“这些三期试验结果提供了令人信服的证据，表明其在预防复发方面具有重要意义，这对于维持患者长期稳定、打破住院循环以及帮助控制症状进展至关重要。”

We're committed to building on the decade of research reinforcing the robust efficacy, proven safety, and favorable tolerability of CAPLYTA.

我们致力于在十年研究的基础上，进一步强化CAPLYTA的显著疗效、已证实的安全性以及良好的耐受性。

and providing additional data to support the long-term use of this medicine in neuropsychiatric disorders.'

并提供额外的数据以支持这种药物在神经精神疾病中的长期使用。'

While its exact mechanism of action is unknown, CAPLYTA

虽然其确切的作用机制尚不清楚，但CAPLYTA

is characterized by high serotonin 5-HT

以高血清素 5-HT 为特征

receptor occupancy and lower amounts of dopamine D

受体占用率和较低量的多巴胺 D

receptor occupancy at therapeutic doses. In short-term clinical studies, CAPLYTA

治疗剂量下的受体占有率。在短期临床研究中，CAPLYTA

was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. The most commonly reported adverse events were somnolence/sedation, dizziness, nausea, and dry mouth. CAPLYTA

体重变化、代谢效应和锥体外系症状与安慰剂相似，这些常常被引为停止治疗的原因。最常见的不良事件报告为嗜睡/镇静、头晕、恶心和口干。CAPLYTA

can be taken at any time of day with or without food and does not require titration, allowing adult patients to start treatment at the effective dose.

可以在一天中的任何时间随餐或空腹服用，无需调整剂量，使成年患者能够从有效剂量开始治疗。

CAPLYTA

卡普利塔

is FDA approved for the treatment of schizophrenia, as well as depressive episodes associated with bipolar I or II disorder in adults, as monotherapy, and as adjunctive therapy with lithium or valproate. An

被FDA批准用于治疗精神分裂症，以及作为单药疗法或与锂盐或丙戊酸联合使用，治疗成人I型或II型双相情感障碍相关的抑郁发作。

sNDA for CAPLYTA

as an adjunctive treatment for adults with major depressive disorder (MDD) is currently under FDA review. If approved, CAPLYTA

作为重度抑郁症（MDD）成人患者的辅助治疗目前正接受FDA审查。如果获批，CAPLYTA

has the potential to become a new standard of care to treat some of today's most prevalent and debilitating mental health disorders.

有潜力成为治疗当今一些最普遍和最令人衰弱的心理健康障碍的新标准。

Editor's note:

编者注：

a. Christoph U. Correll, M.D., has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.

克里斯托夫·U·科雷尔医学博士曾为强生公司提供咨询、顾问和演讲服务。他未因任何媒体工作获得报酬。

About Schizophrenia

关于精神分裂症

Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.

精神分裂症是一种复杂的、慢性的脑部疾病，影响人们的思维、情感、言语和行为。在美国，约有280万成年人受到影响，但仍然存在广泛的误解且治疗不足。

二

Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common. Evidence shows that the first three to five years after diagnosis – 'the critical period' – from symptom onset are key for a patient's treatment, as this is when the condition progresses most rapidly..

症状因人而异，但感知、情绪和行为上的困惑和扭曲是常见的。有证据表明，从症状出现起，诊断后的头三到五年——“关键时期”——对患者的治疗至关重要，因为这是病情进展最快的时期。

v,vi

A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.

一个综合性的治疗计划，可能包括药物、治疗和心理社会服务，对于延缓成人精神分裂症的复发时间至关重要。

iii

About Study 304

关于研究304

This study was a multicenter, multi-national, double-blind, placebo-controlled, randomized withdrawal study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. The approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase.

本研究是一项多中心、多国、双盲、安慰剂对照、随机撤药研究，评估了鲁马特哌酮用于预防成人精神分裂症患者症状复发的效果。这项约47周的研究包括一个18周的开放标签阶段，期间精神分裂症患者每天接受42毫克的鲁马特哌酮治疗。在开放标签期间符合稳定标准的患者进入双盲治疗阶段。

These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase. .

这些患者被随机分为继续服用鲁马特哌酮42毫克（N=114）或转为安慰剂（N=114），持续至26周或直到复发时间。主要终点是首次症状复发的时间，关键次要终点是在双盲阶段因各种原因导致的停药时间。

About CAPLYTA

关于CAPLYTA

(lumateperone)

(卢马特佩酮)

CAPLYTA

卡普利塔

42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA.

42毫克是一种口服的、每日一次的非典型抗精神病药物，被批准用于成人治疗精神分裂症和与I型或II型双相情感障碍（双相抑郁）相关的抑郁发作，可作为单药治疗，也可与锂盐或丙戊酸联合使用。尽管CAPLYTA的作用机制。

is unknown, the efficacy of CAPLYTA

未知，CAPLYTA 的功效

could be mediated through a combination of antagonist activity at central serotonin 5-HT

可能通过中枢血清素5-HT的拮抗剂活性组合来介导

receptors and postsynaptic antagonist activity at central dopamine D

受体和中枢多巴胺D的突触后拮抗剂活性

receptors.

受体。

CAPLYTA

卡普利塔

is under FDA review for potential approval as an adjunctive treatment for adults with major depressive disorder and is being studied for other neuropsychiatric and neurological disorders. CAPLYTA

正在接受 FDA 审查，可能被批准作为成人重度抑郁症的辅助治疗，并且正在研究用于其他神经精神和神经系统疾病。CAPLYTA

is not FDA-approved for these disorders.

未获FDA批准用于这些疾病。

CAPLYTA

卡普利塔

(lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

(lumateperone) 适用于成人治疗精神分裂症以及与 I 型或 II 型双相情感障碍（双相抑郁）相关的抑郁发作，可作为单一疗法或与锂盐或丙戊酸联合使用。

Important Safety Information

重要安全信息

Boxed Warnings:

黑框警告：

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

患有痴呆相关精神病的老年患者使用抗精神病药物会增加死亡风险。CAPLYTA 未获批准用于治疗痴呆相关精神病患者。

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients..

在短期研究中，抗抑郁药增加了儿科和年轻成人患者出现自杀念头和行为的风险。所有接受抗抑郁药治疗的患者都应密切监测临床症状是否恶化，并注意是否出现自杀念头和行为。CAPLYTA 在儿科患者中的安全性和有效性尚未确立。

Contraindications:

禁忌症：

CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

CAPLYTA 禁用于已知对卢美哌酮或 CAPLYTA 任何成分过敏的患者。过敏反应包括瘙痒、皮疹（例如，过敏性皮炎、丘疹性皮疹和全身性皮疹）以及荨麻疹。

Warnings & Precautions:

警告和注意事项：

Antipsychotic drugs have been reported to cause:

抗精神病药物据报道会引起：

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis

老年痴呆相关精神病患者的脑血管不良反应

, including stroke and transient ischemic attack. See Boxed Warning above.

，包括中风和短暂性脑缺血发作。见上文方框警告。

Neuroleptic Malignant Syndrome (NMS)

神经阻滞剂恶性综合征 (NMS)

, which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room..

，这是一种可能致命的反应。体征和症状包括：高烧、肌肉僵硬、意识模糊、呼吸、心率和血压的变化、肌酸磷酸激酶升高、肌红蛋白尿（和/或横纹肌溶解）以及急性肾衰竭。出现NMS体征和症状的患者应立即联系医生或前往急诊室。

Tardive Dyskinesia

迟发性运动障碍

, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.

，一种在面部、舌头或其他身体部位出现无法控制的身体运动的综合症，这种症状可能会随着治疗时间的延长和总累积剂量的增加而加重。即使停用CAPLYTA，TD可能也不会消失。它也可能在停用CAPLYTA后发生。

Metabolic Changes

代谢变化

, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment..

，包括高血糖、糖尿病、血脂异常和体重增加。在接受抗精神病药物治疗的患者中，已有报告出现高血糖的情况，有些病例情况严重，并伴有酮症酸中毒、高渗性昏迷或死亡。在开始使用CAPLYTA时，应测量体重并评估空腹血糖和血脂，在长期治疗期间应定期监测。

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases)

白细胞减少症、中性粒细胞减少症和粒细胞缺乏症（包括致命病例）

. Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.

对于既往白细胞计数 (WBC) 偏低或有白细胞减少症或中性粒细胞减少症病史的患者，应进行全血细胞计数检查。若在无其他致病因素的情况下出现临床上显著的白细胞计数下降，应停用 CAPLYTA。

Decreased Blood Pressure & Dizziness

血压下降和头晕

. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension..

患者在坐姿或卧姿快速起立时可能会感到头晕、眩晕或昏厥（体位性低血压）。应监测心率和血压，并对已知有心血管或脑血管疾病的患者提出警告。对于易患低血压的患者，应监测其体位性生命体征。

Falls

万一

. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.

CAPLYTA 可能导致嗜睡或头晕，并可能减缓思维和运动技能，从而可能导致跌倒，并因此引发骨折和其他伤害。使用 CAPLYTA 时应评估患者的风险。

Seizures

癫痫发作

. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

CAPLYTA 应谨慎用于有癫痫发作史或降低癫痫发作阈值的患者。

Potential for Cognitive and Motor Impairment

认知和运动障碍的潜在可能性

. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.

患者在操作机器或驾驶机动车辆时应谨慎，直到他们了解CAPLYTA对自己的影响。

Body Temperature Dysregulation

体温调节障碍

. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.

CAPLYTA 应谨慎用于可能出现导致核心体温升高的情况的患者，如剧烈运动、极端高温、脱水或同时使用抗胆碱能药物。

Dysphagia

吞咽困难

. CAPLYTA should be used with caution in patients at risk for aspiration.

CAPLYTA 应谨慎用于有吸入风险的患者。

Drug Interactions:

药物相互作用：

CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.

CAPLYTA 不应与 CYP3A4 诱导剂合用。与强效 CYP3A4 抑制剂或中效 CYP3A4 抑制剂同时使用时，建议减少剂量。

Special Populations:

特殊人群：

Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

孕期第三个月暴露于抗精神病药物的新生儿在分娩后有出现锥体外系和/或戒断症状的风险。对于中度或重度肝功能损害的患者，建议减少剂量。

Adverse Reactions

不良反应

: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

：在CAPLYTA与安慰剂的临床试验中，最常见的不良反应是嗜睡/镇静、头晕、恶心和口干。

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

CAPLYTA 有 10.5 毫克、21 毫克和 42 毫克的胶囊可供选择。

Please click here to see full Prescribing Information including Boxed Warnings.

请单击此处查看完整的处方信息，包括加框警告。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity..

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗手段更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全方位的医疗保健解决方案中进行创新，以提供明天的突破性成果，并对人类健康产生深远影响。

Learn more at

了解更多请访问

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com.

关注我们

@JNJInnovMed

。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的“前瞻性声明”，涉及产品开发以及潜在益处和治疗影响。

CAPLYTA

卡普利塔

。

The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

读者被警告不要依赖这些前瞻性陈述。这些陈述是基于对未来事件的当前预期。如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与强生公司的预期和预测有重大差异。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利面临的挑战；因产品功效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗保健改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性及其他因素的进一步列表和描述，请参见强生公司最近的10-K年度报告，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在网上查阅。

www.sec.gov

，

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的义务。

Footnotes

脚注

Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia.

Intra-Cellular Therapies 宣布了在评估 CAPLYTA 用于预防精神分裂症患者复发的 3 期试验中取得积极的初步结果。

GlobeNewswire

全球新闻网

, 05 Nov. 2024,

，2024年11月5日，

https://www.globenewswire.com/news-release/2024/11/05/2974784/30597/en/Intra-Cellular-Therapies-Announces-Positive-Topline-Results-in-Phase-3-Trial-Evaluating-CAPLYTA-for-the-Prevention-of-Relapse-in-Patients-with-Schizophrenia.html

https://www.globenewswire.com/news-release/2024/11/05/2974784/30597/zh/Intra-Cellular-Therapies-宣布-III-期试验评估CAPLYTA预防精神分裂症患者复发的积极顶线结果.html

。

二

'Schizophrenia Fact Sheet.' Treatment Advocacy Center, 10 Mar. 2025,

《精神分裂症事实表》。治疗倡导中心，2025年3月10日，

www.tac.org/reports_publications/schizophrenia-fact-sheet/

www.tac.org/reports_publications/精神分裂症事实表/

。

iii Alphs L, et al. Factors associated with relapse in schizophrenia despite adherence to long-acting injectable therapy.

iii Alphs L, 等。尽管坚持使用长效注射治疗，精神分裂症复发的相关因素。

Int Clin Psychopharmacol.

国际临床精神药理学杂志。

2016;31(4)202-209. doi:10.1097/YIC.0000000000000125

四

Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics.

Lafeuille MH、Gravel J、Lefebvre P 等。接受非典型抗精神病药物治疗的精神分裂症患者的复发模式及相关成本负担。

J Med Econ

医学经济学杂志

. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705

Birchwood, M. 'Early intervention and sustaining the management of vulnerability.'

伯奇伍德，M.《早期干预与持续管理脆弱性》

The Australian and New Zealand journal of psychiatry

澳大利亚和新西兰精神病学杂志

vol. 34 Suppl (2000): S181-4. doi:10.1080/000486700241

第34卷增刊 (2000): S181-4. doi:10.1080/000486700241

vi编辑器

Tandon, Rajiv et al. 'The schizophrenia syndrome, circa 2024: What we know and how that informs its nature.'

坦登，拉吉夫等。《精神分裂症综合征，2024年：我们所知及其本质启示》

Schizophrenia research

精神分裂症研究

vol. 264 (2024): 1-28. doi:10.1016/j.schres.2023.11.015

第264卷（2024年）：1-28页。doi:10.1016/j.schres.2023.11.015

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/supplemental-new-drug-application-submitted-to-us-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo-302499436.html

https://www.prnewswire.com/news-releases/向美国FDA提交了补充新药申请，Caplyta（lumateperone）的数据表明与安慰剂相比在预防精神分裂症复发方面具有显著效果-302499436.html

SOURCE Johnson & Johnson

来源：强生公司

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