Advances Company’s industry-leading portfolio in mental health with addition of CAPLYTA

通过添加CAPLYTA，推进公司在心理健康领域的行业领先组合

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(lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive therapy and monotherapy; also approved for the treatment of schizophrenia in adults

（鲁马特哌酮），首个且唯一获得美国FDA批准用于双相I型和II型抑郁的辅助治疗和单一疗法；同时也被批准用于成人精神分裂症的治疗。

sNDA submitted to U.S. FDA for CAPLYTA

提交给美国FDA的sNDA用于CAPLYTA

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as adjunctive treatment for major depressive disorder; if approved, has potential to become a new standard of care for most common depressive disorders

作为重度抑郁症的辅助治疗；如果获得批准，有可能成为最常见的抑郁症的新护理标准

Addition of CAPLYTA

添加CAPLYTA

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strengthens J&J’s robust lineup of therapies with $5 billion+ potential in peak year sales

加强了J&J强大的治疗阵容，其销售峰值有望超过50亿美元。

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, further solidifying sales growth above analyst expectations now through the remainder of the decade

，进一步巩固了销售增长高于分析师预期的态势，这一趋势将延续至本十年末。

Acquisition also includes promising clinical-stage pipeline with best-in-class potential in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation

收购还包括在广泛性焦虑障碍、阿尔茨海默病相关精神病和躁动方面具有同类最佳潜力的临床阶段管线。

NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--

新不伦瑞克，新泽西州——（商业资讯）——

Johnson & Johnson (NYSE: JNJ) today announced it has completed its acquisition of Intra-Cellular Therapies, Inc. Intra-Cellular Therapies is now part of Johnson & Johnson and will operate as a business unit within Johnson & Johnson Innovative Medicine.

强生公司（纽约证券交易所代码：JNJ）今天宣布已完成对Intra-Cellular Therapies, Inc.的收购。Intra-Cellular Therapies现已成为强生公司的一部分，并将作为强生创新医药业务部门内的一个业务单元运营。

“At Johnson & Johnson, we are committed to transforming care for the millions of people worldwide living with neuropsychiatric and neurodegenerative disorders,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “We are excited to officially welcome the talented Intra-Cellular Therapies team to the Company, and we look forward to working together as we realize our ambition of becoming the number one neuroscience company worldwide.”.

“在强生公司，我们致力于为全球数百万患有神经精神和神经退行性疾病的患者提供变革性的护理，”强生公司董事长兼首席执行官Joaquin Duato表示。“我们很高兴正式欢迎Intra-Cellular Therapies团队的加入，我们期待共同努力，实现成为全球第一神经科学公司的雄心。”

With this acquisition, Johnson & Johnson adds CAPLYTA

通过此次收购，强生公司增加了CAPLYTA。

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(lumateperone) to its robust portfolio of differentiated medicines. CAPLYTA

(lumateperone) 添加到其多样化的强大药物组合中。CAPLYTA

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is a once-daily oral therapy approved to treat adults with schizophrenia, as well as the first and only U.S. Food and Drug Administration (FDA)-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate.

是一种每日一次的口服疗法，获准用于治疗成人精神分裂症，同时也是美国食品药品监督管理局（FDA）批准的首个也是唯一一个用于治疗与I型或II型双相情感障碍（双相抑郁）相关抑郁发作的药物，可作为单一疗法或与锂盐或丙戊酸联合使用。

In February 2025, Intra-Cellular Therapies announced that the U.S. FDA accepted its supplemental new drug application for CAPLYTA.

2025年2月，Intra-Cellular Therapies宣布美国FDA接受了CAPLYTA的补充新药申请。

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as an adjunctive treatment for adults with major depressive disorder (MDD). The acquisition also includes ITI-1284, a promising Phase 2 compound being studied in generalized anxiety disorder (GAD) and Alzheimer’s disease-related psychosis and agitation, as well as a clinical-stage pipeline that further complements Johnson & Johnson’s current areas of focus..

作为重度抑郁症（MDD）成人患者的辅助治疗。此次收购还包括ITI-1284，这是一种处于二期临床试验的有前景的化合物，正在针对广泛性焦虑症（GAD）、阿尔茨海默病相关精神病和激越进行研究，同时还有一条临床阶段的产品线，进一步补充了强生目前的重点领域。

“We are focused on investing in what we believe is the future of innovation across our targeted therapeutic areas, including neuroscience,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. “We are pleased to finalize this acquisition, which serves as a strategic near- and long-term growth catalyst for Johnson & Johnson, and we look forward to working together to continue transforming treatment and patient care for some of today’s most debilitating neuropsychiatric and neurodegenerative disorders.”.

詹森制药全球主席、强生执行副总裁Jennifer Taubert表示：“我们专注于投资我们认为是目标治疗领域创新未来的技术，其中包括神经科学。我们很高兴完成这项收购，这将成为强生在近、长期战略增长的催化剂。我们期待共同努力，继续为当今一些最令人衰弱的神经精神疾病和神经退行性疾病转变治疗和患者护理。”

The transaction is expected to accelerate 2025 sales growth for Johnson & Johnson by approximately 0.8% with approximately $0.7 billion in incremental sales. Inclusive of the impact of financing costs, Johnson & Johnson expects the transaction to dilute adjusted earnings per share (EPS) by approximately $0.25 in 2025, an improvement from the $0.30 – $0.35 originally estimated on the Company’s Q4 2024 earnings call.

该交易预计将使强生公司2025年的销售增长加快约0.8%，增加约7亿美元的销售额。包括融资成本的影响在内，强生公司预计该交易将使其2025年调整后的每股收益（EPS）稀释约0.25美元，较公司在2024年第四季度财报电话会议上最初估计的0.30至0.35美元有所改善。

In 2026, Johnson & Johnson expects the earnings dilution to be reduced to approximately $0.21 per share as annualized financing costs are partially offset by operational accretion. Johnson & Johnson will include these estimates in its full-year 2025 financial outlook when it reports first quarter results on April 15, 2025..

2026年，由于年度融资成本部分被运营增值所抵消，强生公司预计每股收益稀释将减少至约0.21美元。强生公司将在2025年4月15日公布第一季度业绩时，将这些估算纳入其2025年全年财务展望中。

In connection with the completion of the transaction, Intra-Cellular Therapies’ common stock ceased trading on the NASDAQ Global Select Market.

与交易完成相关，Intra-Cellular Therapies的普通股已停止在纳斯达克全球精选市场交易。

Indication

指示

CAPLYTA

卡普利塔

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(lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of 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，以及作为单药治疗或与锂盐或丙戊酸联合使用的双相 I 型或 II 型障碍（双相抑郁）相关抑郁发作的治疗。

Important Safety Information

重要的安全信息

Boxed Warnings:

黑框警告：

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA

使用抗精神病药物治疗的患有痴呆相关精神病的老年患者死亡风险增加。CAPLYTA

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is not approved for the treatment of patients with dementia-related psychosis.

不适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.

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恶化以及自杀念头和行为的出现。CAPLYTA的安全性和有效性。

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have not been established in pediatric patients.

在儿科患者中尚未确定。

Contraindications:

禁忌症：

CAPLYTA

卡普利塔

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is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA

对鲁马替酮或CAPLYTA的任何成分已知过敏的患者禁用。

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. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

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:

据报道，抗精神病药物可引起：

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。参见上述警告框。

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 (TD)

迟发性运动障碍（TD）

, 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

，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。即使使用CAPLYTA，TD也可能不会消失。

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is discontinued. It can also occur after CAPLYTA

已停用。它也可能在CAPLYTA之后发生

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is discontinued.

已停产。

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.

，包括高血糖、糖尿病、血脂异常和体重增加。在某些情况下，接受抗精神病药物治疗的患者报告了极端的高血糖，并伴随酮症酸中毒、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水平。

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and monitor periodically during long-term treatment.

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无粒细胞症（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

对于先前存在白细胞计数 (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。CAPLYTA

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should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.

如果在没有其他致病因素的情况下，白细胞计数出现临床显著下降，则应停止使用。

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..

患者在坐姿或躺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发出警告。对于易患低血压的患者，应监测其体位性生命体征。

Falls

掉下

. CAPLYTA

. CAPLYTA

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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

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

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.

。

Seizures

癫痫发作

. CAPLYTA

. CAPLYTA

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®

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

有癫痫发作史或癫痫阈值降低的患者应谨慎使用。

Potential for Cognitive and Motor Impairment

认知和运动障碍的潜在可能

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

患者在操作机器或机动车辆时应谨慎，直到他们了解CAPLYTA为止。

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affects them.

影响到他们。

Body Temperature Dysregulation

体温调节障碍

. CAPLYTA

. CAPLYTA

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®

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.

在可能出现导致核心体温升高的情况（如剧烈运动、极端高温、脱水或同时使用抗胆碱能药物）的患者中应谨慎使用。

Dysphagia

吞咽困难

. CAPLYTA

. 卡普利塔

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®

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

有误吸风险的患者应谨慎使用。

Drug Interactions:

药物相互作用：

CAPLYTA

卡普利塔

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

不应与CYP3A4诱导剂合用。对于与强效CYP3A4抑制剂或中效CYP3A4抑制剂同时使用，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.

在妊娠第三季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

临床试验中CAPLYTA最常见的不良反应

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vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

与安慰剂相比，嗜睡/镇静、头晕、恶心和口干是最常见的不良反应。

CAPLYTA

卡普利塔

®

®

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

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 Warning.

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，治疗方法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，我们具备独特的优势，能够在当今整个医疗保健解决方案领域进行创新，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。

www.jnj.com/

www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

@JNJInnovMed

.

。

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS:

关于前瞻性声明的注意事项：

This press release contains “forward-looking statements” regarding the acquisition of Intra-Cellular Therapies by Johnson & Johnson and CAPLYTA

本新闻稿包含关于强生公司收购Intra-Cellular Therapies和CAPLYTA的“前瞻性声明”。

®

®

and development programs. 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 or Intra-Cellular Therapies..

和开发项目。读者应注意不要依赖这些前瞻性陈述。这些陈述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实现，实际结果可能与强生公司或Intra-Cellular Therapies的预期和预测大相径庭。

Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; economic conditions, including currency exchange and interest rate fluctuations; the risks associated with global operations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care services and products; and trends toward health care cost containment..

风险和不确定性包括但不限于：产品研究和开发固有的挑战，包括临床成功的不确定性和获得监管批准的不确定性；新产品商业成功的不确定性；生产困难和延误；产品功效或安全问题导致的产品召回或监管行动；经济状况，包括汇率和利率波动；全球运营相关的风险；竞争，包括技术进步、竞争对手获得的新产品和专利；专利挑战；适用法律和法规的变更，包括税法和全球医疗改革；不利的诉讼或政府行为；医疗保健服务和产品购买者的行为和支出模式变化或财务困境；以及医疗成本控制趋势。

In addition, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate the programs, products, technologies and employees/operations and clinical work of Intra-Cellular Therapies. A further list and description of these risks, uncertainties and other factors and the general risks associated with the respective businesses of Johnson & Johnson and Intra-Cellular Therapies can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2024, filed with the SEC on February 13, 2025, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A.

此外，强生公司家族企业能否成功整合Intra-Cellular Therapies的项目、产品、技术以及员工/运营和临床工作也存在风险和不确定性。这些风险、不确定性和其他因素以及与强生和Intra-Cellular Therapies各自业务相关的总体风险的进一步列表和描述，可参见强生于2025年2月13日提交给美国证券交易委员会的截至2024年12月29日财年的Form 10-K年度报告，特别是标题为“关于前瞻性陈述的警示说明”和“第1A项”的章节。

Risk Factors,” and in Johnson & Johnson’s subsequent filings with the SEC and in Intra-Cellular Therapies’ Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 21, 2025, including in the sections captioned “Cautionary Statement Regarding Forward-Looking Statements” and “Item 1A.

风险因素”，以及强生公司随后向美国证券交易委员会提交的文件和Intra-Cellular Therapies公司截至2024年12月31日财年的年度报告Form 10-K中，该报告于2025年2月21日提交给美国证券交易委员会，其中包括标题为“关于前瞻性声明的警示声明”和“项目1A”的部分。

Risk Factors,” and in Intra-Cellular Therapies’ subsequent filings with the SEC. Copies of these filings, as well as subsequent filings, are available online at.

风险因素”，以及Intra-Cellular Therapies随后向美国证券交易委员会提交的文件。这些文件的副本，以及随后的文件，都可以在线获取。

www.sec.gov

www.sec.gov

,

，

www.jnj.com

www.jnj.com

,

，

www.intracellulartherapies.com

www.intracellulartherapies.com

, or on request from Johnson & Johnson or Intra-Cellular Therapies.

，或者根据Johnson & Johnson或Intra-Cellular Therapies的要求。

Neither Johnson & Johnson nor Intra-Cellular Therapies undertakes to update any forward-looking statement as a result of new information or future events or developments, except as required by law.

强生公司和Intra-Cellular Therapies均不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任，除非法律要求。

i

我

Non risk adjusted peak year sales including partner sales

未风险调整的峰值年销售额，包括合作伙伴销售额

Johnson & Johnson

强生公司

Media Contact:

媒体联系人:

Michele Loguidice

米凯莱·洛圭迪斯

media-relations@its.jnj.com

媒体关系@its.jnj.com

Investor Contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

Source: Johnson & Johnson

来源：强生公司