PRINCETON, N.J.

普林斯顿，新泽西州

,

，

April 6, 2025

2025年4月6日

/PRNewswire/ -- Luye Pharma Group today announced that ERZOFRI

/PRNewswire/ -- 绿叶制药集团今天宣布，ERZOFRI

®

®

(paliperidone palmitate) extended-release injectable suspension is now available for commercial sale in the U.S. for the treatment of adults with schizophrenia and as a monotherapy or adjunct therapy for the treatment of adults with schizoaffective disorder.

（棕榈酸帕利哌酮）缓释注射混悬液现在已在美国上市销售，用于治疗成人精神分裂症，以及作为单药治疗或辅助治疗用于治疗成人分裂情感性障碍。

ERZOFRI, administered once a month, delivers the active ingredient, paliperidone, through a long-acting, extended-release delivery system. It simplifies treatment by enabling single-dose initiation due to its unique 351 mg initiation dose. The currently prescribed monthly paliperidone palmitate long-acting injectable (LAI) requires two initiation doses, on Day 1 and Day 8..

ERZOFRI每月给药一次，通过长效缓释递送系统释放活性成分帕利哌酮。由于其独特的351毫克起始剂量，可实现单剂量起始治疗，从而简化了治疗过程。目前处方的每月注射一次的帕利哌酮棕榈酸酯长效注射剂（LAI）需要在第1天和第8天给予两个起始剂量。

ERZOFRI may cause serious side effects, including:

ERZOFRI可能会引起严重的副作用，包括：

Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

患有痴呆相关精神病的老年患者死亡风险增加。ERZOFRI会增加因困惑和记忆力减退（痴呆）而与现实脱节（精神病）的老年患者的死亡风险。

ERZOFRI is not for the treatment of people with dementia-related psychosis. The most common side effects of ERZOFRI include injection site reactions, sleepiness or drowsiness, dizziness, feeling restless or like you need to move, and abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes..

ERZOFRI 不适用于治疗与痴呆相关的精神病患者。ERZOFRI 最常见的副作用包括注射部位反应、嗜睡或困倦、头晕、感觉焦躁不安或需要移动，以及异常的肌肉运动，包括震颤（颤抖）、拖步、无法控制的不自主运动和眼睛的异常运动。

Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurrent relapses

精神分裂症和分裂情感性障碍都是严重的、慢性的精神疾病，其特征是反复发作。

[1]

[1]

. Non-adherence to medication is a major challenge in patients with such conditions. Failure of follow-up care after discharge significantly increases patients' non-adherence to prescribed medications, relapse and rehospitalization

. 不按医嘱服药是这类患者面临的主要挑战。出院后随访护理的缺失显著增加了患者不按处方服药、复发和再住院的风险。

[2]

[2]

. LAI antipsychotics, with a reduced dosage frequency compared to oral antipsychotics, effectively improve medication adherence and reduce the risk of healthcare providers not knowing if their patients fail to follow the prescribed dosage regimen

长效注射用抗精神病药物（LAI）与口服抗精神病药物相比，减少了给药频率，有效提高了患者的用药依从性，并降低了医护人员无法得知患者是否未按处方剂量方案服药的风险。

[3]

[3]

.

。

ERZOFRI's approval by the FDA is based on the results of an open-label, randomized, multiple-dose, parallel-group study evaluating its pharmacokinetic (PK) profile and relative bioavailability at steady state versus an established paliperidone palmitate LAI drug for reference. The study demonstrated the bioequivalence of ERZOFRI to the listed drug at steady state (treatment day 8) without the need for a second initiation injection..

ERZOFRI获得FDA批准是基于一项开放标签、随机、多剂量、平行组研究的结果，该研究评估了其与作为参照的已确立的棕榈酸帕利哌酮长效注射剂（LAI）在稳态下的药代动力学（PK）特征和相对生物利用度。研究表明，在稳态（治疗第8天）下，ERZOFRI与参比药物具有生物等效性，且无需第二次启动注射。

Comparable total drug exposure and a safety profile consistent with the listed drug were established. In addition to the unique 351 mg/2.25mL initiation dose, ERZOFRI is available in single-use kits in the following strengths: 39 mg/0.25mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, and 234 mg/1.5 mL..

建立了与上市药物相当的总药物暴露量和一致的安全性特征。除了独特的351毫克/2.25毫升起始剂量外，ERZOFRI还提供以下规格的单剂量套装：39毫克/0.25毫升、78毫克/0.5毫升、117毫克/0.75毫升、156毫克/毫升和234毫克/1.5毫升。

'This newly approved long-acting injectable antipsychotic for the management of schizophrenia can help address treatment initiation complexities and provides an exciting alternative to help patients reach their treatment goals.' said Christoph U Correll, MD, Professor of Psychiatry,

“这种新批准的长效注射用抗精神病药物用于精神分裂症的管理，可以帮助解决治疗启动的复杂性，并提供了一个令人兴奋的替代方案，以帮助患者实现其治疗目标。” Christoph U Correll医学博士，精神病学教授表示。

Zucker School

茨科学校

of Medicine at

医学部

Hofstra

霍夫斯特拉大学

/Northwell,

/诺斯韦尔，

New York, USA

美国纽约

.

。

Rongbing Yang

杨荣兵

, President of Luye Pharma Group, added: 'Medication adherence and discontinuation present a major challenge in the treatment of schizophrenia and schizoaffective disorder. Using LAIs is effective in increasing medication adherence. ERZOFRI, with its simplified dosage regimen eliminating the need for a second dose when initiating treatment is expected to increase treatment adherence in the initial stage.

绿叶制药集团总裁补充说：“服药依从性和停药是精神分裂症和分裂情感性障碍治疗中的主要挑战。使用长效注射剂（LAIs）能有效提高患者的用药依从性。ERZOFRI凭借其简化的剂量方案，在开始治疗时无需第二剂，有望在初始阶段提高治疗的依从性。”

Its commercial launch in the U.S. marks a major milestone in our commitment to addressing the unmet medical needs of patients in the U.S. The central nervous system is a key therapeutic area of focus for Luye Pharma, and we are committed to providing innovative therapies to combat mental disorders and expand treatment options.'.

其在美国的商业上市标志着我们致力于满足美国患者未被满足的医疗需求的一个重要里程碑。中枢神经系统是绿叶制药的重点治疗领域，我们致力于提供创新疗法以对抗精神疾病并扩大治疗选择。

ERZOFRI

ERZOFRI

®

®

(paliperidone palmitate) extended-release injectable suspension

（棕榈酸帕利哌酮）缓释注射混悬液

INDICATIONS

适应症

What is ERZOFRI

什么是ERZOFRI

®

®

(paliperidone palmitate)?

（棕榈酸帕利哌酮）？

ERZOFRI is a prescription medicine given by injection by a healthcare provider and used to treat:

ERZOFRI 是一种由医护人员注射的处方药，用于治疗：

schizophrenia in adults

成人精神分裂症

schizoaffective disorder in adults either alone or with other medicines such as mood stabilizers or antidepressants

成人分裂情感性障碍，单独使用或与情绪稳定剂或抗抑郁药等其他药物联合使用。

It is not known if ERZOFRI is safe and effective in children.

不知道ERZOFRI在儿童中是否安全有效。

IMPORTANT SAFETY INFORMATION FOR ERZOFRI (paliperidone palmitate)

ERZOFRI（棕榈酸帕利哌酮）的重要安全信息

ERZOFRI may cause serious side effects, including:

ERZOFRI 可能导致严重的副作用，包括：

Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

患有痴呆相关精神病的老年人死亡风险增加。ERZOFRI增加了因困惑和记忆丧失（痴呆）而与现实脱节（精神病）的老年人的死亡风险。

ERZOFRI is not for the treatment of people with dementia-related psychosis.

ERZOFRI 不适用于治疗与痴呆相关的精神病患者。

Do not receive ERZOFRI if you

如果你不符合条件，请勿接受ERZOFRI

are allergic to paliperidone, risperidone, or any of the ingredients in ERZOFRI.

对帕利哌酮、利培酮或ERZOFRI中的任何成分过敏。

What are the possible serious side effects of ERZOFRI?

ERZOFRI可能产生的严重副作用有哪些？

Cardiovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.

患有痴呆相关精神病的老年患者可能出现心血管问题（包括中风），并可能导致死亡。

Neuroleptic Malignant Syndrome (NMS) a serious condition that can lead to death.

神经阻滞剂恶性综合征（NMS）是一种可能致命的严重疾病。

Call your healthcare provider right away or go to your nearest emergency room right away if you get any of the following signs or symptoms:

如果出现以下任何症状或体征，请立即致电您的医疗服务提供者或立即前往最近的急诊室：

high fever

高烧

stiff muscles

肌肉僵硬

confusion

混淆

sweating

出汗

changes in your breathing, pulse, heart rate, or blood pressure

呼吸、脉搏、心率或血压的变化

Problems with your heartbeat.

心跳问题。

These heart problems can cause death. Call your healthcare provider right away if you get any of these symptoms:

这些心脏问题可能会导致死亡。如果您出现以下任何症状，请立即致电您的医疗保健提供者：

passing out or feeling like you will pass out

昏倒或感觉你将要昏倒

dizziness

头晕

feeling as if your heart is pounding or missing beats

感觉心脏在剧烈跳动或漏跳了几拍

Uncontrolled body movements (tardive dyskinesia).

不受控制的身体运动（迟发性运动障碍）。

ERZOFRI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking ERZOFRI. Tardive dyskinesia may also start after you stop taking ERZOFRI.

ERZOFRI 可能会导致您无法控制的面部、舌头或其他身体部位的运动。迟发性运动障碍即使在您停止服用 ERZOFRI 后也可能不会消失。迟发性运动障碍也可能在您停止服用 ERZOFRI 后才开始出现。

Problems with your metabolism such as:

你的新陈代谢问题，例如：

High blood sugar (hyperglycemia) and diabetes.

高血糖（血糖过高）和糖尿病。

Increases in blood sugar can happen in some people who are treated with ERZOFRI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight, or a family history of diabetes, your healthcare provider should check your blood sugar before you start treatment and during your treatment with ERZOFRI..

在一些接受ERZOFRI治疗的人群中可能会出现血糖升高的情况。极度升高的血糖可能导致昏迷或死亡。如果您患有糖尿病或具有糖尿病的风险因素，例如超重或有糖尿病家族史，您的医疗保健提供者应在您开始使用ERZOFRI治疗之前和治疗期间检查您的血糖。

Call your healthcare provider if you get any of these symptoms of high blood sugar during treatment with ERZOFRI:

如果在使用ERZOFRI治疗期间出现高血糖的任何症状，请联系您的医疗保健提供者：

feel very thirsty

感到非常口渴

feel very hungry

感到非常饥饿

feel sick to your stomach

感到恶心

need to urinate more than usual

需要比平常更频繁地排尿

feel weak or tired

感到虚弱或疲倦

feel confused, or your breath smells fruity

感到困惑，或者你的呼吸有水果味

Increased fat levels (cholesterol and triglycerides in your blood).

血脂水平升高（血液中的胆固醇和甘油三酯）。

Your healthcare provider may check your cholesterol and triglyceride levels during treatment with ERZOFRI.

您的医疗保健提供者在使用 ERZOFRI 治疗期间可能会检查您的胆固醇和甘油三酯水平。

Weight gain.

体重增加。

You and your healthcare provider should check your weight regularly during treatment with ERZOFRI.

在使用ERZOFRI治疗期间，您和您的医疗保健提供者应定期检查您的体重。

Decreased blood pressure (orthostatic hypotension) and fainting.

血压下降（体位性低血压）和晕厥。

You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

当你从坐姿或躺姿快速起身时，可能会感到头晕或昏厥。

Falls.

秋天。

ERZOFRI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

ERZOFRI可能会让您感到困倦或头晕，可能会导致您在改变姿势时血压下降（体位性低血压），并可能减缓您的思维和运动技能，从而可能导致跌倒，造成骨折或其他伤害。

Low white blood cell counts.

白细胞计数低。

Your healthcare provider may do blood tests during treatment with ERZOFRI.

您的医疗保健提供者在使用ERZOFRI治疗期间可能会进行血液检查。

Increased prolactin levels in your blood (hyperprolactinemia).

血液中催乳素水平升高（高催乳素血症）。

ERZOFRI may cause a rise in the blood levels of a hormone called prolactin that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection..

ERZOFRI 可能导致一种名为催乳素的激素在血液中的水平升高，这可能会引起副作用，包括月经周期缺失、可怀孕女性的生育能力可逆性下降、乳房溢乳、男性乳房发育或勃起问题。

Sleepiness, drowsiness feeling tired, difficulty thinking and doing normal activities.

困倦、昏昏欲睡、疲惫感，难以思考和进行正常活动。

Seizures (convulsions).

癫痫发作（抽搐）。

Difficulty swallowing

吞咽困难

that can cause food or liquid to get into your lungs.

可能导致食物或液体进入肺部。

Prolonged or painful erection lasting more than 4 hours (priapism).

持续或疼痛的勃起超过4小时（阴茎异常勃起）。

Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.

如果勃起持续超过4小时，请立即联系您的医疗保健提供者或前往最近的急诊室。

Problems with control of your body temperature so that you feel too warm

体温调节问题，使你感到过热

.

。

Before taking ERZOFRI, tell your healthcare provider about all of your medical conditions including if you:

在服用ERZOFRI之前，请告诉您的医疗保健提供者您的所有健康状况，包括如果您：

have never taken paliperidone or risperidone before

以前从未服用过帕利哌酮或利培酮

have had neuroleptic malignant syndrome (NMS)

曾经患有神经阻滞剂恶性综合征 (NMS)

have or had heart problems, including heart attack, heart failure, abnormal heart rhythm, or long QT syndrome

有或曾经有心脏问题，包括心脏病发作、心力衰竭、心律异常或长QT综合征

have or had low levels of potassium or magnesium in your blood

血液中钾或镁含量低或曾经低

have or had uncontrolled movements of your tongue, face, mouth or jaw (tardive dyskinesia)

有或曾经有舌头、面部、口腔或下颌的不可控运动（迟发性运动障碍）

have or had kidney or liver problems

有或曾经有肾脏或肝脏问题

have or had high blood sugar, diabetes or have a family history of diabetes

有或曾经有高血糖、糖尿病或有糖尿病家族史

have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol

总胆固醇、低密度脂蛋白胆固醇或甘油三酯水平高，或高密度脂蛋白胆固醇水平低

have Parkinson's disease or a type of dementia called Lewy Body Dementia

患有帕金森病或称为路易体痴呆的一种痴呆症

have or had problems with dizziness or fainting or are being treated for high blood pressure

有或曾经有头晕、晕厥问题，或正在接受高血压治疗的人员

have or had a low white blood cell count

白细胞计数低或曾经低过

have or had seizures or epilepsy

有或曾经有癫痫发作或癫痫疾病

are pregnant or plan to become pregnant. It is not known if ERZOFRI will harm your unborn baby.

怀孕或计划怀孕。目前尚不清楚ERZOFRI是否会伤害您未出生的宝宝。

If you become pregnant during treatment with ERZOFRI, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit

如果在使用ERZOFRI治疗期间怀孕，请与您的医疗保健提供者讨论注册国家非典型抗精神病药妊娠登记处的事宜。您可以拨打1-866-961-2388或访问进行注册。

http://womensmentalhealth.org/clinical-and-research-

http://womensmentalhealth.org/clinical-and-research-

programs/pregnancyregistry/

程序/妊娠登记处/

.

。

Babies born to women who are treated with ERZOFRI during their third trimester of pregnancy may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare provider know if these symptoms occur..

在怀孕第三个月接受ERZOFRI治疗的妇女所产下的婴儿可能会出现震颤、烦躁、嗜睡过度、眼皮抽搐、肌肉痉挛、食欲下降、呼吸困难或四肢异常运动等症状。如果这些症状发生，请告知您的医疗保健提供者。

are breastfeeding or plan to breastfeed. ERZOFRI can pass into your breastmilk.

正在哺乳或计划哺乳。ERZOFRI 可能会进入您的母乳中。

Talk to your healthcare provider about the best way to feed your baby if you receive ERZOFRI.

如果您接受 ERZOFRI，请咨询您的医疗保健提供者关于喂养宝宝的最佳方法。

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERZOFRI and certain other medicines may affect each other causing possible serious side effects or affect the way each other works. Know the medicines you take. Keep a list of them to show to your healthcare provider or pharmacist when you get a new medicine..

包括处方药和非处方药、维生素以及草药补充剂。ERZOFRI 和某些其他药物可能相互影响，导致可能的严重副作用或影响彼此的作用方式。了解你所服用的药物。保留一份清单，在获取新药时将其出示给你的医疗保健提供者或药剂师。

The most common side effects of ERZOFRI include

ERZOFRI最常见的副作用包括

:

：

injection site reactions

注射部位反应

sleepiness or drowsiness

睡意或嗜睡

dizziness

头晕

feeling restless or like you need to move

感到坐立不安或需要走动

abnormal muscle movements including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes

包括震颤（抖动）、拖步、不受控制的不自主运动以及眼睛的异常运动在内的肌肉活动异常

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ERZOFRI. Call your doctor for medical advice about side effects. You may report side effects to FDA at

告诉您的医疗保健提供者您是否有任何困扰您或未消失的副作用。这些并非ERZOFRI的所有可能副作用。如需有关副作用的医疗建议，请致电您的医生。您可以向FDA报告副作用至

www.fda.gov/medwatch

www.fda.gov/medwatch

or call 1-800- FDA-1088.

或拨打1-800-FDA-1088。

About Luye Pharma Group

关于绿叶制药集团

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in

绿叶制药集团是一家致力于创新药物的研发、生产和销售的国际制药公司。该公司建立了研发中心在

China

中国

, the U.S. and

，美国和

Europe

欧洲

, with a robust pipeline of over 20 drug candidates in

，拥有超过20种候选药物的强大研发管线在

China

中国

and more than 10 drug candidates in other international markets. Luye Pharma maintains high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems. The company has achieved multiple innovations in new chemical entities and antibodies, and is also actively making strategic developments in the fields of cell therapies and gene therapies..

并且在其他国际市场拥有10多个药物候选品。绿叶制药在微球、脂质体以及透皮释药系统等新型药物递送技术上保持高水平的国际标准，公司在新化学实体和抗体领域取得了多项创新，并且积极在细胞治疗和基因治疗领域进行战略性布局。

Luye Pharma is developing a global supply chain of 8 manufacturing sites built up around the world, with GMP quality management and control systems established in line with international standards. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets -- .

绿叶制药围绕国际标准建立八大生产基地的全球供应链，建立符合国际标准的GMP质量管理和控制体系。产品线逾30个上市产品，覆盖中枢神经系统、肿瘤、心血管、代谢等治疗领域，业务遍及全球80多个国家和地区，其中包括全球最大的医药市场。

China

中国

, the U.S.,

，美国，

Europe

欧洲

and

和

Japan

日本

, as well as in fast-growing emerging markets.

，以及在快速增长的新兴市场中。

[1]. Anne Rivelli, Veronica Fitzpatrick, Michael Nelson, et al. Real-world predictors of relapse in patients with schizophrenia and schizoaffective disorder in a large health system. Schizophrenia (Heidelb) (2024). DOI: 10.1038/s41537-024-00448-2.

[1]. 安妮·里韦利，维罗尼卡·菲茨帕特里克，迈克尔·纳尔逊等。大型医疗系统中精神分裂症和分裂情感障碍患者复发的现实预测因素。《精神分裂症（海德堡）》（2024）。DOI：10.1038/s41537-024-00448-2。

[2]. Lee SY, et al. Outpatient Follow-Up Visit after Hospital Discharge Lowers Risk of Rehospitalization in Patients with Schizophrenia: A Nationwide Population-Based Study. Psychiatry Investig. 2015;12(4):425-33. DOI: 10.4306/pi.2015.12.4.425

[2]. 李SY等。出院后门诊随访可降低精神分裂症患者再住院风险：一项全国性人口研究。《精神病学研究》。2015；12（4）：425-33。DOI：10.4306/pi.2015.12.4.425

[3]. Carmela Benson, et al. Treatment patterns and hospitalizations following rejection, reversal, or payment of the initial once-monthly paliperidone palmitate long-acting injectable antipsychotic claim among patients with schizophrenia or schizoaffective disorder. J Manag Care Spec Pharm. 2024 Jun 3:1-13.

[3]. Carmela Benson 等。精神分裂症或分裂情感性障碍患者在初始每月一次棕榈酸帕利哌酮长效注射抗精神病药物索赔被拒绝、撤销或支付后的治疗模式与住院情况。《管理式医疗与专科药房杂志》。2024年6月3日：1-13页。

DOI: 10.18553/jmcp.2024.23252..

DOI：10.18553/jmcp.2024.23252..

US-ERZ-PM-250300020-v1.0-03/2025

美国-ERZ-PM-250300020-v1.0-2025年3月

SOURCE Luye Pharma Group

来源：绿叶制药集团

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