A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia

To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function

开始日期2025-07-01

申办/合作机构-

CTR20244932

/ RecruitingN/A

棕榈帕利哌酮酯注射液（3M）在中国精神分裂症患者中的随机、开放、多中心、两制剂、多次给药、平行设计生物等效性试验。

评价石药集团中诺药业（石家庄）有限公司生产的棕榈帕利哌酮酯注射液（3M）（受试制剂）与Janssen Pharmaceutica N.V的参比制剂棕榈帕利哌酮酯注射液（3M）（参比制剂，商品名：善妥达®）多次给药在稳态下的生物等效性。

开始日期2025-02-12

申办/合作机构

石药集团中诺药业（石家庄）有限公司

ChiCTR2400092341

/ Suspended临床4期IIT

A multicenter and real-world study on the efficacy and safety of paliperidone palmitate injection for schizophrenia

开始日期2024-11-15

申办/合作机构-

100 项与棕榈酸帕利哌酮相关的临床结果

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100 项与棕榈酸帕利哌酮相关的转化医学

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100 项与棕榈酸帕利哌酮相关的专利（医药）

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636

项与棕榈酸帕利哌酮相关的文献（医药）

2025-09-01·Asian Journal of Psychiatry

Barriers to transitioning from monthly to 3-monthly paliperidone palmitate formulation: Patient characteristics and physician intentions

Letter

作者: Ogihara, Mayu ; Takeuchi, Hiroyoshi ; Misawa, Fuminari

2025-09-01·PCN reports : psychiatry and clinical neurosciences

Long‐acting injectable paliperidone palmitate for severe anorexia nervosa and comorbid autism spectrum disorder: A case report

Article

作者: Mori, Yuhei ; Suzuki, Yuhei ; Miura, Itaru

Abstract:

Background:

Anorexia nervosa (AN), comorbid with autism spectrum disorder (ASD), poses significant treatment challenges due to cognitive rigidity, poor insight, and frequent nonadherence to pharmacological interventions. Although second‐generation antipsychotics (SGAs) have been used off‐label in AN, evidence for long‐acting injectable (LAI) formulations remains scarce, particularly in adult patients with neurodevelopmental disorders.

Case Presentation:

We report the case of a 27‐year‐old woman with severe AN and comorbid ASD who exhibited repeated hospitalizations due to critical underweight and persistent refusal of oral medications. Cognitive assessment revealed mild intellectual disability (IQ 56). The patient demonstrated obsessive‐compulsive traits and extreme rigidity toward food intake, and was resistant to multiple oral antipsychotics. While risperidone was tolerated, poor adherence limited its efficacy. After obtaining informed consent, LAI paliperidone palmitate was initiated (initial dose 25 mg, increased to 50 mg monthly). Following a short period of psychoeducation and lifestyle intervention, the patient maintained psychiatric and nutritional stability over a 3‐year outpatient follow‐up without rehospitalization. Her body mass index stabilized at approximately 24 kg/m2. No severe adverse effects were reported.

Conclusion:

This case highlights the potential role of LAI paliperidone palmitate in managing treatment‐refractory AN with comorbid ASD and intellectual disability, particularly in patients with poor adherence and prominent obsessive traits. Although antipsychotics are not standard for AN, LAI formulations may offer pragmatic, sustainable benefits in selected cases. Further studies are warranted to assess long‐term safety and efficacy in this population.

2025-08-01·CNS DRUGS

Efficacy and Safety of Once-Monthly Paliperidone Palmitate Long-Acting Injections in Chinese Patients with Early-, Mid-, and Late-Phase Schizophrenia: A Post-Hoc Analysis of Three Phase 4 Studies

Article

作者: Yang, Yishen ; Jia, Miaomiao ; Ye, Chong ; Si, Tianmei ; Li, Qian ; Li, Yang ; Zhuo, Jianmin

BACKGROUND:

Long-acting injectable (LAI) antipsychotics have improved treatment adherence and continuity compared with oral antipsychotics. However, evidence gaps persist in the endorsement of LAIs for early-phase schizophrenia in China. This post-hoc analysis evaluated the efficacy and safety of once-monthly paliperidone palmitate (PP1M), an LAI antipsychotic, following early-, mid-, and late-phase use in Chinese patients with schizophrenia.

METHODS:

Data from three phase 4 studies (NCT01527305, NCT01947803, and NCT01685931) were used. Chinese patients with schizophrenia (disease duration early: ≤ 2 years; mid: > 2 to ≤ 5 years; late: > 5 years) who received 13 weeks of PP1M treatment were included. The primary endpoint was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 13, and the secondary and exploratory endpoints included change in Clinical Global Impression of Severity scale (CGI-S), PANSS responder rate relative to baseline PANSS total scores (≤ 70, 70-90 [exclusive], and ≥ 90), and treatment-emergent adverse events (TEAEs).

RESULTS:

In total, 1053 patients (early: 383; mid: 290; late: 380) were included. Following PP1M, improvements in efficacy outcomes were observed in all phases of schizophrenia including PANSS total score from baseline to week 13 (least square [LS]-mean change early: - 31.6; mid: - 28.4; late: - 25.6; p = 0.0003 across three groups) and CGI-S (median reduction early: - 2.0; mid: - 1.0; late: - 1.0). The greatest improvements in efficacy outcomes were consistently seen in early-phase patients, indicated by differences in PANSS total score (baseline to week 13 LS-mean differences mid versus early: 3.2 [p = 0.2175], late versus mid: 2.8 [p = 0.2783], and late versus early: 6.0 [p = 0.0011]), and nominal significant differences in CGI-S (mid versus early: p = 0.0015 and late versus early: p = 0.0180). Earlier administration of PP1M results in greater efficacy outcomes regardless of the initial disease severity. For patients with a PANSS score ≤ 70 at baseline, reductions of ≥ 30% were observed in 71.4%, 60.0%, and 50.0% (p = 0.0003 across three groups), and for patients with a PANSS score ≥ 90 at baseline, reductions of ≥ 30% were observed in 76.4%, 72.5%, and 69.6% (p = 0.0003 across three groups) of patients in the early-, mid-, and late-phase, respectively. The proportion of patients experiencing ≥ 1 TEAE (early: 44.3%; mid: 38.4%; late: 39.8%) was numerically higher in the early phase. Incidences of serious TEAEs (early: 2.8%; mid: 4.0%; late: 4.2%) and TEAEs leading to death (early: 0.3%; mid: 0.0%; late: 1.6%) were observed.

CONCLUSIONS:

Treatment with PP1M improves efficacy outcomes in Chinese adult patients with schizophrenia. However, when PP1M was used in earlier phases of schizophrenia, consistently greater improvements in efficacy outcomes were observed compared with later phases, regardless of disease severity at baseline. Safety data were consistent with the existing profile for PP1M. These findings support the use of PP1M in Chinese patients with early-phase schizophrenia.

197

项与棕榈酸帕利哌酮相关的新闻（医药）

2025-08-18

·绿叶制药

绿叶制药宣布1类创新药若欣林®治疗广泛性焦虑障碍的Ⅲ期临床试验完成所有患者入组

绿叶制药集团宣布，其1类创新药若欣林®（盐酸托鲁地文拉法辛缓释片）用于治疗广泛性焦虑障碍的Ⅲ期临床试验已完成所有患者入组。该项Ⅲ期临床试验为一项多中心、随机、双盲、安慰剂对照的研究，以评估若欣林®治疗广泛性焦虑障碍的安全性和有效性。试验共纳入555例患者，主要终点为治疗第8周末汉密尔顿焦虑量表（HAM-A）评分总分较基线的变化。公司预计将于今年年底完成该项临床试验并提交该适应症的上市申请。焦虑障碍是我国最常见的精神障碍1，其患病时间长、复发率高，对患者日常生活质量影响较大2。广泛性焦虑障碍是焦虑障碍的一种常见类型。截至2021年，我国约有5310万人患有焦虑障碍3。近15年来，全球未有治疗焦虑症的创新药获批上市。若欣林®有望成为全球首个用于治疗广泛性焦虑障碍的5-羟色胺（5-HT）、去甲肾上腺素（NE）和多巴胺（DA）三重再摄取抑制剂（SNDRI）。目前，广泛性焦虑障碍的一线治疗药物包括选择性5-羟色胺再摄取抑制剂（SSRI）、5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRI）2。然而，SSRI和SNRI类药物常见的不良反应包括性功能障碍、嗜睡、体重增加、脂代谢紊乱等，导致患者依从性低，进而影响治疗效果，亦是此类药物治疗中断的常见原因。若欣林®是中国首个自主研发并拥有自主知识产权、用于治疗抑郁症的化药1类创新药，自2022年在中国获批上市以来，其治疗抑郁症的疗效和安全性不断获得临床认可。若欣林®过往用于治疗抑郁症的临床试验已证实：该药物可全面改善抑郁症状，尤其对快感缺失、阻滞和认知障碍等改善突出，克服了现有药物的缺陷，且不引起失眠和嗜睡，不影响性功能、体重和脂代谢。此外，若欣林®对于抑郁症患者的HAM-A总分、HAM-A精神性焦虑因子及躯体性焦虑因子评分、17项汉密尔顿抑郁量表（HAM-D17）焦虑/躯体化因子评分均有显著改善，显示该药物发挥抗抑郁作用的同时亦具有潜在的抗焦虑作用。自2022年上市不到三年的时间里，若欣林®已累计服务超过8万名患者，成为近年来国内销售增长最快的抗抑郁新药；2024年底，若欣林®首次纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》，提升创新可及性；随着该药物用于治疗广泛性焦虑障碍Ⅲ期临床试验及相关上市申请的顺利推进，若欣林®有望造福更多患者。包括抑郁症、焦虑症在内的中枢神经系统治疗领域患者需求庞大，但新药研发进展相对较缓。围绕该领域，绿叶制药已在中国、美国、欧洲、日本等市场获批一系列具有国际竞争力的创新药和创新制剂，包括：Erzofri®（棕榈酸帕利哌酮缓释混悬注射液）、Rykindo®（利培酮缓释微球注射剂）已在美国获批上市，利斯的明透皮贴剂（2次/W）已在欧洲多国、日本、中国获批上市，若欣林®（盐酸托鲁地文拉法辛缓释片）、金悠平®（注射用罗替高汀微球）已在中国获批上市等。同时，公司积极布局下一代创新药的研发，另有TAAR1/5-HT2CR双靶点新药LY03020、VMAT2/Sigma-1双靶点新药LY03015、5-HT2AR/5-HT2CR双靶点新药LY03017等多个1类创新药处于临床阶段。关于绿叶制药集团绿叶制药集团是致力于创新药物的研发、生产和销售的国际化制药公司。绿叶制药在中国、美国和欧洲设有研发中心，在微球、脂质体、透皮释药等先进药物递送技术领域达到国际先进水平，并在新分子实体、生物抗体领域收获多项创新成果。2021年至2025年，公司共有14款新产品在美国、中国、日本和欧洲多国获批上市。绿叶制药在全球建有8大生产基地并建立了与国际接轨的GMP质量管理和控制体系。公司现有30余个上市产品，覆盖肿瘤、中枢神经系统、心血管等治疗领域；业务遍及全球80多个国家和地区，其中包括中国、美国、欧洲、日本等全球主要医药市场，以及高速增长的各地新兴市场。参考文献： 1. Huang Y, Wang Y, Wang H, et al. Prevalence of mental disorders in China: a cross‑sectional epidemiological study[J]. Lancet Psychiatry, 2019, 6(3): 211‑224. DOI: 10.1016/S2215‑0366(18)30511‑X. 2. 国家卫生健康委员会. 精神障碍诊疗规范（2020年版）. 2020. 164-179 3. Tian W, et al. Burden of depressive and anxiety disorders in China and its provinces, 1990-2021: findings from the Global Burden of Disease Study 2021. Br J Psychiatry. 2025 Jan 22:1-11. doi: 10.1192/bjp.2024.267.

上市批准临床3期引进/卖出

2025-08-03

·信狐药迅

嘉兴安帝康生物抗病毒1类新药玛氘诺沙韦第二次提交上市申请|新受理（7.28-8.3）

本周药品注册受理数据，分门别类呈现，一目了然。(7.28-8.3）新药上市申请药品名称企业注册分类受理号玛氘诺沙韦片嘉兴安帝康生物科技有限公司1CXHS2500089依达拉奉片杭州中美华东制药有限公司2.2CXHS2500088拉莫三嗪干混悬剂上海奥科远制药有限公司2.2CXHS2500087拉莫三嗪干混悬剂上海奥科远制药有限公司2.2CXHS2500086新药临床申请药品名称企业注册分类受理号GSBR-1001290 L-精氨酸片上海硕迪生物技术有限公司1CXHL2500798GSBR-1001290 L-精氨酸片上海硕迪生物技术有限公司1CXHL2500797GSBR-1001290 L-精氨酸片上海硕迪生物技术有限公司1CXHL2500796GSBR-1001290 L-精氨酸片上海硕迪生物技术有限公司1CXHL2500795GSBR-1001290 L-精氨酸片上海硕迪生物技术有限公司1CXHL2500794QHRD110胶囊常州千红生化制药股份有限公司1CXHL2500793QHRD110胶囊常州千红生化制药股份有限公司1CXHL2500792APH03621片广州一品红制药有限公司1CXHL2500803APH03621片广州一品红制药有限公司1CXHL2500802羧胺三唑软胶囊广东银珠医药科技有限公司1CXHL2500800羧胺三唑软胶囊广东银珠医药科技有限公司1CXHL2500799SA1211注射液苏州时安生物技术有限公司1CXHL2500790ADC118片成都艾迪医药技术有限公司1CXHL2500787HSK42360-Na散海思科医药集团股份有限公司1CXHL2500784HSK42360-Na散海思科医药集团股份有限公司1CXHL2500783HSK47388片(I)海思科医药集团股份有限公司1CXHL2500780BGB-58067片百济神州(苏州)生物科技有限公司1CXHL2500779BGB-58067片百济神州(苏州)生物科技有限公司1CXHL2500778BG-89894片百济神州(苏州)生物科技有限公司1CXHL2500777BG-89894片百济神州(苏州)生物科技有限公司1CXHL2500776吸入用TQC3721混悬液正大天晴药业集团股份有限公司1CXHL2500771吸入用TQC3721混悬液正大天晴药业集团股份有限公司1CXHL2500770伊匹乌肽散剂益承康泰(厦门)生物科技有限公司1CXHL2500769TQB3201片正大天晴药业集团股份有限公司1CXHL2500775TQB3201片正大天晴药业集团股份有限公司1CXHL2500774注射用UBT37034联邦生物科技(珠海横琴)有限公司1CXHL2500772QLS1410片齐鲁制药有限公司1CXHL2500781QLS1410片齐鲁制药有限公司1CXHL2500782BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2500768BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2500767BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2500765AL28979片南京爱德程医药科技有限公司1CXHL2500764TQB3217片正大天晴药业集团南京顺欣制药有限公司1CXHL2500763TQB3217片正大天晴药业集团南京顺欣制药有限公司1CXHL2500762注射用ADB116江苏艾迪药业股份有限公司2.1;2.2;2.4CXHL2500785司美格鲁肽注射液山西嘉源生物医药有限公司2.2CXHL2500791BIFC胶囊装微片北京天衡药物研究院有限公司2.2CXHL2500789BIFC胶囊装微片北京天衡药物研究院有限公司2.2CXHL2500788VHDT口崩片福州长富星生物医药科技有限公司2.2CXHL2500786特立帕肽注射液成都圣诺生物制药有限公司2.2CXHL2500773HKGM-453黑龙江亿达鸿药业有限公司2.3CXHL2500761注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500801注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500766呼吸道合胞病毒mRNA疫苗云南沃森生物技术股份有限公司1.2CXSL2500642呼吸道合胞病毒mRNA疫苗云南沃森生物技术股份有限公司1.2CXSL2500641TQB2868注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2500645VPD/FC01002 注射液微能生命科技集团有限公司1CXSL2500652VUM02注射液武汉光谷中源药业有限公司1CXSL2500651HTB-C042鼻喷雾剂上海惠盾因泰生物科技有限公司1CXSL2500650注射用JSKN003上海津曼特生物科技有限公司1CXSL2500649注射用JSKN022江苏康宁杰瑞生物制药有限公司1CXSL2500648SNC115注射液上海先博生物科技有限公司1CXSL2500647HS-20117-2 注射液上海翰森生物医药科技有限公司1CXSL2500646注射用TQB2103上海正大天晴医药科技开发有限公司1CXSL2500643注射用7MW4911迈威(上海)生物科技股份有限公司1CXSL2500640人源多巴胺能前体细胞注射液睿健毅联医药科技(成都)有限公司1CXSL2500637EA5注射液皮下制剂上海览屹医药科技有限公司1CXSL2500635JL19001注射液杰库(上海)生物医药研究有限公司1CXSL2500633注射用BG-T187(皮下注射)广州百济神州生物制药有限公司1CXSL2500636IBI354信达生物医药科技(杭州)有限公司1CXSL2500632镥[177Lu]-BL-ARC001注射液成都百利多特生物药业有限责任公司1CXSL2500631注射用BA1301山东博安生物技术股份有限公司1CXSL2500628人脐带间充质干细胞注射液北京第一生物科技开发有限公司1CXSL2500627MG-K10人源化单抗注射液湖南麦济生物技术股份有限公司1CXSL2500626MG-K10人源化单抗注射液湖南麦济生物技术股份有限公司1CXSL2500625注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司2.2CXSL2500644注射用MK-2870默沙东研发(中国)有限公司2.2CXSL2500634LY01015注射液山东博安生物技术股份有限公司2.2CXSL2500630LY01015注射液山东博安生物技术股份有限公司2.2CXSL2500629仿制药申请药品名称企业注册分类受理号复方醋酸钠葡萄糖注射液四川奇裕医药科技有限公司3CYHS2502797复方醋酸钠葡萄糖注射液四川奇裕医药科技有限公司3CYHS2502796吡格列酮二甲双胍片广东方盛健盟药业有限公司3CYHS2502785维生素B12注射液海南钧华医疗科技有限公司3CYHS2502772辅酶Q10片西藏奥斯必秀医药有限公司3CYHS2502770盐酸溴己新口服溶液珠海横琴国研医药科技有限公司3CYHS2502768氨磺必利口服溶液成都康弘药业集团股份有限公司3CYHS2502767头孢克肟干混悬剂上海金城素智药业有限公司3CYHS2502757硝普钠氯化钠注射液海南紫程众投生物科技有限公司3CYHS2502762头孢克肟干混悬剂广东万泰科创药业有限公司3CYHS2502761氨溴特罗口服溶液中曦(福建)药业有限公司3CYHS2502745多种微量元素注射液(I)仁合益康汇泽药业河北有限公司3CYHS2502741联苯苄唑溶液安徽肽渡生物医药科技有限公司3CYHS2502740维生素B6注射液南京臣功制药股份有限公司3CYHS2502728卡络磺钠注射液浙江普洛康裕制药有限公司3CYHS2502724磷苯妥英钠注射液四川科瑞德制药股份有限公司3CYHS2502721硝普钠氯化钠注射液南京海辰药业股份有限公司3CYHS2502752中性低钙腹膜透析液(碳酸氢盐-G2.5%)青岛瑞奈医疗科技有限公司3CYHS2502705中性低钙腹膜透析液(碳酸氢盐-G1.5%)青岛瑞奈医疗科技有限公司3CYHS2502704氯化钾注射液河北天成药业股份有限公司3CYHS2502703吲哚布芬片成都纵联医疗健康科技有限公司3CYHS2502710聚乙烯醇滴眼液山东博士伦福瑞达制药有限公司4CYHS2502798乌帕替尼缓释片西洲医药科技(浙江)有限公司4CYHS2502795玛巴洛沙韦片浙江四维医药科技有限公司4CYHS2502794玛巴洛沙韦片浙江四维医药科技有限公司4CYHS2502793苯磺酸氨氯地平片山西汾河制药有限公司4CYHS2502792苯磺酸氨氯地平片山西汾河制药有限公司4CYHS2502791达格列净片甘李药业山东有限公司4CYHS2502790硫酸氨基葡萄糖胶囊郑州卓峰制药有限公司4CYHS2502788盐酸奥洛他定滴眼液广州大光制药有限公司4CYHS2502787盐酸曲唑酮缓释片北京双鹭药业股份有限公司4CYHS2502786比索洛尔氨氯地平片新乡双鹭药业有限公司4CYHS2502784富马酸贝达喹啉片湖南埃威格林医药科技有限公司4CYHS2502774乳酸钠林格注射液合肥源丰顺医药科技有限公司4CYHS2502773双氯芬酸钠盐酸利多卡因注射液江苏欣力元生物制药有限公司4CYHS2502771非奈利酮片江西科伦药业有限公司4CYHS2502783盐酸曲唑酮缓释片哈尔滨三联药业股份有限公司4CYHS2502782非奈利酮片江西科伦药业有限公司4CYHS2502781头孢托仑匹酯颗粒石家庄四药有限公司4CYHS2502780盐酸乙哌立松片北京紫萌医药科技有限公司4CYHS2502779沙库巴曲缬沙坦钠片江苏永安制药有限公司4CYHS2502778沙库巴曲缬沙坦钠片江苏永安制药有限公司4CYHS2502777达格列净片重庆博腾药业有限公司4CYHS2502776达格列净片重庆博腾药业有限公司4CYHS2502775乙酰半胱氨酸注射液海口天行健药物研究有限公司4CYHS2502769盐酸莫西沙星氯化钠注射液新天地药业股份有限公司4CYHS2502766ω-3脂肪酸乙酯90软胶囊海南斯达制药有限公司4CYHS2502765左氧氟沙星片吉林省罗邦药业有限公司4CYHS2502764富马酸福莫特罗吸入溶液复星医药(徐州)有限公司4CYHS2502763泊那替尼片齐鲁制药有限公司4CYHS2502789沙库巴曲缬沙坦钠片四川美大康药业股份有限公司4CYHS2502759沙库巴曲缬沙坦钠片四川美大康药业股份有限公司4CYHS2502758艾拉莫德片辰欣药业股份有限公司4CYHS2502756吗啉硝唑氯化钠注射液湖南华纳大药厂股份有限公司4CYHS2502755过氧苯甲酰凝胶杭州和泽坤元药业有限公司4CYHS2502754美阿沙坦钾片天津华津制药有限公司4CYHS2502760巴瑞替尼片北京万辉双鹤药业有限责任公司4CYHS2502744佩玛贝特片兰西哈三联制药有限公司4CYHS2502743恩扎卢胺软胶囊山东新时代药业有限公司4CYHS2502742头孢托仑匹酯颗粒深圳立健药业有限公司4CYHS2502739头孢托仑匹酯颗粒深圳立健药业有限公司4CYHS2502738甘油磷酸钠注射液上海葆隆生物科技有限公司4CYHS2502737瑞舒伐他汀依折麦布片(I)广东江正药业有限公司4CYHS2502735盐酸伐地那非片杭州民生药物研究院有限公司4CYHS2502734盐酸伐地那非片杭州民生药物研究院有限公司4CYHS2502733二甲双胍恩格列净片(I)石家庄市普力制药有限公司4CYHS2502732二甲双胍恩格列净片(III)石家庄市普力制药有限公司4CYHS2502731二甲双胍恩格列净片(VI)石家庄市普力制药有限公司4CYHS2502730注射用甲苯磺酸奥马环素海南元盈医药科技有限公司4CYHS2502729布瑞哌唑片上海现代制药股份有限公司4CYHS2502727布瑞哌唑片上海现代制药股份有限公司4CYHS2502726布瑞哌唑片上海现代制药股份有限公司4CYHS2502725氟比洛芬凝胶贴膏浙江恒研医药科技有限公司4CYHS2502723利丙双卡因乳膏吉林省奇健生物技术有限公司4CYHS2502722马昔腾坦片宁波美诺华天康药业有限公司4CYHS2502720富马酸伏诺拉生片山东铂源药业股份有限公司4CYHS2502751富马酸伏诺拉生片山东铂源药业股份有限公司4CYHS2502750甲磺酸沙非胺片北京颐康兴医药有限公司4CYHS2502749双氯芬酸钠盐酸利多卡因注射液山东如至生物医药科技有限公司4CYHS2502748佩玛贝特片江苏奥赛康药业有限公司4CYHS2502747甲钴胺片重庆药友制药有限责任公司4CYHS2502746甲苯磺酸索拉非尼片广州白云山医药集团股份有限公司白云山制药总厂4CYHS2502753ω-3脂肪酸乙酯90软胶囊青岛双鲸药业股份有限公司4CYHS2502736非奈利酮片山东鲁抗医药股份有限公司4CYHS2502707硝呋太尔制霉菌素阴道软胶囊海南万玮制药有限公司4CYHS2502706甲钴胺片赤峰维康生化制药有限公司4CYHS2502719盐酸西替利嗪滴剂江苏万高药业股份有限公司4CYHS2502718达格列净二甲双胍缓释片(III)河南立诺制药有限公司4CYHS2502717达格列净二甲双胍缓释片(II)河南立诺制药有限公司4CYHS2502716达格列净二甲双胍缓释片(I)河南立诺制药有限公司4CYHS2502715盐酸达泊西汀片山东济坤生物制药有限公司4CYHS2502714盐酸达泊西汀片山东济坤生物制药有限公司4CYHS2502713乳酸环丙沙星氯化钠注射液湖北津药药业股份有限公司4CYHS2502712吗啉硝唑氯化钠注射液西洲医药科技(浙江)有限公司4CYHS2502711白消安注射液广州合和医药有限公司4CYHS2502709非奈利酮片山东鲁抗医药股份有限公司4CYHS2502708盐酸缬更昔洛韦片宜昌人福药业有限责任公司4CYHS2502702瑞卢戈利片广东方盛健盟药业有限公司3CYHL2500136铜[64Cu]氧奥曲肽注射液通瑞生物制药(成都)有限公司3CYHL2500135甲苯磺酸卢美哌隆胶囊四川科伦药业股份有限公司3CYHL2500134利非司特滴眼液广州大光制药有限公司3CYHL2500133丙氯拉嗪栓海鸿恒隆(海南)生物科技有限公司3CYHL2500132注射用罗普司亭N01齐鲁制药有限公司3.2CXSL2500639注射用罗普司亭N01齐鲁制药有限公司3.2CXSL2500638进口申请药品名称企业注册分类受理号甲磺酸洛美他派胶囊Chiesi Farmaceutici S.p.A.5.1JXHS2500083甲磺酸洛美他派胶囊Chiesi Farmaceutici S.p.A.5.1JXHS2500082甲磺酸洛美他派胶囊Chiesi Farmaceutici S.p.A.5.1JXHS2500081葡萄糖酸苯加兰他敏肠溶片Alpha Cognition, Inc.5.1JXHS2500078葡萄糖酸苯加兰他敏肠溶片Alpha Cognition, Inc.5.1JXHS2500080葡萄糖酸苯加兰他敏肠溶片Alpha Cognition, Inc.5.1JXHS2500079Onasemnogene abeparvovec鞘内注射液Novartis Pharma Schweiz AG2.1JXSS2500106艾沙妥昔单抗注射液(皮下注射)Sanofi Winthrop Industrie2.1JXSS2500107注射用塔拉妥单抗Amgen Inc.3.1JXSS2500104注射用塔拉妥单抗Amgen Inc.3.1JXSS2500105棕榈酸帕利哌酮注射液Pharmathen International S.A.5.2JYHS2500030棕榈酸帕利哌酮注射液Pharmathen International S.A.5.2JYHS2500034棕榈酸帕利哌酮注射液Pharmathen International S.A.5.2JYHS2500033棕榈酸帕利哌酮注射液Pharmathen International S.A.5.2JYHS2500032棕榈酸帕利哌酮注射液Pharmathen International S.A.5.2JYHS2500031LOU064片Novartis Pharma AG1JXHL2500206Icotrokinra片Janssen Research & Development, LLC1JXHL2500207Icotrokinra片Janssen Research & Development, LLC1JXHL2500208PF-08049820水合物片Pfizer Inc.1JXHL2500203PF-08049820水合物片Pfizer Inc.1JXHL2500202BHV-8000缓释片Biohaven Therapeutics, Ltd.1JXHL2500205BHV-8000缓释片Biohaven Therapeutics, Ltd.1JXHL2500204甲磺酸贝舒地尔口服混悬剂Sanofi-Aventis Recherche & Developpement2.2JXHL2500201ABBV-400注射用粉末AbbVie Inc.1JXSL2500137Pasritamig注射液Janssen Research & Development, LLC1JXSL2500135Pasritamig注射液Janssen Research & Development, LLC1JXSL2500136帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2500134纳武利尤单抗注射液Bristol-Myers Squibb Company2.2JXSL2500133中药相关申请药品名称企业注册分类受理号益气升脉颗粒瑞阳制药股份有限公司1.1CXZL2500059益母妇炎颗粒健民药业集团股份有限公司1.1CXZL2500058糖宁通络片百灵毓秀(珠海)医药有限公司1.1CXZL2500055HQY总黄酮胶囊南京三同医药科技有限公司1.2CXZL2500057HQY总黄酮提取物南京三同医药科技有限公司1.2CXZL2500056注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2025-07-29

·PRNewswire

Alkermes plc Reports Second Quarter 2025 Financial Results

— Second Quarter Revenues of $390.7 Million — — GAAP Net Income of $87.1 Million and Diluted GAAP Earnings per Share of $0.52 — — Company Reiterates 2025 Financial Expectations — — Alkermes to Present Detailed Vibrance-1 Results at Upcoming World Sleep Congress — DUBLIN, July 29, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2025. "Our second quarter results reflect strong performance across all three of our proprietary products and robust profitability and cash flow generation," said Richard Pops, Chief Executive Officer of Alkermes. "Against the backdrop of solid financial performance, the recently announced positive topline results from Vibrance-1, our phase 2 study of alixorexton (ALKS 2680) in narcolepsy type 1, were an important milestone in the development program and underscore the differentiated features of alixorexton. These data also highlight the potential of orexin 2 receptor agonists to transform the treatment of narcolepsy. As we prepare to initiate a global phase 3 program, we look forward to sharing detailed results from Vibrance-1 at the upcoming World Sleep Congress and topline results from our Vibrance-2 study in patients with narcolepsy type 2 this fall." Key Financial Highlights Revenue Highlights LYBALVI Revenues for the quarter were $84.3 million. Revenues and total prescriptions for the quarter grew 18% and 22%, respectively, compared to the second quarter of 2024. ARISTADAi Revenues for the quarter were $101.3 million. Revenues for the quarter grew 18% compared to the second quarter of 2024. During the quarter, the company recorded ARISTADA revenue of approximately $11.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments. VIVITROL Revenues for the quarter were $121.7 million. Revenues for the quarter grew 9% compared to the second quarter of 2024. During the quarter, the company recorded VIVITROL revenue of approximately $9.0 million related to gross-to-net favorability, primarily driven by Medicaid utilization adjustments. Manufacturing & Royalty Revenues VUMERITY® manufacturing and royalty revenues for the quarter were $39.4 million. Royalty revenues from XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $30.3 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Balance Sheet At June 30, 2025, the company recorded cash, cash equivalents and total investments of $1.05 billion, compared to $916.2 million at March 31, 2025. Financial Expectations for 2025 Alkermes reiterates its financial expectations for 2025, as set forth in its press release dated Feb. 12, 2025. Notes and Explanations 1. The company determined that upon the separation of its former oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three and six months ended June 30, 2024. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Tuesday, July 29, 2025, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including EBITDA and Adjusted EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. EBITDA represents earnings before interest, tax, depreciation and amortization. Adjusted EBITDA excludes share-based compensation expense in addition to the components of EBITDA from earnings. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, EBITDA and Adjusted EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, EBITDA and Adjusted EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects; and the company's expectations regarding development plans, activities and timelines for, and the potential therapeutic and commercial value of, alixorexton (formerly referred to as ALKS 2680). The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to achieve its financial expectations; clinical development activities may not be initiated or completed on expected timelines or at all; the results of the company's development activities may not be positive, or predictive of future results from such activities, results of future development activities or real-world results; the company's products or product candidates could be shown to be ineffective or unsafe; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies or may make adverse decisions regarding the company's products; potential changes in the cost, scope and duration of the company development programs; the unfavorable outcome of arbitration, litigation, or other proceedings or disputes related to the company's products or products using the company's proprietary technologies; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA HAFYERA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. ___________________ i The term "ARISTADA" as used in this press release refers to ARISTADA and ARISTADA INITIO®, unless the context indicates otherwise. SOURCE Alkermes plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

财报临床2期临床结果

100 项与棕榈酸帕利哌酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05340	棕榈酸帕利哌酮	N05AX13	DB01267

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
分裂情感性障碍	美国	Janssen Pharmaceuticals, Inc.	2014-11-12
精神分裂症	美国	Janssen Pharmaceuticals, Inc.	2009-07-31

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
中枢神经系统疾病	临床1期	美国	綠葉製藥集團有限公司	2021-09-08
精神运动性激动	临床1期	美国	綠葉製藥集團有限公司	2021-09-08
情绪障碍	临床1期	美国	綠葉製藥集團有限公司	2021-01-13
神经认知障碍	临床1期	美国	綠葉製藥集團有限公司	2021-01-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS 人工标引	N/A	精神分裂症	-	Erzofri	襯繭膚鹽襯糧觸膚醖範(築鑰夢憲壓憲鬱夢鏇夢) = 糧簾獵鑰網構窪廠觸築獵淵鹹鑰積構築鬱鏇選 (遞製獵衊衊構構餘鏇淵 ) 更多	积极	2025-05-22
				安慰剂组	襯繭膚鹽襯糧觸膚醖範(築鑰夢憲壓憲鬱夢鏇夢) = 壓選窪遞製鹹餘獵積艱獵淵鹹鑰積構築鬱鏇選 (遞製獵衊衊構構餘鏇淵 ) 更多
Pubmed	-	精神分裂症	121	棕榈帕利哌酮酯(6个月长效剂型)	鹽鬱壓齋膚顧築淵獵範(繭鹹襯繭壓鹽衊淵醖獵) = 糧鹹遞廠壓襯鹽醖膚鬱蓋鹽範夢齋夢夢獵壓襯 (選積鹹範積艱憲憲鏇膚 ) 更多	积极	2024-07-01
NCT02431702 \| NCT01081769 \| NCT01157351 (PRIDE \| PROSIPAL \| and DREaM, Pubmed \| J Clin Psychiatry)	N/A	精神分裂症	-	Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI)	獵淵網壓觸糧醖憲鹽簾(範鬱選醖製襯選選窪醖) = 廠範憲膚餘膚壓積壓鬱製選膚鑰醖簾簾壓膚築 (襯鹹鏇遞艱淵齋鏇鏇積 )	积极	2023-09-25
				Oral Antipsychotic (OAP)	獵淵網壓觸糧醖憲鹽簾(範鬱選醖製襯選選窪醖) = 鑰襯鑰窪壓淵淵鹹糧壓製選膚鑰醖簾簾壓膚築 (襯鹹鏇遞艱淵齋鏇鏇積 )
NCT04072575 (CTgov)	临床3期	精神分裂症	178	Paliperidone Palmitate	構鹽廠壓襯鏇窪壓選積 = 齋選淵鏇選構鑰觸壓壓獵蓋築願鏇範齋築鬱窪 (鏇淵積鑰簾願壓膚廠選, 積獵鑰衊艱顧簾鑰鏇鬱 ~ 鹽願鏇鹽網選艱夢構壓) 更多	-	2023-05-31
NCT04922593 (Corporate Publications) 人工标引	临床1期	分裂情感性障碍 \| 精神分裂症	281	LY03010	齋網顧憲糧築壓餘夢鹽(襯鏇選鬱糧鏇範獵鑰觸) = LY03010 has an optimized initial dosed regimen and is bioequivalent when stable state is reached with multiple doses compared to the initial dosed regimen of INVEGA SUSTENNA® 積鹽遞願廠獵願網網繭 (築膚網廠夢艱糧簾築壓 ) 更多	积极	2022-11-21
				INVEGA SUSTENNA
NCT03345342 (CTgov)	临床3期	精神分裂症	841	PP3M (DB PP3M)	遞鬱憲遞積鹹餘範蓋築(夢醖膚鬱簾製夢衊選齋) = 願夢憲簾齋觸鏇觸繭膚餘衊築齋範艱範窪壓築 (網顧衊觸餘顧鹽衊築廠, 衊廠窪鹹糧遞醖觸蓋蓋 ~ 鬱鏇膚蓋鏇願網膚壓蓋) 更多	-	2021-12-09
				placebo+PP6M (DB PP6M)	遞鬱憲遞積鹹餘範蓋築(夢醖膚鬱簾製夢衊選齋) = 蓋醖鬱淵製淵餘鹹鹹鑰餘衊築齋範艱範窪壓築 (網顧衊觸餘顧鹽衊築廠, 繭齋遞淵蓋廠範願淵齋 ~ 願齋憲簾獵顧繭憲鏇鹽) 更多
NCT01529515 \| NCT01515423 (Pubmed \| Braz J Psychiatry)	临床3期	精神分裂症	-	Paliperidone palmitate 3-monthly (PP3M)	鏇廠鏇選鑰觸醖齋鏇顧(顧淵獵製壓艱範憲齋鑰) = 網鹹構獵獵壓夢網膚糧鏇繭鏇壓網蓋顧選鑰餘 (製鹽積簾觸選鹽糧簾鏇 )	-	2019-12-01
				Paliperidone palmitate 1-monthly (PP1M)	鏇廠鏇選鑰觸醖齋鏇顧(顧淵獵製壓艱範憲齋鑰) = 鏇艱襯艱範築製蓋觸構鏇繭鏇壓網蓋顧選鑰餘 (製鹽積簾觸選鹽糧簾鏇 )
NCT01529515 \| NCT01515423 \| NCT01559272 (Pubmed \| Clin Pharmacokinet)	N/A	精神分裂症	651	Paliperidone Palmitate 3-month formulation	蓋糧鹽鬱夢範選鏇衊衊(餘遞鏇築顧製簾觸鹹鏇) = 範觸鬱顧艱蓋艱衊蓋願淵壓夢積繭淵襯鏇願範 (淵範壓網鹽顧願壓壓鹹 )	-	2017-04-01
NCT01515423 (Pubmed \| Int J Neuropsychopharmacol) 人工标引	临床3期	精神分裂症	1,016	paliperidone palmitate (PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal))	夢顧築構獵糧醖範鑰壓(膚糧壓繭艱選鹹齋鏇襯) = 襯遞淵遞網醖築構構餘襯顧獵觸選繭醖淵鹽淵 (鑰範築網構夢構範獵蓋 )	积极	2016-07-05
				paliperidone palmitate (PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal))	夢顧築構獵糧醖範鑰壓(膚糧壓繭艱選鹹齋鏇襯) = 範製積鑰壓醖廠鑰膚遞襯顧獵觸選繭醖淵鹽淵 (鑰範築網構夢構範獵蓋 )
NCT01515423 (CTgov)	临床3期	精神分裂症	1,429	Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 3 Month Formulation)	網簾衊鏇壓鑰淵積遞夢 = 觸獵憲築製鏇獵選壓獵獵觸齋鏇鏇艱糧選選窪 (鏇鬱獵築蓋襯鹽獵憲構, 齋築簾淵簾淵製壓憲糧 ~ 構觸糧鏇壓觸蓋鏇憲構) 更多	-	2016-05-02
				Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 1 Month Formulation)	網簾衊鏇壓鑰淵積遞夢 = 積範觸衊鑰憲繭築憲醖獵觸齋鏇鏇艱糧選選窪 (鏇鬱獵築蓋襯鹽獵憲構, 襯襯餘獵顧蓋製餘夢鹹 ~ 糧夢襯顧獵鏇選選選壓) 更多