单次给药主要研究目的：考察中国健康受试者在空腹条件下，单次口服不同剂量水平的醋酸艾司利卡西平片的药代动力学（Pharmacokinetics, PK）特征和PK种族敏感性。多次给药主要研究目的：考察中国健康受试者在空腹条件下，多次口服同一剂量的醋酸艾司利卡西平片的药代动力学（Pharmacokinetics, PK）特征。

开始日期2024-09-24

申办/合作机构

上海上药中西制药有限公司

[+1]

CTR20220017

/ Completed临床3期

一项多中心、随机、双盲、安慰剂对照短期研究及为期一年的开放性、非对照安全扩展研究，评价醋酸艾司利卡西平片用于成人局灶起源癫痫伴有或不伴有局灶进展为双侧强直阵挛发作添加治疗的有效性和安全性以及长期疗效和安全性

评价醋酸艾司利卡西平片用于成人局灶起源癫痫伴有或不伴有局灶进展为双侧强直阵挛发作添加治疗的疗效。

开始日期2022-07-28

申办/合作机构

上海中西药业股份有限公司

[+1]

CTR20201102

/ CompletedN/A

醋酸艾司利卡西平片在健康受试者中随机、开放、两周期、双交叉空腹和餐后状态下的生物等效性试验

研究空腹或餐后状态下，单次口服醋酸艾司利卡西平片受试制剂(规格：400mg，生产商：扬子江药业集团有限公司，提供商：扬子江药业集团北京海燕药业有限公司）与参比制剂（Aptiom®，规格：400mg，持证商：Sunovion Pharmaceuticals Inc. ）在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

开始日期2020-06-08

申办/合作机构

扬子江药业集团北京海燕药业有限公司

100 项与醋酸艾司利卡西平相关的临床结果

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100 项与醋酸艾司利卡西平相关的转化医学

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100 项与醋酸艾司利卡西平相关的专利（医药）

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685

项与醋酸艾司利卡西平相关的文献（医药）

2025-12-01·Acta Epileptologica

Psychiatric disorders with antiseizure medications in children: an analysis of the FDA adverse event reporting system database

Article

作者: Jiang, Li ; Meng, Linxue ; Wang, Lingman ; Gui, Jianxiong ; Zhang, Xiaofang ; Ma, Jiannan

Abstract:

Background:

Epilepsy is a chronic neurological disorder marked by a persistent tendency to generate seizures, leading to substantial cognitive, behavioral, and psychosocial consequences. This study investigated psychiatric disorder-related adverse events (AEs) associated with antiseizure medications (ASMs) in children using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods:

This study conducted a comprehensive analysis of FAERS data from 2004 to 2024, focusing on psychiatric AEs in children with epilepsy or seizures treated with ASMs. Signal values were computed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results:

A total of 2539 preferred terms (PTs) were included, involving 25 system organ classifications (SOCs). Nervous system, skin and subcutaneous tissue, and psychiatric disorders are the three most common SOCs for ASMs in children. There were 24 ASMs, whose AEs involved psychiatric disorders, totaling 110 PTs and 214 drug-PT relationships. Psychotic symptoms (notably lorazepam and topiramate, n = 116 and 109), substance dependence and abuse (notably pregabalin and clonazepam, n = 291 and 110), and the other neuropsychiatric symptoms (notably levetiracetam and valproic acid, n = 70 and 62) were the common types of psychiatric disorder-related AEs of ASMs in children. A total of nine ASMs (brivaracetam, clonazepam, diazepam, eslicarbazepine, gabapentin, lamotrigine, lorazepam, perampanel, and tiagabine) were associated with suicidal and self-injurious behavior in children.

Conclusions:

This study highlights psychiatric AEs of ASMs in children, offering critical insights to improve clinical medication practices and enhance treatment safety. Further research with broader clinical data is needed to promote safe and rational medication use.

2025-12-01·EPILEPSY & BEHAVIOR

Switching from oxcarbazepine to eslicarbazepine in pediatric patients with focal epilepsy is safe and well-tolerated

Article

作者: Kim, Hunmin ; Kim, Woo Joong ; Shim, Youngkyu ; Kim, Ki Joong ; Cho, Jaeso ; Chae, Jong Hee ; Lim, Byung Chan

OBJECTIVE:

To assess the safety and tolerability of overnight switching from twice-daily oxcarbazepine to once-daily eslicarbazepine acetate (eslicarbazepine) in pediatric patients with focal epilepsy.

METHODS:

Pediatric patients with focal epilepsy (<19 years old) who were switched from oxcarbazepine to eslicarbazepine were recruited through a retrospective review of medical records at three tertiary hospitals. Patient outcomes were evaluated for retention rate, changes in seizure burden, and treatment-emergent adverse effects.

RESULTS:

A total of 60 patients (median age, 15 years; range, 6-18 years) had been switched from oxcarbazepine to eslicarbazepine during the study period. The median initial eslicarbaepine dosage was 13.7 mg/kg/day (range, 7-34 mg/kg/day), with a median oxcarbazepin-to-eslicarbazepine conversion ratio of 0.89 (range, 0.33-1.33). The treatment retention rates for eslicarbazepine were 86.7 % at 3 months, 84.2 % at 6 months, and 78.3 % at 12 months. No significant difference in retention rate was observed when patients were divided into two age groups (<12 years and 12-18 years). During the 1-year follow-up, 10 (16.7 %) patients discontinued eslicarbazepine. Among theses patients, 8 (80 %) reverted to oxcarbazepine-mostly at the first follow-up visit after the transition (median, 2 months). All 13 patients (21.7 %) who transitioned from oxcarbazepine to eslicarbazepine because of oxcarbazepine-related side effects reported resolution of symptoms after the switch.

CONCLUSION:

Overnight switching from oxcarbazepine to eslicarbazepine is well tolerated in pediatric patients with focal epilepsy. Switching to eslicarbazepine is particularly beneficial for patients experiencing oxcarbazepine-related adverse effects.

2025-11-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Effects of dibenzazepine compounds on Nav1.2 channels and neuronal network activity: A systematic comparison

Article

作者: Araki, Kunihiko ; Marku, Griselda ; Opitz, Thoralf ; Schoch, Susanne ; Schwering-Sohnrey, Merlin Felix ; Wenzel, Michael ; Beck, Heinz

Voltage-gated Na⁺ channels are critical therapeutic targets of anti-seizure medications. The anti-seizure medications such as carbamazepine (CBZ), oxcarbazepine (OXC) and eslicarbazepine acetate (ESL) of the dibenzazepine family are structurally similar, but a comparative analysis under identical conditions is lacking. Here, we rigorously compared their effects on biophysical properties of Na_v1.2 Na ⁺ channels and effects on network properties in primary neuron cultures. HEK 293T cells stably expressing human Na_v1.2 channels were employed to assess biophysical profiles using whole-cell patch clamp techniques. Additionally, the impact on neuronal networks in primary cortical neurons was evaluated using microelectrode array recordings. CBZ and OXC exhibited similar effects on voltage-dependent fast inactivation and recovery from inactivation. ESL and its active metabolite S-licarbazepine (S-Lic) also influenced fast inactivation, but their effects were less pronounced than those observed with CBZ. Notably, S-Lic exhibited comparatively small effects on use-dependent block. In these in vitro settings, all compounds had a subtle effect on slow inactivation. With regards to neuronal network activity, CBZ, OXC, and ESL induced substantial changes in spiking, bursting, and synchrony. S-Lic elicited significant and selective effects on network synchrony without effects on other parameters. In conclusion, CBZ, OXC and ESL exhibited similar activity profiles on properties of Na_v1.2 channels and neuronal networks. The structurally similar S-Lic showed significantly less use-dependent blocking effect, and a selective effect on distributed network bursts. These results emphasize that structurally similar dibenzazepine anti-seizure medications can exhibit substantial differences in activity on the ion channel and network level.

项与醋酸艾司利卡西平相关的新闻（医药）

2025-03-28

·医脉通

《新生儿肠外营养管理专家共识（2025）》发布！近期更新重点指南一览~

经常错过自己最关注的指南上新内容？想要及时接收到指南上新提醒？临床指南APP——微信绑定功能即可满足~TIPS：首次完成绑定还可得3天临床指南VIP！>具体方法本周热门指南推荐直接点击即可阅读新生儿肠外营养管理专家共识（2025）肠外营养（parenteral nutrition, PN）已广泛应用于新生儿医学领域，本文对PN 的适应证、应用途径、能量、液体量、营养液组成、停止时机及监测等7 个方面提出24 条推荐意见，旨在为相关从业人员提供PN 管理的建议，以改善新生儿近远期预后。直接点击即可阅读预防性人乳头瘤病毒疫苗中国临床应用指南（2025版）该指南分为人乳头瘤病毒及其流行病学，预防性HPV疫苗，一般人群HPV疫苗接种，高风险、特殊人群HPV疫苗接种，HPV疫苗的安全性，以及注意事项等6个部分，为HPV疫苗的临床应用提供了权威指导。直接点击即可阅读儿童暴发性心肌炎诊治专家建议（2025）本文主要内容包括儿童暴发型心肌炎的诊断标准、鉴别诊断、治疗措施等，以期对儿童暴发性心肌炎的诊治提供依据，提高儿童暴发性心肌炎的救治水平。直接点击即可阅读成人创伤性颅脑损伤院前与急诊诊治中国专家共识创伤性颅脑损伤(TBI)是高死亡率和高致残率的严重损伤，本共识包括TBI 院前和急诊诊治2 个部分，形成24 条推荐意见，以便指导TBI 院前和急诊相关的临床工作。直接点击即可阅读2025 AHA科学声明：血培养阴性心内膜炎与血培养阳性的心内膜炎相比，血培养阴性心内膜炎的预后更差。新的诊断工具已经改变了这种综合征的现状，并可能改善患者的预后。本文提供了血培养阴性心内膜炎的最新情况以协助一线临床医生诊断和管理血培养阴性心内膜炎。直接点击即可阅读消化心身疾病中西医结合诊疗共识意见（2024）消化心身疾病是指心理、社会、环境因素参与消化系统疾病发生、发展、转归全过程的一种心身疾病。本文参照2017 年中国中西医结合学会消化系统疾病专业委员会发布的《消化心身疾病中西医结合整体诊治专家指导意见》 ,组织有关专家进行充分讨论、补充、完善,达成共识,形成《消化心身疾病中西医结合诊疗共识意见》,以期满足临床、教学和科研的需求。直接点击即可阅读2024 JGES指南：非静脉曲张性上消化道出血的管理（第2版）出血性胃十二指肠溃疡是非静脉曲张性上消化道出血的主要原因，内镜下止血是目前非静脉曲张上消化道出血的一线治疗方法。本文主要介绍了非静脉曲张上消化道出血的评估和初始治疗，以及非静脉曲张上消化道出血的内镜止血方法的选择和内镜止血后的处理。直接点击即可阅读阿尔茨海默病疾病修饰治疗专家共识本共识对阿尔茨海默病修饰治疗的适用人群、禁忌及高风险人群、用药前的评估流程、用药方法和周期、药物有效性评估和不良反应监测等临床应用实践及相关研发进展进行了系统梳理并给出17条推荐意见，旨在为阿尔茨海默病疾病修饰治疗的临床应用提供指导。直接点击即可阅读成人患者营养不良诊断与应用指南（2025版）本文涵盖了成人患者营养不良的定义、流行病学、营养风险筛查和多层次营养评估以及诊断的全过程，并针对不同患者群体（如肥胖、危重症患者）提出个性化诊断策略，提出营养不良诊断的规范流程，最终形成27个问题、38条推荐意见，以期提升中国营养不良诊断的实践能力。直接点击即可阅读2025 中国专家共识：钠通道阻滞剂治疗局灶性癫痫（英文版）本文主要针钠通道阻滞剂（SCBs）在局灶性癫痫治疗中的使用提供共识建议。涉及局灶性癫痫患者奥卡西平、拉莫三嗪、拉考沙胺、艾司利卡西平（eslicarbazepine）、托吡酯、唑尼沙胺和苯巴那酯(cenobamate)的治疗建议，并SCB的治疗调整等9项声明达成共识。临床指南app-医问答临床指南app7.3及之后版本新增医问答板块，汇聚临床专业问答知识，扫描下方二维码进入临床指南app，按如下步骤操作，即可参与学习~点点击“阅读原文”，即可查看相关指南内容

AHA会议疫苗

2023-07-10

·BioSpace

Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities

CAMBRIDGE, Mass., July 10, 2023 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets, with topline data for two of its Phase 3 candidates in the fields of psychiatry and urology expected this quarter. The company will apply its proprietary advanced analytics and computational technology platforms to support and accelerate its diverse pipeline and commercial programs as well as needed innovations in priority areas of discovery, science, research and development. SMPA's President and Chief Executive Officer, Myrtle Potter, Chief Executive Officer of Biopharma, Adele Gulfo, and Chief Medical Officer, Armin Szegedi, were appointed as Executive Officers of Sumitomo Pharma Co., Ltd. effective July 1, 2023. Innovation Growth Engine "We are pleased to have successfully completed the combination of Sumitomo Pharma's U.S. subsidiaries to form SMPA," said Hiroshi Nomura, Representative Director, President and Chief Executive Officer of Sumitomo Pharma. "As a Sumitomo Pharma Group growth engine, SMPA will focus on maximizing the value of the three key products early, namely, ORGOVYX®, MYFEMBREE®, and GEMTESA®. SMPA will propel scientific and therapeutic innovations to meaningfully impact the evolving health needs of patients in North America and promote development to meet the needs of patients worldwide while also delivering long-term value to society as a stronger, more profitable enterprise." "SMPA comprises some of the brightest talent in drug development, business, science, and technology, operating as one global team to push beyond industry norms and reimagine what's possible," said Myrtle Potter, President and Chief Executive Officer, Sumitomo Pharma America. "Our goal is to realize new treatments with greater benefit to patients while maximizing the potential of our key marketed and development assets to better support areas of critical need and provide potential treatment options where solutions are lacking or do not exist." Commercial Biopharma Business Adele Gulfo, Chief Executive Officer of Biopharma Commercial of Sumitomo Pharma America, said, "SMPA is poised to help solve health challenges in critical disease areas through the exceptional talents and dedication of our highly experienced cross-functional team. SMPA's broad product portfolio, including key brands, ORGOVYX®, MYFEMBREE® and GEMTESA®, will drive the growth of our business and fuel future potential investments. We are deeply committed to the patients we serve in oncology, women's health, urology, rare disease, psychiatry, and neurology, as well as our additional products APTIOM®, RETHYMIC®, and LATUDA®, which healthcare providers and patients continue to rely on." R&D & Pipeline Armin Szegedi, Chief Medical Officer of Sumitomo Pharma America, said, "SMPA has a robust and balanced pipeline, with more than 30 assets and dozens of clinical trials currently underway, to address areas of significant need in psychiatry, neurology, oncology, urology, and regenerative medicine. I am excited about the opportunities we have at SMPA to develop innovative treatments across multiple therapeutic indications, including our lead pipeline candidate, ulotaront, which is being studied in individuals living with schizophrenia, generalized anxiety disorder and the adjunctive treatment of major depressive disorder." Jatin Shah, Chief Oncology Development Officer of Sumitomo Pharma America, added, "SMPA is uniquely positioned with a strong internal discovery and translational research engine committed to the identification and development of innovative, best-in-class, oncology therapies. We are also looking forward to quickly advancing our oncology programs including, TP-3654, an investigational selective oral PIM1 kinase inhibitor, being studied for patients with myelofibrosis (MF) and DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, being evaluated for the treatment of acute myeloid leukemia (AML)." SMPA's leadership team comprises industry-leading experts with deep life sciences expertise across the business and drug development spectrum, as well as quality & manufacturing, commercialization, and data & analytics. We invite you to learn about SMPA's full leadership team and capabilities on our new website: . About Sumitomo Pharma America, Inc. Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. The company's diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. SMPA leverages proprietary in-house advanced analytics and computational technology platforms to accelerate discovery, research, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma Co., Ltd., company. For more information on SMPA, visit our website or follow us on LinkedIn. About Sumitomo Pharma Co., Ltd. Sumitomo Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries with more than 6,000 employees worldwide. Sumitomo Pharma defines its Mission as "To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide." Additional information about Sumitomo Pharma is available through its corporate website at . Forward-Looking Statements This press release contains forward-looking statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws and Sumitomo Pharma America, Inc. may make related oral, forward-looking statements on or following the date hereof. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Forward-looking statements, by their nature, are subject to a variety of inherent risks and uncertainties that could cause actual results to differ materially from the results projected and reported results should not be considered as an indication of future performance. Many of these risks and uncertainties cannot be controlled by Sumitomo Pharma America, Inc. and you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Sumitomo Pharma America, Inc. as of the date of this communication and speak only as of the date of this communication. Sumitomo Pharma America, Inc. does not assume any obligation to publicly update any forward-looking statements, except as may be required by law. No information contained on any website referenced in this press release is incorporated by reference herein. Sumitomo Pharma America, Inc. is a registered trademark of Sumitomo Pharma Co., Ltd. Sumitomo Pharma America, Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd. © 2023 Sumitomo Pharma America, Inc. All rights reserved. SMPA IR / Media Contact: Maya Frutiger VP, Head of Corporate Communications Sumitomo Pharma America, Inc. CorpComms@us.sumitomo-pharma.com View original content to download multimedia: SOURCE Sumitomo Pharma America, Inc.

高管变更临床3期

2023-02-20

·CPHI制药在线

闲聊2023年度可能获批的重磅仿制药（三）

关注并星标CPHI制药在线系列文章：《闲聊2023年度可能获批的重磅仿制药（一）》《闲聊2023年度可能获批的重磅仿制药（二）》本部分介绍的是以3类仿制药申报的候选首仿药，具体情况依次如下： 01-酒石酸阿福特罗雾化吸入溶液酒石酸阿福特罗雾化吸入溶液一种长效β2受体激动剂，用于治疗慢性阻塞性肺病（COPD）。酒石酸阿福特罗雾化吸入溶液原研厂家为Sunovion制药，商品名为Brovana，该产品最早于2006年获得FDA批准，原研产品暂未进入中国市场销售。公开数据显示，2017年，酒石酸阿福特罗雾化吸入溶液（Brovana）销售额大约为3亿美元。 2021年3月，酒石酸阿福特罗雾化吸入用溶液被国家纳入第2批鼓励仿制药目录，目前国内有正大天晴、江苏长泰药业和江苏和晨药业以仿制药3类申报，正大天晴于2019年11月29日提交酒石酸阿福特罗雾化吸入用溶液申请，是首家进行申报的企业，有望拿下该产品的首仿。（详见图1）图1 酒石酸阿福特罗雾化吸入用溶液注册进展（源自CDE数据库） 02-醋酸艾司利卡西平片醋酸艾司利卡西平是S (+)-利卡西平醋酸酯前药，是现有抗癫痫药物奥卡西平(Trileptal)的活性代谢物，它通过阻断动作电位的传导，以抑制脑神经元的反复异常放电，控制癫痫发作。该药长期给药耐受性好，疗效和安全性较高醋酸艾司利卡西平原研是由Bial-Portela、卫材（Eisai）和日本住友（Dainippon Sumitomo）联合开发，最早于2009年在欧洲获批，商品名为Zebinix。2013年11月Sunovion 公司的醋酸艾司利卡西平在美国获批，商品名为Aptiom，批准其用于局灶性癫痫发作辅助治疗，并在2015年将适应证扩大至局灶性癫痫发作的单一药物治疗。目前醋酸艾司利卡西平片原研在国内未获批上市。据公开数据显示，2019 年该药物全球销售额为 2.75 亿美元。另外2020年4月至2021年3月的12个月,醋酸艾司利卡西平制剂全球销售额为4.4亿美元,同比增长10.3%。 2021年3月醋酸艾司利卡西平片被我国纳入第二批鼓励仿制药品目录中。目前，国内已由多家企业布局艾司利卡西平仿制药市场。北京四环制药是首家仿制申报企业，并在2019年3月以"儿童用药"为由纳入优先审评，但是扬子江药业注册进度后来居上，谁将率先拿下首仿，我们拭目以待。（详见图2）另外，2021年9月22日，上药集团下属控股子公司上海上药中西制药的醋酸艾司利卡西平片ANDA已获得美国FDA的暂时批准。图2 醋酸艾司利卡西平片注册进展（源自CDE数据库） 03-环孢素眼用乳剂环孢素是由11个氨基酸残基组成的环状多肽药物，因其具有优异的免疫抑制效果，最初被用于器官移植后的免疫抑制。环孢素眼用乳剂是一种含有0.05%浓度环孢素的滴眼液，主要用于干燥性角膜结膜炎相关的眼部炎症。环孢素眼用乳剂原研是美国艾尔健公司，2002 年12月，艾尔健公司的环孢素眼用乳剂（商品名：Restasis）上市，是全球首个上市的治疗干眼症的环孢素制剂。目前环孢素眼用乳剂原研在国内未获批上市。据公开数据显示，自Restasis上市后，2003-2016 年销售额复合增速高达32.59%，2016 年实现峰值销售14.88 亿美元，之后Restasis的销售额趋于平稳。近年来随着诺华收购日本武田的干眼症药物Xiidra（Xiidra原本是Shire的重磅眼科药物，2019年1月被武田制药收购），Restasis的市场份额逐渐减少，2020年销售额一路下滑至7.87亿美元。国内环孢素眼用乳剂竞争药企较少，目前只有江西科伦药业提交了环孢素眼用乳剂的仿制药申请，有望斩获该品种国内首仿药。（详见图3）图3 环孢素眼用乳剂注册进展（源自CDE数据库） 04-氨己烯酸片氨己烯酸是一种抗癫痫药，它是GABA氨基转移酶的抑制剂，具有高度的选择性，对耐药性的部分发作型癫痫特别有效，对继发的全面性癫痫发作疗效差。临床上用于治疗其他抗癫痫药无效的癫痫，特别是部分性发作。还可治疗婴儿痉挛症(韦斯特综合征、West综合征)，属于罕见病药物。氨己烯酸最早是由美国Merrell Dow公司研发，1989年首先在英国上市，用于部分性及全身性癫痫发作的治疗，其专利权属于Ovation公司。2009年3月，灵北（H.LundbeckA/S）公司收购了Ovation公司。2009年8月LUNDBECK的氨己烯酸片(商品名：Sabril)以孤儿药身份在美国获批，用于婴儿痉挛症治疗药和成人复杂难治性癫痫部分发作的辅助治疗药。 2000年国内曾有企业申请进口，但最终未获批准。2019年10月，氨己烯酸片入选国家第一批鼓励仿制药品目录。目前只有远大医药（中国）于2019年1月提交了氨己烯酸片的仿制药申请，而且2019年3月以"罕见病"为由纳入优先审评，远大医药有望迎来该品种国内首仿药上市。（详见图4）图4 氨已烯酸片注册进展（源自CDE数据库） 05-奥贝胆酸片奥贝胆酸是法尼酯X核受体（FXR）的强效激动药，其可通过活化法尼醇X受体，间接抑制细胞色素7A1（CYP7A1）的基因表达，增强FGF-19的表达。奥贝胆酸是近20年来首个研发用于治疗PBC的药物，可抑制胆酸合成，用于治疗原发性胆汁性肝硬化（PBC）、非酒精性脂肪性肝病（NASH）、原发性硬化性胆管炎。奥贝胆酸由美国Intercept 制药公司研发，2016年5月，奥贝胆酸获得美国 FDA 批准上市，用于治疗原发性胆汁性肝硬化。2016 年 12 月，奥贝胆酸获得欧盟批准上市，后陆续在加拿大、澳大利亚等国家获批上市。另外奥贝胆酸还于2010年获得欧洲药品管理局孤儿药委员会（COMP）的孤儿药资格认定。自上市以来，奥贝胆酸在全球销售额呈现不断增长态势，获批上市后首年销售额约1800万美元，2018年就达到约1.78亿美元，增长近10倍，2019年奥贝胆酸销售额为2.5亿美元， 2020年奥贝胆酸全球销售额已达到3.1亿美元，同比增长24.8%。目前原研厂家的产品还未在国内上市。国内布局奥贝胆酸片的药企不少，包括正大天晴、江苏恒瑞、上海复旦张江、华润三九、成都倍特、扬子江药业、四川科伦、苏州泽璟生物等，2021年3月，奥贝胆酸入选我国第二批鼓励仿制药品目录。2019年6月，正大天晴药业控股公司南京正大天晴制药按仿制药3类提交的奥贝胆酸片上市申请获得受理，成为国内首家奥贝胆酸申报上市的药企，有望年内获批。（详见图5）图5 奥贝胆酸片注册进展（源自药智网数据库） 06-卡格列净二甲双胍缓释片卡格列净二甲双胍缓释片是一款口服复方降糖药，是由固定剂量卡格列净和缓释二甲双胍组成。这两种复方药在单一片剂中结合了两种机制互补的降糖药，可提供卡格列净及二甲双胍的临床属性。卡格列净是为日服一次的口服糖尿病药物，属于选择性钠葡萄糖共转运体2（SGLT2）抑制剂的一类新药，也是FDA批准的第一个SGLT2抑制剂。该类药物通过阻断肾脏对血糖的重吸收以及增加尿液中血糖的排泄，来降低机体血糖水平。二甲双胍则是2型糖尿病早期治疗时的一线药物，可单独或与其他药物（包括胰岛素）联合用药。卡格列净二甲双胍缓释片原研是强生，2016年9月FDA批准了强生的糖尿病复方新药卡格列净二甲双胍缓释片（Invokamet XR，卡格列净/缓释二甲双胍），结合饮食和运动，用于2型糖尿病成人患者的一线治疗。目前卡格列净二甲双胍缓释片原研在国内未获批上市。乐普药业近几年在降糖药市场加紧布局，口服降糖药单方制剂已获批的产品有阿卡波糖片、磷酸西格列汀片，2021年11月乐普药业首家提交卡格列净二甲双胍缓释片的上市申请，目前该品种暂无其它药企申报，乐普药业有望拿下首仿。（详见图6）图6 卡格列净二甲双胍缓释片注册进展（源自CDE数据库） 07-右兰索拉唑肠溶胶囊右兰索拉唑属于质子泵抑制剂，为兰索拉唑的 R-异构体，通过抑制胃壁细胞酸生成部位的 H+-K+-ATP 酶的活性而抑制胃酸分泌。右兰索拉唑肠溶胶囊原研是武田制药(Takeda Pharma.)北美公司， 2009 年1月首先在美国上市，随后在加拿大批准上市，用于治疗各种程度的糜烂性食管炎、非糜烂性反流性食管炎及相关症状的维持治疗。目前右兰索拉唑肠溶胶囊原研在国内未获批上市。据公开数据显示，2016-2019年，武田制药的右兰索拉唑全球销售额均保持在600亿日元以上，2020年受新冠疫情影响，销售额下滑至556亿日元（约5亿美元）。目前国内有正大天晴药业和江苏豪森药业布局此产品，正大天晴是首家报产。另外，改良型新药注射用右兰索拉唑最早由盛禾(中国)生物制药于2019年首家申报上市，2022年11月30日已获批上市。（详见图7）图7 右兰索拉唑肠溶胶囊注册进展（源自CDE数据库） 08-磷丙替诺福韦片磷丙替诺福韦，与替诺福韦酯同是新型核苷酸类逆转录酶抑制剂，是国外乙肝初始治疗首推药物替诺福韦二吡呋酯（TDF）的升级版，是目前公认的治疗乙肝的优选药物。磷丙替诺福韦是替诺福韦的前体修饰药，在肝细胞中，被分解成为有活性的代谢产物--二磷酸替诺福韦。在保持较高病毒抑制率的情况下，磷丙替诺福韦没有发现耐药性，较替诺福韦能更有效改善骨骼安全性系数，降低骨质疏松症风险，且对肾脏的危害更小。磷丙替诺福韦片（TAF），又称富马酸替诺福韦艾拉酚胺片，由吉利德研发，用以治疗伴有代偿性肝病的慢性乙肝（HBV）感染患者的药物。原研产品于2016年11月10日在美国获批上市（商品名：Vemlidy），随后12月19日于日本上市，2017年1月9日获欧洲EMA批准，成为欧洲近10年来首个获批上市的乙肝新药。2017年10月9日，吉利德在中国提交了磷丙替诺福韦片的上市申请，随后于2017年12月被纳入到CDE优先审评程序。截止目前，原研尚未在国内获批上市。 2018年10月22日，正大天晴以"化药新注册分类3类"提交了磷丙替诺福韦片的上市申请，这是本品首家国产仿制药的上市申请。正大天晴的肝病用药业务，在国内一直处于领先地位，主力产品有恩替卡韦分散片、异甘草酸镁注射液、甘草酸二铵肠溶胶囊、马来酸恩替卡韦片、阿德福韦酯胶囊等。另外还有申报该品种的还有江西青峰药业。这一场首仿争夺之战是仿制与原研进口之战，谁能率先进口上市，谁能争得首仿，对其市场布局都至关重要。（详见图8）图8 磷丙替诺福韦片/富马酸替诺福韦艾拉酚胺片注册进展（源自CDE数据库） 09-司替戊醇干混悬剂司替戊醇（Stiripentol），是一种新型抗癫痫药物，与氯巴占联用于治疗婴儿期严重肌阵挛性癫痫（Dravet 综合征）相关的癫痫发作。司替戊醇原研是法国Biocodex公司，有胶囊和干混悬剂两种剂型， 2001 年司替戊醇因其可用于婴儿严重肌阵挛性癫痫（SMEI）而被欧盟认定为"孤儿药"。随后于 2007 年1月获得欧盟上市授权（商品名：Diacomit），可与氯巴占和丙戊酸盐联合使用，用于婴儿期严重肌阵挛性癫痫（SMEI，Dravet 综合征）的难治性全身性强直性阵挛性癫痫发作的辅助治疗；2018 年8月，司替戊醇获美国 FDA 批准与氯巴占联合治疗 2 岁及以上 Dravet 综合征相关癫痫发作患者。在国内，司替戊醇尚未获批上市。 2022年4月石家庄四药提交了司替戊醇干混悬剂的上市申请，是国内独家申报。司替戊醇干混悬剂是符合儿童生理特征的罕见病药物，主要用于治疗严重肌肉震颤性小儿癫痫，2022年5月司替戊醇干混悬剂上市申请以"符合儿童生理特征的儿童用药品新品种、剂型和规格"为由纳入了CDE的优先审评品种名单。（详见图9）图9 司替戊醇干混悬剂注册进展（源自CDE数据库）说明：本文不构成任何投资建议和价值判断。参考资料： 1-NMPA官网数据库 2-丁香园Insight数据库 3-FDA官网数据库 4-药智网数据库 5-EMA官网数据库 6-米内网数据库作者简介：zhulikou431，高级工程师、PDA会员、ISPE会员、ECA会员、PQRI会员、资深无菌GMP专家，在无菌工艺开发和验证、药品研发和注册、CTD文件撰写和审核、法规审计、国际认证、国际注册、质量体系建设与维护领域，以及无菌检验、环境监控等领域皆具有较深造诣。近几年开始着力关注制药宏观领域趋势分析和制药企业并购项目的风险管理工作。智药研习社3月直播讲座报名智药研习社3月线下研习会报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

优先审批上市批准

100 项与醋酸艾司利卡西平相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09612	醋酸艾司利卡西平	N03AF04	DB09119

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
癫痫	韩国	Whan In Pharmaceutical Co., Ltd.	2020-11-10
癫痫部分性发作	欧盟	BIAL-Portela & Cia SA	2009-04-21
癫痫部分性发作	冰岛	BIAL-Portela & Cia SA	2009-04-21
癫痫部分性发作	列支敦士登	BIAL-Portela & Cia SA	2009-04-21
癫痫部分性发作	挪威	BIAL-Portela & Cia SA	2009-04-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病周围神经性疼痛	临床3期	葡萄牙	BIAL-Portela & Cia SA	2010-11-01
疱疹后神经痛	临床3期	德国	BIAL-Portela & Cia SA	2010-09-01
癫痫的复杂部分性发作	临床3期	美国	Sumitomo Pharma America, Inc.	2008-12-02
癫痫的复杂部分性发作	临床3期	美国	BIAL-Portela & Cia SA	2008-12-02
癫痫的复杂部分性发作	临床3期	阿根廷	BIAL-Portela & Cia SA	2008-12-02
癫痫的复杂部分性发作	临床3期	阿根廷	Sumitomo Pharma America, Inc.	2008-12-02
癫痫的复杂部分性发作	临床3期	比利时	Sumitomo Pharma America, Inc.	2008-12-02
癫痫的复杂部分性发作	临床3期	比利时	BIAL-Portela & Cia SA	2008-12-02
癫痫的复杂部分性发作	临床3期	巴西	Sumitomo Pharma America, Inc.	2008-12-02
癫痫的复杂部分性发作	临床3期	巴西	BIAL-Portela & Cia SA	2008-12-02

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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


NCT06597084 (CTgov)	临床2期	脑卒中 \| 癫痫发作 \| 癫痫 ... 更多	129	ESL 800 mg (Group A)	積遞齋築積構襯廠鏇醖 = 觸廠膚鏇觸窪餘顧選鏇夢鹹膚製淵膚積壓鹽膚 (簾蓋遞夢膚網襯鏇鹽衊, 積醖廠餘簾鏇鹽願蓋膚 ~ 膚蓋繭襯糧廠鬱蓋夢壓) 更多	-	2025-05-02
				Placebo (Group B)	積遞齋築積構襯廠鏇醖 = 網遞餘範餘廠築衊製獵夢鹹膚製淵膚積壓鹽膚 (簾蓋遞夢膚網襯鏇鹽衊, 鬱網鏇範鹹繭築艱觸夢 ~ 鬱淵艱蓋顧遞繭糧蓋蓋) 更多
IEC2023	N/A	-	849	Eslicarbazepine Acetate	壓夢鏇積齋醖構遞鹹鬱(簾鹽築餘獵網遞窪遞糧) = 43 reports 鑰製齋遞鏇觸鏇齋觸遞 (遞鏇鏇顧顧鑰簾壓壓衊 ) 更多	-	2023-09-04
AAN2023	临床3期	癫痫发作	1,447	Eslicarbazepine Acetate 800mg	艱蓋積窪糧餘積範齋鏇(窪鹽觸築願淵鬱觸鑰鹽) = Incidence of AEs and AEs leading to discontinuation increased with ESL dose 襯鬱鏇壓觸網構鹹遞繭 (選醖構廠築鑰顧選範鹹 ) 更多	积极	2023-04-25
				Eslicarbazepine Acetate 1200mg
NCT02484001 (NCT01162460/NCT02484001; EudraCT 2009-011135-13/2015-001243-36, Pubmed \| Ther Adv Neurol Disord)	临床3期	癫痫发作 plasma lipid levels \| total cholesterol \| low-density lipoprotein (LDL) cholesterol	184	Eslicarbazepine acetate (ESL)	憲選淵遞齋廠顧範糧願(網獵艱築製鏇襯繭夢膚) = 鹹鏇窪膚壓範衊壓積壓憲顧遞範製蓋簾鏇網鑰 (壓積選簾鬱憲憲構壓鑰 ) 更多	积极	2023-01-01
				Controlled-release carbamazepine (CBZ-CR)	憲選淵遞齋廠顧範糧願(網獵艱築製鏇襯繭夢膚) = 獵廠窪壓選網鏇遞夢鬱憲顧遞範製蓋簾鏇網鑰 (壓積選簾鬱憲憲構壓鑰 ) 更多
BIA-2093-208 \| BIA-2093-305 (EAN2022)	临床2/3期	癫痫发作	-	Eslicarbazepine acetate	膚醖鏇觸鬱簾觸襯鏇夢(選糧糧蓋糧衊鑰構積夢) = 襯鬱蓋築艱壓蓋觸襯襯衊廠醖顧襯窪鬱簾製獵 (繭簾壓網醖鑰鏇艱鏇繭 ) 更多	积极	2022-06-24
				Placebo	膚醖鏇觸鬱簾觸襯鏇夢(選糧糧蓋糧衊鑰構積夢) = 醖齋窪觸鏇襯餘衊選艱衊廠醖顧襯窪鬱簾製獵 (繭簾壓網醖鑰鏇艱鏇繭 ) 更多
BIA-2093-304 (EAN2021)	N/A	-	496	Eslicarbazepine acetate 800mg/day	糧衊鬱膚艱鏇鑰鑰遞遞(觸齋餘蓋築衊鏇齋鏇醖) = 7.5% in Part II and not reported in Part III 鑰衊構鏇顧獵觸壓遞衊 (鹹夢遞夢鹹淵製鏇積鹽 ) 更多	积极	2021-06-18
				Eslicarbazepine acetate 400-1600mg/day
NCT00957047 \| NCT00957684 \| NCT00988429 (Pubmed \| Epilepsy Res)	临床3期	癫痫部分性发作 \| 癫痫发作	-	eslicarbazepine acetate (Older adults (≥60 years))	鏇獵壓簾鬱醖鏇齋窪憲(襯鹽廠鏇鏇選製憲積襯) = 範範憲淵鹹範簾廠醖積衊鏇製願鹽鹽蓋鬱糧鹹 (蓋網簾願醖膚構顧願襯 ) 更多	-	2021-01-01
				eslicarbazepine acetate (Younger adults (18-59 years))	鏇獵壓簾鬱醖鏇齋窪憲(襯鹽廠鏇鏇選製憲積襯) = 積繭願壓遞積膚夢膚餘衊鏇製願鹽鹽蓋鬱糧鹹 (蓋網簾願醖膚構顧願襯 ) 更多
NCT02484001 (Pubmed) 人工标引	临床3期	癫痫部分性发作	184	eslicarbazepine acetate (ESL/ESL)	鑰窪鬱憲壓築衊糧衊鬱(糧繭範鏇選齋獵鏇繭鬱) = 遞餘鏇蓋鏇觸鬱顧壓網鹹壓顧選獵選淵襯觸鹹 (觸壓鬱蓋積鹽餘範鑰獵, 0.0292 ~ 0.1366) 更多	积极	2020-10-01
				controlled-release carbamazepine+eslicarbazepine acetate (CBZ-CR/ESL)	鑰窪鬱憲壓築衊糧衊鬱(糧繭範鏇選齋獵鏇繭鬱) = 鹽餘壓餘積糧夢艱蓋選鹹壓顧選獵選淵襯觸鹹 (觸壓鬱蓋積鹽餘範鑰獵, 0.0180 ~ 0.1210) 更多
NCT03116828 (1585, CTgov)	临床4期	癫痫部分性发作	102	eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 1))	餘艱鹹鑰鹹壓蓋鑰窪願 = 顧衊膚願鏇衊膚遞鹽範廠獵製齋簾鬱壓繭積構 (齋蓋壓糧醖齋鑰範簾顧, 繭衊範窪餘膚繭膚構糧 ~ 鏇鏇壓膚鏇齋鏇壓鏇鏇)	-	2020-06-16
				eslicarbazepine acetate (Eslicarbazepine Acetate (Arm 2))	餘艱鹹鑰鹹壓蓋鑰窪願 = 淵鹹鹽積鑰壓築壓膚構廠獵製齋簾鬱壓繭積構 (齋蓋壓糧醖齋鑰範簾顧, 齋鏇壓糧簾觸齋鏇餘淵 ~ 窪鬱憲衊觸製遞餘願繭)
NCT03116828 (1585, AAN2020)	临床4期	癫痫发作	102	Eslicarbazepine Acetate as first adjunctive therapy with Levetiracetam	鹹選憲壓製繭壓網範蓋(繭淵窪網鬱製願構艱淵) = 淵窪艱淵窪願繭顧壓獵襯膚壓網艱積夢網窪窪 (膚顧衊願鬱蓋膚鏇衊艱 ) 更多	积极	2020-04-14
				Eslicarbazepine Acetate as later adjunctive therapy	鹹選憲壓製繭壓網範蓋(繭淵窪網鬱製願構艱淵) = 蓋廠壓憲鏇糧齋襯觸淵襯膚壓網艱積夢網窪窪 (膚顧衊願鬱蓋膚鏇衊艱 ) 更多