预约演示

更新于：2026-09-09

Fentanyl

芬太尼

更新于：2026-09-09

概要

基本信息

简介芬太尼是一种合成阿片类药物，非常有效地用于治疗严重的疼痛，特别是癌症患者。它通过结合中枢神经系统中的阿片受体来产生镇痛作用。芬太尼有多种剂型，包括贴片、含片和注射溶液。但由于其强效性，芬太尼具有高度的成瘾性、呼吸抑制和过量的风险。因此，它在美国被归类为II级受控物质。目前的研究重点是开发更安全和更有效的芬太尼给药途径，如抗滥用制剂和新颖的给药途径。

药物类型

小分子化药

别名

AeroLEF、AVERSA Fentanyl、Fentany Transdermal System

+ [39]

靶点

Opioid receptors

作用方式

激动剂

作用机制

Opioid receptors激动剂(阿片样受体激动剂)

治疗领域

神经系统疾病其他疾病肿瘤

在研适应症

癌症疼痛疼痛肝转移+ [5]

非在研适应症

急性疼痛晚期癌症突出痛+ [11]

原研机构

Janssen Global Services LLC

在研机构

Medrx Co., Ltd.

Nutriband, Inc.Janssen-Cilag Pty Ltd.

+ [7]

非在研机构

Janssen Pharmaceuticals, Inc.

Janssen Pharmaceutica NV

INSYS Therapeutics, Inc.

+ [5]

权益机构

Terumo Corp. /Hemodialyzer Marketing Operations/

Nutriband, Inc.

Kindeva Drug Delivery LP

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (1990-08-07),

通气不足术后疼痛

最高研发阶段(中国)临床2期

特殊审评-

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结构/序列

分子式C22H28N2O

InChIKeyPJMPHNIQZUBGLI-UHFFFAOYSA-N

CAS号437-38-7

关联

782

项与芬太尼相关的临床试验

CTRI/2026/05/109969

/ Not yet recruitingN/AIIT

Incidence, risk factors and pattern of distribution of pruritis in patients receiving intrathecal fentanyl vs intrathecal buprenorphine as an adjuvant to spinal anaesthesia with bupivacaine - a prospective observational study - NIL

开始日期2027-04-08

申办/合作机构-

NCT07748884

/ Not yet recruiting临床4期IIT

A Comparative Study on the Incidence of Respiratory Adverse Events Between Esketamine Combined With Remazolam and Traditional Propofol in Pediatric Gastroscopy

Gastroscopy is important for diagnosing and treating upper gastrointestinal diseases in children. To ensure the procedure is safe and smooth, most children require sedation. Compared to adults, children have more fragile airways, lower lung capacity, and poorer oxygen reserves, making them more prone to breathing difficulties and low oxygen levels during sedation.
Esketamine, a stronger form of ketamine, helps maintain heart rate and blood pressure and may reduce breathing-related risks. Remimazolam, a new short-acting sedative, acts quickly, allows faster recovery, and has a better safety profile than propofol-it doesn't cause breathing problems or injection pain.
The safety and effectiveness of combining remimazolam with esketamine for pediatric gastroscopy have not been well studied. This research will compare this new combination with the traditional propofol-based approach to evaluate its potential benefits and safety in children.

开始日期2026-08-01

申办/合作机构

温州医科大学附属第二医院（温州医科大学附属育英儿童医院）

ACTRN12621000850875

/ Not yet recruiting临床4期IIT

The effect of fentanyl co-administration on sneezing during nasal local anaesthetic injection for adults undergoing plastic surgery under propofol-based intravenous sedation: Randomised-Controlled Blinded Trial

开始日期2026-07-01

申办/合作机构

Portland District Health

[+1]

100 项与芬太尼相关的临床结果

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100 项与芬太尼相关的转化医学

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100 项与芬太尼相关的专利（医药）

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24,954

项与芬太尼相关的文献（医药）

2026-12-31·Canadian Journal of Pain-Revue Canadienne de la Douleur

A Survey of Knowledge, Attitudes, and Behaviours of Canadian Family Physicians in Response to the Canadian Guideline on Prescribing Opioids for Chronic Non-cancer Pain

Article

作者: Selby, Peter ; Mian, Najam ; Hatcher, Lydia ; Bootsman, Nicole ; Saberian, Lillian ; Dale, Craig M ; Parmar, Nagina ; Lau, Jenny ; Carol, Angela ; Sud, Abhimanyu ; Furlan, Andrea D

Background:

Chronic non-cancer pain (CNCP) is widespread in Canada, with Family Physicians (FPs) playing a crucial role in patient care and opioid stewardship amidst high prescribing rates. Two national surveys conducted in 2010 and 2018 revealed notable knowledge gaps and poor adherence to safe opioid prescribing practices among Canadian FPs.

Aims:

To provide an update on Canadian FPs' knowledge, attitudes, and behavior regarding opioid prescribing for CNCP.

Methods:

This study is the third national cross-sectional online survey of Canadian FPs. The results are presented narratively, and only descriptive statistics are offered.

Results:

A total of 529 responses were collected from July 2023 to June 2024, primarily from female participants (52%) and Ontario (50%). Eighteen percent of respondents did not prescribe opioids for CNCP, and 17% prescribed only weak opioids. Wait time for a pain specialist and for a non-urgent referral to an addiction specialist were less than one month among 23% and 25% of respondents, respectively. Only 27% of respondents were able to correctly identify the minimum daily dose of morphine equivalents to start prescribing a transdermal fentanyl patch. Respondents' adherence to recommended practices before starting opioids varied from 16% for "providing written information about opioid therapy" to 93% for "explaining potential harms of long-term opioid therapy."

Conclusion:

Several knowledge gaps and a lack of adherence to certain guideline-recommended practices were observed among respondents, along with reduced wait times for consultations with pain specialists.

2026-12-31·Journal of Maternal-Fetal & Neonatal Medicine

Exploration of the relationship between miR-146a rs2910164 polymorphisms and the efficacy of epidural fentanyl in labor analgesia among pregnant women

Article

作者: Liu, Jie ; Wang, Bei ; Shen, Yiyi

BACKGROUND:

miR-146a influences an individual's pain sensitivity through the regulation of inflammation-related pathways, and its genetic polymorphism may play a role in labor analgesia.

OBJECTIVES:

This study aimed to investigate the impact of the miR-146a rs2910164 polymorphism on the efficacy of epidural fentanyl in labor analgesia.

MATERIALS AND METHODS:

In this study, a total of 142 primiparas who received epidural fentanyl analgesia were enrolled. Genotyping was conducted using the SNPscan^™ Kit, and the miR-146a expression was measured by RT-qPCR. The 24-hour Visual Analogue Scale (VAS) score was utilized as an indicator to assess analgesic efficacy, and a logistic regression was employed to analyze the association between different genotypes and the effectiveness of pain relief.

RESULTS:

At the rs2910164 locus, the miR-146a expression in individuals with the CC genotype was significantly lower than that in those with the GG and GC genotypes, whereas no significant difference was observed between the GG and GC genotypes. Regarding clinical characteristics, the 24-hour VAS pain score was significantly higher in the CC genotype group compared to the GG and GC genotype groups. When the GG and GC genotypes were combined and compared against the CC genotype, the difference in VAS scores remained statistically significant. Logistic regression analysis revealed a significant association between the rs2910164 polymorphism and the 24-hour VAS score (OR = 3.189, 95% CI: 1.142-8.901, p = 0.027).

CONCLUSION:

The CC genotype at the rs2910164 locus served as an independent risk factor associated with decreased efficacy of epidural fentanyl analgesia. However, further validation in larger multicenter studies is required before any clinical application can be considered.

2026-12-31·Global Public Health

Sanctioning the supply chain: Analyzing US executive orders on tariffs as a tool against the fentanyl crisis

Article

作者: Bastos, Francisco I. ; Brogim, Gabriela

This commentary examines the use of trade tariffs embedded in U.S. executive orders issued during the Trump administration as a strategy to address the fentanyl crisis. The key issue is whether it will be effective to curb the opioid epidemic or would rather mean more of the same. By combining quantitative classification of executive orders with exploratory discourse analysis, the article demonstrates that fentanyl is predominantly framed as a problem of trade, border security, and economic coercion rather than as a public health challenge. Our findings indicate a strong overlap between fentanyl-related orders and tariff measures, revealing a policy logic that prioritizes supply-side control through international economic pressure. The paper argues that this approach reflects a continuity of the U.S. war on drugs under a new trade-centered rhetoric, raising concerns about its effectiveness and potential risks for health systems, medical supply chains, and evidence-based public health responses.

975

项与芬太尼相关的新闻（医药）

2026-09-08

·BioSpace

Nutriband Receives USPTO Notice of Publication of Commercial Brand Name Trademarks for Its Abuse Deterrent Fentanyl Patch

Nutriband has received a Notice of Publication from the United States Patent and Trademark Office (USPTO) for commercial brand name trademarks for its lead product, an abuse deterrent fentanyl transdermal system. Once allowed, Nutriband plans to submit its commercial worldwide brand name to the FDA and other international regulatory agencies for approval. ORLANDO, Fla., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has received a Notice of Publication from the United States Patent and Trademark Office (USPTO) dated September 2, 2026 for commercial brand name trademarks for its lead product, an abuse deterrent fentanyl transdermal system. Trademarks will be published in the USPTO Trademark Official Gazette. If no objections are filed during the 30-day opposition period, the USPTO is expected to issue a Notice of Allowance. Nutriband intends to secure full intellectual property rights for its commercial brand names in the United States and internationally. The proposed brand name and product labeling will be submitted to the FDA and other international regulatory agencies for review and approval. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Nutriband’s fentanyl transdermal system is based on its AVERSA™ abuse deterrent transdermal technology and has the potential to be the world’s first abuse-deterrent patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl. Nutriband’s abuse deterrent fentanyl transdermal system has the potential to reach peak annual US sales of $80 million to $200 million. 1 While initially concentrating on the US market, the unmet medical need for adequate pain management is a global problem, and the product is in development for all major medical markets worldwide. Nutriband’s AVERSA™ abuse-deterrent technology is utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. __________________________________________________________________________ 1 Health Advances Aversa Fentanyl market analysis report 2022 ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); About AVERSA™ Abuse-Deterrent Transdermal Technology Nutriband's AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety pro transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia. About Nutriband, Inc. We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); The Company's website is . Any material contained in or derived from the Company's websites or any other website is not part of this press release. Forward-Looking Statements Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes," "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof. Nutriband is a registered trademark of Nutriband, Inc. AVERSA is a trademark of Nutriband, Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); Brand Institute and Drug Safety Institute are registered trademarks of Brand Institute, Inc. Contact Information : Nutriband Inc. Phone: 407-377-6695 Email: info@nutriband.com SOURCE: Nutriband Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(135); });

2026-09-07

·微信

41款进口药退出中国

近日，国家药监局发布公告，依据《中华人民共和国药品管理法实施条例》《药品注册管理办法》的有关规定，正式决定注销氯雷他定片等80个药品注册证书。 01 注销药品概况本次注销的80个药品注册证书，覆盖临床多个治疗领域与剂型，其中41款被注销药品为进口药，占比超五成，国内药企则以老药、普药注销为主。从企业维度看，多家跨国药企均有产品退出。例如，默克公司（Merck Sharp&Dohme LLC）注销了4个规格的甲型肝炎灭活疫苗；强生旗下杨森（Janssen-Cilag NV）注销了6个规格的芬太尼透皮贴剂；勃林格殷格翰则注销了6个规格的二甲双胍恩格列净片。此外，辉瑞的注射用盐酸多柔比星（抗肿瘤化疗药）、磷酸雌莫司汀胶囊，诺华的格隆溴铵吸入粉雾剂（呼吸系统用药），拜耳的利伐沙班干混悬剂（抗凝药）也均在注销名单中。国内药企方面，江苏恒瑞、海南双成、特一药业、金陵药业等企业也有药品注销，品种多为上市多年的老药、普药。例如，太仓制药厂一次性注销了11个品种，包括异烟肼片、复方利血平片等基础药物；海南双成药业集中注销了7个注射剂，涵盖注射用盐酸克林霉素和注射用肌苷多个规格；恒瑞医药注销了酒石酸长春瑞滨软胶囊。从治疗领域来看，注销药品覆盖范围广泛，其中抗感染、抗肿瘤和心血管代谢类疾病药物占比较高。抗感染类包括异烟肼片、注射用盐酸克林霉素等老药；抗肿瘤类有酒石酸长春瑞滨软胶囊、注射用盐酸多柔比星等常用化疗药；心血管与代谢类涵盖吲达帕胺片（降压）、二甲双胍恩格列净片（降糖复方制剂）、利伐沙班干混悬剂（抗凝）等。其中二甲双胍恩格列净片涉及6个规格，均由勃林格殷格翰申请注销。从剂型角度分析，片剂与注射剂两类剂型的合计占比超过六成，是注销品种中的主要类别。片剂共有25个，包括氯雷他定片、异烟肼片（太仓制药厂注销100mg和300mg两种规格）等；注射剂共30个，涵盖注射用盐酸多柔比星（抗肿瘤）、盐酸左氧氟沙星氯化钠注射液（抗感染）、利司那肽注射液（降糖）等。此外，滴眼液、乳膏剂、栓剂（如美沙拉秦栓）、贴剂（如芬太尼透皮贴剂）等局部用药，以及甲型肝炎灭活疫苗、注射用重组人II型肿瘤坏死因子受体-抗体融合蛋白（治疗类风湿关节炎）等生物制品，也均在注销名单中。 02 依申请注销，是唯一原因根据国家药监局公告及注销药品目录，80个药品均为“依申请注销”，即由药品上市许可持有人主动向监管部门提出申请，而非因安全性问题被强制退市。医药行业的竞争力源于创新，当新型药品在疗效、安全性、便利性上形成优势，老药自然缺乏竞争力。以此次注销品种为例，抗感染领域的注射用盐酸克林霉素虽为常用抗生素，但近年来新型β-内酰胺类抗生素（如头孢他啶阿维巴坦）在抗菌谱、耐药性上更具优势，临床使用占比持续提升，导致老药市场需求下滑。降糖领域的利司那肽注射液（每日一次给药），则因司美格鲁肽、替尔泊肽等长效GLP-1药物（一周一次给药、兼具减重效果）的普及而被挤压市场空间，此次赛诺菲申请注销其6个规格，正是产品迭代的直接体现。这种“新替旧”的逻辑，是医药行业持续进步的必然结果。药品作为特殊商品，其生产与销售始终受到成本、利润与市场需求的影响。在医药市场竞争日趋激烈的背景下，企业倾向于将有限资源集中于核心产品，因此会主动注销销量低、利润薄或不符合战略方向的产品。本次注销名单中，不少品种属于市场竞争极度激烈的普药、仿制药，如肌苷片、维生素B2片等，由于这类产品利润微薄，生产厂家众多，价格战激烈，对企业而言，注销此类品种，有助于将资源转移到高价值药或优势专科药上，这是应对市场竞争的理性选择。归根结底，无论是产品迭代、资源优化还是战略调整，这些药品被注销的根本原因在于——不赚钱了。 03 外企撤退的背后 7月1日，国家药监局发布公告，宣布注销56个药品的注册证书。值得关注的是，在注销名单中，外资企业的产品超过30个，占比过半，涉及辉瑞、诺华、葛兰素史克、勃林格殷格翰等多家知名药企旗下的部分原研药。这些退市产品大多为专利已到期或面临仿制药激烈竞争的成熟品种。例如，辉瑞的利奈唑胺葡萄糖注射液、诺华的依维莫司片等，均因在国家集采中中标价格大幅下降（部分降幅超过80%），难以维持原有利润空间，最终选择退出。 8月，市场再度传出消息，赛诺菲中国正在调整其心血管领域的市场策略和产品管线，旗下重点降脂药波立达（阿利西尤单抗）将停止在中国市场的推广，并逐步退出。退出原因主要有两方面：一是2025版《中国国家医保药品目录》中纳入了更多国产PCSK9抑制剂，使得胆固醇管理治疗选择更加多元；二是受到全球原料供应紧张的影响，该药物在中国市场的供应也面临挑战。对外资企业而言，全球产品战略调整是申请注销药品或者退出市场的一个重要原因。部分产品因在全球市场中不再是战略重点，或已有新一代替代品上市，企业会选择从某些区域市场退出，以集中资源深耕核心领域。本次注销涉及41个进口药，背后折射出外资企业进口药或者原研药退出中国市场的三大现实因素：其一，集采政策的影响。集采政策通过“以量换价”模式对药品利润进行压缩，部分未参与或未中选的产品其市场布局面临调整，这也推动了外资企业对现有产品组合的评估与调整。其二，药企低价竞争。在氯雷他定等专利过期药品领域，国内仿制药企凭借价格优势占据市场，外企因运营成本高难以参与价格战，不得不退出激烈竞争的“红海”。其三，企业战略转向。面对激烈的仿制药竞争，越来越多外企选择将资源转向创新药领域，主动退出低利润、高竞争的普通药品市场。 04 结语国家药监局此次批量注销80个药品注册证书，主要是淘汰那些市场竞争力弱的产品，进而优化临床上的用药结构。对医药企业而言，聚焦创新研发、契合临床未满足的需求等等是在激烈的竞争中实现可持续发展的关键。附表：注销药品注册证书目录资料来源：国家药监局信息来源：药智网往期推荐 ! 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。喜欢的点个“看一看”和"喜欢"吧不然微信推送规则改变，有可能每天都会错过我们哦~

疫苗申请上市

2026-09-06

·Jeff5886

二类改良型新药立项报告——2.1 / 2.2 / 2.3 / 2.4 各品类产品方向深度分析

▶ 报告日期：2026年9月6日 ▶ 编制目的：为企业改良型新药研发立项提供系统性方向建议一、背景与政策概述根据2020年版《药品注册管理办法》及配套文件，二类改良型新药是指对已上市药品进行优化改造，具备明显临床优势的药品，具体分为四个亚类：类别定义核心优势 2.1 含有已知活性成分的新适应症拓展治疗领域 2.2 含有已知活性成分的新剂型（含新给药系统）改善依从性/疗效/安全性 2.3 含有已知活性成分的新复方制剂协同增效/简化治疗 2.4 含有已知活性成分的新规格精准给药/差异化政策驱动因素： • 国家鼓励改良型新药，因其研发风险低于一类创新药，周期相对可控• 仿制药集采压力下，企业向高附加值改良型新药转型是必然路径• 改良型新药享有新药监测期，保护期内市场独占• 2.2类（特殊剂型）在部分地区享有优先审评政策二、2.1类——新适应症方向2.1.1 定义与立项逻辑对已上市活性成分开发新的治疗适应症，利用已有的人体安全性数据，通过桥接试验或探索性临床即可上市，研发成本约为新分子的1/5～1/3。 2.1.2 推荐方向（按治疗领域细分）已有药物潜在新适应症备注阿帕替尼胃癌伴腹水、胸腺癌抗血管生成通路跨适应症贝伐珠单抗生物类似物卵巢癌、输卵管癌、原发性腹膜癌参照原研适应症扩展路径卡瑞利珠单抗鼻咽癌、肝癌辅助治疗 PD-1/L1跨适应症是热点仑伐替尼分化型甲状腺癌、肾癌联合方案扩展多靶点TKI跨适应症奥拉帕利胰腺癌、HRD+泛癌种 PARP抑制剂跨适应症成熟度伐利尤单抗小细胞肺癌巩固治疗、膀胱癌新辅助 ICI巩固治疗模式已有药物潜在新适应症备注二甲双胍多囊卵巢综合征（PCOS）、非酒精性脂肪肝（NASH/MASH）、抗衰老最具潜力超适应症 GLP-1受体激动剂（司美格鲁肽、利拉鲁肽） NASH/MASH、酒精性肝病、心衰、CKD 代谢通路全局调节 SGLT-2抑制剂（达格列净、恩格列净）心衰（不论EF值）、CKD（不合并糖尿病）心肾保护已成标配度拉糖肽肥胖症（已有FDA批准，国内尚未报批）国内GLP-1减重赛道火热已有药物潜在新适应症备注达比加群酯/利伐沙班癌症相关VTE、外科手术围术期预防 DOAC适应症持续扩展重组人组织型纤溶酶原激酶衍生物（rt-PA）扩展时间窗（9h内）、醒后卒中再灌注时间窗扩展丁苯酞血管性痴呆、轻度认知障碍神经血管单元保护机制银杏内酯突发性耳聋（已有证据，可系统化开发）微循环改善跨学科应用已有药物潜在新适应症备注托珠单抗系统性硬化症（SSc-ILD）、Castleman病 IL-6通路多病种阿达木单抗化脓性汗腺炎、葡萄膜炎 TNF-α抑制剂适应症扩展巴瑞替尼重症斑秃（已有）、系统性红斑狼疮（SLE） JAK抑制剂跨适应症度普利尤单抗嗜酸性食管炎（EoE）、慢阻肺（COPD）2型炎症型度普利尤已有中国数据已有药物潜在新适应症备注恩曲他滨/丙酚替诺福韦（FTC/TAF） HBV母婴阻断暴露后预防抗病毒跨适应症干扰素α 血液病骨髓增殖性肿瘤（PMF、PV）抗病毒→免疫调节跨域羟甲香豆素新冠后遗症（Long COVID）、RSV预防老药新用，国内有初步数据已有药物潜在新适应症备注普瑞巴林纤维肌痛综合征、外周神经病理性疼痛扩展神经痛跨亚型伏硫西汀糖尿病周围神经痛、创伤后应激障碍（PTSD）抗抑郁药跨适应症右美托咪定术后谵妄预防、新生儿镇静 α2激动剂ICU应用扩展金诺芬帕金森病左旋多巴相关异动症金属离子的神经保护潜力 2.1.3 2.1类立项策略建议优先选择：已有充分安全性数据且新适应症存在明确未被满足需求的药物开发策略：采用"适应性设计+篮式试验"，一个临床方案覆盖多个潜在适应症风险提示：需关注原研厂家专利布局，避免侵权；部分适应症已有竞品布局三、2.2类——新剂型（含新给药系统）方向2.2.1 定义与立项逻辑开发新的剂型或给药系统，使药物在安全性、有效性、便利性方面具有明显优势。2.2类是近年最活跃的改良型新药赛道，缓控释、透皮、长效注射、吸入制剂是四大主流方向。 2.2.2 推荐方向（按剂型/技术平台细分）原药现有问题改良方向临床优势左氧氟沙星半衰期短，每日多次左氧氟沙星缓释片（每日一次）依从性提升，峰谷波动减小盐酸羟考酮癌痛患者吞咽困难缓释口腔崩解片无水吞服，适合吞咽障碍患者盐酸哌甲酯作用时间不足，ADHD症状覆盖不全盐酸哌甲酯缓释口服混悬液儿童友好，剂量调整灵活普拉克索每日多次，早晨延迟开普拉克索缓释片（晨起单次）改善"剂末现象" 文拉法辛停药综合征明显文拉法辛肠溶缓释双释控释片降低停药反应碳酸锂治疗窗窄，血药浓度波动大碳酸锂缓释制剂血药更平稳，减少中毒风险原药适应症改良方向市场前景吡非尼酮特发性肺纤维化透皮贴剂减少口服胃肠道反应东莨菪碱术后恶心呕吐、晕动症透皮贴剂（已有）、新规格扩展 OTC市场潜力罗匹尼罗帕金森病透皮贴剂（7天贴）长效持续给药，减少血药波动卡巴拉汀阿尔茨海默病透皮贴剂（已有一日贴）改善口服顺应性，减少恶心雌二醇/炔雌醇更年期激素替代透皮凝胶/贴剂规避肝脏首过效应奥昔布宁膀胱过度活动症透皮贴剂减少抗胆碱能中枢副作用克利哌啶醇精神分裂症透皮贴剂（长效）每月一贴，提高依从性原药适应症改良方向目标人群利培酮精神分裂症棕榈酸帕利哌酮注射液（1月/3月）口服依从性差的患者奥氮平精神分裂症奥氮平长效注射剂（2周/4周）院外维持治疗亮丙瑞林前列腺癌、子宫内膜异位症醋酸亮丙瑞林微球（1月/3月/6月） GnRH脉冲调节曲普瑞林性早熟、子宫肌瘤曲普瑞林缓释微球 GnRH激动剂系列艾塞那肽 2型糖尿病艾塞那肽微球（周制剂）已有周制剂，开发更长周期生长激素矮小症聚乙二醇化重组人生长激素（rhGH）减少注射频率至每月阿立哌唑精神分裂症阿立哌唑长效注射剂（月制剂）精神分裂症维持治疗原药适应症改良方向技术壁垒沙丁胺醇哮喘急性发作吸入气雾剂（新型助推剂/HFA替代CFC）环保型助推剂布地奈德/福莫特罗哮喘、COPD 软雾吸入剂（DPI干粉/Respimat）肺部沉积率优化噻托溴铵 COPD 干粉吸入剂（新装置）简化操作维拉脲酶 α-1抗胰蛋白酶缺乏症吸入型酶替代疗法靶向肺部胰岛素糖尿病吸入胰岛素（Exubera模式借鉴）已有失败案例，需技术突破原药改良方向临床优势咪达唑仑口腔黏膜贴片/含片癫痫发作急性终止、儿童术前镇静曲安奈德口腔黏膜炎缓释贴片局部缓释，减少全身暴露硝酸甘油口腔崩解片心绞痛快速起效氯硝西泮口腔崩解片癫痫丛集发作塞来昔布口腔崩解片急性疼痛快速起效原药改良方向目标适应症溴芬酸钠眼用凝胶（防腐剂优化）术后炎症拉坦前列素眼用纳米乳/原位凝胶青光眼，减少给药频率环孢素眼用乳剂（Restasis型）、纳米胶束干眼病曲安奈德眼内注射缓释植入物（玻璃体）视网膜疾病（已有Ozurdex）技术平台适用药物改良目标 pH敏感型结肠靶向制剂蛋白/多肽类药物（胰岛素、GLP-1类似物口服化）口服多肽纳米晶体技术难溶性药物（泊沙康唑、维莫非尼）提高生物利用度热熔挤出（HME）技术青少年/儿童制剂改善适口性和剂量准确性 3D打印制剂个体化剂量药物精准医疗微针经皮给药疫苗、胰岛素、疫苗无痛给药 2.2.3 2.2类立项策略建议4.优先关注：微球/PLGA长效注射、透皮贴剂、吸入制剂——技术壁垒高、竞争格局好、定价能力强5.特殊关注：儿童专用制剂（政策鼓励+市场需求双驱动），含特殊辅料（氧化锌、离子交换树脂）制剂6.技术合作：2.2类对制剂工艺要求极高，建议与药学CRO深度绑定，或收购有成熟制剂平台的企业7.差异化重点：不仅做"剂型转换"，要在临床终点上体现明显优势（疗效相当但安全性更优，或依从性显著改善）四、2.3类——新复方制剂方向4.3.1 定义与立项逻辑将两种或以上已知活性成分组合成复方制剂，发挥协同作用、减少各自用量、简化治疗方案。复方制剂具有明确的临床依从性优势和固定剂量组合的疗效协同价值。 4.3.2 推荐方向（按治疗领域细分）组分组合适应症改良逻辑备注阿司匹林+氯吡格雷冠心病/卒中二级预防抗血小板双靶点（已有波立维）进一步开发固定剂量片氨氯地平+培哚普利高血压钙通道阻滞+ACEI协同降压，抵消反射性心动过速已有百安适奥美沙坦酯+氨氯地平高血压 ARB+CCB复方，血管扩张协同已有复方缬沙坦+沙库巴曲心衰（HFrEF） ARNI已单独成药，探索单片复方诺欣妥是核心品种依那普利+叶酸 H型高血压伴高Hcy ACEI+叶酸降低同型半胱氨酸已有依那普利叶酸片（依叶片）阿托伐他汀+氨氯地平冠心病合并高血压+高血脂降压+降脂双管理已有复方利伐沙班+阿司匹林冠脉疾病/外周动脉疾病抗凝+抗血小板已有Xa因子抑制剂+抗血小板复方氢氯噻嗪+螺内酯难治性高血压、心衰保钾利尿剂联合已有组分组合适应症改良逻辑二甲双胍+达格列净 2型糖尿病二甲双胍+SGLT2i，机制互补二甲双胍+西格列汀 2型糖尿病二甲双胍+DPP-4i，低血糖风险低二甲双胍+吡格列酮 2型糖尿病伴胰岛素抵抗二甲双胍+TZDs，针对性解决IR GLP-1RA+胰岛素 2型糖尿病基础胰岛素+GLP-1RA复合制剂（已有iDegLira）非奈利酮+二甲双胍糖尿病肾病 MR antagonist + 二甲双胍卡格列净+恩格列净家族复方糖尿病+心衰多种SGLT2i组合阿格列汀+二甲双胍 2型糖尿病 DPP-4i+二甲双胍（已有）组分组合适应症改良逻辑恩曲他滨+丙酚替诺福韦（FTC/TAF） HIV暴露前预防（PrEP）双核苷酸反转录酶抑制剂联合多西环素+伊维菌素多种寄生虫/立克次体感染抗菌+抗寄生虫协同阿奇霉素+硫酸沙利度胺贝赫切特综合征（白塞病）抗菌+免疫调节（老药新用）替诺福韦+恩曲他滨+多替拉韦 HIV完整治疗方案三合一单片制剂利福平+异烟肼+吡嗪酰胺（固定剂量）结核病短程化疗已有FDC，优化规格组分组合适应症改良逻辑左氧氟沙星+利福平脓胸/复杂性胸腔感染（辅助）抗菌+抗炎氟哌啶醇+劳拉西泮急性精神兴奋激越抗精神病+苯二氮䓬联合帕利哌酮+棕榈酸帕利哌酮精神分裂症（诱导+维持）口服+注射序贯复方策略拉莫三嗪+丙戊酸钠难治性癫痫抗癫痫药双靶点联合舍曲林+丁螺环酮抑郁症伴焦虑 SSRI+5-HT1A部分激动普拉克索+雷沙吉兰帕金森病运动症状+非运动症状多巴胺激动剂+MAO-Bi 组分组合适应症改良逻辑对乙酰氨基酚+曲马多中重度疼痛非阿片+弱阿片协同（已有）布洛芬+对乙酰氨基酚发热/中轻度疼痛 NSAIDs+对乙酰氨基酚（已有多种）羟考酮+纳洛酮慢性疼痛伴便秘阿片+抗便秘副作用地塞米松+利多卡因（外用）局部镇痛抗炎糖皮质激素+局麻复方芬太尼+咪达唑仑麻醉诱导阿片+镇静组分组合适应症改良逻辑沙美特罗+氟替卡松哮喘/COPD（已有信必可） LABA+ICS经典组合布地奈德+福莫特罗哮喘（已有信必可都保） ICS+LABA 噻托溴铵+奥达特罗 COPD LAMA+LABA（双支气管扩张）格隆溴铵+茚达特罗 COPD LAMA+LABA 沙丁胺醇+异丙托溴铵急性哮喘/COPD急性发作 SABA+SAMA（雾化经典复方） 4.3.3 2.3类立项策略建议8.黄金赛道：心脑血管复方（单片复方 SPC 是全球趋势，国内渗透率仍低）9.政策优势：慢病管理要求"简化方案"，复方制剂顺应分级诊疗需求10.专利布局：关注原研复方专利到期时间（HTN/HIV/HCV复方有大量机会）11.注意风险：两药复方需各自有明确剂量依据，安全性叠加需充分评估五、2.4类——新规格方向5.1 定义与立项逻辑对已上市药物开发新规格，以满足特殊人群（儿童、老年人）、剂量调整需求或差异化竞争需求。新规格看似简单，但需有充分的临床依据。 5.2 推荐方向原药现有规格问题新规格方向政策背景氯苯那敏只有成人片剂（4mg）开发0.5mg/1mg小儿糖浆/滴剂儿童用药政策布洛芬混悬液浓度不统一，家长给药困难统一100mg/5mL，补充低剂量滴剂儿童专用规格泼尼松龙无儿童专用规格开发1mg/2mg小规格片剂儿童激素规范使用孟鲁司特钠 4mg/5mg/10mg（已有）补充0.5mg/1mg更低规格极低龄婴幼儿左氧氟沙星口服无儿童规格开发50mg/100mg儿童咀嚼片氟喹诺酮儿童使用政策放开阿奇霉素干混悬剂 0.1g/袋开发更低剂量0.05g/袋儿科用药规格细化维生素D3滴剂规格单一开发400IU/800IU/1000IU分规格营养素补充剂氨溴索口服溶液成人浓度开发儿童专用低浓度规格儿科祛痰原药新规格方向理由华法林增加0.5mg/1.5mg等分规格精准剂量滴定，治疗窗窄地高辛开发0.0625mg（1/16片）规格心衰老年患者低剂量需求左甲状腺素钠开发极低剂量（12.5mcg）甲状腺癌抑制治疗分层普伐他汀开发10mg小规格老年人肝功能不全低剂量起始培哚普利开发1mg低剂量规格老年高血压/心衰低剂量起始螺内酯开发12.5mg规格心衰起始低剂量（循证医学支持）原药新规格方向理由阿司匹林开发25mg肠溶片心血管预防不同剂量分层二甲双胍开发500mg以下规格（250mg）胃肠道耐受性改善舍曲林开发12.5mg/25mg低规格抑郁症起始治疗低剂量滴定普瑞巴林开发25mg极低规格神经痛起始滴定奥氮平开发1mg/2.5mg规格精神分裂症个体化剂量原药新规格方向理由重组人胰岛素开发300IU/mL高浓度（已有）减少注射体积贝伐珠单抗开发100mg/400mg小规格精准给药，减少浪费曲妥珠单抗开发150mg小规格灵活给药重组人凝血因子VIII 开发250IU/500IU/1000IU系列血友病A按体重精准给药顺铂注射液开发小规格（10mg）精准化疗剂量地塞米松磷酸钠开发2mg/5mg小规格雾化/局部用药精准剂量 5.3 2.4类立项策略建议12.儿童专用规格：政策最支持，进入优先审评审批通道概率高，是当前最值得投入的方向13.规格开发应以临床方案驱动：必须有对应的患者群和剂量调整依据，不是简单拆分14.与2.2类联动：很多新剂型（如缓释片）本身也涉及新规格，可组合申报六、综合立项策略建议6.1 优先级矩阵优先级类别具体方向理由 ⭐⭐⭐⭐⭐ 2.2 GLP-1类长效注射（减重/NASH方向）市场巨大，技术壁垒高 ⭐⭐⭐⭐⭐ 2.2 微球/PLGA长效注射（精神/肿瘤）竞争格局好，定价能力强 ⭐⭐⭐⭐ 2.1 二甲双胍+GLP-1新适应症（NASH/MASH/PCOS）超适应症潜力巨大 ⭐⭐⭐⭐ 2.3 心血管SPC复方（降压+降脂+抗板三联）慢病管理金矿 ⭐⭐⭐⭐ 2.4 儿童专用制剂（口服液、混悬液）政策红利+临床急需 ⭐⭐⭐ 2.2 透皮贴剂（老年/精神科用药）技术壁垒+OTC渠道 ⭐⭐⭐ 2.1 度伐利尤单抗新适应症（广泛期SCLC巩固）已有数据支撑 ⭐⭐⭐ 2.3 糖尿病复方（二甲双胍+SGLT2i/DPP-4i）血糖管理主流方向 ⭐⭐⭐ 2.2 吸入制剂（COPD/哮喘生物制剂）高门槛，市场稳定 6.2 企业能力匹配建议企业类型推荐优先方向传统仿制药企业（转型期） 2.4儿童规格 + 2.3慢病复方（门槛相对低，政策支持）具备制剂平台的企业 2.2微球/透皮/缓释（技术护城河）有研发实力的药企 2.1新适应症 + 2.3创新复方生物药企业 2.2长效注射（多肽/抗体）+ 2.1生物药新适应症有国际化意愿的企业参考FDA 505(b)(2)路径中美双报 6.3 立项决策关键问题15. 该品种的原研专利保护期还剩多久？（侵权风险）16. 该品种国内仿制药竞争格局如何？（改良是否有差异化优势）17. 目标适应症是否存在明确的未被满足临床需求？（能否通过桥接试验快速上市）18. 企业是否具备对应的制剂平台或合作伙伴？19. 预估研发投入与市场回报比是否合理？七、附录：近年政策动态汇总政策文件关键内容对二类改良型新药影响《药品注册管理办法》（2020）正式确立二类改良型新药地位分类明确，路径清晰《化学药品注册分类及申报资料要求》明确2.1-2.4定义与技术要求申报规范统一《儿童用药（化学药品）药学开发指导原则》儿童用药规格开发要求直接利好2.4类儿童规格《以临床价值为导向的抗肿瘤药物临床研发指导原则》要求临床优势 2.1类新适应症需证明优效性优先审评审批政策改良型新药可进入优先通道审评周期缩短专利补偿制度改良型新药可申请专利期补偿延长市场独占本报告为企业内部立项参考，具体品种选择需结合企业战略、现有产品线、研发能力和市场渠道综合评估。建议正式立项前开展详细的技术可行性分析和市场调研。

优先审批临床研究临床结果上市批准

100 项与芬太尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00320	芬太尼	N02AB03 N01AH01	DB00813

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
癌症疼痛	日本	Janssen Pharmaceutical KK	2011-02-01
疼痛	澳大利亚	Janssen-Cilag Pty Ltd.	2005-11-23
急性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
慢性疼痛	美国	Janssen Pharmaceuticals, Inc.	2005-02-04
通气不足	美国	Janssen Pharmaceuticals, Inc.	1990-08-07
术后疼痛	美国	Janssen Pharmaceuticals, Inc.	1990-08-07

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
粘膜炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
实体瘤	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
口腔炎	临床3期	美国	INSYS Therapeutics, Inc.	2009-10-01
腰痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
骨关节炎	临床3期	日本	Janssen Pharmaceuticals, Inc.	2009-01-01
复杂性局部疼痛综合征	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疱疹后神经痛	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
疼痛障碍	临床3期	日本	Janssen Pharmaceuticals, Inc.	2008-12-01
肿瘤	临床3期	加拿大	INSYS Therapeutics, Inc.	2007-12-01
肿瘤	临床3期	印度	INSYS Therapeutics, Inc.	2007-12-01

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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


NCT03434678 (CTgov)	临床3期	胰腺癌	133	Open Pancreaticoduodenectomy+Propofol+Fentanyl Inhalational Agent+Rocuronium+Bupivacaine (Epidural-General Anesthesia)	齋鹹鏇構鹹積蓋廠獵構 = 廠構夢衊簾艱糧積壓觸衊繭壓鏇遞膚構壓築鏇 (鬱壓範鏇築願壓衊獵襯, 獵壓夢齋繭簾膚憲鹽衊 ~ 願鑰願襯齋夢窪醖選艱) 更多	-	2025-07-30
				Open Pancreaticoduodenectomy+Propofol+Fentanyl+Rocuronium (General Anesthesia)	齋鹹鏇構鹹積蓋廠獵構 = 淵製膚製鏇觸廠淵獵餘衊繭壓鏇遞膚構壓築鏇 (鬱壓範鏇築願壓衊獵襯, 窪範構願獵選衊餘膚衊 ~ 窪築簾鹽糧艱蓋淵壓範) 更多
ASH2024	N/A	急性疼痛 \| 镰状细胞血症	-	Intranasal Fentanyl (INF)	願簾遞衊淵蓋醖淵鏇鬱(餘憲壓醖糧顧糧壓願廠) = 7 (18%) of visits 選願觸簾糧鏇遞製鹽膚 (蓋夢願鑰餘膚糧襯願淵 ) 更多	-	2024-12-08
NCT05244226 (CTgov)	临床2期	阻塞性睡眠呼吸暂停综合征 \| 扁桃体炎 \| 操作性疼痛	66	Hydromorphone+Fentanyl	積簾壓糧餘膚積淵襯蓋(膚艱齋艱鬱製築蓋顧積) = 願壓鬱醖積膚壓壓齋鬱鏇範艱蓋餘艱壓衊願憲 (構觸淵餘範憲齋淵糧夢, 醖顧範窪觸積願顧製艱 ~ 網願餘艱鹹憲顧範繭壓) 更多	-	2024-10-17
NCT05209906 (Pubmed \| BMC Palliat Care)	N/A	突出痛	30	Fentanyl Buccal Soluble Film (FBSF)	網壓構膚衊獵窪遞壓製(鹹築鑰鏇願構醖壓選鏇) = Only grade 1/2 adverse events were reported, including somnolence, malaise, and dizziness 鹹繭窪窪鹽蓋膚鏇製鹽 (簾窪鏇襯窪廠鹹壓餘壓 )	积极	2024-06-14
NCT05531422 (Pubmed \| ASCO2024)	临床2期	癌症疼痛	59	AZ003	廠艱願鹽觸糧觸顧齋觸(顧壓衊繭鹽遞鹹醖餘繭) = 鹽觸鬱夢蓋鹽廠選觸簾鏇獵齋觸遞淵膚積餘積 (積淵願夢淵蓋遞選鑰獵 ) 更多	积极	2024-05-24
				安慰剂	廠艱願鹽觸糧觸顧齋觸(顧壓衊繭鹽遞鹹醖餘繭) = 壓範簾廠遞窪鹹顧淵願鏇獵齋觸遞淵膚積餘積 (積淵願夢淵蓋遞選鑰獵 ) 更多
NCT03872700 (CTgov)	临床3期	脓肿	49	Intranasal fentanyl (Intranasal Fentanyl)	艱廠醖夢簾壓餘鑰淵糧(顧艱衊簾廠鏇範觸觸製) = 襯壓餘鹹鑰鏇製窪遞願鬱壓餘簾壓壓壓艱網網 (鏇蓋憲顧夢膚餘壓齋餘, 1.5) 更多	-	2023-08-15
				Placebo (Placebo)	艱廠醖夢簾壓餘鑰淵糧(顧艱衊簾廠鏇範觸觸製) = 鏇鏇醖齋鹽簾餘構簾鹹鬱壓餘簾壓壓壓艱網網 (鏇蓋憲顧夢膚餘壓齋餘, 2.9) 更多
ICML2023	N/A	18 FDG	-	Fentanyl pre-treatment	醖築膚鏇壓鬱構觸糧製(鹽遞範繭艱蓋齋鹹構選) = 窪襯衊壓選獵餘衊築艱遞鑰壓醖獵蓋齋鏇選觸 (淵夢製選築衊遞選遞網 )	积极	2023-06-09
				No fentanyl pre-treatment	醖築膚鏇壓鬱構觸糧製(鹽遞範繭艱蓋齋鹹構選) = 網艱蓋繭繭鏇壓鏇蓋窪遞鑰壓醖獵蓋齋鏇選觸 (淵夢製選築衊遞選遞網 )
NCT00580489 (CTgov)	N/A	疼痛 \| 药物不良反应	204	fentanyl+morphine (Arm C Morphine)	淵積壓積艱膚齋糧範鹽 = 選壓壓製選夢醖簾選鬱鹹積製膚膚繭廠網獵憲 (齋網築齋繭獵鹹憲願繭, 顧膚築製網齋壓簾醖網 ~ 夢網觸鹹壓構醖鑰憲淵)	-	2022-08-16
				fentanyl+morphine (Arm D Fentanyl)	淵積壓積艱膚齋糧範鹽 = 獵觸獵網膚膚廠鑰糧餘鹹積製膚膚繭廠網獵憲 (齋網築齋繭獵鹹憲願繭, 衊遞夢繭鬱壓構顧衊淵 ~ 鏇觸鏇壓遞製鹹製構壓)
NCT03792191 (CTgov)	N/A	麻醉 \| 肥胖	280	Lumbar Spinal Ultrasonography+Intrathecal Fentanyl+Intrathecal Bupivacaine (Ultrasonography)	衊獵壓鹹糧鬱鹹構衊夢(衊繭窪築築窪遞糧網窪) = 遞壓構製鬱齋選鹹齋範鑰鬱選鏇鹽選膚淵衊壓 (願鏇選製窪遞觸鬱鬱齋, 築蓋築鏇鹽鹽衊築顧艱 ~ 醖艱廠壓膚選選壓蓋繭) 更多	-	2021-05-24
				Conventional Landmark Palpation+Intrathecal Fentanyl+Intrathecal Bupivacaine (Palpation)	衊獵壓鹹糧鬱鹹構衊夢(衊繭窪築築窪遞糧網窪) = 淵遞糧窪襯窪憲醖構憲鑰鬱選鏇鹽選膚淵衊壓 (願鏇選製窪遞觸鬱鬱齋, 鹽醖壓糧觸糧廠廠觸膚 ~ 蓋糧願獵襯網築壓壓鏇) 更多
NCT02514252 (CTgov)	临床2期	突出痛 \| 晚期癌症	6	Study Diary+Fentanyl	壓鏇鏇構蓋選築襯糧繭(壓淵獵糧築鹹齋積餘選) = 廠鬱壓襯膚遞網鹹觸繭膚襯簾淵鹽選鹹築鏇築 (衊選選夢廠艱範鹹衊構, 鏇繭淵壓遞願築衊願夢 ~ 製餘夢遞淵衊鏇遞夢願) 更多	-	2021-05-18