Safety and Efficacy Trial of Mass Drug Administration With Moxidectin Versus Ivermectin in Combination With Diethylcarbamazine and Albendazole for Lymphatic Filariasis, Scabies, and Strongyloidiasis in Fiji

The goal of this clinical trial is to learn if mass drug administration with moxidectin in combination with diethylcarbamazine, and albendazole (MoxDA) can treat lymphatic filariasis, scabies and strongyloidiasis in children and adults living in communities where these diseases are common. The main questions it aims to answer are:
1. Does MoxDA clear infection in people with lymphatic filariasis ?
2. Does MoxDA cause any medical problems in infected and uninfected people?
Researchers will compare MoxDA with ivermectin given together with diethylcarbamazine and albendazole (IDA) to see if it works better to clear infection and does not cause any more medical problems.
Participants will:
1. Be tested to see if they are infected with the parasites that cause lymphatic filariasis, scabies and strongyloidiasis
2. Take 3 single doses of MoxDA or IDA, 12 months apart
3. Visit their village centre once or twice in the 1 week after each treatment for safety checkups

开始日期2026-03-01

申办/合作机构

Medicines Development for Global Health Ltd

[+2]

NCT07145736

/ Recruiting临床4期

Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases: A Cluster-randomised Trial

This clinical trial compares two treatments - ivermectin and moxidectin - to learn which is better at reducing the proportion of people with onchocerciasis (river blindness) when given through mass drug administration (MDA) in Angola. Both drugs are approved by the United States Food and Drug Administration (FDA) to treat this disease. The study also explores how these treatments affect other infections common in the region, including intestinal worms (soil-transmitted helminths) and scabies.
The trial aims to answer the following key questions:
* How do moxidectin and ivermectin compare in reducing the prevalence (how common the disease is) and intensity (amount of parasites per person) of onchocerciasis in the community?
* Do the treatments differ in their effect on the prevalence and intensity of soil-transmitted helminths and the prevalence of scabies?
* Does moxidectin reduce transmission of onchocerciasis more effectively than ivermectin, based on genetic testing of parasites in people and lab testing of the blackflies that carry the infection?
* How many more years of treatment would be needed to reach elimination with each drug, based on mathematical disease modelling?
* How do communities feel about receiving moxidectin versus ivermectin, and what factors help or make it harder to carry out MDA programs with moxidectin versus ivermectin?
The study takes place in Bié Province, Angola, and involves 20 groups of villages randomly assigned to receive either moxidectin or ivermectin once a year for four years. Prior to every round of MDA, researchers will collect skin, stool and blood samples from a sample of the people living in the study area. We believe the results will help guide global policy on the use of moxidectin in efforts to eliminate onchocerciasis and control related diseases.

开始日期2025-08-04

申办/合作机构

Kirby Institute

[+9]

100 项与莫昔克丁相关的临床结果

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100 项与莫昔克丁相关的转化医学

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100 项与莫昔克丁相关的专利（医药）

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项与莫昔克丁相关的文献（医药）

2026-04-01·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Rapid and sensitive detection of moxidectin and fluralaner in wombat skin

Article

作者: Stott, Eliza ; Doran, Gregory S

Sarcoptic mange in wombats is caused by the scabies mite (Sarcoptes scabiei) and is treated with antiparatsitic pour-ons used in cattle and companion animals, such as moxidectin and fluralaner. These treatments are applied topically by pouring the chemical along the back of infected animals, allowing the active ingredient to be absorbed by the skin and then entering the blood stream. While blood is most commonly analysed to investigate absorption and metabolism of these pesticides, analysis of skin is essential to understanding their potential bioaccumulation. Wombat skin is used as a defence mechanism and is much thicker than most animals. No method appears to be available that describes how to disrupt and extract wombat skin for analysis of moxidectin and fluralaner. A 5 mm biopsy punch was used to sample skin harvested from a deceased roadkill wombat. Several approaches were tested to disrupt skin tissue to allow the simultaneous extraction and analysis of moxidectin and fluralaner. The optimal approach was to pulp and extract skin in acetone using an Ultra-Turrax. This approach effectively overcame the mechanical strength of the thick skin, and efficiently extracted both chemicals due to their high acetone solubilities. As the two processes occurred simultaneously in the same vessel, the likelihood of sample loss and cross contamination was dramatically reduced. Moxidectin and fluralaner recoveries from wombat skin were 101 ± 3.7% and 120 ± 2.8%, respectively, over the range of 1-80 ng/g when using their respective internal standard. The limit of quantitation for each chemical was 1 ng/g using a 50 mg skin sample, but the moxidectin limit of quantitation is likely to be lower, but was limited in the current study by a low moxidectin background in the harvested skin used for spike recoveries. The extraction and analysis approach reported in this study is rapid and efficient, and is only limited by having to analyse moxidectin and fluralaner separately due to the need for different optimal MS conditions for each analyte. The method resulted in the simultaneous recovery of both moxidectin and fluralaner in the same extraction process, making screening of a large number of samples highly efficient.

2026-03-09·AMERICAN JOURNAL OF VETERINARY RESEARCH

Validation of a flow cytometric competitive efflux assay for assessing clinically important drugs as canine P-glycoprotein substrates

Article

作者: Mealey, Katrina L. ; Burke, Neal S.

Abstract:

Objective:

Because dogs with P-glycoprotein (P-gp) deficiency experience enhanced susceptibility to adverse reactions caused by P-gp substrate drugs, this study’s purpose was to validate and employ a competitive efflux assay to assess clinically relevant drugs as P-gp substrates.

Methods:

A competitive efflux assay employing a cell line expressing canine P-gp was used in these studies. Intracellular fluorescence was detected flow cytometrically following the coincubation of experimental drugs with 2 intrinsically fluorescent P-gp substrates (rhodamine 123 or calcein AM) that bind different sites within the P-gp binding pocket. The fluorescence intensity was determined for cells treated with each experimental drug and fluorescent P-gp substrate combination and compared to the fluorescence intensity of cells treated with rhodamine 123 and calcein AM alone. Additionally, assay validation parameters were assessed.

Results:

Mean fluorescence intensity (MFI) ratios < 2 indicate non–P-gp substrates [cisplatin (negative control), ropinirole, doxycycline, and trilostane]; MFI ratios from 2 to 5 indicate weak canine P-gp substrates (apomorphine, capromorelin, and enrofloxacin); MFI ratios > 5 but < 10 indicate moderate P-gp substrates (trazodone); and MFI ratios > 10 indicate strong P-gp substrates [loperamide (positive control), and moxidectin]. Assay specificity, precision, and linearity were within established acceptance criteria.

Conclusions:

Several clinically relevant drugs were identified as P-gp substrates. The competitive efflux assay is a useful tool for screening drugs as canine P-gp substrates.

Clinical Relevance:

These results imply that P-gp–deficient dogs may be at increased risk of adverse effects if treated with apomorphine, capromorelin, enrofloxacin, or moxidectin, depending on the dose administered.

2026-03-01·ENVIRONMENTAL RESEARCH

Independent impacts of co-formulants contained in anthelmintic formulations on seed germination of grassland species

Article

作者: García, Andrés ; Jaß, Scarlett ; Eichberg, Carsten ; Donath, Tobias W ; Laber, Lars

Agrochemicals have been shown to affect non-target organisms and are often applied as mixtures of active ingredient and co-formulants. Although there is evidence that co-formulants play a role in these effects, their contribution has hardly been studied. Therefore, we studied effects of co-formulants on seed germination (percentage, time, synchrony) using a common anthelmintic formulation. The seeds of four species of temperate grasslands (Achillea ptarmica, Agrostis capillaris, Dianthus deltoides, Plantago lanceolata) were exposed to a commercial moxidectin formulation at a concentration of 10 mg l^-1 as well as three of its co-formulants: benzyl alcohol (BA), butylated hydroxytoluene (BHT) and disodium ethylenediamine tetraacetic acid (EDTA-Na₂). Results showed that the tested anthelmintic formulation as a whole and two of its co-formulants (BA, BHT) as individual substances significantly impacted germination behaviour of the test species. Formulation, BA and BHT significantly reduced germination percentage in all species compared to the control, with BA exerting the strongest effect (reduction up to 99 %). The same three treatments significantly increased mean germination time in all species by a factor of two to four. Germination synchrony showed a weaker response and was only affected in two species (A. capillaris, D. deltoides) and only by BHT (reduction of 49 % and 60 %, respectively). The strong effects of BA and BHT on seed germination suggest that their contribution to effects of anthelmintic formulations is at least partly due to an independent impact. Therefore, co-formulants should be given greater consideration both in the design of ecotoxicological experiments and in environmental risk assessments.

项与莫昔克丁相关的新闻（医药）

2026-03-25

·AI读财报

丽珠集团（000513）财报分析报告

丽珠集团（000513）财报分析报告报告日期：2026-03-251. 公司与业务一句话定位丽珠集团是一家以化学制剂为核心利润来源、原料药为稳定现金流基础的综合性医药集团，在消化道、辅助生殖和精神神经三个细分领域拥有强势产品组合，正从仿制药企业向创新药+国际化方向转型。主营业务构成根据2025年年报，公司营业收入120.20亿元，100%来自医药制造业。按产品线拆分：产品线收入（亿元）收入占比毛利率同比变化化学制剂 62.22 51.76% 81.06% +1.67% 原料药及中间体 31.17 25.93% 34.84% -4.23% 中药制剂 16.74 13.92% 74.82% +18.81% 诊断试剂及设备 6.57 5.46% 57.22% -8.56% 生物制品 2.01 1.67% 60.81% +17.50% 化学制剂是公司核心利润引擎：虽然收入占比约52%，但81%的毛利率意味着其贡献了绝大部分毛利润。原料药收入占26%，但毛利率仅35%，在利润贡献上远低于收入占比。中药制剂是近两年增长较快的板块，2025年收入同比增长18.81%，主要受参芪扶正注射液医保癌种解限和品牌渗透驱动。按地区划分：境内收入99.67亿元（83%），境外收入19.30亿元（16%），境外收入同比增长11.97%。境内毛利率69.74%，境外毛利率48.27%，境外业务以低毛利的原料药出口为主。产品/服务详解化学制剂（核心）覆盖三个主要治疗领域： • 消化道（收入25.20亿元，占营收21%）：核心产品为艾普拉唑系列（壹丽安），包括艾普拉唑肠溶片和注射用艾普拉唑钠，属于质子泵抑制剂（PPI）；枸橼酸铋钾系列（丽珠得乐）用于幽门螺杆菌治疗。消化道收入近年受集采和医保谈判降价影响，2024年同比下降11.60%，2025年继续微降1.81%。 • 促性激素/辅助生殖（收入29.04亿元，占营收24%）：核心产品为注射用醋酸亮丙瑞林微球（贝依），此外还有注射用尿促卵泡素（丽申宝）、注射用尿促性素（乐宝得）等。该板块保持稳定增长，2025年同比增长3.25%。 • 精神产品（收入6.28亿元，占营收5%）：马来酸氟伏沙明片（瑞必乐）、盐酸哌罗匹隆片（康尔汀）等。2025年同比增长3.54%。原料药及中间体：主要产品包括万古霉素、替考拉宁、达托霉素等高端抗生素原料药，米尔贝肟、莫昔克丁等宠物驱虫药原料，以及美伐他汀、阿卡波糖等中间体。出口占原料药收入约60%，规范市场（欧美）销售占比稳步提升，与全球多家头部药企建立长期战略合作。中药制剂：参芪扶正注射液（肿瘤辅助治疗）和抗病毒颗粒为两大拳头产品。参芪扶正受益于医保癌种解限持续放量，抗病毒颗粒2023年因流感高基数后2024年回落，2025年恢复增长。诊断试剂及设备：主要产品包括肺炎支原体检测、HIV诊断试剂盒、自免检测试剂等。2025年收入同比下降8.56%。生物制品：目前收入规模较小（2.01亿元），包括托珠单抗注射液等。2023年因新冠疫苗相关收入下滑严重（毛利率一度为-21.51%），2024-2025年恢复正增长。商业模式公司收入确认以经销为主（71%），直销为辅（29%）。经销模式毛利率78%，直销模式毛利率35%——直销主要对应原料药出口业务（向海外药企直接销售），经销对应境内制剂通过医药分销商进入医院和零售渠道。前五大客户合计占销售收入8.48%，单一客户最高占比仅2.03%，客户集中度很低。前五大供应商合计占采购额30.64%，第一名供应商焦作健康元（健康元全资子公司）占12.38%，为关联交易——健康元是丽珠集团的控股股东（持股24.93%），实际控制人均为朱保国。现金流特征：公司经营现金流持续为正且高于净利润。2025年经营活动现金流净额31.45亿元，净利润24.11亿元，收现比优良。大量货币资金（93亿元）中约18.65亿元受限（主要为越南IMP股权收购保证金），其余部分通过结构性存款进行现金管理。客户与供应商客户高度分散，前五大客户合计占比逐年在8-9%之间，无重大客户依赖风险。供应商方面，第一大供应商为关联方焦作健康元，采购占比约12%，主要提供原材料。需关注的是，关联供应商占比虽不算极高，但健康元同时作为控股股东和主要供应商的双重角色值得留意。业务演进与战略方向近3-4年，丽珠集团的战略重心发生了明显转变： 1. 从仿制药向创新药转型：2023年公司大幅优化研发管线，砍掉普通仿制、缺乏市场竞争优势的在研项目，集中资源推进创新药和高壁垒复杂制剂。研发投入从2022年的14.27亿元下降到2025年的9.38亿元（费用化部分），但资本化研发支出从0.37亿增至1.44亿，资本化率从3.51%升至13.67%，说明管线正从早期研究阶段向后期临床/注册阶段推进。 2. 国际化从”产品出口”到”体系出海”：境外收入从2021年的15.39亿元增长至2025年的19.30亿元，占比从12.75%提升至16.06%。2025年启动收购越南上市药企IMP，是公司国际化的标志性事件——从单纯出口升级为海外本土化运营。同时在印尼建设原料药工厂，在巴西设立办事处。 3. 微球技术平台成为核心差异化资产：注射用阿立哌唑微球2025年获批上市，注射用醋酸曲普瑞林微球已覆盖多个适应症，注射用醋酸亮丙瑞林微球3个月剂型在申报中。微球类长效制剂技术壁垒高，竞争者少，是公司最具辨识度的竞争力。 4. 向控股子公司丽珠生物增资（2024年增资10亿元，持股比例从61.66%提升至66.54%），加码生物药。莱康奇塔单抗（IL-17A/F双靶点）、司美格鲁肽注射液是近期最重要的在研品种。 2. 行业分析行业概况丽珠集团所处的医药制造业是中国战略性产业。根据2025年年报引用的国家统计局数据，2025年全国规模以上医药制造企业实现营业收入24,870亿元（同比下降1.2%），利润总额3,490亿元（同比增长2.7%）。行业呈现”营收端承压、利润端率先回暖”的特征，说明行业内部正在发生结构性分化——高附加值产品（创新药、高端制剂）的盈利贡献在提升，而同质化产品的收入在缩水。 2024年数据显示行业更为低迷：营收25,298.5亿元（同比持平），利润总额3,420.7亿元（同比下降1.1%），这意味着2025年利润端已经开始恢复。行业驱动因素需求端：医药行业具有刚需属性，人口老龄化和慢性病负担增加构成长期需求支撑。辅助生殖领域受生育政策放开和生育意愿下降的矛盾影响，技术辅助需求持续增长。精神神经疾病的社会关注度和诊疗率逐年提升。供给端/政策：近年来对行业影响最大的政策因素包括： - 药品集采：已进行十一批，平均降价超50%，对仿制药企业形成持续挤压。丽珠的注射用伏立康唑、雷贝拉唑钠肠溶胶囊等已被纳入集采。 - 医保谈判：创新药和独家品种通过谈判进入医保，以价换量。注射用艾普拉唑钠经历了医保谈判降价。 - DRG/DIP支付改革：按病种付费推动临床用药向成本效益比高的产品倾斜，但同时为创新药设置了特例单议机制。 - 反腐合规：2023年全国医药领域反腐集中整治，2025年《医药企业防范商业贿赂风险合规指引》发布，推动营销模式从”带金销售”向学术推广转型。技术演进：AI+制药正在成为行业新趋势，从靶点发现、分子设计到临床试验运营均有应用场景。微球等复杂制剂技术壁垒较高，全球范围内具备产业化能力的企业有限。生物药（单克隆抗体、重组蛋白）和GLP-1类药物（以司美格鲁肽为代表）是当前资本和研发投入最密集的方向。竞争格局丽珠集团在2025年度中国医药工业百强榜中排名第27位。公司在多个细分领域的市场地位： - 消化道领域：艾普拉唑为公司独家品种，但面临集采压力和P-CAB新一代产品（如公司自己在研的JP-1366）的迭代威胁。 - 辅助生殖领域：注射用醋酸亮丙瑞林微球（贝依）在国内GnRH类长效制剂中占据重要地位。 - 精神神经领域：注射用阿立哌唑微球为国内首款上市品种，差异化优势明显。 - 原料药：高端抗生素（万古霉素、替考拉宁、达托霉素）全球市场占有率领先，宠物驱虫药（米尔贝肟）与国际动保巨头深度合作。竞争格局的核心特征是：传统仿制药领域竞争加剧（集采驱动），创新药和高壁垒复杂制剂领域竞争者较少但研发投入门槛高。丽珠的定位介于传统仿制药企业和纯创新药企业之间——既有成熟产品提供现金流，又有创新管线储备。行业趋势 1. 集采和医保谈判持续推进，仿制药利润空间将进一步压缩，行业集中度提升，缺乏创新能力和成本优势的中小企业加速出清。 2. 创新药审评审批加速（30日临床试验审评通道），从研发到上市的周期缩短。 3. 海外市场成为中国药企新的增长极，东南亚、南美等新兴市场是制剂出海的主要目标区域。 4. 生物药和GLP-1类药物竞争白热化，司美格鲁肽仿制药/生物类似药将在未来两年密集上市。 5. AI制药从概念进入落地阶段，在药物发现、临床运营等环节开始显现效率提升。本行业分析框架基于以上行业特性，后续章节应重点关注： • 核心竞争力：（1）微球等长效制剂的技术壁垒和产业化能力——这是区分丽珠和普通仿制药企的关键；（2）研发管线的质量和推进节奏——决定未来3-5年增长的可持续性；（3）国际化体系的实质进展——从概念到真实收入贡献的距离。 • 财务关键指标：（1）研发费用率和研发资本化率的变化——反映管线成熟度和管理层对研发投入的态度；（2）销售费用率趋势——反映营销模式转型的进展和效率；（3）经营现金流/净利润比率——验证盈利质量。 • 重点风险类型：（1）集采和医保谈判对存量产品的持续价格侵蚀；（2）在研创新药的临床和审批风险；（3）国际化扩张（尤其是越南IMP收购）的整合和执行风险。 3. 核心竞争力微球技术平台与长效制剂产业化能力丽珠拥有中国第一个国家级缓释微球技术平台，这是公司最具辨识度的技术资产。微球制剂的核心技术难点在于突释控制、释放周期稳定性和规模化生产——全球范围内具备成熟产业化能力的企业屈指可数。已上市微球产品： - 注射用醋酸亮丙瑞林微球（1个月剂型，贝依）：全球首个按照FDA个药指南完成生物等效性研究获批的GnRH类长效制剂。 - 注射用醋酸曲普瑞林微球：2023年获批（前列腺癌），2024年新增子宫内膜异位症适应症，中枢性性早熟适应症III期临床已完成入组。 - 注射用阿立哌唑微球：2025年4月获批，国内首款、全球首个自主研发的阿立哌唑长效微球制剂，当年即纳入医保目录和《中国精神分裂症防治指南》。在研微球管线：注射用醋酸亮丙瑞林微球（3M）已申报上市，注射用醋酸丙氨瑞林微球处于II期临床，注射用布瑞哌唑微球已申报临床。微球技术的战略价值在于：（1）技术壁垒高，仿制难度大，竞争者进入需要5-10年；（2）长效制剂在精神科和肿瘤科具有显著的患者依从性优势，临床推广有天然需求；（3）微球平台可以复用于多个药物分子，形成”平台×分子”的矩阵扩张模式。截至2025年底，公司累计拥有991项国内外有效授权专利（其中发明专利523项），专利覆盖新药分子结构、制备工艺、晶型、制剂配方等核心环节，专利授权率保持80%以上。研发管线的深度与推进节奏截至报告披露日，公司制剂在研项目40个，其中：上市申报阶段12项、III期临床4项、II期临床6项。近期最具商业潜力的在研品种： 1. 莱康奇塔单抗注射液（IL-17A/F双靶点）：国内首个、全球第二申报上市的IL-17A/F抑制剂，银屑病适应症已提交上市申请并纳入优先审评，强直性脊柱炎III期完成、预计2026年上半年申报上市。这是公司在自免领域的潜在重磅产品。 2. 司美格鲁肽注射液：2型糖尿病适应症处于上市审评阶段，减重适应症预计2026年提交上市申请。GLP-1赛道竞争激烈，但市场空间巨大。 3. JP-1366片/注射剂（P-CAB）：消化道领域下一代产品，反流性食管炎适应症已申报上市。若获批，将实现公司在抑酸治疗领域从PPI到P-CAB的产品迭代。 4. 重组人促卵泡激素注射液：已申报上市，预计2026年获批。若成功，公司将成为国内唯一同时拥有”尿源+重组”双技术路径的辅助生殖药企。研发投入趋势：2021年11.46亿元 → 2022年14.27亿元 → 2023年13.35亿元 → 2024年10.33亿元 → 2025年9.38亿元（均为费用化部分）。研发费用绝对值在下降，但这与2023年砍掉低价值项目、聚焦核心管线的策略一致。同时研发资本化金额从2024年的0.37亿大幅增长至2025年的1.44亿元（资本化率从3.51%升至13.67%），说明更多项目进入后期开发阶段。国际化体系的实质进展境外收入近5年趋势：年度境外收入（亿元）占营收比境外毛利率 2021 15.39 12.75% 36.57% 2022 15.65 12.39% 44.30% 2023 15.71 12.64% 43.74% 2024 17.24 14.59% 48.90% 2025 19.30 16.06% 48.27% 境外业务的增长是真实的——收入从15.39亿元增长至19.30亿元（4年CAGR约5.8%），占比从12.75%提升至16.06%。更值得关注的是境外毛利率的跃升（从36.57%到48.27%），反映了产品结构向高附加值方向优化。关键进展包括：原料药出口占比达60%，长期协议销售占比超50%；制剂海外销售2024年同比增长65.98%（虽然基数较小）；通过马来西亚PIC/S GMP认证，巴西PIC/S GMP认证已提交申请；2025年启动收购越南IMP公司。竞争力评估优势： 1. 微球技术平台是真正的技术壁垒，不依赖资金壁垒或牌照壁垒，可复制性强（平台可搭载不同分子）。 2. 多元化产品组合使公司在集采和医保谈判冲击下表现出经营韧性——没有单一产品占营收超25%。 3. 原料药出口为国际化积累了质量体系认证和客户资源的基础，制剂出海有支撑。薄弱环节： 1. 创新药管线虽然在推进中，但尚未产生规模收入。莱康奇塔单抗和司美格鲁肽即便顺利获批，从上市到放量仍需时间。 2. 生物制品板块连续多年亏损或微利（丽珠生物2024年亏损4.84亿元），大规模增资后仍需持续投入，回报时间不确定。 3. 越南IMP收购是公司历史上最大的海外并购，整合风险不可忽视。4. 财务分析行业关键指标（近5年趋势）研发费用率与研发资本化率年度研发投入（亿元）研发费用率资本化率 2021 11.46 9.50% - 2022 14.27 11.30% - 2023 12.35 9.94% 14.52% 2024 10.44 8.84% 3.51% 2025 10.56 8.79% 13.67% 注：2021-2022年资本化率数据未在摘要中单独披露。研发投入总额为费用化+资本化合计。研发投入总额在2022年达到峰值14.27亿元后回落至10亿元左右区间，与公司主动收缩管线、聚焦核心项目的策略一致。2024年资本化率骤降至3.51%可能与部分项目研发支出减值有关（当年资产减值损失1.82亿元中包含开发支出减值准备），2025年回升至13.67%则反映了核心项目进入后期阶段。销售费用率趋势年度销售费用（亿元）销售费用率 2021 38.84 32.19% 2022 38.87 30.78% 2023 35.98 28.95% 2024 32.55 27.55% 2025 35.81 29.79% 2023-2024年销售费用率持续下降，部分受益于反腐政策下营销模式转型（从高费用推广向学术营销过渡），部分因为收入结构中仿制药占比下降。2025年销售费用率回升至29.79%，绝对值从32.55亿增至35.81亿（+10.02%），公司解释为新产品上市推广投入增加（如注射用阿立哌唑微球等）。需持续观察这一回升是否为阶段性的新品推广投入，还是费率趋势逆转。经营现金流/净利润比率年度经营现金流净额（亿元）净利润（亿元）比率 2021 19.02 19.52 0.97 2022 27.73 19.56 1.42 2023 32.49 18.98 1.71 2024 29.79 23.04 1.29 2025 31.45 24.11 1.30 经营现金流持续超过净利润，且比率稳定在1.3倍以上（2023年高达1.71倍主要因为存货消化和应收改善），表明公司盈利质量优良，不存在大规模应收账款堆积或收入确认激进的问题。成长性与盈利能力营收与利润增速年度营收（亿元）营收增速归母净利润（亿元） 2021 120.64 - 17.76 2022 126.30 +4.69% 19.09 2023 124.30 -1.58% 19.54 2024 118.12 -4.97% 20.61 2025 120.20 +1.76% 20.23 年度归母净利增速扣非归母净利润（亿元） 2021 - 16.27 2022 +7.49% 18.80 2023 +2.36% 18.81 2024 +5.50% 19.79 2025 -1.85% 20.09 2021-2025年营收CAGR仅约-0.09%，基本持平。归母净利润CAGR约3.3%。值得注意的是营收和利润的背离——2023-2024年营收连续下降但利润持续增长。这一背离的主要驱动力是：（1）毛利率从2021年的64.75%提升至2025年的65.90%，化学制剂毛利率从约79%提升至81%；（2）四项费用率从2021年的46.62%下降至2025年的40.80%，尤其是销售费用率和研发费用率的下降。 ROE趋势（近似计算：归母净利润/平均归属母公司股东权益）年度归母净利润（亿元）归母股东权益（亿元） ROE（近似） 2021 17.76 130.04 13.7% 2022 19.09 138.76 14.2% 2023 19.54 140.42 14.0% 2024 20.61 138.62 14.8% 2025 20.23 138.88 14.6% ROE稳定在14-15%区间，属于医药行业中等偏上水平。归母股东权益从2021年的130亿增长至2025年的139亿，增幅较小，部分原因是公司持续回购注销股份和较高的分红。财务健康度资产负债率与有息负债率年度资产负债率有息负债率有息负债（亿元） 2021 36.03% 12.04% 26.95 2022 39.93% 14.56% 36.19 2023 41.04% 16.54% 41.42 2024 39.05% 16.32% 39.91 2025 35.18% 12.76% 30.60 资产负债率从2023年的高点41.04%回落至2025年的35.18%，有息负债也从41.42亿降至30.60亿。财务杠杆在适度范围内，且趋于改善。公司持有货币资金93.05亿元，远超有息负债30.60亿元，净现金头寸充裕。重大科目异常变化 1. 其他应付款：2025年末29.30亿元，在总负债84.38亿元中占比较高（35%）。该科目2021年为24.17亿元，逐年增长。其中可能包含与健康元等关联方的往来款项、限制性股票回购义务等，需关注其具体构成。 2. 资产减值损失：2023年高达3.10亿元，2024年为1.82亿元，2025年为1.09亿元。2023年的大额减值主要包括存货跌价准备和开发支出减值准备（即研发项目终止），反映了公司管线优化的代价。 3. 交易性金融资产：从2024年末的0.89亿元跃升至2025年末的13.45亿元，主要是结构性存款业务大幅增加（投资活动现金流出增加约100亿元用于购买结构性存款）。这本质上是现金管理行为，不影响主业判断。 4. 少数股东权益：从2023年的7.24亿增长至2025年的16.59亿，少数股东损益从2023年的-0.56亿变为2025年的3.88亿。这与丽珠生物等子公司经营改善以及增资后少数股东份额变化有关。2024年丽珠生物亏损4.84亿元对少数股东权益的影响需关注后续走势。 5. 风险因素管理层披露的主要风险 1. 集采和医保政策对存量产品的持续价格压力：公司已有多个品种（注射用伏立康唑、雷贝拉唑钠肠溶胶囊等）被纳入集采，注射用艾普拉唑钠经历了医保谈判降价。这一风险是实质性的——消化道产品收入从2022年的34.36亿元（按细分口径）下降至2025年的25.20亿元，降幅超过26%，直接体现了政策侵蚀效应。 2. 新药研发不确定性：管线中的创新药（莱康奇塔单抗、JP-1366、NS-041等）均面临临床失败或审批延迟的风险。公司2023年曾因项目优化计提大额开发支出减值准备（资产减值损失3.10亿元中的一部分），说明研发失败并非小概率事件。 3. 国际化扩张风险：越南IMP收购涉及跨境交易、外国法律环境、文化整合等多重挑战。截至2025年末，股权收购保证金已冻结货币资金约18.65亿元，交易尚在进行中。这是公司历史上最大的单笔对外投资。 4. 原材料价格波动与汇率风险：原料药板块依赖大宗原材料采购，受大宗商品价格周期影响。公司60%以上的原料药收入来自境外，美元/人民币汇率波动直接影响损益——公司已通过远期外汇合约进行对冲（2025年末未平仓合约约4.33亿元）。风险变化对比2023年年报与2025年年报的风险披露：新增风险： - 越南IMP收购带来的跨境并购整合风险在2025年首次出现。 - 研发资本化率大幅波动（2024年降至3.51%，2025年回升至13.67%）暗示的管线判断不确定性。缓解的风险： - 生物制品板块在2023年因新冠疫苗需求消退而大幅下滑（收入同比下降79.33%，毛利率-21.51%），到2025年已恢复正增长（+17.50%，毛利率60.81%），最坏阶段已过。 - 2023年医药反腐导致的行业性销售冲击（多家药企销售活动一度暂停）已在2024-2025年常态化，公司销售费用率虽有波动但趋势向好。隐含风险 1. 控股股东及关联交易结构：健康元持有丽珠集团24.93%股份，实际控制人朱保国同时担任两家公司的董事长。第一大供应商焦作健康元是健康元的全资子公司，占采购额12.38%。丽珠生物的增资由丽珠集团和健康元共同参与——这种关联方交叉持股和交易结构虽然合规，但增加了利益冲突的潜在风险。值得注意的是，“其他应付款”科目长期维持在28-30亿元的高位，其中关联方往来款项的具体金额和性质需要进一步关注。 2. 研发资本化政策的灵活性：2024年研发资本化率3.51%，2025年骤升至13.67%（资本化金额从0.37亿增至1.44亿元），这一大幅波动在同一公司的连续年度间是不寻常的。资本化率的提高会减少当期费用、增加利润，尽管公司可能有合理的项目进展解释，但这赋予了管理层一定的利润调节空间。 3. 丽珠生物的持续亏损与增资依赖：丽珠生物2024年净亏损4.84亿元，丽珠集团在2024年向其增资10亿元（持股从61.66%提升至66.54%）。生物药研发投入大、回报周期长，但该子公司的持续亏损规模值得跟踪——它消耗了母公司的资源但尚未贡献利润，且莱康奇塔单抗、司美格鲁肽等核心品种何时实现盈亏平衡存在不确定性。后续跟踪重点基于本次分析，持续跟踪应优先关注： 1. 莱康奇塔单抗（IL-17A/F）的上市和放量节奏 → 验证信号：银屑病适应症的审批结果（已纳入优先审评）、上市后首年销售额、医保谈判进展。这是公司从仿制药企业向创新药企业转型的标志性品种，其商业化成败对公司估值逻辑有根本性影响。 2. 越南IMP收购的完成与整合 → 验证信号：交易最终完成时间、收购对价、IMP并表后的营收和利润贡献、管理层整合进展。截至2025年末交易仍在进行中，18.65亿元保证金已冻结，需关注交易能否顺利完成以及整合后能否实现协同效应。 3. 消化道产品收入的止跌信号 → 验证信号：艾普拉唑系列收入是否企稳、JP-1366片审批进展。消化道产品收入已从高点下降超过26%，如果JP-1366获批上市并实现从PPI到P-CAB的产品迭代，将成为消化道板块的新增长引擎。 4. 销售费用率是否回归下降通道 → 验证信号：2026年中报的销售费用率。2025年费率回升至29.79%，管理层归因于新品推广投入。若费率在新品推广高峰期过后不能回落，需重新评估营销效率。 5. 丽珠生物扭亏时间表 → 验证信号：丽珠生物的半年度/年度盈亏状况。信息来源建议：丽珠集团财报中”主要控股参股公司分析”章节。免责声明：本报告由 Insight 分析系统生成，仅供个人学习和研究参考，不构成任何投资建议。报告内容基于公开披露信息整理，不保证准确性和完整性。作者可能持有报告中提及的证券。投资有风险，决策需谨慎。

2026-03-19

·BioSpace

FDA Approves BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) from Merck Animal Health to Treat and Control Asian Longhorned Tick and Gulf Coast Tick for 12 Months in Dogs

Expanded label for once-yearly parasiticide treatment for dogs now includes Haemaphysalis longicornis (Asian longhorned tick) and Amblyomma maculatum (Gulf Coast tick) for 12 months RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), today announced the U.S. Food and Drug Administration (FDA) approved an expanded label for BRAVECTO ® QUANTUM ( fluralaner for extended-release injectable suspension ) in dogs. The updated indication adds treatment and control of Asian longhorned tick ( H. longicornis ) and Gulf Coast tick ( A. maculatum ) for 12 months, when administered as a single, veterinarian‑delivered injection. BRAVECTO QUANTUM was approved in the U.S. on July 10, 2025, and continues to be indicated to kill adult fleas, for the treatment and prevention of flea infestations, and for the treatment and control of Ixodes scapularis , Dermacentor variabilis , and Rhipicephalus sanguineus infestations for 12 months and A. americanum infestations for 8 months in dogs and puppies 6 months of age and older. “For more than a decade, BRAVECTO has set the benchmark for extended‑duration flea and tick protection, and today’s label expansion reinforces our leadership in parasiticide innovation,” said Meg Conlon, DVM, executive director, U.S. Companion Animal Veterinary Services, Merck Animal Health. “With BRAVECTO QUANTUM, Merck Animal Health continues to deliver the longest‑lasting protection available in a single dose – now covering an even broader range of clinically important tick species. This advancement reflects our unwavering commitment to help veterinarians protect dogs with the most comprehensive, convenient, and science‑driven solutions on the market.” Key Information: What’s new: BRAVECTO QUANTUM is now approved to provide 12 months of treatment and control for two additional tick species – Asian longhorned tick ( H. longicornis ) and Gulf Coast tick ( A. maculatum ) – following a single injection administered by a veterinarian. This approval expands the product’s already robust label, reinforcing BRAVECTO’s position as the longest‑lasting flea and tick protection available for dogs in the United States. Complete Parasite Protection Profile: BRAVECTO QUANTUM is indicated to kill adult fleas and for treatment and prevention of flea infestations. BRAVECTO QUANTUM also provides 12 months of protection against Asian longhorned ticks, Gulf Coast ticks, black‑legged ticks, American dog ticks, and brown dog ticks, along with 8 months of protection against lone star ticks following a single veterinarian administered‑injection. Why this matters: The extended‑release injectable formulation offers veterinarians and pet owners a simple, once‑yearly approach that supports improved compliance and consistent, uninterrupted protection. This label update helps veterinarians address the evolving parasite landscape, as both Asian longhorned and Gulf Coast ticks continue to expand geographically and present risks to canine health. Where it’s available: BRAVECTO QUANTUM remains available exclusively through licensed veterinarians, ensuring appropriate in‑clinic administration, guidance, and support. The expanded indication underscores Merck Animal Health’s continued leadership in delivering innovative, extended‑duration parasite protection solutions. With BRAVECTO QUANTUM, veterinarians have an unmatched, once‑yearly option that now defends dogs against an even broader range of ticks – supporting year‑round protection and helping meet the evolving needs of pets and the people who care for them. For more information, visit us.bravecto.com or follow BRAVECTO on Instagram @bravecto.us . About BRAVECTO ® Since its introduction in 2014, BRAVECTO has provided longer-lasting flea and tick protection, with more than 450 million doses distributed in 100 countries over eight years. BRAVECTO is available in a variety of formulations, including products for both dogs and cats. The flea lifecycle can last as long as 12 weeks, and monthly treatments may leave gaps in protection. Providing pets with continuous flea and tick protection is essential – whether the pet goes outside or not. Contrary to popular belief among pet owners, fleas and ticks are not only active in the spring and summer months and are a year-round risk. Fleas and ticks can easily latch onto dogs and cats and can spread serious diseases. Fleas are the most common external parasite found on pets. BRAVECTO products are available through licensed veterinarians. About Merck Animal Health Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is a global animal health business committed to The Science of Healthier Animals™. For more than 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. For more information, visit and connect with us on LinkedIn , Facebook , X (formerly Twitter) and Instagram . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( ). FAQ: What changed with today’s approval? The BRAVECTO QUANTUM label now includes treatment and control of H. longicornis (Asian longhorned tick) and A. maculatum (Gulf Coast tick) for 12 months following a single injection administered by a veterinarian, in addition to existing indications (fleas and other listed tick species) and the 8‑month indication for A. americanum (lone star tick). Why focus on Asian longhorned and Gulf Coast ticks? These ticks are clinically relevant and expanding in geographic range. Adding them strengthens year‑round, single‑dose tick control options for more dogs across more U.S. regions. How is BRAVECTO QUANTUM administered? BRAVECTO QUANTUM is administered via a single subcutaneous injection delivered by a licensed veterinarian. Is this the same BRAVECTO formulation that was introduced in 2025? Yes. BRAVECTO QUANTUM remains the once‑yearly fluralaner extended‑release injectable. Today’s update expands the label’s tick species coverage. Is BRAVECTO QUANTUM safe? BRAVECTO QUANTUM has undergone extensive safety testing. In fact, safety was demonstrated when dosed at 5 times the recommended dose every 4 months for a total of 6 doses. In a U.S. field study with client owned dogs, 0.9% (2 out of 225 dogs) experienced seizures. This rate is consistent with estimates reported in the general dog population. BRAVECTO QUANTUM (fluralaner) is a member of the isoxazoline class, which has been associated with neurologic adverse reactions, including tremors, ataxia, and seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Where can veterinarians find full prescribing information? Please see the Prescribing Information (PI) here and consult Merck Animal Health for training and ordering support. Can cats receive BRAVECTO QUANTUM? No. BRAVECTO QUANTUM is approved only for dogs and puppies 6 months of age and older and must be administered by a licensed veterinarian. It is not approved for use in cats. For cats, Merck Animal Health offers BRAVECTO ® Plus, a topical formulation that provides broad‑spectrum, extended‑duration protection against fleas, ticks, and internal parasites. IMPORTANT SAFETY INFORMATION: BRAVECTO (fluralaner) Chews for Dogs: The most commonly reported adverse reactions include vomiting, lethargy, diarrhea, anorexia and pruritus. In some cases, adverse events have been reported following use in breeding females. BRAVECTO Chews has not been shown to be effective for 12-weeks' duration in puppies less than 6 months of age. BRAVECTO Chews is not effective against lone star ticks beyond 8 weeks of dosing. Indicated for dogs 6 months of age and older. BRAVECTO 1-MONTH (fluralaner) Chews: The most commonly reported adverse reactions include itching, diarrhea, vomiting, decreased appetite, elevated ALT, lethargy, and weight loss. Not effective against lone star ticks in puppies less than 6 months of age. Indicated for dogs 8 weeks of age and older. BRAVECTO (fluralaner topical solution) for Dogs: The most commonly reported adverse reactions include vomiting, hair loss, diarrhea, lethargy, decreased appetite, and moist dermatitis/rash. BRAVECTO Topical Solution for Dogs has not been shown to be effective for 12-weeks' duration in puppies less than 6 months of age. BRAVECTO Topical Solution for Dogs is not effective against lone star ticks beyond 8 weeks of dosing. For topical use only. Avoid oral ingestion. Indicated for dogs 6 months of age and older. BRAVECTO QUANTUM (fluralaner for extended-release injectable suspension) for Dogs: The most commonly reported adverse reactions in a US field study included lethargy, decreased appetite, vomiting, diarrhea, elevated liver enzymes and pruritus. BRAVECTO QUANTUM is not effective against lone star ticks beyond 8 months of dosing. Indicated for dogs 6 months of age and older. BRAVECTO (fluralaner topical solution) for Cats: The most commonly reported adverse reactions include vomiting, itching, diarrhea, hair loss, decreased appetite, lethargy, and scabs/ulcerated lesions. BRAVECTO Topical Solution for Cats is not effective against American dog ticks beyond 8 weeks of dosing. BRAVECTO Topical Solution for Cats has not been shown to be effective for 12-weeks' duration in kittens less than 6 months of age. The safety of BRAVECTO Topical Solution for Cats have not been established in breeding, pregnant and lactating cats. For topical use only. Avoid oral ingestion. Indicated for cats 6 months of age and older. BRAVECTO PLUS (fluralaner and moxidectin topical solution) for Cats: The most commonly reported adverse reactions include vomiting, hair loss, itching, diarrhea, lethargy, dry skin, elevated ALT, and hypersalivation. BRAVECTO PLUS has not been shown to be effective for 2 months in kittens less than 6 months of age. Use with caution in cats that are heartworm positive. The effectiveness of BRAVECTO PLUS to prevent heartworm disease after bathing or water immersion has not been evaluated. The safety of BRAVECTO PLUS have not been established in breeding, pregnant and lactating cats. Indicated for cats 6 months of age and older. All BRAVECTO products contain fluralaner, which is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Neurologic adverse reactions have been reported in cats receiving isoxazoline class drugs, even in cats without a history of neurologic disorders. Use with caution in cats with a history of neurologic disorders. Contacts Media Contact: Laurel Sawicki (908) 872-9783 laurel.mundth@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Hayley Kasko (732) 594-4237 hayley.kasko@merck.com

上市批准临床研究

2026-01-19

·普思生物

2014-2025年天然产物及衍生化合物在临床试验与药物审批中的现状和展望

点击下方音频播放键，收听关于“2014-2025年天然产物及衍生化合物在临床试验与药物审批中的现状和展望”播客内容→ 在医药科研领域，天然产物及其衍生物一直是备受瞩目的焦点，它们为新药研发提供了丰富的灵感与物质基础。今天，普思生物特别为大家带来一场深度解读，聚焦于发表在《Natural Product Reports》上的文章——《Natural product-derived compounds in clinical trials and drug approvals》。这篇文章将带我们一同探索天然产物及衍生化合物在临床试验与药物审批方面的最新进展与前沿动态。 1 引言天然产物（NPs）是药物研发的传统基石，从古代草药到吗啡、奎宁等经典药物，应用贯穿医学发展史，20 世纪中叶迎来抗生素研发 “黄金时代”。但 20 世纪后期，合成化学、分子生物学技术兴起及生物制剂崛起，使其核心地位有所下降，但依然是多元研发手段之一。本文基于 2014 年 1 月至 2025 年 6 月全球药物审批数据及截至 2024 年底的临床试验信息，系统分析天然产物衍生（NP-D）药物的发展态势。文中明确天然产物为海洋、陆地植物、微生物等来源的纯小分子化合物（萜类、聚酮类等），排除初级代谢或营养功能分子；相关化合物分为 NP（天然产物）、NP-D（天然产物衍生）、NP-ADC（NP-抗体偶联药）三类，制造方式含天然分离、半合成、全合成。 2 全球获批的天然产物相关药物（一）总体概况 2014-2025 年 6 月，全球共批准 58 种天然产物相关药物，包括 45 种 NP/NP-D 新化学实体（NCEs）和 13 种 NP-ADCs。在 2014-2024 年全球获批的 579 种新药（388 种 NCEs、191 种新生物实体 NBEs）中，天然产物相关药物占 9.7%（56 种），其中 NCEs 占 7.6%（44 种），NBEs 中 NP-ADCs 占 6.3%（12 种）。这些药物年批准量波动于 0-8 种，年均 5 种，虽非研发主流，但产出稳定。值得关注的是，中国、印度等国的中小制药企业在天然产物衍生药物首次批准中的占比持续提升，成为核心推动力。（二）按治疗领域分类 ·抗感染药物：15 种获批，含 11 种抗菌药、2 种抗真菌药、1 种抗病毒药和 1 种抗寄生虫药。抗菌药覆盖四环素类、糖肽类等经典类别，中国获批卡利霉素；抗真菌药有首个 “fungerp” 类伊布拉芬净等；抗病毒药斑蝥素源自中药，抗寄生虫药莫昔克丁由兽用药物重开发。·神经系统疾病药物：包括术后镇痛药、精神疾病复方制剂等，2024 年获批的 xanomeline - 曲司氯铵复方制剂源自槟榔碱，经结构优化与复方设计降低不良反应，获批用于精神分裂症。 ·心血管与代谢疾病药物：14 种获批，11 种为 “格列净类” 根皮苷衍生物，用于 2 型糖尿病；另有米加司他（法布里病）、沃拉帕沙（血栓性心血管事件）、铁麦芽酚（缺铁性贫血）等。 ·免疫、炎症及相关疾病药物：涵盖阿片类便秘治疗药、多发性硬化症治疗药等，首创药物他匹莫德（银屑病）、奥马韦洛酮（弗里德赖希共济失调）彰显罕见病治疗价值。 ·抗癌药物：含米哚妥林等首创药物，异补骨脂素源自中药获批用于肝癌；NP-ADCs 表现突出，2014-2024 年获批 12 种，弹头多来自天然产物，通过靶向递送提升疗效、降低毒性。滑动下方滑块查看更多图片 3 临床试验阶段的核心化合物截至 2024 年底，125 种独特 NP/NP-D 化合物处于临床试验或注册阶段（合计 129 项试验），覆盖五大领域，肿瘤学（27.1%）和神经系统疾病（25.6%）占比最高。 ·感染性疾病：抗菌药结构与机制多样，那非霉素已在印度获批，培西加南提交中国新药申请，新型作用机制化合物（如 Zaloganan、EBC-1013）受关注；抗寄生虫、抗病毒、抗真菌药物均有候选化合物推进，Sabizabulin 在 COVID-19 相关 ARDS 试验中死亡率降低 24.9%。滑动下方滑块查看更多图片 ·神经系统疾病：致幻剂 / 迷幻剂研发复苏，裸盖菇素、LSD 衍生物等推进难治性抑郁症、PTSD 等适应症试验；其他领域有疼痛治疗药、神经退行性疾病药物等，苔藓抑素 1、Buntanetap 等展现潜力。滑动下方滑块查看更多图片 ·心血管与代谢疾病：延续经典靶点优化，阿帕他酮、荣格列净等推进临床试验，黄连素熊去氧胆酸盐、Vutiglabridin 等探索新机制，覆盖糖尿病、肥胖症、MASH 等适应症。 ·免疫、炎症及相关疾病：基于天然产物抗炎、免疫调节活性优化，Vatiquinone 提交新药申请，Acoltremon 获批干眼症治疗，多款化合物推进罕见病、自身免疫病试验。滑动下方滑块查看更多图片 ·肿瘤学：植物、微生物与海洋来源化合物丰富，EGCG、plinabulin 等推进实体瘤、血液肿瘤试验；NP-ADCs 成研发热点，46 种处于 II 期及以上阶段，中国企业研发的 SHR-A1904 等展现潜力。滑动下方滑块查看更多图片 4 新药效团与研发趋势（一）新药效团发现 33 种新药效团处于临床试验阶段，覆盖肿瘤学、神经系统疾病等领域。仅 PharmaMar 公司的 PM534 为过去 15 年新发现并进入临床试验的药效团，其余多为已知骨架结构修饰产物，新药效团发现面临挑战。（二）核心研发趋势 ·治疗领域集中化：肿瘤学和神经系统疾病成为核心研发方向，占临床试验化合物的 27.1% 和 25.6%，契合两大领域未满足的医疗需求，同时发挥天然产物结构多样性优势。 ·作用机制多元化：除传统的酶抑制、代谢干扰机制外，新增免疫细胞功能调节、生物膜破坏、表观遗传调控因子靶向等新型机制，如 Vatiquinone 抑制铁死亡、apabetalone 靶向 BET 蛋白。 ·研发主体转变：中国、印度等国中小制药企业成为主力，大型制药企业参与度下降，与抗感染、罕见病等领域研发投入回报周期长、风险高相关。 ·技术融合创新：半合成和全合成技术解决天然产物供应短缺问题（如苔藓抑素 1 通过全合成实现临床试验供应）；ADC 技术与天然产物结合打造精准治疗新范式，拓展其在肿瘤治疗中的应用。 ·老药新用与重新开发：部分早期终止研发的化合物通过适应症拓展或结构优化重返临床试验，如 sanfetrinem cilexetil 从呼吸道感染转向结核病治疗，体现天然产物研发韧性。 5 结论与展望天然产物虽非药物研发核心主导，但仍具持久价值。2014-2025 年，相关药物获批稳定，临床试验覆盖多领域，NP-ADCs 崛起、新机制发现及中小药企参与注入新活力。同时面临新药效团发现放缓、大型药企投入不足、技术门槛高等挑战。未来需加强天然产物分离与机制研究，结合合成生物学、人工智能等新技术，通过外包合作降低研发风险。天然产物作为结构复杂、机制多样的分子库，有望在更多未满足医疗需求领域实现突破，为人类健康提供新治疗选择。成都普思生物作为天然产物分离纯化与化合物库构建领域的领军企业，凭借多年技术积淀与创新实践，为全球天然产物药物研发企业提供全链条、高品质的技术与产品服务。能够实现从天然产物原料中高效分离、纯化高纯度单体化合物，满足药物研发过程中活性筛选、结构鉴定、药理研究等多环节的严苛需求。此外，普思生物构建了涵盖数千种天然产物单体的特色化合物库，覆盖黄酮类、生物碱类、萜类、多酚类等多个核心类别，精准匹配肿瘤学、神经学、免疫炎症、心血管代谢等热门治疗领域，一站式解决您的研发需求。需要《Natural product-derived compounds in clinical trials and drug approvals》原文的请联系普思工作人员哦。电话/微信：18080489829 往期精彩推荐普思生物天然产物化合物库活性多糖定制化服务：精准分离·高效纯化普思生物检验检测业务介绍如何提高高分辨质谱成分鉴定准确性普思生物成立于2005年，是一家专业从事天然药物分离纯化并提供药物药学研究服务的国家高新技术企业，提供超过5000种天然产物单体物质，其中包括不同等级、规格、纯度等近万种产品。普思对照品，为您的实验精准赋值！普思生物核心业务中药对照品/化合物库生产和销售中药标准物质原料制备高效定制化分离服务中药检验检测、高分辨质谱成分分析、多糖结构表征等医疗机构制剂、配方颗粒、经典名方开发与服务新药天然原料药及制剂开发与申报服务普思生物主要荣誉资质 2007年国家高新技术企业 2011年四川省天然药物分离纯化工程技术研究中心 2015年四川省天然化合物库 2017年国家中小企业公共服务示范平台 2018年中国食品药品检定研究院标准物质原料供应商（第一批），成都市天然药物分离纯化创新示范中心 2019年 CNAS认证检验检能力认可实验室 2021年成都市“守合同重信用”企业 2023年武侯区创新药（含中医药）产业优势企业，武侯区优质创新平台 2024年成都市中药创新药物中试研发服务平台普思生物参与的部分项目多版药典新增对照品研发，推动中药质控国际化。 2012年，我公司参与了国际合作项目“香港中药材标准研究项目”，公司是唯一一家参与了该项目的民营企业。 2017年10月公司科技项目“高附加值中药成分分离纯化技术研究及产业化”荣获武侯区2015-2016年度科技进步特等奖，是武侯区生物制药领域的第一家获奖企业。 2019年9月普思作为主要完成单位之一申报的“基于构效关系的中药活性物质发现及其开发应用”项目，荣获四川省科学技术厅科技进步一等奖。电话/微信：18080489829

抗体药物偶联物上市批准临床研究

100 项与莫昔克丁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05084	莫昔克丁	P02CX03	DB11431

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
盘尾丝虫病	美国	Medicines Development for Global Health Ltd	2018-06-13

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
疥疮	临床3期	斐济	Medicines Development for Global Health Ltd	2026-03-01
类圆线虫病	临床3期	斐济	Medicines Development for Global Health Ltd	2026-03-01
丝虫性象皮病	临床3期	科特迪瓦	Medicines Development for Global Health Ltd	2021-05-03
丝虫性象皮病	临床3期	刚果民主共和国	Medicines Development for Global Health Ltd	2021-05-03
肠道蠕虫病	临床2期	澳大利亚	Medicines Development for Global Health Ltd	2022-08-09
眼盘尾丝虫病	临床1期	美国	Medicines Development for Global Health Ltd	2017-01-01
感染	临床1期	法国	Wyeth AB	2008-11-01
感染	临床1期	英国	Wyeth AB	2008-11-01
虱病	临床前	澳大利亚	Medicines Development for Global Health Ltd	2022-01-30

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临床结果

适应症

分期

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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


NCT04311671 (CTgov)	临床3期	盘尾丝虫病 \| 丝虫性象皮病	12,979	Moxidectin (Moxidectin)	壓簾餘壓膚鏇齋獵鹹選 = 製襯艱廠壓鹽衊壓夢壓簾繭憲簾襯膚餘築簾繭 (廠壓願夢糧願鑰襯衊憲, 觸壓憲築衊築夢衊糧夢 ~ 繭簾簾齋窪淵築襯鑰繭) 更多	-	2026-02-05
				Ivermectin (Ivermectin)	壓簾餘壓膚鏇齋獵鹹選 = 鏇艱艱衊鑰願艱壓製齋簾繭憲簾襯膚餘築簾繭 (廠壓願夢糧願鑰襯衊憲, 鹹衊淵範憲糧網齋鹹選 ~ 鹽鏇餘範遞壓築憲餘觸) 更多
NCT04410406 (CTgov)	临床3期	丝虫性象皮病	164	Albendazole+Ivermectin (IA (Ivermectin + Albendazole))	壓鬱糧鏇鹹襯衊構憲願 = 簾衊蓋範夢壓觸製襯積糧鏇構夢獵顧範餘窪鑰 (構範鹽衊衊醖獵鑰製遞, 觸淵襯製鬱鑰窪淵選醖 ~ 顧願鹽網顧蓋選簾鏇鑰) 更多	-	2026-01-29
				Albendazole+Moxidectin (MoxA (Moxidectin + Albendazole))	壓鬱糧鏇鹹襯衊構憲願 = 壓糧鬱餘構鹽簾築鏇製糧鏇構夢獵顧範餘窪鑰 (構範鹽衊衊醖獵鑰製遞, 簾鑰簾顧範積鏇淵願衊 ~ 衊壓鬱廠顧願遞窪鏇襯) 更多
NCT06188715 (Moxiped, CTgov)	临床3期	鞭虫病 \| 钩虫感染 \| 蛔虫病	224	Albendazole 400 mg Oral Tablet+Moxidectin 2 mg Oral Tablet (Arm A: Moxidectin 4/8 mg & Albendazole)	窪艱積獵醖糧廠夢鑰艱 = 襯範襯鬱膚願鑰艱顧醖範夢夢衊獵繭壓構糧繭 (鹽蓋築餘願觸願獵壓觸, 積夢網積願艱醖鹽醖製 ~ 廠範遞製鏇蓋糧衊鹽積) 更多	-	2025-09-19
				Placebo Mox+Albendazole 400 mg Oral Tablet (Arm B: Albendazole)	窪艱積獵醖糧廠夢鑰艱 = 選遞艱餘繭糧鹽繭糧壓範夢夢衊獵繭壓構糧繭 (鹽蓋築餘願觸願獵壓觸, 鹹顧繭窪願願醖觸壓壓 ~ 鹹築淵廠觸網膚選製醖) 更多
NCT04056325 (StrongMoxi, CTgov)	临床2/3期	类圆线虫病	617	Moxidectin (Phase 2a - Arm A (Moxidectin 2 mg))	廠醖構積觸願醖顧醖襯 = 鹹艱糧獵顧鑰憲鹽範願繭艱夢壓構遞鹽膚繭積 (構觸衊積網淵構膚製築, 顧淵窪遞簾淵衊網醖簾 ~ 選衊積網壓衊鹹繭鹽醖) 更多	-	2024-12-09
				Moxidectin (Phase 2a - Arm B (Moxidectin 4 mg))	廠醖構積觸願醖顧醖襯 = 夢蓋鏇觸衊窪願壓築鹽繭艱夢壓構遞鹽膚繭積 (構觸衊積網淵構膚製築, 餘糧窪壓顧繭範夢憲築 ~ 鏇淵範鏇鹹齋獵醖顧襯) 更多
NCT04700423 (CTgov)	临床2/3期	鞭虫病 \| 钩虫感染 \| 蛔虫病 ... 更多	536	albendazole+moxidectin (A: Moxidectin (8 mg) / Albendazole (400 mg))	醖簾窪願選簾夢廠範顧(製廠觸鏇選衊鹽鹹製築) = 壓襯簾觸糧範夢夢積廠觸繭鏇壓鏇醖餘醖範繭 (獵簾壓繭鏇淵餘淵顧網, 淵遞夢壓襯築醖艱衊鑰 ~ 築襯壓鬱壓夢憲壓醖醖) 更多	-	2024-12-05
				albendazole+ivermectin (B: Ivermectin (200 µg/kg) / Albendazole (400 mg))	醖簾窪願選簾夢廠範顧(製廠觸鏇選衊鹽鹹製築) = 糧選觸繭構淵範遞顧廠觸繭鏇壓鏇醖餘醖範繭 (獵簾壓繭鏇淵餘淵顧網, 範鹹鏇蓋衊繭糧餘繭糧 ~ 醖鬱簾餘鹽糧範繭築膚) 更多
NCT04049851 (Pubmed)	临床2期	罗阿丝虫病 \| 眼盘尾丝虫病	72	Moxidectin 2mg	艱餘繭廠鏇憲淵壓願構(窪鏇憲繭衊糧鹽壓網餘) = 49 AEs occurred in the MOX arm vs 59 AEs in the IVM arm 願遞夢窪積鏇鑰淵觸鹹 (淵襯夢獵築簾觸範醖築 ) 更多	积极	2024-06-28
				Ivermectin 150µg/kg
NCT04848688 (StrongMoxi_KH, CTgov)	临床3期	类圆线虫病	332	Placebo+Moxidectin 2 mg (Moxidectin)	積鏇餘繭選願淵鹽窪製 = 範醖製觸鹽糧夢鬱鏇鏇製願壓蓋鏇餘積夢顧憲 (繭夢壓選糧繭夢衊醖廠, 鑰選構鹹繭顧壓夢蓋製 ~ 構糧夢餘憲醖衊鏇簾鏇) 更多	-	2024-01-24
				Placebo+Ivermectin 3 mg (Ivermectin)	積鏇餘繭選願淵鹽窪製 = 遞繭鑰顧顧遞築遞鑰膚製願壓蓋鏇餘積夢顧憲 (繭夢壓選糧繭夢衊醖廠, 膚窪範範願鹹餘製鹹壓 ~ 製夢夢構糧範積鹹積製) 更多
NCT03905265 (CTgov)	临床2期	疥疮	22	Moxidectin Oral Product (Moxidectin 2 mg)	簾簾鑰選鹽積鬱鹹糧獵 = 鑰選餘窪艱選鬱廠艱憲積網壓鹽鬱糧襯壓餘構 (顧繭壓窪醖鬱簾簾衊鑰, 艱構築艱齋鹽獵襯獵獵 ~ 觸餘蓋獵醖廠繭鏇築願) 更多	-	2023-09-22
				Moxidectin Oral Product (Moxidectin 8 mg)	簾簾鑰選鹽積鬱鹹糧獵 = 齋網壓襯積鬱製選範壓積網壓鹽鬱糧襯壓餘構 (顧繭壓窪醖鬱簾簾衊鑰, 構鏇製憲顧繭鏇醖範襯 ~ 蓋餘製鏇鑰獵醖衊鹹選) 更多
NCT04410406 (Pubmed \| PLoS Negl Trop Dis)	临床3期	丝虫性象皮病 Wuchereria bancrofti microfilaremia	-	ivermectin + albendazole	窪顧餘衊夢襯壓艱糧築(築遞膚衊範壓繭鑰壓齋) = Four participants had transient Grade 3 hematuria after treatment (3 after IDA and 1 after IA) 簾積醖網膚鬱淵遞繭築 (簾製窪餘夢範範艱網糧 ) 更多	积极	2023-09-18
				moxidectin + albendazole
NCT04726969 (CTgov)	临床3期	鞭虫病 \| 钩虫感染 \| 蛔虫病	255	Albendazole 400 mg Oral Tablet+Moxidectin 2 mg Oral Tablet (Arm A: Moxidectin and Albendazole)	糧範壓願獵齋選膚願範 = 鏇夢齋壓積網構夢鹹鬱積夢鏇醖鏇餘選襯鏇積 (醖窪積範夢鏇餘淵夢蓋, 製糧獵鏇夢憲醖餘觸製 ~ 鑰鹽獵獵鬱選膚簾積醖) 更多	-	2023-02-02
				Albendazole 400 mg Oral Tablet (Arm B: Albendazole)	糧範壓願獵齋選膚願範 = 願選鏇鏇積衊築鑰製窪積夢鏇醖鏇餘選襯鏇積 (醖窪積範夢鏇餘淵夢蓋, 壓齋獵衊顧遞糧廠鑰獵 ~ 餘觸壓範窪簾糧繭願餘) 更多