A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Bilastine 20 mg Tablets and Reference Product (Bilaxten) in Healthy Thai Volunteers under Fasting Conditions

开始日期2025-07-21

申办/合作机构-

CTRI/2025/03/082777

/ Not yet recruiting临床4期IIT

Comparison of efficacy, safety, and cost-effectiveness of levocetirizine, fexofenadine, and bilastine in treatment of allergic rhinitis: A randomized, open-label, parallel-group study - NIL

开始日期2025-04-15

申办/合作机构-

TCTR20241223002

/ Not yet recruiting临床2/3期IIT

A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Bilastine 20 mg Tablets and Reference Product (Bilaxten) in Healthy Thai Subjects under Fasting Conditions

开始日期2025-03-17

申办/合作机构-

100 项与比拉斯汀相关的临床结果

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100 项与比拉斯汀相关的转化医学

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100 项与比拉斯汀相关的专利（医药）

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335

项与比拉斯汀相关的文献（医药）

2025-04-01·ENVIRONMENTAL RESEARCH

Is the European regulatory model for predicting worker exposure conservative? Comparison of predicted and measured under usual working conditions exposures in fruit growing

Article

作者: Duporté, Geoffroy ; Bureau, Mathilde ; Lebailly, Pierre ; Budzinski, Hélène ; De Graaf, Lucie ; Baldi, Isabelle ; Bouchart, Valérie ; Bresson, Morgane

INTRODUCTION:

Pesticide exposure increases the risk of chronic disease among farmers. Understanding exposure is necessary for epidemiological and regulatory purposes. In Europe, worker exposure is assessed during the registration process using the OPEX model, which is based on a limited number of studies, often unpublished and carried out by pesticide companies. We assessed the conservativeness of OPEX for workers performing post-application tasks (re-entry, harvesting).

METHODS:

In 2016-2017, dermal exposure to captan/THPI and dithianon was measured in French fruit farm workers during 65 re-entry (net folding and deployment, thinning, tying) and 58 harvesting days, using patches and cotton gloves. We used linear regression to compare measured and corresponding OPEX-calculated exposure using 1) default parameters; 2) field parameters (actual task duration, measured dislodgeable foliar residues) for 20 observations.

RESULTS:

Workers were exposed several days after the last application, which is not considered in the pesticide registration process. We found that the model underestimated exposure calculated with field parameters in all observations for dithianon and 60% for captan, linked to an underestimation of OPEX transfer coefficients (ratio of 0.40 for captan and 0.26 for dithianon between default and measured transfer coefficients).

DISCUSSION:

When observation occurred several days after application, OPEX tended to underestimate exposure. An industry study conducted under controlled working conditions found divergent results. It seems important to include field studies conducted under usual working conditions in the registration process to ensure a truly conservative approach and to consider cumulative exposure, since post-application tasks account for around 600 working hours a year.

2025-02-01·SCIENCE OF THE TOTAL ENVIRONMENT

Relationship between antihistamine residues in wastewater and airborne pollen concentrations: Insights into population-scale pollinosis response

Article

作者: Schmid-Grendelmeier, Peter ; Singer, Heinz ; Crouzy, Benoît ; Baumgartner, Stephan ; Ort, Christoph ; Salvisberg, Michelle ; Clot, Bernard

Pollinosis is the most prevalent allergic disorder. Assessing the impact of real-world pollen exposure on symptoms remains challenging due to extensive patient-level efforts required. This study explores the potential of wastewater-based epidemiology (WBE) to investigate the relationship between airborne pollen concentrations and antihistamine residues in wastewater as an indicator of pollinosis symptom treatment at the population-scale. In Zurich (Switzerland), 279 wastewater samples were collected during 2021-2023. Each sample represents a 24-h period with excreta from approximately 471,000 individuals. Eleven antihistamine markers were analyzed in the samples using liquid chromatography high-resolution mass spectrometry. The relationship between antihistamine loads in wastewater and airborne pollen concentrations (47 taxa and miscellaneous pollen) was investigated by determining seasonal components of antihistamine loads and exploring pollen-specific contributions using Non-Negative Least Squares (NNLS) optimization. Four antihistamines were detected in quantifiable amounts in wastewater. The first-generation antihistamine, diphenhydramine, demonstrated rather constant levels. In contrast, the three second-generation antihistamines - bilastine, cetirizine, and fexofenadine - showed pronounced day-to-day variation with strong correlations among each other. For fexofenadine, which was investigated in detail for its correlation with airborne pollen concentrations, approximately 50 % of the annual wastewater loads were associated with acute pollen exposure. Another 20 % related to baseline consumption during the pollen season, while the remaining 30 % seems unrelated to pollen. Birch, grasses, hazel, hornbeam, plane, and plantain explained most of the variance in wastewater loads (R² = 0.82), with grass pollen alone accounting for a quarter of the annual loads. Increased fexofenadine loads during periods without elevated concentrations of common allergenic pollen suggests the presence of additional triggers for allergy symptoms, potentially yew pollen. Our study demonstrates that WBE can effectively reveal substantial day-to-day variation in antihistamine use related to pollen exposure. Thus, WBE presents an objective and questionnaire-independent method for investigating pollinosis symptom treatment at a population-scale.

2025-01-01·JOURNAL OF VETERINARY MEDICAL SCIENCE

Comparing the effectiveness of four antihistamines with olopatadine in healthy Thoroughbred horses

Article

作者: MITA, Hiroshi ; IKEDA, Yasuhiko ; TAMURA, Norihisa ; OHTA, Minoru ; KURODA, Taisuke

We compared the antihistamine effect of four new antihistamines with olopatadine, which is used to treat equine allergic diseases. Six healthy Thoroughbred horses received oral doses of olopatadine (50 mg), levocetirizine (50 mg), bilastine (200 mg), rupatadine (100 mg), and desloratadine (50 mg) at >2-week intervals. The effects were investigated by measurement of the wheal area induced by histamine intradermal injection, and inhibition rate was compared with positive and negative controls. The maximum wheal inhibition rate (mean ± SD) of olopatadine (85.3% ± 7.7%) was significantly higher than those of bilastine (51.1% ± 11.8%), rupatadine (55.3% ± 6.6%), and desloratadine (59.8% ± 6.4%), but not levocetirizine (85.4% ± 8.0%). Levocetirizine is expected to have a high antihistamine effect on horses.

项与比拉斯汀相关的新闻（医药）

2025-04-07

·信狐药迅

抗精神病改良新布瑞哌唑口溶膜，第五家南通慧聚提交上市申请|新受理（3.24-3.30）

本周药品注册受理数据，分门别类呈现，一目了然。(3.24-3.30）新药上市申请药品名称企业注册分类受理号布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500026布瑞哌唑口溶膜南通慧聚制药有限公司2.2CXHS2500025新药临床申请药品名称企业注册分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500342DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500341DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500340AOD113408注射液成都奥达生物科技有限公司1CXHL2500339EDP167注射液亿腾医药(珠海)有限公司1CXHL2500336VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500335VVN432鼻喷雾剂维眸生物科技(浙江)有限公司1CXHL2500334CPI-818片嘉兴和剂药业有限公司1CXHL2500332CPI-818片嘉兴和剂药业有限公司1CXHL2500331WJ47156片上海君实生物医药科技股份有限公司1CXHL2500330WJ47156片上海君实生物医药科技股份有限公司1CXHL2500329JKN2301干混悬剂健康元药业集团股份有限公司1CXHL2500327BW-40202注射液上海舶望制药有限公司1CXHL2500338RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500325RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500324RO7673396薄膜包衣片罗氏研发(中国)有限公司1CXHL2500323WSD0922-FU片杭州威瑞宝生物医药有限公司1CXHL2500322WSD0922-FU 片杭州威瑞宝生物医药有限公司1CXHL2500321JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500320JZ-14胶囊云白药征武科技(上海)有限公司1CXHL2500319SVHRSP注射液沈阳万锦医药科技有限公司1CXHL2500318Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500316Alpha-0261片深圳阿尔法分子科技有限责任公司1CXHL2500315AKZ002直服颗粒海南爱科制药有限公司2.2CXHL2500343WS-011湖北午时药业股份有限公司2.2CXHL2500337ZL-0018山东则正医药技术有限公司2.2CXHL2500328硫酸镁无菌溶液广东迈恒医药研发有限公司2.2CXHL2500326EP-0203XR成都苑东生物制药股份有限公司2.3CXHL2500333注射用甲苯磺酸瑞马唑仑江苏恒瑞医药股份有限公司2.4CXHL2500317注射用JS207上海君实生物医药科技股份有限公司1CXSL2500252HD006细胞华道(上海)生物医药有限公司1CXSL2500251Cizutamig注射液上海坦蒂生物医药科技有限公司1CXSL2500249注射用人白介素-2(高亲和型复合物)北京良远生物医药研究有限公司1CXSL2500248注射用SSGJ-705沈阳三生制药有限责任公司1CXSL2500247注射用BC2027无锡智康弘义生物科技有限公司1CXSL2500245注射用TQB2102正大天晴药业集团南京顺欣制药有限公司1CXSL2500241AZD0901阿斯利康全球研发(中国)有限公司1CXSL2500242注射用MK-2870默沙东研发(中国)有限公司2.2CXSL2500244注射用重组A型肉毒毒素北京博特维克生物技术有限公司2.4CXSL2500246仿制药申请药品名称企业注册分类受理号马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501232马来酸曲美布汀片浙江东亚药业股份有限公司3CYHS2501231厄贝沙坦氨氯地平片(III)浙江昂利康制药股份有限公司3CYHS2501230维生素B6注射液湖南先施制药有限公司3CYHS2501229厄贝沙坦氨氯地平片(I)浙江昂利康制药股份有限公司3CYHS2501228重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501227重酒石酸卡巴拉汀口服液海南海和制药有限公司3CYHS2501226盐酸依匹斯汀滴眼液参天制药(中国)有限公司3CYHS2501218法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501216法莫替丁注射液山西铭羽生物科技有限公司3CYHS2501215维生素B6注射液西洲医药科技(浙江)有限公司3CYHS2501201琥珀酸亚铁片山西同达药业有限公司3CYHS2501200琥珀酸亚铁片上海金不换兰考制药有限公司3CYHS2501199布美他尼注射液重庆博腾药业有限公司3CYHS2501196吡格列酮二甲双胍片上海青平药业有限公司3CYHS2501195罗沙司他片石家庄市华新药业有限责任公司3CYHS2501188盐酸伊立替康脂质体注射液石药集团欧意药业有限公司3CYHS2501187复方聚乙二醇电解质散(儿童型)福州基石医药科技有限公司3CYHS2501182硝普钠注射液中润药业有限公司3CYHS2501180硝普钠注射液山西九康医药科技有限公司3CYHS2501176硝普钠注射液海南海和制药有限公司3CYHS2501159比拉斯汀口服溶液湖南科伦制药有限公司3CYHS2501158盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501157盐酸丁螺环酮片浙江京新药业股份有限公司3CYHS2501156山梨醇甘露醇冲洗剂西安京西双鹤药业有限公司3CYHS2501155铝碳酸镁混悬液江苏润恒制药有限公司3CYHS2501173盐酸精氨酸注射液四川邈济生物医药科技有限公司3CYHS2501162碳酸氢钠注射液安徽双鹤药业有限责任公司3CYHS2501161注射用吲哚菁绿仁合益康汇泽药业河北有限公司3CYHS2501160聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501225聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501224聚多卡醇注射液苏州朗科生物技术股份有限公司4CYHS2501223甲磺酸溴隐亭片江苏诚康药业有限公司4CYHS2501222乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501221乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501220乌帕替尼缓释片复星万邦(江苏)医药集团有限公司4CYHS2501219盐酸尼卡地平注射液国药集团容生制药有限公司4CYHS2501217注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501214注射用氟氧头孢钠齐鲁安替制药有限公司4CYHS2501213盐酸托莫西汀口服溶液山东步长制药股份有限公司4CYHS2501212利多卡因凝胶贴膏南京海纳医药科技股份有限公司4CYHS2501211双氯芬酸二乙胺乳胶剂湖南九典制药股份有限公司4CYHS2501210苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501209苯磺酸左氨氯地平片河南普瑞药业有限公司4CYHS2501208硫酸氨基葡萄糖胶囊山东诚康药业有限公司4CYHS2501207棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501206棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501205棕榈酸帕利哌酮注射液石药集团中诺药业(石家庄)有限公司4CYHS2501204比拉斯汀片桂林南药股份有限公司4CYHS2501203阿帕他胺片成都倍特药业股份有限公司4CYHS2501202舒更葡糖钠注射液海南斯达制药有限公司4CYHS2501198妥布霉素滴眼液深圳大佛药业股份有限公司4CYHS2501197硫酸氨基葡萄糖胶囊南京海鲸药业股份有限公司4CYHS2501194骨化三醇注射液山西康成利安医药有限公司4CYHS2501193地夸磷索钠滴眼液广东恒健制药有限公司4CYHS2501192硫酸氨基葡萄糖胶囊山东诺禾康药业有限公司4CYHS2501191骨化三醇注射液河南泰丰生物科技有限公司4CYHS2501190达格列净片山东普瑞曼药业有限公司4CYHS2501189艾普拉唑肠溶片浙江高跖医药科技股份有限公司4CYHS2501186阿奇霉素干混悬剂云鹏医药集团有限公司4CYHS2501185氟比洛芬凝胶贴膏湖南金圃医药科技有限公司4CYHS2501184布洛芬缓释胶囊郑州泰丰制药有限公司4CYHS2501183阿帕他胺片正大天晴药业集团南京顺欣制药有限公司4CYHS2501181沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501179沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501178沙库巴曲缬沙坦钠片海南赛立克药业有限公司4CYHS2501177玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501175玻璃酸钠滴眼液石家庄四药有限公司4CYHS2501174阿莫西林克拉维酸钾干混悬剂山东益康药业股份有限公司4CYHS2501154黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501171黄体酮软胶囊深圳大佛药业股份有限公司4CYHS2501170乳果糖口服溶液湖北午时药业股份有限公司4CYHS2501168蛋白琥珀酸铁口服溶液中山百灵生物技术股份有限公司4CYHS2501167八氟丙烷脂质微球注射液广州康臣药业有限公司4CYHS2501166硫酸镁钠钾口服用浓溶液湖北午时药业股份有限公司4CYHS2501165富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501164富马酸伏诺拉生片蚌埠丰原涂山制药有限公司4CYHS2501163乌帕替尼缓释片上海信谊百路达药业有限公司4CYHS2501172硫酸氨基葡萄糖胶囊江苏诺泰澳赛诺生物制药股份有限公司4CYHS2501169破伤风人免疫球蛋白浙江海康生物制品有限责任公司3.4CXSS2500038盐酸达克罗宁局部溶液剂深圳珐玛易药品科技有限公司3CYHL2500073溴莫尼定凝胶深圳珐玛易药品科技有限公司3CYHL2500072酮洛芬贴剂北京福元医药股份有限公司3CYHL2500071酮洛芬贴剂北京福元医药股份有限公司3CYHL2500070盐酸毛果芸香碱滴眼液苏州欧康维视生物科技有限公司3CYHL2500067米诺地尔泡沫剂深圳珐玛易药品科技有限公司3CYHL2500066双氯芬酸依泊胺贴深圳珐玛易药品科技有限公司3CYHL2500065硝呋太尔制霉菌素阴道软胶囊山东华铂凯盛生物科技有限公司4CYHL2500069沙美特罗替卡松吸入粉雾剂杭州知兴制药有限公司4CYHL2500068吸附破伤风疫苗北京智飞绿竹生物制药有限公司3.3CXSL2500250流感病毒裂解疫苗陕西昆秦生物科技有限公司3.3CXSL2500243进口申请药品名称企业注册分类受理号艾伏尼布片Servier Pharmaceuticals LLC5.1JXHS2500042利多卡因丙胺卡因气雾剂PLETHORA SOLUTIONS LIMITED5.1JXHS2500041度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500038度伐利尤单抗注射液AstraZeneca UK Limited3.1JXSS2500037PF-07985045片Pfizer Inc.1JXHL2500066PF-07985045片Pfizer Inc.1JXHL2500065Orforglipron胶囊Eli Lilly and Company1JXHL2500064Orforglipron胶囊Eli Lilly and Company1JXHL2500063Orforglipron胶囊Eli Lilly and Company1JXHL2500062Orforglipron胶囊Eli Lilly and Company1JXHL2500061Orforglipron胶囊Eli Lilly and Company1JXHL2500060Orforglipron胶囊Eli Lilly and Company1JXHL2500059TPST-1120片Tempest Therapeutics, Inc.1JXHL2500058Golcadomide胶囊Celgene Corporation1JXHL2500055Golcadomide胶囊Celgene Corporation1JXHL2500054Golcadomide胶囊Celgene Corporation1JXHL2500053Golcadomide胶囊Celgene Corporation1JXHL2500052醋酸甲地孕酮口服混悬液TWi Pharmaceuticals, Inc.2.4JXHL2500056罗氟司特泡沫Arcutis Biotherapeutics INC5.1JXHL2500057Empasiprubart注射用浓溶液argenx BV1JXSL2500047DS-1062aASTRAZENECA AB1JXSL2500045AZD2936AstraZeneca AB1JXSL2500044AZD2936AstraZeneca AB1JXSL2500042仑卡奈单抗注射液(皮下注射)Eisai Co., Ltd.2.1JXSL2500046TarlatamabAmgen Inc.2.2JXSL2500041TarlatamabAmgen Inc.2.2JXSL2500040TarlatamabAmgen Inc.2.2JXSL2500039帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2500043中药相关申请药品名称企业注册分类受理号桃核承气汤颗粒合肥华润神鹿药业有限公司3.1CXZS2500012肺热咳喘颗粒海南葫芦娃药业集团股份有限公司2.3CXZL2500020注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市临床申请

2025-03-27

·摩熵医药

科伦药业新一代抗组胺药申报上市，剑指70亿大市场！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 2025年3月25日，湖南科伦制药有限公司按注册分类3类申报的比拉斯汀口服溶液上市申请获受理。公开资料显示，比拉斯汀（Bilastine）是一种非镇静型长效抗组胺药，属于第2代组胺H1-受体拮抗剂，临床上主要用于过敏性鼻炎（季节性和常年性）和荨麻疹的对症治疗。截图来源：摩熵医药-中国药品审评审批数据库作为一种高选择性的二代抗组胺药，比拉斯汀起效快、作用持续时间长，与CYP酶系统无显著的相互作用、耐受性良好。与其他抗组胺药相比，其与H1受体亲和力比西替利嗪高3倍，比非索非那定高6倍。比拉斯汀（Bilastine）原研产品由西班牙FAES制药开发，最早于2010年8月获准在欧盟上市销售，用于治疗成人和12岁以上青少年的荨麻疹和变应性鼻炎。据摩熵医药-中国药品审评审批数据库显示，2023年6月，意大利生物制药集团美纳里尼旗下的比拉斯汀片（商品名：力敏能®）通过5.1类新药注册类型获得NMPA批准上市，用于12岁及以上青少年和成年人荨麻疹的对症治疗。 2024年11月，江苏华阳制药比拉斯汀片（商品名：新敏特®）通过4类仿制药注册类型获得NMPA批准上市，成为国内首个过评的产品。据摩熵医药-销售数据库显示，目前这两款药物均未上市销售。另外，已有山东新时代、石家庄四药、江苏悦兴药业、华益药业、深圳是贝美药业、浙江诺得药业等多家药企提交了比拉斯汀口服溶液上市申请，均获受理，竞争激烈。截图来源：摩熵医药-中国药品审评审批数据库中国慢性荨麻疹的发病率达到了2.6%-4.2%，超过了全球慢性荨麻疹的发病率。慢性荨麻疹患者的病程更长，复发率较高，不但会给患者造成严重的疾病负担，而且大部分病人还会伴有失眠、焦虑等精神方面的问题。因此，急需一种能够被患者接受的、高效的、新颖的治疗方法来解决中国慢性特发性荨麻疹患者对该病的需求。当前的荨麻疹治疗方案难以满足患者的临床需求，第一代抗组胺药可诱发镇静、精神运动和认知功能降低等副作用，损害患者学习能力并降低工作效率。相较之下，第二代H1抗组胺药的镇静作用较低或极低，无抗胆碱能作用，被推荐为荨麻疹患者新的一线治疗选择。比拉斯汀口服溶液剂型可以准确给药剂量，提高儿童服药便利性和依从性。比拉斯汀口服溶液为过敏性鼻炎和荨麻疹儿童提供了一种新的治疗药物选择。据摩熵医药-销售数据库显示，2023年和2024年上半年全国医院端抗组胺药物的销售额分别为50.94亿元和25.69亿元；全国药店零售端的销售额分别为26.25亿元和12.55亿元。市场巨大。小结虽然比拉斯汀申报上市的企业众多，竞争激烈，但其为新一代抗组胺药，相比第一代，有明显的优势，同时目前众多企业都在同一起跑线上，并为形成垄断格局。未来谁能分得抗组胺药物大市场的一杯羹，我们拭目以待。 END 本文为原创文章，转载请留言获取授权近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

上市批准医药出海申请上市

2025-03-24

·SYNAPSE

Faes Farma signs an agreement to acquire Laboratorios Edol, a leader in ophthalmology in Portugal

Bilbao, 25 2025 – Faes Farma, S.A. has today signed a sale and purchase agreement, subject to suspensive conditions, to acquire 100% of Laboratorios Edol Productos Farmacêuticos, S.A., consolidating its expansion in the Portuguese market and in the ophthalmology area. Founded in 1952, Laboratorios Edol is a leader in ophthalmology in Portugal, with annual sales in 2024 exceeding 30 million euros. It also has a modern production plant and a portfolio that strengthens Faes Farma’s portfolio by adding complementary products. The transaction, valued at 75 million euros (to be adjusted for net debt), will allow the Spanish group to double sales in Portugal and capitalise on commercial and operational synergies. The acquisition of Laboratorios Edol represents a new strategic milestone in Faes Farma’s commitment to growth in international markets and strengthens its position in the Portuguese market , where the Group has been present for more than 80 years. Laboratorios Edol has a portfolio of products and registrations that will also enable Faes Farma’s expansion and positioning in markets other than Portugal, taking advantage of Faes Farma’s existing commercial networks, both in Spain and in international markets. Ophthalmology, a specialisation of Laboratorios Edol, is an area in which Faes Farma already has expertise in the development and launch of bilastin ophthalmic. In addition, represents a key strategic opportunity, with expected double-digit growth, driven not only by the ageing of the population resulting in pathologies such as glaucoma and dry eye, but also by the increase in symptoms caused by seasonal allergies and prolonged use of screens. In short, this operation is part of Faes Farma’s international growth strategy, reinforcing its direct presence in Portugal and supporting the growth of the business through new therapeutic areas allowing the creation of synergies with the current R&D&I team. The closing of the transaction is subject to the satisfactory completion of conditions precedent, including the submission of audited annual accounts for 2024 and the continuation of some of the existing commercial agreements with Laboratorios Edol.

并购

100 项与比拉斯汀相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09570	比拉斯汀	R06AX29	DB11591

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
慢性荨麻疹	加拿大	Old API Wind-down Ltd.	2016-12-02
皮炎	日本	Faes Farma SA	2016-09-28
湿疹	日本	Faes Farma SA	2016-09-28
瘙痒	日本	Taiho Pharmaceutical Co., Ltd.	2016-09-28
瘙痒	日本	Faes Farma SA	2016-09-28
过敏性鼻炎	日本	Faes Farma SA	2016-09-28
过敏性鼻炎	日本	Taiho Pharmaceutical Co., Ltd.	2016-09-28
季节性过敏性鼻炎	加拿大	Aralez Pharmaceuticals Canada, Inc.	2016-04-21
过敏性鼻结膜炎	奥地利	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	比利时	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	保加利亚	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	塞浦路斯	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	捷克	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	丹麦	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	爱沙尼亚	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	芬兰	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	法国	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	德国	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	希腊	Grünenthal GmbH	2010-09-08
过敏性鼻结膜炎	匈牙利	Grünenthal GmbH	2010-09-08

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
变应性结膜炎	临床3期	美国	Faes Farma SA	2018-04-07
常年性变应性鼻炎	临床3期	-	Faes Farma SA	2004-05-01
季节性过敏性结膜炎	临床2期	美国	Faes Farma SA	2007-12-01
鼻结膜炎	临床2期	加拿大	Faes Farma SA	2007-10-01

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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


NCT03479307 (CTgov)	临床3期	变应性结膜炎	228	Bilastine Ophthalmic Solution 0.6% (Bilastine Ophthalmic Solution 0.6%)	壓鬱餘鬱鹹築製餘獵鏇(簾繭構糧醖夢夢糧夢淵) = 獵鏇遞鑰顧願顧遞糧壓築襯範顧鹹壓範鬱憲鏇 (顧遞鏇簾艱願顧繭遞獵, 0.9013) 更多	-	2021-12-14
				Ketotifen Ophthalmic Solution 0.025% (Zaditen) (Ketotifen Ophthalmic Solution 0.025% (Zaditen))	壓鬱餘鬱鹹築製餘獵鏇(簾繭構糧醖夢夢糧夢淵) = 顧製窪蓋簾夢願築膚醖築襯範顧鹹壓範鬱憲鏇 (顧遞鏇簾艱願顧繭遞獵, 0.9504) 更多
NCT03231969 (CTgov)	临床2期	变应性结膜炎	121	Bilastine 0.2% (Bilastine 0.2%)	窪積鹽醖鹽鹹顧範憲窪(觸顧繭製衊觸遞糧願範) = 鹹餘壓窪夢鏇簾齋製鏇選壓鹹鏇廠簾遞願鹽衊 (願憲範憲蓋繭醖築選選, 0.7809) 更多	-	2021-11-24
				Bilastine 0.4% (Bilastine 0.4%)	窪積鹽醖鹽鹹顧範憲窪(觸顧繭製衊觸遞糧願範) = 艱繭廠構艱淵遞鹹襯簾選壓鹹鏇廠簾遞願鹽衊 (願憲範憲蓋繭醖築選選, 0.9449) 更多
ARVO2020	临床1期	一线	12	Bilastine Eye Drops	選鏇鬱膚積蓋製範繭簾(艱齋選範鏇觸艱襯鹹襯) = 築壓鹽繭製艱願齋獵壓積鏇窪鬱膚膚鑰鬱餘淵 (鬱膚廠夢簾壓壓願鑰憲 ) 更多	-	2020-06-01
NCT02761252 (SKY, CTgov)	临床4期	哮喘 \| 季节性过敏性结膜炎	454	Montelukast 10mg+Bilastine 20mg (Bilastine+Montelukast)	鑰顧窪壓選繭顧窪鹹淵(艱願製淵遞餘觸衊觸廠) = 顧糧衊顧糧壓鹽憲憲鑰積淵願餘糧範鏇餘簾淵 (淵壓壓範鬱餘鹽鏇繭廠, 糧襯壓網艱淵艱夢醖窪 ~ 窪繭網醖網窪鑰襯廠顧) 更多	-	2019-07-12
				Placebo Montelukast 10mg+Bilastine 20mg (Bilastine+Placebo Montelukast)	範夢顧簾夢鏇醖選鑰築(醖顧構鏇襯鹹簾窪鏇顧) = 簾壓製鑰襯簾壓鑰顧廠網膚鬱鏇繭簾窪構糧餘 (膚膚觸廠鹽範鹽鹽蓋壓, 願夢夢夢糧淵糧蓋鹹壓 ~ 膚蓋繭鹹壓餘夢範積餘) 更多
NCT02576041 (F1, CTgov)	临床4期	过敏性鼻炎 \| 荨麻疹	19	Placebo+Bilastine	鏇衊廠齋積蓋蓋襯醖窪(糧簾鹹積製衊鏇鹽夢襯) = 積選鑰齋糧糧淵鏇衊繭網膚醖範鏇齋鏇鹽蓋鹹 (廠鑰夢築衊繭顧選製齋, 夢繭廠築膚觸鑰淵鏇蓋 ~ 觸憲顧廠鹽鑰餘憲遞艱) 更多	-	2017-01-16
NCT01124123 (Pubmed \| Clin Drug Investig)	临床1期	-	12	20-mg oral tablet	構鹽鏇簾獵製糧選願顧(壓糧願襯襯選醖鏇齋齋) = 夢襯蓋繭鑰繭鏇廠積範顧繭製鹽積窪範蓋糧構 (構選製壓繭廠艱繭蓋壓, 53.79 ~ 67.56)	-	2013-05-01
NCT00419783 (Pubmed \| J Clin Pharmacol)	临床1期	-	30	Bilastine at therapeutic dose (20 mg once daily)	觸觸鹹網餘鑰觸顧糧衊(憲膚鹽遞築鏇窪艱淵壓) = 獵繭顧鏇獵蓋餘襯顧餘齋觸鹽蓋襯糧製鹹齋壓 (範夢襯淵鏇夢憲蓋淵襯 )	-	2012-06-01
				Bilastine at supratherapeutic dose (100 mg once daily)	觸觸鹹網餘鑰觸顧糧衊(憲膚鹽遞築鏇窪艱淵壓) = 衊繭窪鬱鹽遞艱繭遞膚齋觸鹽蓋襯糧製鹹齋壓 (範夢襯淵鏇夢憲蓋淵襯 )
NCT00504933 (Pubmed \| Clin Exp Allergy)	临床3期	季节性过敏性鼻炎	683	Bilastine 20 mg	淵製獵鑰鑰醖鹽鏇襯鹽(蓋顧簾鑰壓鑰膚觸廠膚) = 餘襯齋積範構繭艱夢衊獵憲選簾鹹網鏇選襯夢 (襯廠繭觸選糧淵顧網鏇 )	积极	2009-09-01
				Cetirizine 10 mg	淵製獵鑰鑰醖鹽鏇襯鹽(蓋顧簾鑰壓鑰膚觸廠膚) = 鑰範鬱鏇廠顧簾獵獵糧獵憲選簾鹹網鏇選襯夢 (襯廠繭觸選糧淵顧網鏇 )