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富马酸氯马斯汀为第一代H₁抗组胺药，靶点为组胺H₁受体，通过竞争性阻断组胺结合发挥抗过敏作用，临床用于过敏性疾病。国内注射液化药3类仿制制剂已有2家企业获批，化合物专利已到期。 基本信息 药物分类：第一代乙醇胺类（二苯甲醚类）H₁受体拮抗剂 原研信息 原研公司：诺华制药（Novartis Pharmaceuticals Corp.），其研发历史可追溯至 Sandoz（山德士）/Siegfried AG 原研商品名：Tavist（美国市场）；Tavegil（欧洲及全球其他市场） 首批上市国家/时间：美国，1977年2月25日（FDA NDA 017661首次批准片剂） 美国市场现状：已退市（Discontinued）；联邦公报明确认定非因安全性或有效性原因撤市 欧洲市场现状：Tavegil 注射液仍在部分欧洲国家销售，现持证商为GSK Consumer Healthcare/Gebro Pharma GmbH 靶点：组胺H₁受体（Histamine H₁ receptor），属成熟靶点。 作用机制： 竞争性阻断H₁受体，阻止组胺与靶细胞（血管内皮、平滑肌、神经末梢）结合； 减少毛细血管扩张与通透性增加，抑制水肿形成、红斑及风团反应； 对抗胃肠道及呼吸道平滑肌收缩； 兼具中枢镇静与外周抗胆碱能副作用（口干等）； 不能灭活组胺，也不抑制组胺释放—— 仅阻断其效应； 特点：起效快、作用持续时间长（可达12小时）。 适应症 注射液：急性过敏性疾病（急性荨麻疹、过敏性鼻炎急性发作、药物过敏反应等），用于不宜口服的急性期患者。 口服剂型：过敏性鼻炎、荨麻疹、湿疹、皮肤瘙痒症、变应性结膜炎；亦可用于支气管哮喘的抗过敏辅助治疗。 竞品信息（注射用抗组胺药） 上市情况 美国市场仅有口服片剂且已退市；注射液剂型主要在欧洲（以Gebro Pharma的Tavegil为代表）和中国市场流通，美国从未上市该注射液剂型。 国产药品上市信息： 参比制剂 注册与受理信息 专利情况原研化合物专利：氯马斯汀于1960年代由Sandoz/Siegfried首次发明并申请专利，美国市场核心化合物专利已于1997年前后到期；中国化合物专利已过期。因此该品种属完全开放的仿制药品种，无化合物专利壁垒。 国际专利 其他药品分享链接如下，欢迎点击查看： Ormeloxifene OTF慢性体重管理的新型药物-Tirzepatide 新型的非阿片类小分子镇痛药-Suzetrigine 奥麦利昔芬口腔薄膜立项调研报告 纳米技术双氯芬酸乳胶剂药学研究 2025年9月药品批准信息快讯（八）——利斯的明透皮贴剂分享 2025年9月药品批准信息快讯（九）——米托坦片分享 CDE-《化学仿制药参比制剂目录（第一百批）》（征求意见稿）[附: 药品分享——阿达苏(洛沙平吸入剂)] 药品分享-塞来昔布盐酸曲马多片 药品分享——伐莫洛龙口服混悬液 【药品分享】盐酸菲优拉生片 【药品分享】拉坦噻吗滴眼液 【药品分享】Baxdrostat 片 【药品分享】Omecamtiv Mecarbil缓释片 【药品分享】曲地匹坦（Rolapitant） 【药品分享】Zasocitinib 胶囊 【药品分享】甲磺酸阿帕替尼片 【药品分享】巴氯芬口服溶液 【药品分享】奥德昔巴特胶囊 【药品分享】扎维吉泮鼻喷雾剂 【药品分享】左羟丙哌嗪糖浆 【药品分享】利丙双卡因凝胶贴膏 【药品分享】司来吉兰改良型新药（缓释片） 【药品分享】复方甘菊利多卡因凝胶 【药品分享】盐酸索安非托片 【药品分享】地塞米松口溶膜 【药品分享】盐酸来罗西利片 【药品分享】马来酸噻吗洛尔凝胶 【药品分享】褪黑素颗粒 【药品分享】罗氟司特乳膏 【药品分享】盐酸芬戈莫德胶囊 【药品分享】示踪用盐酸米托蒽醌注射液 【药品分享】美洛昔康纳米晶注射液 【药品分享】Clasoterone 5%外用溶液 【药品分享】马来酸依那普利口服溶液 【药品分享】注射用双氯芬酸钠利多卡因 【药品分享】马来酸依那普利叶酸片—复方降压药 【药品分享】依曲帕米鼻喷雾剂—用于治疗成人阵发性室上性心动过速的可自行给药鼻喷雾剂 【药品分享】奥卡西平口服混悬液—一款可用于儿童的钠通道调节类抗癫痫药 【药品分享】泊沙康唑口服混悬液——一种常用的抗真菌药物 【药品分享】舒沃替尼片 【药品分享】依伏卡塞片——第二代口服拟钙剂 【药品分享】西诺氨酯片——第三代抗癫痫发作药物 【药品分享】匹妥布替尼片——非共价可逆 BTK 抑制剂（用于复发 / 难治套细胞淋巴瘤（MCL）） 【药品分享】贝美前列素【产品分享】达普司他片 【药品分享】水合氯醛糖浆——镇静催眠药 【产品分享】苏沃雷生（Suvorexant）——全球首个食欲素受体拮抗剂类催眠药 【药品分享】贝沙罗汀 【药品分享】地夫可特干混悬剂——一种糖皮质激素类药物 【药品分享】伊卢多啉片——治疗成人腹泻型肠易激综合征（IBS‑D）的首创口服阿片受体调节剂 【药品分享】卢美哌隆胶囊——一种新型的非典型抗精神病药物 【药品分享】奥氟格列隆片——口服非肽类小分子 GLP-1 受体激动剂 【药品分享】苯磺酸克利加巴林胶囊——一种新型的治疗神经病理性疼痛的药物 【药品分享】苯磺酸美洛加巴林片——治疗周围神经病理性疼痛（PNP）的第三代钙离子通道调节剂 【药品分享】Iberdomide胶囊——一款新一代cereblon（CRBN）E3连接酶调节剂（CELMoD）化合物 【药品分享】酒石酸伐尼克兰鼻喷雾剂——一种用于治疗干眼症的西药 【药品分享】赛沃替尼片——中国首个获批的高选择性 MET 酪氨酸激酶抑制剂 【药品分享】盐酸阿夫唑嗪缓释片——一种用于治疗良性前列腺增生（BPH） 的 α1 - 受体阻滞剂 【药品分享】索格列净片——全球首个获批的SGLT1/SGLT2 双重抑制剂 【药品分享】奥吡卡朋胶囊——新一代的儿茶酚-氧位-甲基转移酶抑制剂（COMT） 【药品分享】奎扎替尼片——一种口服高选择性 FLT3 抑制剂 【药品分享】硫酸拉罗替尼胶囊 / 口服溶液——全球首个高选择性口服 TRK 抑制剂 【药品分享】司帕生坦片——成人IgA肾病领域首个非免疫抑制疗法 【药品分享】黄体酮阴道栓剂/阴道缓释凝胶剂——主要用于辅助生殖技术（ART）中的黄体支持 【药品分享】替戈拉生片——首款国产钾离子竞争性酸阻滞剂类药物（P-CAB） 【药品分享】拉坦前列烯酯滴眼剂——一种新型眼科用药 【药品分享】布比卡因脂质体注射液——一种长效局部麻醉药 【药品分享】甲磺酸加诺沙星片——一种喹诺酮类抗菌药 【药品分享】磷酸芦可替尼乳膏——中国首款且唯一获批的白癜风治疗靶向药 【药品分享】甲磺酸洛美他派胶囊——全球唯一口服MTP抑制剂 【药品分享】依达拉奉口服混悬液——肌萎缩侧索硬化症（ALS，渐冻人症）新药 【药品分享】依达拉奉右莰醇舌下片——全球卒中领域首个获FDA突破性疗法认定的舌下脑保护剂 【药品分享】马来酸氟诺替尼片——JAK2/FLT3/CDK6 三靶点抑制剂 【药品分享】普拉替尼胶囊——国内首个获批的高选择性 RET（转染重排）酪氨酸激酶抑制剂 【药品分享】右美托咪定舌下膜——新型 α₂肾上腺素受体激动剂舌下膜剂 【药品分享】卡匹色替片——全球首个获批上市的AKT抑制剂 【药品分享】库莫西利胶囊——全球首个CDK2/4/6抑制剂 【药品分享】赛贝曲司他片——全球首个HAE急性发作口服疗法 【药品分享】KYGEVVI（Doxecitine/Doxribtimine）——全球首款且唯一获批的TK2d针对性治疗药物 【药品分享】Forzinity（Elamipretide）注射剂——全球首个用于治疗Barth综合征的药物 【药品分享】Brinsupri（Brensocatib, 布伦索卡替布）片——全球首个获批上市的二肽基肽酶1（DPP-1）抑制剂 【药品分享】维立西呱片——全球首个心衰适应症的可溶性鸟苷酸环化酶（sGC）刺激剂 【药品分享】盐酸哌罗匹隆片——非典型抗精神病药 【药品分享】盐酸托泊替康胶囊/注射用盐酸托泊替康——经典的拓扑异构酶Ⅰ抑制剂类抗肿瘤药 【药品分享】阿普昔腾坦片——全球首个获批用于难治性高血压的口服双重内皮素受体拮抗剂（ERA） 【药品分享】注射用盐酸依拉环素——全球首个氟环素类抗生素 【药品分享】奥洛格列净胶囊——国内首款抑制SGLT1与SGLT2的1类创新药 【药品分享】盐酸匹米替尼胶囊——国内首个、全球首个获批的腱鞘巨细胞瘤（TGCT）系统性靶向药，高选择性CSF-1R抑制剂 【药品分享】布地奈德肠溶胶囊——全球首个、中国唯一获批用于原发性IgA肾病对因治疗的靶向药物 【药品分享】艾拉莫德片——中国原研、全球首个上市的小分子抗风湿药（csDMARD） 【药品分享】索托克拉片——新一代BCL2抑制剂 【药品分享】利奈昔巴特片——口服、选择性、可逆性回肠胆汁酸转运体（IBAT/ASBT）抑制剂 【药品分享】多替诺雷片——高选择性URAT1抑制剂 【药品分享】瑞普泊肽片——口服GLP‑1/GIP双靶点激动剂 【药品分享】硫酸索西美雷塞片——口服、强效的KRAS G12C共价抑制剂 【药品分享】罗伐昔替尼片——全球首创JAK/ROCK双靶点口服小分子抑制剂 【药品分享】埃诺格鲁肽注射液——全球首个获批上市的cAMP偏向型长效GLP-1受体激动剂 【药品分享】维培那肽注射液——长效GLP-1受体激动剂 【药品分享】普乐司兰钠注射液——全球首个靶向APOC3 mRNA的siRNA降脂药 【药品分享】玛仕度肽注射液——全球首个GCG/GLP-1双激动剂 【药品分享】瑞米布替尼片——全球首个获批用于CSU的口服靶向药 【药品分享】溴莫尼定噻吗洛尔滴眼液——α₂受体激动剂与非选择性 β 受体阻滞剂组成的复方降眼压药 【药品分享】吡洛西利片——国内首个CDK2/4/6多靶点抑制剂 【药品分享】奥氟格列隆片（Orforglipron） ——中国首个、全球首批上市的口服小分子 GLP-1受体激动剂 【药品分享】Copper Histidine注射液（Zycubo）——全球首个、唯一用于治疗儿童门克斯病（Menkes disease）的铜替代注射剂 【药品分享】依来格列隆片（Elecoglipron）——口服小分子非肽类GLP-1受体激动剂 【药品分享】阿利奈普仑（Aleniglipron）——口服小分子、非肽类、偏向性GLP-1受体激动剂 【药品分享】甲磺酸阿美替尼片——中国首个原研三代EGFR酪氨酸激酶抑制剂（TKI） 【药品分享】甲磺酸达麦利替尼片——口服高选择性c-MET酪氨酸激酶抑制剂 【药品分享】盐酸Acoramidis片——转甲状腺素蛋白（TTR）稳定剂 【药品分享】阿莫西林伏诺拉生胃漂浮片——3D打印胃漂浮片 【药品分享】盐酸伊可白滞素片——全球首创口服IL‑23受体拮抗剂 【药品分享】马来酸吡咯替尼片——中国首个自研的HER1/HER2/HER4不可逆酪氨酸激酶抑制剂（TKI） 【药品分享】本维莫德乳膏——全球首创芳香烃受体（AhR）调节剂（TAMA）类皮肤病外用药 【药品分享】盐酸莫托咪酯注射液——化药1类静脉麻醉新药 【药品分享】注射用罗哌卡因微晶——长效缓释局部麻醉药 【药品分享】盐酸伊立替康脂质体注射液——一款针对吉西他滨治疗失败的转移性胰腺癌的二线标准脂质体化疗药 【药品分享】甲磺酸氟马替尼片——Bcr-Abl酪氨酸激酶选择性抑制剂 【药品分享】注射用阿加糖酶β——国内获批的首个用于治疗法布雷病的药物 【药品分享】甲苯磺酸尼拉帕利胶囊——高选择性PARP1/2抑制剂 【药品分享】帕米帕利胶囊——强效、选择性PARP1/2抑制剂 【药品分享】苯环喹溴铵鼻喷雾剂——选择性M胆碱能受体拮抗剂 【药品分享】注射用拉罗尼酶浓溶液——MPS Ⅰ型的特异性酶替代治疗药物 【药品分享】海博麦布片——国产自主原研的胆固醇吸收抑制剂 【药品分享】盐酸可洛派韦胶囊——直接抗病毒药物（DAA）→ NS5A抑制剂 【药品分享】克拉考特酮乳膏——外用、非甾体、选择性雄激素受体（AR）抑制剂 【药品分享】非卢替尼片——全球首个用于多发性硬化的口服BTK抑制剂 【药品分享】Brenipatide注射液——GLP-1R/GIPR双受体激动剂（继替尔泊肽之后的第二款） 【药品分享】罗赛促红素α注射液——国产首个长效重组促红细胞生成素（EPO）创新药 【药品分享】贝组替凡片——全球首个口服小分子HIF-2α抑制剂 【药品分享】那米司特片——口服选择性PDE4B抑制剂 【药品分享】富马酸立康可泮胶囊——一款针对罕见病PNH的口服补体B因子抑制剂 【药品分享】醋酸索乐匹尼布片——高选择性脾酪氨酸激酶（Syk）抑制剂 【药品分享】甲磺酸艾多替尼片——全球首款专为肺癌脑转移设计的第三代EGFR-TKI 【药品分享】安瑞克芬注射液——全球首个获批镇痛适应症的高选择性外周κ-阿片受体（KOR）激动剂 【药品分享】Difelikefalin注射液——全球首个获批的外周选择性κ-阿片受体（KOR）激动剂 【药品分享】Obefazimod——口服、靶向 CBC、特异性增强miR-124的首创小分子 【药品分享】拉尼兰诺片——口服泛PPAR激动剂 【药品分享】舒洛地特注射液——抗血栓药、血管保护剂 【药品分享】贝普若韦生注射液——反义寡核苷酸（ASO）类乙肝新药 【药品分享】氨酚右敏口服溶液（奥肯能®）——中国内地唯一获批的氨酚右敏口服溶液 【药品分享】佩玛贝特片——新型过氧化物酶体增殖物激活受体α/δ双重激动剂 (PPARα/δ) 【药品分享】盐酸依匹斯汀乳膏——外用第二代非镇静抗组胺抗过敏药膏 【药品分享】注射用双羟萘酸帕瑞肽微球——一款用于治疗肢端肥大症的第二代长效生长抑素类似物（SRL）微球制剂 【药品分享】埃拉菲布拉诺片——治疗原发性胆汁性胆管炎（PBC）的口服靶向新药 【药品分享】泽卢克布仑钠注射液——新一代皮下注射型C5补体抑制剂 【药品分享】依达拉奉右莰醇注射用浓溶液——一款复方神经保护类注射剂 【药品分享】醋酸戈那瑞林注射液——促性腺激素释放激素（GnRH）类药物 【药品分享】甲磺酸贝舒地尔片——全球首个选择性ROCK2激酶抑制剂 【药品分享】伊托法替布软膏——外用JAK抑制剂（JAK1/JAK3） 【药品分享】注射用华卟啉钠——新型肿瘤光动力治疗（PDT）专用光敏剂 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】艾普美妥司他片——EZH1/2双靶创新药 【药品分享】精氨酸艾曲莫德片——新型选择性鞘氨醇1-磷酸受体（S1P₁）调节剂 【药品分享】磷酸芦可替尼乳膏——全球/国内首款、唯一获批用于非节段型白癜风复色的外用JAK1/JAK2选择性抑制剂 【药品分享】盐酸右哌甲酯缓释胶囊——治疗6岁及以上注意缺陷多动障碍（ADHD）的一线药物 【药品分享】抗菌肽PL-3301口腔凝胶——中国首创的抗菌肽类抗口腔真菌感染药物 【药品分享】Zasocitinib (TAK-279) 胶囊——新一代高选择性口服 TYK2 抑制剂 【药品分享】注射用Abelacimab——一款全人源IgG1单克隆抗体，靶向凝血因子XI（FXI） 【药品分享】Duvakitug注射液——首创性人源化IgG1-λ2单克隆抗体，靶向TL1A（TNFSF15） 【药品分享】醋酸氟轻松/氢醌/维A酸乳膏——治疗中重度黄褐斑疗效明确的外用复方 【药品分享】富马酸伏诺拉生氯化钠注射液——钾离子竞争性酸阻滞剂（P‑CAB）||东阳光药业研发的2.2,2.4类改良新型新药 【药品分享】盐酸阿曲生坦片——诺华研发的高选择性内皮素 A（ETA）受体拮抗剂||中国首个获批用于IgA 肾病的非免疫性口服靶向药 【药品分享】RGT-274-CR胶囊——上海齐鲁锐格医药研发的口服小分子GLP-1受体激动剂 【药品分享】酒石酸西尼必利片——高选择性5-HT₄受体激动剂类胃肠动力药 【药品分享】石杉碱甲控释片——采用双相控释/渗透泵技术的2.2类改良型新药 【药品分享】塞伐艾替尼片——口服、可逆、选择性酪氨酸激酶抑制剂（TKI） 【药品分享】Admilparant片——口服小分子LPA₁受体拮抗剂 【药品分享】瑞拉可兰胶囊——全球首个选择性糖皮质激素受体（GR）拮抗剂 【药品分享】盐酸依特卡肽注射液——全球首个、国内唯一获批的静脉注射型拟钙剂 【药品分享】Avacincaptad pegol玻璃体内注射液——全球首批用于AMD继发地图样萎缩（GA）的靶向药物 【药品分享】盐酸达利雷生片——新一代非管制、非苯二氮䓬类抗失眠药物 【药品分享】甲磺酸瑞索利塞片——高选择性PI3Kα小分子靶向抑制剂 || 全球首个获批用于特定卵巢癌的靶向新药 【药品分享】富马酸西他沙星注射液——新型喹诺酮类抗菌药物 【药品分享】Icotrokinra——全球首个获批的口服 IL-23 受体（IL-23R）选择性拮抗多肽 【药品分享】氘可来昔替尼片（Deucravacitinib）——全球首个口服、选择性 TYK2 变构抑制剂 【药品分享】柯美奇拜单抗注射液——鼻用糖皮质激素治疗后症状控制不佳的成人中重度季节性过敏性鼻炎患者的福音 【药品分享】吉诺昔替尼——口服小分子JAK1/TYK2双重抑制剂 【药品分享】洛替拉纳（Lotilaner）——GABA 门控氯离子通道非竞争性拮抗剂 || 兼具兽医驱虫与人用眼科两大用途 【药品分享】CagriSema——由卡格列肽（cagrilintide）2.4 mg与司美格鲁肽（semaglutide）2.4 mg组成的强效减重复方药 【药品分享】苹果酸卡博替尼——口服、多靶点酪氨酸激酶抑制剂（TKI） 【药品分享】迪高替尼（Delgocitinib）——一款外用泛JAK抑制剂 【药品分享】拉氟莫司(Laflunimus)——口服免疫抑制剂 || 兼具免疫抑制与抗炎双重活性 【药品分享】伏昔尼布片——全球首个IDH1/IDH2双重突变抑制剂靶向药 【药品分享】盐酸奥昔布宁片——M受体抗胆碱药 【药品分享】贝泽昔替尼片——国内首款获批的高选择性JAK2单靶点抑制剂 【药品分享】苯甲酸安达艾替尼胶囊——新型小分子酪氨酸激酶不可逆抑制剂（EGFR-TKI） 【药品分享】伏欣奇拜单抗注射液——全人源抗IL‑1β单克隆抗体 || 用于急性痛风性关节炎的1类创新生物药 【药品分享】利多卡因丁卡因乳膏 【药品分享】伐米奇拜单抗注射液——玻璃体内注射用抗IL-6人源化单抗 【药品分享】依赛弗酶α注射液（Efzimfotase alfa 注射液）——第二代重组组织非特异性碱性磷酸酶（TNSALP）酶替代疗法 【药品分享】格达托利西布（Gedatolisib）——first‑in-class 泛 PI3K/mTORC1/2 双重抑制剂 【药品分享】伯瑞替尼肠溶胶囊——中国原研、高选择性c-MET小分子抑制剂 || 首个获批MET扩增NSCLC单药治疗的靶向药 【药品分享】力胜克拉片——中国首个申报上市的原研Bcl-2抑制剂、全球第二款Bcl-2抑制剂 【药品分享】BGM0504注射液——GLP-1/GIP 双受体激动剂 【药品分享】塞利尼索片——全球首个口服选择性核输出蛋白XPO1抑制剂 【药品分享】Seltorexant薄膜包衣片——选择性食欲素2受体（OX2R）高选择性拮抗剂 【药品分享】盐酸埃克替尼片——国内首个自主研发的一代EGFR-TKI 【药品分享】盐酸伊普可泮胶囊——全球首个口服补体B因子抑制剂 【药品分享】恩考芬尼胶囊——靶向BRAF V600突变的口服激酶抑制剂 【药品分享】Enpatoran——口服、选择性TLR7/8小分子抑制剂 【药品分享】硝酸异康唑阴道片——抗真菌外用药物 【药品分享】Zorevunersen注射液——全球独家ASO上调蛋白表达技术 【药品分享】妥拉美替尼胶囊——全球首个针对NRAS突变黑色素瘤的MEK抑制剂 【药品分享】盐酸替那帕诺片——全球首创NHE3抑制剂类新型降磷药物 【药品分享】注射用莱古比星——新型蒽环类抗肿瘤药 【药品分享】优替德隆胶囊——口服埃博霉素类微管抑制剂 【药品分享】伊那利塞片——中国首个PIK3CA突变乳腺癌精准靶向药 【药品分享】呋喹替尼胶囊——中国首个自主研发VEGFR-TKI || VEGFR靶点靶向抗癌药 【药品分享】琥珀酸瑞波西利片——CDK4/6抑制剂 【药品分享】盐酸替那帕诺片——全球首个且唯一获批的肠道磷吸收抑制剂 【药品分享】芬布替尼片——口服、可逆、可透过血脑屏障的BTK抑制剂 【药品分享】炔丙基半胱氨酸胶囊——全球首个进入临床的硫化氢（H₂S）供体I类创新药 【药品分享】Balcinrenone达格列净胶囊——选择性盐皮质激素受体拮抗剂（MRA）+SGLT-2抑制剂 【药品分享】诺拉西班（Nolasiban）分散片——选择性口服催产素受体拮抗剂 || 早产二线/辅助治疗药物 【药品分享】塞多明基注射液——国内首款裸质粒基因治疗药物 【药品分享】鲁兹诺雷钠片——国产首个高选择性URAT1抑制剂 【药品分享】玛伐凯泰胶囊——全球首创、中国唯一获批的心肌肌球蛋白抑制剂 【药品分享】依托芬那酯凝胶——外用非甾体抗炎镇痛药 【药品分享】聚卡波非钙片——国际指南首选容积性缓泻剂 【药品分享】Mezigdomide胶囊——新一代IMiDs/cereblon E3泛素连接酶调节 【药品分享】洛布替尼片——全球首款共价+非共价双机制第四代 BTK 靶向药 【药品分享】奥莱泊肽注射液——PEG修饰长效GLP‑1单靶点激动剂 【药品分享】安瑞曲替尼胶囊 ——国内第二款国产二代NTRK广谱抗癌药 【药品分享】麦格司他胶囊——抑制葡萄糖神经酰胺合成酶的罕见病口服靶向药 【药品分享】乌帕替尼片（Upadacitinib）——选择性JAK1抑制剂 【药品分享】Dordaviprone胶囊——全球首款、目前唯一获批用于 H3 K27M 突变型弥漫性中线胶质瘤（DMG）的靶向药 【药品分享】屈昔多巴胶囊——去甲肾上腺素前体药物  || 帕金森、多系统萎缩、神经源性体位低血压一线对症用药 【药品分享】康特替尼颗粒——第二代ALK多靶点激酶抑制剂 【药品分享】盐酸兰诺可泮片——国产首个获批上市的补体因子B（CFB）抑制剂 【药品分享】Elinzanetant软胶囊——全球首款NK1/NK3双重神经激肽受体拮抗剂 【药品分享】Fosmanogepix注射液——全球首创（First-in-class）Gwt1抑制剂类抗真菌前药 【药品分享】Zorevunersen注射液——反义寡核苷酸药物 【药品分享】宗艾替尼片——高选择性不可逆HER2（ERBB2）酪氨酸激酶抑制剂（TKI） 【药品分享】甲苯磺酸他拉唑帕利胶囊——高选择性PARP抑制剂 【药品分享】Bexicaserin口服溶液——选择性5-HT2C受体激动剂口服液体制剂 【药品分享】醋酸伏诺拉生注射用浓溶液——钾离子竞争性酸阻滞剂（P-CAB） 【药品分享】甲苯磺酸依仑司群片——新一代口服选择性雌激素受体降解剂（SERD） 【药品分享】硫酸瑞美吉泮口崩片——CGRP 受体拮抗剂（降钙素基因相关肽）|| 偏头痛靶向特效药 【药品分享】阿托吉泮片——全球首款口服长效CGRP靶点预防偏头痛药物 【药品分享】乌布吉泮片——CGRP受体拮抗剂 || 第二代口服偏头痛急性期药物 【药品分享】扎维吉泮鼻喷雾剂——高选择性CGRP受体拮抗剂  || 全球唯一获批鼻喷CGRP吉泮类急性期药物 【药品分享】培来加南喷雾剂——全球首款上市加南类多肽抗菌药（FIC） 【药品分享】艾沙利酮片——高选择性非甾体醛固酮受体拮抗剂（MRA）  || 全球首个上市的非甾体选择性MR拮抗剂 【药品分享】布美他尼鼻喷雾剂——全球首款、唯一鼻内给药袢利尿剂 【药品分享】注射用盐酸依拉环素——新型全合成氟环素类（四环素衍生物）静脉抗生素 【药品分享】舒瑞基奥仑赛注射液——全球首款实体瘤自体CLDN18.2靶向CAR-T细胞新药 【药品分享】盐酸环喷托酯滴眼液——儿童验光首选短效睫状肌麻痹剂之一 【药品分享】盐酸赛庚啶口服溶液——抗过敏抗组胺药 【药品分享】Rinzimetostat (ORIC-944)——口服选择性 EED别构型PRC2表观遗传抑制剂 【药品分享】Empasiprubart注射用浓溶液——全球首创靶向补体C2人源化IgG1清扫型单克隆抗体 【药品分享】阿更葡糖钠注射液——全球第二款、中国首款自主研发的环糊精类靶向肌松逆转剂 【药品分享】盐酸罗哌卡因缓释溶液——国产自主长效局麻缓释制剂 || 填补国内切口原位长效镇痛空白 【药品分享】Telisotuzumab Adizutecan 注射用粉末——抗c-Met抗体偶联药物（ADC） 【药品分享】L606 (曲前列尼尔脂质体吸入混悬液)——靶向肺动脉高压 【药品分享】佩米替尼片——选择性FGFR1/2/3酪氨酸激酶抑制剂 【药品分享】唑尼沙胺胶囊——磺酰胺类结构 || 广谱抗癫痫药，偏头痛预防 【药品分享】琥珀酸安维吖啶片——双靶点胆碱酯酶抑制剂 【药品分享】布莱昔替尼片（Bleximenib）——口服高选择性Menin-KMT2A相互作用抑制剂 【药品分享】利厄替尼片——第三代EGFR-TKI靶向药 【药品分享】注射用苯磺酸瑞马唑仑——苯二氮䓬类短效静脉镇静/麻醉药 【药品分享】瑞维鲁胺片——国产全新二代雄激素受体抑制剂 【药品分享】塞普替尼胶囊——全球首款高选择性RET靶向药  || 国内唯一拥有12岁以上儿童甲状腺肿瘤完整临床证据的RET抑制剂 【药品分享】注射用和厚朴酚脂质体冻干粉——全球首创小分子脂质体靶向制剂 【药品分享】注射用顺铂聚合物胶束——前沿纳米化疗创新赛道  || 改良型新药-纳米靶向注射制剂 【药品分享】奥普雷顿片——国内首个获批的口服OX2R选择性激动剂 【药品分享】琥珀酸思普可泮片——口服选择性补体B因子（CFB/FB）小分子抑制剂  || 全球首个每日一次口服FB抑制剂 【药品分享】苹果酸法米替尼胶囊——多靶点TKI创新药  || 国内唯一获批用于宫颈癌的口服抗血管TKI 【药品分享】盐酸伊普可泮胶囊 【药品分享】枸橼酸伊沙佐米胶囊——第二代、全球首个口服可逆性蛋白酶体抑制剂 【药品分享】注射用西罗莫司（白蛋白结合型）——mTOR 激酶抑制剂  || 白蛋白纳米粒递送系统 【药品分享】Bleximenib片——Menin抑制剂（KMT2A/Menin 相互作用抑制剂） 【药品分享】Eloralintide注射液——选择性长效胰淀素（Amylin）受体激动剂（AMY1R激动剂） 【药品分享】阿柏西普眼内注射溶液——重组人源VEGF融合蛋白的治疗用生物制品 【药品分享】艾托莫德片——高选择性S1PR1（鞘氨醇‑1‑磷酸受体1）小分子激动剂 【药品分享】GBI268注射液——复方局部镇痛注射剂 【药品分享】Edecesertib片——IRAK‑4小分子激酶抑制剂 【药品分享】阿布昔替尼片——高选择性JAK‑1小分子抑制剂 【药品分享】盐酸阿思尼布片——全球首个且目前唯一基于ABL肉豆蔻酰口袋（STAMP）创新机制的靶向药物 【药品分享】Venglustat——葡萄糖神经酰胺合成酶（GCS/UGCG）抑制剂 【药品分享】塞瑞替尼胶囊——第二代ALK酪氨酸激酶抑制剂（ALK-TKI） 【药品分享】泊那替尼片——第三代BCR-ABL酪氨酸激酶抑制剂（TKI）|| 唯一能够有效抑制BCR‑ABL T315I耐药突变的TKI 【药品分享】盐酸阿那格雷胶囊——PDE3抑制剂 【药品分享】奥雷巴替尼片——国内首个获批可有效抑制T315I突变的三代BCR-ABL抑制剂 【药品分享】比克恩丙诺片——HIV‑1感染单片复方抗病毒药 【药品分享】甲磺酸奥希替尼片——第三代EGFR靶向药 【药品分享】醋酸戈舍瑞林缓释植入剂——促性腺激素释放激素激动剂缓释皮下植入制剂 【药品分享】拉考沙胺缓释胶囊——钠通道调节剂 【药品分享】纳曲酮利培酮植入剂——新的缓释植入剂型 【药品分享】普那布林注射用浓溶液——GEF‑H1（ARHGEF2）激动剂 【药品分享】Petrelintide注射液——长效胰淀素（Amylin）受体激动剂 【药品分享】酒石酸凡瑞格拉替尼片——1类高选择性FGFR口服小分子创新药 【药品分享】醋酸兰瑞肽缓释注射液（预充式）——长效生长抑素类似物（SSA） 【药品分享】吡非尼酮胶囊——多细胞因子通路调节剂 【药品分享】罗替高汀贴片——非麦角类多巴胺受体激动透皮贴剂  || 全球首个经皮吸收的帕金森治疗药物 【药品分享】芦沃美替尼片——高选择性MEK1/2（丝裂原活化蛋白激酶激酶 1/2）抑制剂 【药品分享】硫酸阿托品滴眼液——竞争性 M‑胆碱（毒蕈碱）受体拮抗剂 【药品分享】盐酸恩沙替尼胶囊——国产第二代间变性淋巴瘤激酶(ALK)-酪氨酸激酶抑制剂(TKI)靶向药 【药品分享】富马酸奥赛利定注射液——新型静脉镇痛药物 || G蛋白偏向性μ‑阿片受体激动剂 【药品分享】司美格鲁肽微针贴片——用于2型糖尿病与肥胖体重管理的新剂型药品 【药品分享】甲苯磺酸利特昔替尼胶囊——国内首个获批可用于12–17岁青少年重度斑秃的口服系统治疗药物 【药品分享】艾曲帕米鼻喷雾剂——经鼻给药的速效钙通道阻滞剂 【药品分享】盐酸替扎尼定胶囊——中枢性α2肾上腺素受体激动剂 【药品分享】格贝前列素滴眼液——单分子双功能NO供体型前列腺素前药 【药品分享】盐酸伊司特韦片——全球首个依托DEL结合AI技术成功获批的原创小分子药物 【药品分享】布格替尼片——口服小分子ALK酪氨酸激酶抑制剂 【药品分享】司来帕格片——口服选择性前列腺素受体（IP受体）激动剂 【药品分享】甲磺酸伏美替尼片——国产第三代EGFR靶向药（EGFR-TKI） 【药品分享】帕替罗姆山梨醇钙干混悬剂——不吸收入血的口服阳离子交换聚合物类新型降钾药物 【药品分享】塞拉维诺片——CCR5（C-C 趋化因子受体 5）拮抗剂 【药品分享】盐酸西替利嗪滴眼液——局部抗组胺滴眼液  || 高选择性 H₁组胺受体拮抗剂（第二代抗组胺） 【药品分享】注射用莱古比星——全球首创的小分子偶联化疗药 【药品分享】尤帕卡塞钠注射液——CaSR钙敏感受体正向变构调节剂 【药品分享】马来酸依格美妥司他片——口服小分子EZH2表观遗传抑制剂 【药品分享】Laroprovstat瑞舒伐他汀片——口服小分子 PCSK9 抑制剂 【药品分享】利扎布替尼片（Rilzabrutinib片）——全球首款获批用于ITP的BTK抑制剂 【药品分享】Trontinemab注射液——罗氏Brainshuttle™平台开发的2+1型双特异性IgG1抗体 【药品分享】Risankizumab注射液——人源化IgG1单克隆抗体 【药品分享】Zasocitinib (TAK-279) 片——口服小分子别构TYK2抑制剂 【药品分享】双氯芬酸依泊胺凝胶贴膏——全新活性成分凝胶贴膏 || 美国首个获批的NSAID外用凝胶贴膏 【药品分享】拉索昔芬片——第三代选择性雌激素受体调节剂（SERM） 【药品分享】苯丁酸氮芥片——非靶向细胞毒烷化剂 【药品分享】达依泊汀α注射液——第二代长效重组促红细胞生成素（ESA，红细胞生成刺激剂） 【药品分享】Ferric Bepectate IV Injection——静脉用三价铁胶体补铁制剂 【药品分享】Momelotinib片——口服ATP竞争性激酶抑制剂 免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。

Daridorexant, a dual orexin receptor antagonist, is the first investigational treatment in its class to demonstrate positive results in pediatric insomnia disorder, an area in which significant unmet needs remain for children and their families. A single 50 mg dose increased sleep time by 50 minutes overall and 64 minutes in children with neurodevelopmental disorders, moving participants closer to their recommended age‑appropriate sleep duration. Daridorexant was well tolerated across doses including 50 mg, the highest recommended dose for adults, with a pediatric safety profile consistent with the established adult evidence Sixteen presentations showcased the breadth of daridorexant research across adult clinical trials, real-world evidence and investigator-initiated studies in diverse populations with insomnia Allschwil, Switzerland – October 23, 2026 Idorsia Ltd (SIX: IDIA) today announced results from the first and only Phase 2 study with a dual orexin receptor antagonist in children with insomnia disorder, presented to the scientific community at Sleep Europe 2026. Daridorexant featured prominently throughout the congress, with 16 Idorsia-sponsored and investigator-initiated presentations spanning pediatric and adult clinical research, real-world evidence, diverse populations with insomnia and changes in prescribing practice. Professor Carmen M. Schröder, MD, PhD, Department of Child and Adolescent Psychiatry, Strasbourg University Hospitals, commented: “This is the first controlled clinical study to show that a dual orexin receptor antagonist, with the right pharmacokinetic profile, can rapidly and meaningfully increase sleep duration in children and adolescents with insomnia disorder, without causing morning sleepiness. The clear dose-response and the consistency of the findings across objective and subjective sleep measures warrant further investigation in a Phase 3 study. While total sleep time improved in the overall children population, the results in children with neurodevelopmental disorders are particularly important, because insomnia worsens their core symptoms and comorbidities, while treatment options remain limited.” Marked efficacy of daridorexant in children with insomnia In pediatric age, insomnia disorder causes persistent night-time symptoms and significant daytime impairment for children and their families, yet treatment options remain limited, with no approved pharmacotherapies in the US. The randomized, double-blind, placebo-controlled Phase 2 study (NCT05423717, Abstract) evaluated treatment with daridorexant 10, 25 and 50 mg, or placebo, over two weeks in 165 children and adolescents aged 10 to under 18 years with DSM-5 insomnia disorder. More than half of the participants had a diagnosed or subthreshold neurodevelopmental disorder, including autism spectrum disorder and/or attention-deficit/hyperactivity disorder. The study met its primary endpoint, demonstrating a statistically significant dose-response in objectively measured total sleep time after the first dose. A single dose of daridorexant 50 mg increased objective total sleep time by 50 minutes from baseline, compared with 20 minutes with placebo (least-square mean). In children and adolescents with neurodevelopmental disorders, daridorexant 50 mg increased objective total sleep time by 64 minutes from baseline, compared with 27 minutes with placebo (least-square mean). After two weeks, in the overall population, caregiver-reported total sleep time increased from baseline by approximately 69 minutes with daridorexant 50 mg, compared with approximately 30 minutes with placebo (least-square mean). Daridorexant 50 mg also provided the highest and most consistent improvements across measures of sleep initiation, sleep maintenance, and sleep quality while numerically reducing morning sleepiness. Daridorexant was well tolerated across all doses studied. At 50 mg, the highest recommended adult dose, the incidence of adverse events was similar to placebo, and the safety profile was consistent with the known adult safety profile. No adverse events suggestive of abuse potential or physical dependence and no withdrawal symptoms were observed. Professor Carmen M. Schröder concluded: “The efficacy findings are compelling, and the favorable safety and tolerability results add to our confidence in taking the next steps. The highest recommended adult dose was studied in children, including those with lower body weight, with no new safety findings observed. This provides a strong foundation for the future development of daridorexant in pediatric populations” Amer Joseph, MD, CMO and Head Global Clinical Development & Medical Affairs, commented: “Once again, the properties that we designed into daridorexant – rapid absorption, rapid elimination, and a relatively short terminal half-life – have proven to provide efficacy through the night without negatively impacting the next morning. In fact, the safety measures show an improvement in next- morning alertness. The compelling results in children with insomnia and ADHD and/or ASD as well as in children without neurodevelopmental disorders allow us to target a broad and underserved pediatric population. As the only DORA being investigated in children, daridorexant could become not only the sole drug recommended by the ESRS guideline for short and long-term treatment of insomnia in adults, but also a first-in-class treatment for the pediatric population.” Next steps in pediatric insomnia The manuscript describing the full dataset is currently under evaluation with a high-ranked scientific journal. In parallel, the team is consolidating supportive comments from global health authorities on the protocol for the pediatric Phase 3 clinical development program. The company expects to initiate the new program in the second half of next year. Presentation replay A recording of Professor Carmen Schröder's presentation, featuring the same scientific content presented at Sleep Europe 2026, is available here: Watch the presentation An expanding evidence base in adults Beyond the pioneering pediatric study, 15 additional presentations demonstrated the growing breadth of evidence for daridorexant in adults. Across controlled clinical studies and routine clinical practice, improvements were observed in objective and subjective sleep measures, insomnia severity and daytime functioning, including in adults with psychiatric, neurological and neurodevelopmental comorbidities. In adults with insomnia and objectively measured short sleep duration, three months of continuous daridorexant 50 mg treatment improved sleep onset, sleep maintenance and total sleep time, based on both objective and subjective measures. Investigator-initiated research further reported improvement of sleep with daridorexant in menopausal women with insomnia and in patients with insomnia and epilepsy, major depressive disorder or sedative-hypnotic use disorder. The growing real-world evidence also showed improvements beyond the night. Prospective and retrospective studies reported reductions in insomnia severity alongside improvements in depressive symptoms, quality of life, and work productivity. Finally, a separate analysis of prescribing patterns across six countries found that increased DORA use coincided with reductions in benzodiazepine and Z-drug use, two classes of drugs associated with public safety concern. The overall volume of insomnia medication was not changed. Dieter Kunz, M.D., Director of the Sleep Research and Clinical Chronobiology Research Group at Charité - Universitätsmedizin Berlin, commented: “The research presented at Sleep Europe demonstrates both the breadth and maturity of the evidence for daridorexant. Across controlled studies and routine clinical practice, improvements were observed in objective and subjective sleep, insomnia severity and daytime functioning, including in patients with complex psychiatric, neurological and neurodevelopmental comorbidities. These findings show that the benefits established in the pivotal program are increasingly being observed in the diverse patients we treat in everyday practice. At the same time, prescribing data suggest that when DORAs are accessible, clinical practice can move away from traditional hypnotics, which are symptomatic only, towards a more disease-modifying-type of treatment for insomnia disorder.” An exploratory study in adults with ADHD and insomnia reported improvements in insomnia symptoms and sleep parameters in nearly two-thirds of patients after four weeks of daridorexant treatment, alongside improvements in measures of attention, mood, and anxiety. Giacomo Grassi, M.D., Ph.D., psychiatrist and researcher at Brain Center Firenze, commented: “A growing number of real-world studies show that the efficacy of daridorexant observed in clinical trials is also seen in the complex clinical populations we treat every day. This is particularly relevant for adults with ADHD, in whom sleep problems are the rule rather than the exception, and for whom, until now, we had no evidence-based options for treating insomnia. The good news is that our real-world data suggest that daridorexant may represent a valuable treatment option for a substantial proportion of patients with ADHD and insomnia disorder. Sleep should be routinely assessed in these patients, and insomnia should be treated according to the guidelines.” Global availability Daridorexant is marketed as QUVIVIQ for adult patients with insomnia by Idorsia in North America and Europe and is available in key Asia-Pacific and Middle East markets through commercial partnerships. Daridorexant for pediatric use is investigational and not approved or marketed in any country. Notes to the editor About daridorexant – a different kind of insomnia treatment Insomnia affects millions worldwide, yet commonly used treatments can lead to next day drowsiness, dependence, and withdrawal symptoms – leaving a clear unmet need for safer, effective alternatives. Discovered by Idorsia, daridorexant works differently from traditional hypnotics. As a dual orexin receptor antagonist, it selectively targets the orexin system, helping to regulate overactive wake signaling without broadly suppressing brain activity. Its optimized pharmacokinetics promote restorative sleep throughout the entire night, reducing morning sleepiness and improving daytime functioning. Clinical trials published in The Lancet Neurology demonstrated that daridorexant significantly improved sleep onset, sleep maintenance, and self-reported total sleep time in adult patients with insomnia at 25mg and 50mg doses compared to placebo. Daridorexant 50 mg also demonstrated a significant improvement in daytime functioning compared to placebo. About pediatric insomnia Pediatric insomnia is characterized by difficulty initiating or maintaining sleep that is perceived as a problem by the child or caregiver due to its severity, chronicity, frequency, and the significant daytime impairment it causes for the child or the family. About the pediatric Phase 2 study (NCT05423717) The multicenter, randomized, double-blind, placebo-controlled Phase 2 dose-finding study evaluated daridorexant 10, 25 and 50 mg, or placebo, over two weeks in 165 children and adolescents aged 10 to under 18 years with insomnia disorder. The primary objective of the Phase 2 study was to characterize the dose-response relationship of daridorexant on objective total sleep time (TST), using polysomnography (PSG). Patients were randomized in a 1:1:1:1 ratio to 10, 25, or 50 mg daridorexant. The primary endpoint was the change from baseline to Day 1 in TST measured by PSG. Additional assessments included objective and subjective sleep measures, sleep quality, morning sleepiness and alertness, daytime functioning, pharmacokinetics, safety and tolerability. The study included children and adolescents with insomnia disorder without neurodevelopmental disorders, participants with subthreshold autism spectrum disorder or attention-deficit/hyperactivity disorder traits, and participants with diagnosed neurodevelopmental disorders. Analysis of the primary endpoint demonstrated a statistically significant (p=0.0185) dose‑dependent improvement in TST from baseline on Day 1, accompanied by additional dose-dependent improvements across multiple objective and subjective sleep parameters. Importantly, the study confirmed the excellent safety and tolerability profile of daridorexant for the first time in pediatric patients as young as ten. Even at 50 mg – the recommended adult dose – daridorexant’s safety profile remained similar to placebo, with no adverse events denoting drug abuse during treatment and no indication of withdrawal symptoms upon treatment discontinuation. About Professor Schröder Carmen Schröder, MD, PhD, is Professor of Child and Adolescent Psychiatry at Strasbourg University and head of the Department of Child and Adolescent Psychiatry at Strasbourg University Hospitals in France, as well as the coordinator of the Excellence Centre for Autism and Neurodevelopmental disorders STRAS&ND and the Centre for Rare Diseases with genetic expression. Prof. Schröder’s career trajectory is international: of German origin, she has studied medicine in Germany and France, before specializing first in General Psychiatry and then in Child and Adolescent Psychiatry in France, Switzerland (Basel) and the United States (post-doctorate and junior faculty, Stanford University). She represents France since 2016 within the European Union of Medical Specialists for CAP (UEMS-CAP) and has served as its president between 2020 and 2026; she is also on the Board of Directors of the European and of the International Association of CAP (ESCAP, since 2023). Beyond her CAP positions, Prof. Schröder is a European ESRS Board-Certified Sleep expert and is the national coordinator of the French sleep diploma. Her main clinical and research interests (within a CNRS group at the Institute for Cellular and Integrative Neurosciences in Strasbourg) are focused on sleep and circadian rhythm disturbances in children and adolescents, in particular in neurodevelopmental disorders such as autism and ADHD. She has published more than 100 publications, mostly on implications of sleep disorders and/or circadian rhythm disorders on child’s development or child and adolescent psychiatric disorders. Prof Schröder serves as a consultant for Idorsia. About Dr Kunz Dieter Kunz, M.D., is Head of the Clinic of Sleep & Chronomedicine at St. Hedwig Hospital in Berlin, Germany, and Director of the Sleep Research and Clinical Chronobiology Research Group at Charité - Universitätsmedizin Berlin. A board-certified psychiatrist and somnologist, he has dedicated much of his career to the diagnosis and treatment of sleep disorders and to advancing research in sleep medicine and chronobiology. Dr. Kunz has served as principal investigator in numerous clinical studies and is widely recognized for his contributions to the understanding of sleep regulation and circadian biology. About Dr Grassi Giacomo Grassi, MD, PhD, is a Surgeon, specialized in Psychiatry and has a PhD in Neuroscience cum laude from the University of Florence. His clinical activity focuses on the pharmacological and non-pharmacological treatment of neuropsychiatric disorders. He deals with mood and anxiety disorders and is an expert in impulsive-compulsive spectrum disorders and attention deficit hyperactivity disorder (ADHD). He is an expert in neuromodulation therapy (transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)) applied to treatment-resistant neuropsychiatric disorders (mood disorders, anxiety disorders, obsessive-compulsive spectrum disorders, attention deficit hyperactivity disorder, behavioral addictions). In these areas she carried out research at the Academic Medical Center of Amsterdam between 2013 and 2014 and carried out clinical and research activities at the Institute of Neuroscience in Florence from 2015 to 2019. Dr Grassi carries out research in the field of ADHD, obsessive-compulsive disorder and neuromodulation and is the author of numerous scientific publications in international journals (see CV). Since 2017 he has been elected a member of the board of directors of the International College of Obsessive-Compulsive Spectrum Disorders (ICOCS, UK) of which he is still a member and in 2018 he was appointed a member of the board of directors of the Italian Academy of Behavioral Addiction Sciences (AiSdICO). He is also a member of the ADHD World Federation. For neuromodulation he is a member of the European Society for Brain Stimulation (ESBS) and the Clinical TMS Society. He is a member of the editorial board of the international journal Comprehensive Psychiatry and the Brazilian Journal of Psychiatry and works as a peer-reviewer of many international journals of psychiatry and neuroscience. Dr Grassi serves as a consultant for Idorsia. About Sleep Europe 2026 Sleep Europe 2026, the 28th Congress of the European Sleep Research Society, will take place in Maastricht, the Netherlands, from October 20 to 23, 2026. Held every two years, the congress brings together more than 3000 clinicians, researchers, scientists and other sleep professionals to share and discuss the latest advances in sleep medicine and sleep research. About Idorsia The purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact: Investor & Media Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as “intend”, "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Idorsia has transferred its rights for aprocitentan, cenerimod and selatogrel to Idorsia Investments SARL to allow the repayment of notes issued in connection with the repurchase offer completed in August 2025. More details on the transfer can be found in the current Financial Report. Attachment Press Release PDF