Treprostinil diethanolamine

本周药品注册受理数据，分门别类呈现，一目了然。(8.17-8.23） 新药上市申请 药品名称 企业 注册分类 受理号 HRG2010胶囊 江苏恒瑞医药股份有限公司 2.2 CXHS2600121 HRG2010胶囊 江苏恒瑞医药股份有限公司 2.2 CXHS2600120 注射用多西他赛(白蛋白结合型) 石药集团中诺药业(石家庄)有限公司 2.2 CXHS2600118 玛舒拉沙韦片 江西科睿药业有限公司 2.4 CXHS2600119 四价流感病毒裂解疫苗(MDCK细胞) 武汉生物制品研究所有限责任公司 2.2 CXSS2600129 四价流感病毒裂解疫苗(MDCK细胞) 武汉生物制品研究所有限责任公司 2.2 CXSS2600128 注射用奥帕替苏米单抗 南京维立志博生物科技股份有限公司 1 CXSS2600131 LP-003注射液 天辰生物医药(苏州)股份有限公司 1 CXSS2600130 安尼妥单抗注射液 上海津曼特生物科技有限公司 2.2 CXSS2600126 重组人血清白蛋白注射液 深圳普罗吉医药科技有限公司 2.4 CXSS2600127 新药临床申请 药品名称 企业 注册分类 受理号 HJ065片 华健未来(成都)科技股份有限公司 1 CXHL2601037 HJ065片 华健未来(成都)科技股份有限公司 1 CXHL2601036 奥莱泊肽注射液 江苏豪森药业集团有限公司 1 CXHL2601035 奥莱泊肽注射液 江苏豪森药业集团有限公司 1 CXHL2601034 奥莱泊肽注射液 江苏豪森药业集团有限公司 1 CXHL2601033 普那布林注射用浓溶液 大连万春布林医药有限公司 1 CXHL2601022 HRS-4642注射液 上海恒瑞医药有限公司 1 CXHL2601032 HRS-7172片 江苏恒瑞医药股份有限公司 1 CXHL2601031 HRS-7172片 江苏恒瑞医药股份有限公司 1 CXHL2601030 HRS-7172片 江苏恒瑞医药股份有限公司 1 CXHL2601029 HRS-7172片 江苏恒瑞医药股份有限公司 1 CXHL2601028 HRS-2329片 江苏恒瑞医药股份有限公司 1 CXHL2601027 HRS-2329片 江苏恒瑞医药股份有限公司 1 CXHL2601026 HRS-2329片 江苏恒瑞医药股份有限公司 1 CXHL2601025 HRS-2329片 江苏恒瑞医药股份有限公司 1 CXHL2601024 PSTA100胶囊 普罗思特(南京)生物科技有限公司 1 CXHL2601015 PSTA100胶囊 普罗思特(南京)生物科技有限公司 1 CXHL2601014 CPD705注射液 北京泰德制药股份有限公司 1 CXHL2601021 CPD705注射液 北京泰德制药股份有限公司 1 CXHL2601020 BW-41012注射液 上海舶望制药有限公司 1 CXHL2601019 BW-41012注射液 上海舶望制药有限公司 1 CXHL2601018 QLS1510片 上海齐鲁制药研究中心有限公司 1 CXHL2601017 QLS1510片 上海齐鲁制药研究中心有限公司 1 CXHL2601016 LY4064809片 礼来苏州制药有限公司 1 CXHL2601013 LY4064809片 礼来苏州制药有限公司 1 CXHL2601012 LY4064809片 礼来苏州制药有限公司 1 CXHL2601011 SIM0518胶囊 上海先声再明科技有限公司 1 CXHL2601010 SIM0518胶囊 上海先声再明科技有限公司 1 CXHL2601009 68Ga-NRT6020注射液 成都纽瑞特医疗科技股份有限公司 1 CXHL2601008 曲前列尼尔二乙醇胺吸入粉雾剂 上海上药睿尔药品有限公司 2.2 CXHL2601023 Pumitamig注射液 百时美施贵宝(中国)投资有限公司 1 CXSL2600892 人脐带间充质干细胞注射液 深圳市茵冠生物科技有限公司 1 CXSL2600895 SHR-4610注射液 上海盛迪医药有限公司 1 CXSL2600884 IBI3038 信达生物制药(苏州)有限公司 1 CXSL2600881 RLX-2508注射液 广东恒瑞医药有限公司 1 CXSL2600882 重组抗CD19m-CD3抗体注射液 天劢源和生物医药(长春)有限公司 1 CXSL2600889 RGL-208注射液 上海瑞宏迪医药有限公司 1 CXSL2600886 SJ018注射液 申基生物(宜兴)有限公司 1 CXSL2600885 注射用RGL-232 上海瑞宏迪医药有限公司 1 CXSL2600883 IBI343 信达生物制药(苏州)有限公司 1 CXSL2600879 注射用LM-350 礼新医药科技(上海)有限公司 1 CXSL2600880 CG-BM1异体人骨髓间充质干细胞注射液 广州赛隽生物科技有限公司 1 CXSL2600877 BC008-1A注射液 四川泸州步长生物制药有限公司 1 CXSL2600878 人脐带间充质干细胞注射液 长春拓华医药有限公司 1 CXSL2600871 SZ1003注射液 广东普罗凯融生物医药科技有限公司 1 CXSL2600874 注射用Efimosfermin alfa 葛兰素史克(中国)投资有限公司 1 CXSL2600872 注射用GenSci136 长春金赛药业有限责任公司 1 CXSL2600870 SHR-1139注射液 广东恒瑞医药有限公司 1 CXSL2600876 注射用MK-2870 默沙东研发(中国)有限公司 2.2 CXSL2600891 注射用MK-2870 默沙东研发(中国)有限公司 2.2 CXSL2600890 信迪利单抗注射液 信达生物制药(苏州)有限公司 2.2 CXSL2600894 阿得贝利单抗注射液 上海盛迪医药有限公司 2.2 CXSL2600888 瑞拉芙普α注射液 苏州盛迪亚生物医药有限公司 2.2 CXSL2600887 艾米迈托赛注射液 铂生卓越生物科技(北京)有限公司 2.2 CXSL2600873 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) 苏州若弋生物科技有限公司 2.4 CXSL2600875 仿制药申请 药品名称 企业 注册分类 受理号 美沙拉秦肠溶缓释颗粒 上海惠永制药有限公司 3 CYHS2602081 生理氯化钠溶液 河北广祥医药科技有限公司 3 CYHS2602085 注射用盐酸多西环素 南京易亨制药有限公司 3 CYHS2602083 生理氯化钠溶液 石药银湖制药有限公司 3 CYHS2602082 中性腹膜透析液(乳酸盐-G1.35%) 河北天成药业股份有限公司 3 CYHS2602086 布立西坦片 浙江诺得药业有限公司 3 CYHS2602090 布立西坦片 浙江诺得药业有限公司 3 CYHS2602089 布立西坦片 浙江诺得药业有限公司 3 CYHS2602088 吡非尼酮片 四川依科制药有限公司 3 CYHS2602065 阿齐沙坦片 浙江诺得药业有限公司 3 CYHS2602071 磷酸二氢钠磷酸氢二钠颗粒 知和(山东)大药厂有限公司 3 CYHS2602070 盐酸卡替洛尔滴眼液 浙江赛默制药有限公司 3 CYHS2602069 硫酸长春新碱注射液 深圳万乐药业有限公司 3 CYHS2602076 米诺地尔泡沫剂 山东京卫制药有限公司 3 CYHS2602075 硫辛酸片 广东健信制药股份有限公司 3 CYHS2602051 注射用盐酸兰地洛尔 天津天士力之骄药业有限公司 3 CYHS2602049 注射用盐酸兰地洛尔 苏州天马医药集团天吉生物制药有限公司 3 CYHS2602046 吡非尼酮片 安徽泰恩康制药有限公司 3 CYHS2602045 二硫化硒洗剂 宏越科技(湖州)有限公司 3 CYHS2602027 吲哚布芬片 深圳市朗博生物医药股份有限公司 3 CYHS2602023 盐酸西替利嗪注射液 山东百诺医药股份有限公司 3 CYHS2602030 比拉斯汀口腔崩解片 山东百诺医药股份有限公司 3 CYHS2602029 螺内酯片 津威士(天津)科技有限公司 3 CYHS2602033 螺内酯片 津威士(天津)科技有限公司 3 CYHS2602032 盐酸溴己新口服溶液 四川群乐康药业有限公司 3 CYHS2602035 硫酸氨基葡萄糖胶囊 湖南抱抱团药业有限公司 4 CYHS2602084 硫酸氨基葡萄糖胶囊 江苏天平药业有限公司 4 CYHS2602087 利那洛肽胶囊 成都地奥制药集团有限公司 4 CYHS2602062 氯雷他定片 辰欣药业股份有限公司 4 CYHS2602061 蒙脱石混悬液 江西普丽尔药业有限公司 4 CYHS2602066 乳果糖口服溶液 石家庄凯达生物工程有限公司 4 CYHS2602064 乳果糖口服溶液 石家庄凯达生物工程有限公司 4 CYHS2602063 非布司他片 山西同达药业有限公司 4 CYHS2602060 非布司他片 山西同达药业有限公司 4 CYHS2602059 阿司匹林肠溶片 黑龙江省林宝药业有限责任公司 4 CYHS2602074 左乙拉西坦口服溶液 翎耀生物科技(上海)有限公司 4 CYHS2602072 沙格列汀二甲双胍缓释片 郑州泰丰制药有限公司 4 CYHS2602068 沙格列汀二甲双胍缓释片 郑州泰丰制药有限公司 4 CYHS2602067 艾普拉唑肠溶片 山东鲁抗医药集团赛特有限责任公司 4 CYHS2602077 双氯芬酸钠缓释片 天津梅花生物医药科技有限公司 4 CYHS2602079 双氯芬酸钠缓释片 天津梅花生物医药科技有限公司 4 CYHS2602078 注射用氨曲南阿维巴坦钠 山东鲁抗医药股份有限公司 4 CYHS2602080 氯吡格雷阿司匹林片 山东诺禾康药业有限公司 4 CYHS2602052 妥布霉素地塞米松滴眼液 仁合益康汇泽药业河北有限公司 4 CYHS2602050 贝美替尼片 齐鲁制药(海南)有限公司 4 CYHS2602054 雌二醇凝胶 西藏珠峰寿高生物药业有限公司 4 CYHS2602057 雌二醇凝胶 西藏珠峰寿高生物药业有限公司 4 CYHS2602056 罗替高汀贴片 湖南九典制药股份有限公司 4 CYHS2602053 阿司匹林肠溶片 山西风帆博康医药有限公司 4 CYHS2602058 盐酸尼卡地平注射液 绪必迪药业(沧州)有限公司 4 CYHS2602055 盐酸奥布卡因滴眼液 石家庄格瑞药业有限公司 4 CYHS2602039 草酸艾司西酞普兰片 武汉人福药业有限责任公司 4 CYHS2602037 草酸艾司西酞普兰片 武汉人福药业有限责任公司 4 CYHS2602036 氧(液态) 苏州工业园区林德工业气体有限公司 4 CYHS2602048 氧(液态) 林德气体(青岛)有限公司 4 CYHS2602047 非布司他片 广东彼迪药业有限公司 4 CYHS2602044 非布司他片 广东彼迪药业有限公司 4 CYHS2602043 硫酸氨基葡萄糖胶囊 华益药业科技(安徽)有限公司 4 CYHS2602040 艾拉莫德片 璟济生物医药科技(泰州)股份有限公司 4 CYHS2602038 注射用头孢他啶 杭州沐源生物医药科技股份有限公司 4 CYHS2602042 注射用头孢他啶 杭州沐源生物医药科技股份有限公司 4 CYHS2602041 注射用醋酸西曲瑞克 安徽安科生物工程(集团)股份有限公司 4 CYHS2602026 氟比洛芬凝胶贴膏 湖南金圃医药科技有限公司 4 CYHS2602025 醋酸地非法林注射液 陕西季诺康禾药业有限公司 4 CYHS2602024 注射用托伐普坦磷酸钠 湖南埃威格林医药科技有限公司 4 CYHS2602028 盐酸阿莫罗芬乳膏 福元药业有限公司 4 CYHS2602031 洛索洛芬钠贴剂 乐明药业(苏州)有限公司 4 CYHS2602034 司美格鲁肽注射液 质肽药业(泰州)有限公司 3.3 CXSS2600124 司美格鲁肽注射液 质肽药业(泰州)有限公司 3.3 CXSS2600125 纳曲酮利培酮植入剂 深圳善康医药科技股份有限公司 2.2;2.3;2.4 CXHL2601038 甲硝唑栓 江苏瑜兴医药科技有限公司 3 CYHL2600088 蛋白C 广西莱士生物制药有限公司 3.2 CXSL2600893 进口申请 药品名称 企业 注册分类 受理号 拉考沙胺缓释胶囊 Aucta Pharmaceuticals, Inc. 5.1 JXHS2600099 拉考沙胺缓释胶囊 Aucta Pharmaceuticals, Inc. 5.1 JXHS2600097 拉考沙胺缓释胶囊 Aucta Pharmaceuticals, Inc. 5.1 JXHS2600098 维奈克拉片 AbbVie Inc. 5.1 JXHS2600096 维奈克拉片 AbbVie Inc. 5.1 JXHS2600095 维奈克拉片 AbbVie Inc. 5.1 JXHS2600094 司来帕格片 Janssen-Cilag International NV 5.1 JXHS2600092 司来帕格片 Janssen-Cilag International NV 5.1 JXHS2600091 马来酸阿可替尼片 AstraZeneca Pty Ltd. 5.1 JXHS2600093 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600075 帕博利珠单抗注射液(皮下注射) Merck Sharp & Dohme B.V. 3.1 JXSS2600074 盐酸氨溴索口服溶液 BRIGHT FUTURE PHARMACEUTICAL CO. LIMITED 5.2 JYHS2600017 盐酸氨溴索口服溶液 BRIGHT FUTURE PHARMACEUTICAL CO. LIMITED 5.2 JYHS2600016 [111In]In-FL-261注射液 Full-Life Techinologies UK Limited 1 JXHL2600359 [225Ac]Ac-FL-261注射液 Full-Life Techinologies UK Limited 1 JXHL2600358 BMS-986368胶囊 Celgene Corporation 1 JXHL2600357 BMS-986368胶囊 Celgene Corporation 1 JXHL2600356 LY900043注射液 Eli Lilly and Company 1 JXHL2600353 LY900043注射液 Eli Lilly and Company 1 JXHL2600352 LY900043注射液 Eli Lilly and Company 1 JXHL2600351 LY900043注射液 Eli Lilly and Company 1 JXHL2600350 LY900043注射液 Eli Lilly and Company 1 JXHL2600349 LY900043注射液 Eli Lilly and Company 1 JXHL2600348 LY900043注射液 Eli Lilly and Company 1 JXHL2600347 CDR132L注射液 Novo Nordisk A/S 1 JXHL2600346 甲磺酸奥希替尼片 AstraZeneca AB 2.4 JXHL2600355 甲磺酸奥希替尼片 AstraZeneca AB 2.4 JXHL2600354 艰难梭菌佐剂疫苗 Pfizer Inc. 1.1 JXSL2600209 20价肺炎球菌多糖结合疫苗 Pfizer Europe MA EEIG 3.1 JXSL2600221 注射用BMS-986525 Bristol-Myers Squibb Company 1 JXSL2600220 Ixoberogene Soroparvovec 注射液 Eli Lilly and Company 1 JXSL2600217 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600216 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600215 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600214 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600213 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600212 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600211 zenagamtide注射液 Novo Nordisk A/S 1 JXSL2600210 ALPN-303注射液 Vertex Pharmaceuticals Incorporated 1 JXSL2600207 VAY736注射液 Novartis Pharma AG 1 JXSL2600208 MK-3475A注射液 Merck Sharp & Dohme LLC 2.2 JXSL2600219 MK-3475A注射液 Merck Sharp & Dohme LLC 2.2 JXSL2600218 中药相关申请 药品名称 企业 注册分类 受理号 天葛定眩颗粒 四川光大制药有限公司 1.1 CXZL2600077 YFZ-002 宿州亿帆药业有限公司 2.2 CXZL2600079 西帕依固龈液 黑龙江华玺生物医药科技有限公司 4 CYZS2600005 YFZ-002 宿州亿帆药业有限公司 2.2 CXZL2600078 注：绿色字体部分为潜在首仿品种； 咸达数据2026年7月每月药讯已出！ 关注“咸达数据”，微信关键词回复 ” 年+月，如202606” 获得最新药迅！ 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。

Approximately 200,000 patients in the United States have PPF, with limited treatment options Topline data expected in the second half of 2027 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR ) announced full enrollment of its TETON-PPF study evaluating the use of Tyvaso ® (treprostinil) inhalation solution ( nebulized Tyvaso ) for the treatment of progressive pulmonary fibrosis ( PPF ). The TETON-PPF study enrolled 754 patients. “The rapid pace of enrollment underscores both the significant unmet need for new treatment options in PPF and the strong interest in nebulized Tyvaso’s potential in addressing the burden of this disease, particularly following the highly successful results observed in our TETON-1 and TETON-2 studies in idiopathic pulmonary fibrosis ( IPF ),” said Peter Smith, Pharm. D. , Senior Vice President, Product Development at United Therapeutics and the lead for the global TETON program. “Due to the similarities in the mechanism of fibrosis between IPF and PPF, we are optimistic that anti-fibrotic therapies, such as inhaled treprostinil, will impact disease progression similarly in patients with these conditions. We are deeply grateful to the participants, investigators, and study teams whose commitment made this milestone possible.” If the TETON-PPF trial is successful, United Therapeutics intends to use the data from the study to support a supplemental New Drug Application ( sNDA ) to the U.S. Food and Drug Administration ( FDA ) to add PPF to the labeled indications for nebulized Tyvaso. Nebulized Tyvaso has not been approved by the FDA for PPF and remains investigational for this indication. United Therapeutics is currently seeking priority review of an sNDA submitted to the FDA in June 2026 to add IPF to the labeled indications for nebulized Tyvaso based on data from the TETON-1 and TETON-2 studies. Data from these studies were published in the New England Journal of Medicine , available here and here , respectively. About TETON-PPF The TETON-PPF study is a 754-patient, multinational, randomized, double-blind, placebo-controlled phase 3 registration study to evaluate the safety and efficacy of nebulized Tyvaso in subjects with PPF over a 52-week period. The study reached full enrollment in August 2026 and topline data is expected in the second half of 2027. Subjects were randomly allocated 1:1 to receive nebulized Tyvaso or placebo. All subjects will initiate nebulized Tyvaso or placebo at a dose of three breaths administered four times daily ( QID ) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. The primary endpoint of the study is the change in absolute forced vital capacity ( FVC ) from baseline to week 52. Secondary endpoints include: (1) time to first clinical worsening; (2) time to first acute exacerbation of ILD; (3) overall survival at week 52; (4) change in percent predicted FVC from baseline to week 52; (5) change in the King’s Brief Interstitial Lung Disease questionnaire score from baseline to week 52; and (6) change in diffusing capacity of the lungs for carbon monoxide from baseline to week 52. Other data collected in the study will include the plasma N-terminal pro-brain natriuretic peptide concentration and supplemental oxygen use. Safety assessments include the development of adverse events, serious adverse events, vital signs, clinical laboratory parameters, and electrocardiogram parameters. Subjects who complete the Week 52 visit may be offered the opportunity to enter an open-label extension study after completing the final study visit. About PPF PPF occurs in interstitial lung diseases ( ILD ) and exhibits progressive, self-sustaining fibrosis, and a similar disease course to IPF. PPF includes idiopathic interstitial pneumonias, autoimmune ILDs, chronic fibrosing hypersensitivity pneumonitis, and fibrotic ILDs related to environmental/occupational exposure. It is estimated that 13% to 40% of patients with these various ILDs will go on to develop PPF. Patients with PPF exhibit decreased lung function, poor quality of life, and increased mortality despite usual treatments for the underlying ILD. Estimates for median transplant free survival and overall survival are approximately 2.9 years and 3.7 years, respectively. While estimates vary, we believe the size of the U.S. PPF population is approximately 200,000 patients. About Tyvaso ® (treprostinil) Inhalation Solution INDICATION TYVASO (treprostinil) Inhalation Solution is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with TYVASO establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities. While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration. Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension. TYVASO inhibits platelet aggregation and increases the risk of bleeding. Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness. Like other inhaled prostaglandins, TYVASO may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO. DRUG INTERACTIONS/SPECIFIC POPULATIONS The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8. Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. Safety and effectiveness in pediatric patients have not been established. Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety pro in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy. ADVERSE REACTIONS Pulmonary Arterial Hypertension (WHO Group 1) In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea. Pulmonary Hypertension Associated with ILD (WHO Group 3) In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions with TYVASO were similar to the experience in studies of PAH. Please see Full Prescribing Information for TYVASO, the TD-300 TYVASO ® Inhalation System Instructions for Use manual, and additional information at or call 1 844 UNITHER (1-844-864-8437). About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Visit us at and follow us on LinkedIn , Facebook , and Instagram . Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding: the potential timing and outcome of the TETON-PPF study; our plans to obtain FDA approval of sNDAs to add PPF and IPF to the labeled indications for nebulized Tyvaso; the potential benefits of nebulized Tyvaso for patients with PPF; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language, and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of August 17, 2026, and assume no obligation to update or revise the information contained in this press release whether because of new information, future events or any other reason. TYVASO is a registered trademark of United Therapeutics Corporation. Contacts For Further Information Contact: Investor Inquiries Media Inquiries communications@unither.com