Treprostinil diethanolamine

上药控股与赛诺菲举行高层交流沟通会 8月19日，赛诺菲与上药控股举行高层战略合作交流沟通会。双方基于长期稳固的合作基础，围绕行业发展趋势、双方合作进展、合规体系建设、未来合作展望等议题进行了深入交流。双方一致认为，面对医药产业加速变革的新形势，应进一步发挥各自优势，持续提升合作质效，以更高效的业务协同推动赛诺菲优质产品在中国市场广泛覆盖，更好满足患者用药需求。 上药康德乐携手禾柏生物拓展海外市场 8月24日下午，上药康德乐与禾柏生物举行战略合作签约仪式。双方将聚焦体外诊断产品海外市场拓展，充分发挥各自在医药供应链服务、海外渠道布局、产品研发创新等方面的优势，携手推动中国创新诊断产品走向世界。此次合作不仅是双方在IVD领域深化协同的重要起点，也是上药康德乐海外业务部成立后，推动本土优质医疗器械走向全球市场的重要实践。 上药睿尔 改良型创新药临床试验申请获得受理 近日，上海上药睿尔药品有限公司研发的2.2类改良型创新药曲前列尼尔二乙醇胺吸入粉雾剂临床试验申请获国家药品监督管理局受理。该项目由上海上药睿尔药品有限公司和上海新黄河制药有限公司联合申报。 养心氏片YOUNG研究亮相ESC 2026 当地时间2026年8月31日，2026年欧洲心脏病学会年会（ESC 2026）在德国慕尼黑举办召开。由天津医科大学第二医院心脏内科牵头、上药国风支持开展的“养心氏片对既往无心血管事件冠心病患者的疗效大样本回顾性研究”入选本次大会壁报交流。这是养心氏片首次登上ESC这一国际权威学术舞台，标志着其临床循证研究获得更广泛的国际学界认可，也为冠心病患者的早期管理注入了新的有力证据。 上药天普申报“广东省蛋白质药物工程技术研究开发中心”通过动态评估 近日，上药天普申报的“广东省蛋白质药物工程技术研究开发中心”，顺利通过2025年度广东省工程技术研究中心动态评估。这是继2006年申报获批以来，工程中心历经二十年建设发展后取得的又一阶段性成果，彰显了天普深耕急危重症领域、坚持原研创新的发展定力。目前，工程中心已拥有41项发明专利和3项中国专利优秀奖。 上海和黄 通过ISO9001质量管理体系再认证 日前，上海和黄药业有限公司成功通过ISO9001国际质量管理体系再认证。这标志着公司“两化+两全”现代中药质量管理体系建设持续符合国际标准要求，体系运行的有效性、适宜性与充分性再次获得权威认可，进一步夯实了公司“以质量和安全为基石”的发展根基，为持续推进中药现代化、国际化提供了坚实的体系保障。 上药慧远在全国中药饮片联采中斩获佳绩 近日，2026年全国中药饮片联合采购结果正式公布。上药药材旗下重庆上药慧远药业有限公司全资子公司——重庆上药慧远庆龙药业有限公司凭借扎实的产业基础与高效的统筹调度，实现41 个品种、78个品规全部中选，覆盖全国 23 省/市/自治区，中选规模在全国及重庆地区均位居前列，取得亮眼的阶段性成果。此次联采工作的顺利开展，是上药药材坚定推进“一体两翼”发展战略的重要成果。以此为契机，公司将进一步夯实“一体”根基，做强中药饮片核心主业；以联采业务拓展为纽带，联动中药材、大健康“两翼”协同发展，持续完善全产业链与供应链生态。 上药睿尔“小睿”志愿队 与“铜娃娃”们逐梦筑光之旅 2026年夏末，海风漫过滩涂，浪涛轻轻翻涌。小睿志愿队第三次奔赴铜娃娃罕见病中心 “看海夏令营”，陪伴孩子们赴一场海边之约。孩童奔跑嬉戏、捡拾贝壳，得以暂时卸下病痛带来的压力与拘束。咸湿海风与无垠碧波，为 “铜娃娃” 们留下一段烂漫轻松的户外时光。志愿者们带来的不只是协助与陪伴，更是科普的力量 —— 为“铜娃娃” 家庭量身打造的“随身灯塔”。 上药雷允上、上药中华、上药神象 参与2026上海书展 近日，2026上海书展暨“书香中国”上海周在上海展览中心与上海书城“双主场”举办。展会期间，上海医药旗下三大中华老字号匠心齐聚，与市民进行了一场面对面的国潮互动。 作为深耕中医药文化的老字号品牌，上药雷允上携多款经典好物亮相，并在现场设置AI四诊仪免费体验服务，打造雷氏健康潮玩站。上药中华携百年龙虎，聚焦夏日逛展人群的消暑、醒神需求，激活专属清凉补给点位的健康属性。上药神象则通过直播科普、手作体验、茶饮品鉴等多元形式，将中医药养生文化与阅读雅韵相融，开展了多样惠民活动。 神象“元气养生铺” 入选上海国企老字号创新场景 近日，由市国资委主办的“探访老字号 解码新国潮”上海国企老字号创新场景推介活动正式启动，十大创新场景集中亮相，将开展为期75天的线上线下联动，预计发放千万元级专属消费券，涵盖医药健康、时尚消费、文化艺术等多个业态。上海医药旗下“中华老字号”上药神象凭借“元气养生铺”成功入选，成为本次推介活动中医药健康领域的亮眼名片。

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the FDA has accepted the supplemental New Drug Application (sNDA) for nebulized Tyvaso® (treprostinil) Inhalation Solution to treat IPF. United Therapeutics anticipates the agency's review to be complete in late April 2027. Nebulized Tyvaso has not been approved by the FDA for IPF and remains investigational for this indication. “Nebulized Tyvaso combines direct lung delivery with multimodal activity across fibrotic, vascular, and inflammatory pathways that are central to IPF, with the potential to help address a significant unmet need for this life-threatening disease,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “We’re galvanized by the FDA’s acceptance of the nebulized Tyvaso sNDA for review and believe the strength and rigor of our TETON clinical program support an approvable application for this differentiated multi-pathway treatment for patients managing this life-threatening disease.” The filing was based on positive results from the phase 3 TETON-1 and TETON-2 studies. Combined analyses of TETON-1 and TETON-2 met the primary efficacy endpoint, with nebulized Tyvaso demonstrating statistically significant superiority over placebo for the change in absolute forced vital capacity (FVC) by 111.8 mL (Hodges-Lehmann estimate, 95% confidence interval, 79.7 to 144.0 mL; p<0.0001) from baseline to week 52 in an IPF population broadly treated with background therapy. The combined analyses also showed that nebulized Tyvaso achieved statistical significance for most key secondary endpoints, including reduced risk of a clinical worsening event, reduced risk of acute IPF exacerbation, and changes in percent of predicted FVC, King’s Brief Interstitial Lung Disease quality of life questionnaire (K-BILD), and diffusion capacity of lungs for carbon monoxide (DLCO). TETON-1 data were presented as part of the Breaking News: 2026 Clinical Trial Results in Pulmonary Medicine session at the 2026 annual meeting of the American Thoracic Society (ATS). TETON-2 data were published in The New England Journal of Medicine. Combined results from TETON-1 and TETON-2 were presented during an oral session at ATS and simultaneously published in The New England Journal of Medicine. Both the FDA and the European Medicines Agency have granted orphan designation for treprostinil to treat IPF. TETON Clinical Program A post-hoc analysis of the INCREASE study in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) suggested that nebulized Tyvaso was associated with a significant improvement in FVC, laying the foundation for the TETON clinical program to evaluate the use of nebulized Tyvaso in IPF and progressive pulmonary fibrosis (PPF). The TETON-1 (NCT04708782) and TETON-2 (NCT05255991) studies were multicenter, randomized, double-blind, placebo-controlled phase 3 registration studies evaluating the safety and efficacy of nebulized Tyvaso in patients with IPF over a 52-week period. TETON-1 enrolled patients with IPF in the United States and Canada, and TETON-2 enrolled patients with IPF outside the United States and Canada. The primary endpoints of the studies were the change in absolute FVC from baseline to week 52. Secondary endpoints included: (1) time to clinical worsening; (2) time to first acute exacerbation of IPF; (3) overall survival at week 52; (4) change in percent predicted FVC from baseline to week 52; (5) change in the K-BILD questionnaire from baseline to week 52; and (6) change in DLCO from baseline to week 52. Safety assessments included the development of adverse events, serious adverse events, vital signs, clinical laboratory parameters, and electrocardiogram parameters. Eligible patients completing the TETON-1 and TETON-2 studies could enroll in the TETON-OLE study (NCT04905693), an ongoing open-label extension study to evaluate the long-term safety and tolerability of nebulized Tyvaso in patients with fibrotic lung disease. TETON-PPF is evaluating the use of nebulized Tyvaso in PPF in patients globally, and enrollment is complete. Nebulized Tyvaso has not been approved by the FDA for IPF or PPF and remains investigational for these indications. About IPF Idiopathic pulmonary fibrosis, or IPF, is a scarring disease of the lungs of an unknown (idiopathic) cause and is the most common of the idiopathic interstitial pneumonias. IPF is characterized by the progressive loss of the ability of the lungs to transfer oxygen into the blood, ultimately resulting in respiratory failure and death. While the precise causes of IPF remain unknown, IPF rarely presents before age 50 and can be associated with cigarette smoking and certain genetic dispositions. In addition, some evidence suggests that gastroesophageal reflux (acid reflux, or heartburn), certain viral infections, air pollution, and workplace exposures may be risk factors for IPF. IPF is estimated to affect between 2.4 and 2.98 people per 10,000 persons in North America. Further, United Therapeutics estimates there are at least 100,000 people living with IPF in the United States. 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 profile observed 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 www.TYVASOHCP.com 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 www.unither.com 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 the FDA’s review of our sNDA to add IPF to the labeled indications for nebulized Tyvaso; the potential for nebulized Tyvaso to become a treatment option for IPF patients; our TETON-PPF study of nebulized Tyvaso in PPF patients; 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 September 2, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. TYVASO is a registered trademark of United Therapeutics Corporation.