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更新于：2026-10-15

Treprostinil diethanolamine

曲前列素二乙醇胺

更新于：2026-10-15

概要

基本信息

药物类型

小分子化药

别名

曲前列尼尔二乙醇胺、UT-15C SR、Orenitram

+ [2]

靶点-

作用方式-

作用机制-

治疗领域

呼吸系统疾病其他疾病

在研适应症

肺动脉高压

非在研适应症

指溃疡系统性硬皮病可见病灶

原研机构-

在研机构

United Therapeutics Corp.上海新黄河制药有限公司上海上药睿尔药品有限公司

非在研机构

United Pharmaceuticals SAS

兆科药业（合肥）有限公司

Ferrer Internacional SA

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (2013-12-20),

肺动脉高压

最高研发阶段(中国)临床申请

特殊审评-

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结构/序列

分子式C27H45NO7

InChIKeyRHWRWEUCEXUUAV-ZSESPEEFSA-N

CAS号830354-48-8

关联

项与曲前列素二乙醇胺相关的临床试验

CTR20140524

/ Completed临床3期

肺动脉高压患者中UT-15C 的开放标签延长期研究

1. 为之前参加评价肺动脉高压患者的UT-15C TDE-PH-310临床试验方案的合格受试者继续提供UT-15C药物治疗。 2. 在口服UT-15C受试者中的长期安全性进行评价。 3. 在长期使用UT-15C 的受试者中，评价持续UT-15C治疗对于运动耐力的影响。

开始日期2014-01-29

申办/合作机构

United Pharmaceuticals SAS

[+1]

EUCTR2012-000098-21-AT

/ Completed临床3期

An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310

开始日期2012-10-18

申办/合作机构

United Therapeutics Corp.

NCT01746485

/ Completed临床1期

A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

开始日期2012-07-01

申办/合作机构

United Therapeutics Corp.

100 项与曲前列素二乙醇胺相关的临床结果

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100 项与曲前列素二乙醇胺相关的转化医学

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100 项与曲前列素二乙醇胺相关的专利（医药）

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项与曲前列素二乙醇胺相关的文献（医药）

2025-11-02·Expert Opinion On Drug Safety

ORENITRAM’s decadal journey: unveiling safety profiles and adverse event through a real-world pharmacovigilance study of FAERS events

Article

作者: Chai, Shengjun ; Cai, Chunmei ; Xu, Guocai ; Xu, Haiming

BACKGROUND:

ORENITRAM, an oral treprostinil formulation, was approved in 2013 for pulmonary arterial hypertension (PAH) treatment, necessitating ongoing safety monitoring.

RESEARCH DESIGN AND METHODS:

This retrospective analysis used FDA Adverse Event Reporting System data from Q4 2013 to Q4 2023, employing disproportionality analysis and the reporting odds ratio (ROR) to identify adverse events (AEs) linked with ORENITRAM.

RESULTS:

Out of 15,660,695 reports, ORENITRAM was the primary suspect in 10,125 cases. We identified 174 significant adverse events across 27 organ systems, with notable issues like pulmonary edema, ascites, and ventricular fibrillation. Females reported more AEs (75.6%) than males (24.0%), suggesting potential metabolic differences. AEs were most common within 30 days of starting treatment or after one year.

CONCLUSIONS:

The study indicates significant safety issues with ORENITRAM, including serious unexpected events such as pulmonary edema, ascites, and ventricular fibrillation. These findings highlight the necessity for careful clinical monitoring and effective risk management, particularly with observed gender differences in AE profiles. The study's retrospective nature and reliance on spontaneous reports may affect result generalizability.

2020-04-01·Clinical rheumatology3区 · 医学

Vascular biomarkers and digital ulcerations in systemic sclerosis: results from a randomized controlled trial of oral treprostinil (DISTOL-1)

3区 · 医学

Article

作者: Van Eyk, Jennifer E ; Wigley, Fredrick M ; Zhu, Jie ; Perin, Jamie ; Zeger, Scott ; Shah, Ami A ; Mecoli, Christopher A ; Allmon, Andrew G ; Fu, Qin ; Hummers, Laura K ; Rao, Youlan

INTRODUCTION:

Although there is abundant evidence of vascular perturbation from studies of peripheral blood in systemic sclerosis (SSc), there are few data about the ability to use biomarkers of vascular injury and growth factors to predict vascular outcomes and response to therapy. We sought to explore the association between candidate vascular biomarkers and digital ulcerations (DU) in a clinical trial context.

METHODS:

We examined 19 circulating vascular, angiogenic, and inflammatory biomarkers in 124 patients with scleroderma and DU who participated in a randomized controlled trial of oral treprostinil diolamine (ClinicalTrials.gov identifier NCT00775463). Correlation, regression, and random forest analyses were conducted to assess biomarker relationships in response to drug treatment.

RESULTS:

Over the 20-week trial, 82 (66%) patients had their cardinal ulcer completely heal, 54 (44%) developed new ulcers, and 72 (58%) had complete healing of all ulcers; mean change in ulcer burden comparing week 20 with baseline was - 0.36 ± 1.70. Nineteen biomarkers were analyzed for their association and ability to predict clinical DU outcomes. After adjusting for multiple comparisons, no individual biomarker (baseline level, week 20 level, or change over time) was significantly associated with any of the clinical outcomes, suggesting that traditional vascular, angiogenic or inflammatory drivers are not predictive of ulcer fate.

CONCLUSIONS:

The lack of strong response to any of the vascular, angiogenic, or inflammatory markers suggest that these pathways are not primary drivers in the development of DU clinical outcomes in a SSc population with prevalent DU.

KEY POINTS:

• Currently we lack robust biomarkers to predict vascular outcomes or response to therapy in scleroderma patients with Raynaud's phenomenon.• Longitudinal assessment of vascular biomarkers in a clinical trial setting provides a unique opportunity to define biomarkers that predict vascular outcomes.• In a randomized controlled trial of oral treprostinil diolamine for treatment of scleroderma-associated digital ulcers, biomarkers involved in several vascular, inflammatory, and angiogenic pathways did not predict short-term clinical response to therapy or digital ulcer outcomes.• Further study of these and other biomarkers should be considered in Raynaud's clinical trials in scleroderma patients without prevalent digital ulcers.

2019-10-01·Journal of pharmacy practice

Transitioning Parenteral or Inhaled Treprostinil to Oral Treprostinil Diolamine: Case Series and Review of the Literature

Review

作者: Hegab, Sara ; Awdish, Rana L. ; Smith, Zachary R. ; Kelly, Bryan

Treprostinil diolamine is the first oral dosage preparation of a prostacyclin analogue for use in treatment naive pulmonary arterial hypertension (PAH). This case series and review of the available literature describes the experience of patients with PAH receiving treprostinil by intravenous (IV), subcutaneous (SQ), or inhalation route who were transitioned to treprostinil diolamine. At our institution, 3 patients were transitioned to treprostinil diolamine who received treprostinil administered by each of the alternative routes: IV, SQ, and inhalation. All patients tolerated the transition without significant worsening of disease end points. In the literature, 5 additional reports representing 48 patients were transitioned to treprostinil diolamine from an alternate route of administration. A majority (92%) of patients were hospitalized during the cross-titration phase and tolerated the transition without changes in disease markers or significant adverse effect. Six (13%) patients required reinitiation of parenteral therapy due to clinical decline. The most common dosing frequency utilized for treprostinil diolamine was 3 times per day. In patients with stable PAH receiving parenteral or inhaled treprostinil, a transition to treprostinil diolamine was a safe approach in a highly select population meeting clinical end points. Additional studies are required to further describe this clinical strategy before accepted in clinical practice.

项与曲前列素二乙醇胺相关的新闻（医药）

2026-10-14

·ir.unither.com

United Therapeutics Statement on Settlement Agreement with Liquidia Technologies

October 14, 2026 United Therapeutics moved quickly over the last week to reach a settlement agreement with Liquidia Technologies, Inc. that enables continuity of therapy for all patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) currently being treated with Yutrepia®. The agreement allows Liquidia to keep Yutrepia on the market for PAH while they pursue FDA approval of an updated product label that removes the indication for PH-ILD. Effective immediately, Yutrepia should not be prescribed for new PH-ILD patients. We are grateful that our significant investments in research and development brought nebulized Tyvaso® and Tyvaso DPI® to people living with PH-ILD after previous therapies failed to effectively treat this challenging disease. The U.S. Patent and Trademark Office awarded us a patent for our innovative PH-ILD treatment in November 2023. After using our clinical trial data for Tyvaso in PH-ILD to develop Yutrepia, Liquidia disregarded our patent and the pending patent litigation and began marketing Yutrepia for PH-ILD in 2025, knowing that a ruling like the federal court’s recent decision could require it to remove the PH-ILD indication from its approved product label. Prior to the court’s recent ruling, United Therapeutics offered Liquidia a settlement that would have kept Yutrepia available for PAH and PH-ILD patients. Liquidia chose not to accept our proposal and instead let the court proceedings play out. United Therapeutics continues to invest heavily in new technologies to advance care for patients with PAH, PH-ILD, and other rare lung diseases. With multiple products under FDA review for idiopathic pulmonary fibrosis and PAH, and ongoing clinical trials for new therapies and delivery systems, we are continuing to innovate for people living with rare pulmonary diseases. We also have established programs to help enable eligible patients to quickly and seamlessly transition to nebulized Tyvaso or Tyvaso DPI without interruption for their treatment. Furthermore, we have the manufacturing capacity and current inventory to meet increased demand. United Therapeutics was founded by a parent trying to save the life of their daughter with PAH. Our deep connection to patients and families desperate for life-saving treatment drives our longstanding commitment to ensuring that they receive them. 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. INDICATION TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics 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 and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension. Both products inhibit platelet aggregation and increase 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 and TYVASO DPI 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 and TYVASO DPI. The concomitant use of either product 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. 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. In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%). 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 or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI® Inhalation Powder, and additional information at www.TYVASOHCP.com or call 1-844-UNITHER (1-844-864-8437). 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: our expectation concerning continuity of therapy for all patients with PAH and PH-ILD; currently being treated with Yutrepia; the removal of PH-ILD from the Yutrepia label; our expectation that Yutrepia should not be prescribed for PH-ILD, effective immediately; our continuing investments in new technologies to advance care for patients with PAH, PH-ILD, and other rare lung diseases; our products under FDA review for idiopathic pulmonary fibrosis and PAH; our clinical trials for new therapies and delivery systems; our continued innovation for people living with rare pulmonary diseases; our programs to help enable eligible patients to quickly and seamlessly transition to nebulized Tyvaso or Tyvaso DPI without interruption for their treatment; the sufficiency of our manufacturing capacity and current inventory to meet increased demand. our efforts to bring innovative therapies to the patients we serve; our goal of ensuring that no patient goes without the therapy they need; 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 October 14, 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 and TYVASO DPI are registered trademarks of United Therapeutics Corporation. YUTREPIA is a registered trademark of Liquidia Technologies, Inc. For Further Information Contact: Investors https://ir.unither.com/contact-ir Media mrteam@unither.com

临床结果上市批准专利侵权

2026-09-05

·化学改变生活笔记

CDE 新药申报更新化药-2026.08

🧪 新药研发笔记 · 月度速览CDE 化药新药申报月度更新 2026 年 8 月 | 113 个受理号 · 41 个独立品种 · 49 家申报单位数据来源：CDE 药品审评中心公开信息 · 整理日期：2026-09-05 🏆 本月重点品种按公开资料完备程度排序。每个模块附"靶点/作用机制 + 当前研发阶段 + 过往申报背景"。① HRS-2329 片 — 江苏恒瑞 8 个受理号 · 月度 TOP1 受理号：CXHL2601003/1004/1005/1006/1007/1024/1025/1026靶点/机制：新型口服泛 RAS（pan-RAS）抑制剂，与亲环蛋白 A（CypA）形成三元复合物，阻断 RAS-GTP 与下游蛋白结合；覆盖 KRAS G12V/G12C/G12D/野生型、NRAS、HRAS适应症： RAS 突变或扩增的晚期实体瘤当前阶段：国内 I 期临床进行中（CTR20253819，2025-09 首次公示）；海外 I 期 NCT07189949，2025-10 启动入组；与 B7-H3 ADC（HS-20093）等联合用药的 1b/2 期 NCT07736612 已于 2026-08-15 启动本次承办： 2026-08-14（4 个）与 2026-08-20（4 个），按不同规格/适应症分批申报过往申报： 2025-06 IND 受理；2025-09 获临床试验默示许可；本次为后续扩适应症/扩展队列的 IND 提交② HRS-7172 片 — 江苏恒瑞受理号：CXHL2601028/1029/1030/1031靶点/机制：公司自主研发的新型抗肿瘤小分子抑制剂，靶向 RAS 突变/扩增通路（具体靶点未公开披露）适应症： RAS 突变或扩增的晚期实体瘤当前阶段：国内 I 期临床进行中（CTR20253376，复旦大学附属肿瘤医院，虞先濬教授）；海外 NCT07142980 I 期（120 例，预计 2028-12 完成）本次承办： 2026-08-20（4 个受理号），按不同规格或队列拆分申报过往申报： 2025-06-12 IND 受理（CXHL2500566/567/568）；2025-09-02 公告获临床试验默示许可；累计研发投入约 2,841 万元；本次为 IND 后扩适应症的扩展队列申报③ HRS-4642 注射液 — 恒瑞（上海恒瑞 + 江苏恒瑞）受理号：CXHL2601002、1023 重复件（共 2 个受理号）靶点/机制： KRAS G12D 特异性抑制剂，脂质体剂型；抑制 MEK、ERK 磷酸化，阻断 MAPK 与 PI3K 信号通路适应症： KRAS G12D 突变晚期实体瘤（核心：胰腺癌、非小细胞肺癌）当前阶段：全球首个 KRAS G12D 公开人体数据项目；2026-02 纳入 CDE 突破性治疗品种（联合 AG 化疗一线治疗胰腺癌）；III 期 HRS-4642-302（NCT07232875，588 例，2025-11 已启动）本次承办： 2026-08-14、2026-08-20，预计为 III 期补充材料或扩适应症 IND过往申报： 2022-08 首次获 NMPA 临床批件；2023 ESMO 公布 I 期数据；2026-01 再获临床试验批准通知书；累计研发投入约 2.54 亿元④ HRS-6093 片 — 江苏恒瑞受理号：CXHL2601001、1003靶点/机制：新型、高效、口服选择性 KRAS G12D 抑制剂，特异性结合 KRAS G12D 突变蛋白适应症： KRAS G12D 突变的晚期恶性实体瘤（包括胰腺癌、结直肠癌、非小细胞肺癌等）当前阶段： I 期临床进行中（NCT07134998，153 例，2025-09 启动）；多项联合方案（阿得贝利单抗/贝伐珠单抗/SHR-8068 等）也已获批本次承办： 2026-08-14，IND 后扩适应症申报过往申报： 2025-06-09 IND 受理；2025-08-25 获临床试验批准通知书；累计研发投入约 2,984 万元⑤ HRS-9308 片 — 成都盛迪医药（恒瑞）受理号：CXHL2601052、1053靶点/机制：化药 1 类小分子创新药，靶点/机制以企业官方披露为准（本次为首次 IND）适应症： CDE 公示未披露，企业按"新药 1 类"首次提交本次承办： 2026-08-28，2 个受理号按不同规格/适应症申报，系该品种首次提交 IND⑥ HRS-4508 片 — 江苏恒瑞受理号：CXHL2600967靶点/机制：新型、高效、选择性酪氨酸激酶抑制剂（TKI），抑制肿瘤细胞增殖适应症：晚期实体瘤（涵盖乳腺癌、肺癌等多项 II 期进行中）当前阶段：多项 II 期临床试验稳步推进本次承办： 2026-08-05过往申报： 2026-03-17 IND 受理；2026-06 获临床试验批准通知书（CXHL2600335）；累计研发投入约 8,180 万元⑦ HRS-5346 片 — 山东盛迪医药（恒瑞）受理号：CXHL2600979靶点/机制：口服小分子脂蛋白(a)[Lp(a)] 抑制剂适应症：脂蛋白紊乱——心血管事件高风险伴 Lp(a) 升高的成人患者当前阶段：国内 II 期临床进行中（HRS-5346-201，120 例）；2026-01 纳入 CDE 突破性治疗品种本次承办： 2026-08-10，预计为 II 期扩展或新队列 IND过往申报： 2024-05 山东盛迪/北京盛迪获 NMPA 临床试验批准通知书；2025-03 与默沙东（MSD）签署海外授权协议（首付款 2 亿美元 + 最高 17.7 亿美元里程碑）；2025 同期国内 II 期启动⑧ HRS-2189 片 — 山东盛迪医药（恒瑞）受理号：CXHL2600977、0978靶点/机制：化药 1 类（具体靶点/机制待企业披露）本次承办： 2026-08-10，2 个受理号，按不同规格或适应症申报⑨ LY4064809 片 — 礼来苏州制药受理号：CXHL2601011、1012、1013靶点/机制：口服高选择性、变构型 PI3Kα 抑制剂，专门针对 PIK3CA 突变型 PI3Kα；突变选择性设计，避免抑制野生型 PI3Kα，显著降低传统 PI3K 抑制剂的高血糖等代谢毒性适应症： HR+/HER2- 晚期乳腺癌（携带 PIK3CA 突变）当前阶段：全球 III 期 PIKALO-2（NCT07174336，CTRC CTR20255191，920 例）；2025 SABCS 已展示数据；2025-01 礼来收购 Scorpion Therapeutics（STX-478），交易总额最高 25 亿美元本次承办： 2026-08-19，3 个受理号（不同规格或联合方案）过往申报：原研 STX-478 由 Scorpion Therapeutics 开发；2025-01 礼来完成对 Scorpion 收购；2025-12 启动 III 期 PIKALO-2 中国部分；本次为 III 期中国桥接试验的新药申请⑩ DZD6008 片 — 迪哲（江苏）医药受理号：CXHL2600968、0969靶点/机制：全新四代 EGFR TKI；可完全穿透血脑屏障；覆盖敏感突变（L858R/19del）、双突变/三重突变（L858R/19del+T790M+C797X）；对野生型 EGFR 选择性 > 50 倍适应症：经治 EGFR 突变（含 C797X 耐药）非小细胞肺癌（含脑转移）当前阶段： I/II 期临床进行中（CTR20241790/TIAN-SHAN2）；与舒沃替尼联合的 TIAN-SHAN8（NCT07079475）启动；2026 ASCO 公布最新数据：60 mg 剂量组 ORR 60%、中位 PFS > 10 个月；脑脊液/游离血浆浓度比 > 1.0本次承办： 2026-08-05，2 个受理号，预计为 I/II 期扩适应症/扩展队列过往申报： 2024-05 在 CDE 公示 TIAN-SHAN2 I 期；2025 ASCO 首次公布人体数据（10/12 例患者肿瘤缩小）；舒沃替尼（ZEGFROVY）2025-07 FDA 获批、2026-07 迪哲与阿斯利康达成全球独家许可⑪ 奥莱泊肽注射液 — 江苏豪森药业受理号：CXHL2601033、1034、1035靶点/机制： GLP-1 / GIP 双受体激动剂；分子具有 GLP-1R、GIPR 双偏向性；显著降低 β-arrestin2 募集与受体内化适应症：肥胖或超重成人的长期体重管理（拓展：2 型糖尿病）当前阶段：NDA 已于 2026-06-04 获 NMPA 受理，本次承办（2026-08-21）预计为补充资料或新规格/新适应症的 II 期补充申请过往申报： 2026-03 公布中国 III 期（HS-20094-301，604 例）：48 周体重降幅最高 19.3%，≥5% 减重比例达 97.2%；恶心 <10%、呕吐 <5%；2025-06 与再生元（Regeneron）达成海外授权（不含中国大陆/港澳）；NDA 已纳入优先审评⑫ HRG2010 胶囊 — 江苏恒瑞受理号：CXHS2600119、0120靶点/机制：左旋多巴 + 卡比多巴复方制剂（化药 2.2 类改良型新药）；优化释放机制以兼顾起效迅速与药效持久适应症：帕金森病伴症状波动患者当前阶段：NDA 受理 ——2026-08-21 CDE 受理上市许可申请本次承办： 2026-08-21，2 个受理号（不同规格）过往申报： 2021-09 获批临床；2023-04 启动 II 期；2026-08-21 NDA 受理；III 期 HRG2010-301 完成（84 家中心，陈海波教授领衔），达成主要终点；累计研发投入约 8,420 万元；同类参照：卡左双多巴缓释片（息宁）、Amneal RYTARY/CREXONT（2025 全球销售额合计约 3.28 亿美元）⑬ 盐酸阿氟色替片（QLC1536）— 上海齐鲁制药 + 无锡合全药业受理号：CXHS2600116、0117靶点/机制：口服强效泛 AKT 激酶抑制剂（抑制 AKT1/AKT2/AKT3），靶向 PI3K/AKT 信号通路适应症： HR+/HER2- 局部晚期或转移性乳腺癌（携带 PIK3CA/AKT1/PTEN 改变、且内分泌治疗耐药）当前阶段：NDA 已于 2026-08-11 受理，本次承办 2026-08-11，2 个受理号（不同规格）过往申报：原研 afuresertib 由来凯医药开发；2025-11 齐鲁与来凯达成 20.45 亿元中国独家许可协议（净销售分成为十余至二十余个百分点）；III 期 AFFIRM-205 达成主要终点（与对照组相比 PFS 显著改善）；有望成为首款获批上市的国产 AKT 抑制剂（同靶点全球仅 AZ 卡匹色替 1 款获批）⑭ AHB-137 注射液 — 杭州浩博医药受理号：CXHL2601049靶点/机制：新型非偶联反义寡核苷酸（ASO），靶向 HBV RNA；通过化学修饰技术在转录层面抑制 HBsAg、抑制病毒复制、重激活特异性免疫——三重协同机制适应症：慢性乙型肝炎（追求临床治愈/功能性治愈）当前阶段：中国大陆 III 期 AUSHINE 已完成入组（CTR20252792 / NCT07246889，>570 例，2025-12-22 完成）；中国 II 期 AB-10-8008 在 EASL 2026 首次公布：基线 HBsAg 100-1000 IU/mL 的初治慢乙肝患者，24 周停药 24 周后临床治愈率达 70%本次承办： 2026-08-27过往申报： 2024-09 启动全球 I 期；2025 II 期数据陆续披露；2025-12 III 期 AUSHINE 完成入组；本次为III 期临床试验申请/扩适应症的国内 IND⑮ ZX-8177 片 — 征祥医药（南京）集团受理号：CXHL2601055、1056靶点/机制：高选择性口服小分子 ENPP1 抑制剂；通过抑制 ENPP1 → 阻止 2'3'-cGAMP 水解 → 激活 cGAMP-STING 通路 → 促进 I 型干扰素（IFN-β）产生；同时重塑肿瘤微环境（增加 CD8+ T 细胞、NK 细胞、M1 巨噬细胞比例）适应症：晚期实体瘤（一线 IND）；同期拓展低碱性磷酸酶血症（HPP，2026-08 已提交 IND）当前阶段：国内 I 期临床进行中（NCT07310134 / CTR20254582，2025-11-25 启动，2025-12-26 首例给药）；2025 EHA、ESMO 等会议披露数据；与化放疗、PARP 抑制剂、PD-L1 抗体联用呈现协同效应本次承办： 2026-08-28，2 个受理号系国内首款进入临床的肿瘤适应症 ENPP1 抑制剂过往申报： 2024-06-19 获 IND 默示许可；2025-11 启动 I 期；2025-12 首例给药；本次为 IND 后扩适应症的扩展队列⑯ KQB198 胶囊 — 今桔生物科技（上海）受理号：CXHL2601050、1051靶点/机制：口服小分子 SOS1 抑制剂；抑制 RAS 通路下游信号传导；用于 RAS 驱动的血液肿瘤与胃肠道间质瘤适应症：转移性胃肠道间质瘤（GIST）+ 慢性期费城染色体阳性慢性粒细胞白血病（Ph+ CML）当前阶段：海外 II 期 KQB198-103（NCT07406633，2026-06-23 启动，GIST 一线 KQB198+ 伊马替尼）；I/1b 期 KQB198-101（实体瘤，NCT06507306）、KQB198-102（血液肿瘤，NCT06645886）进行中本次承办： 2026-08-27，本次为该品种国内 IND 首次提交⑰ MWX205 注射液 — 上海民为生物（乐普医疗子公司）受理号：CXHL2601057靶点/机制：双靶点 siRNA（PCSK9 + ANGPTL3）；一次给药同时调控 LDL-C 与 TG/TRL适应症：高脂血症、动脉粥样硬化性心血管疾病（ASCVD）当前阶段：澳洲 HREC I 期已获批；本次为该品种国内首次 IND 提交过往申报： 2026-03 澳洲 HREC I 期获批（全球首个进入临床的 PCSK9/ANGPTL3 双靶 siRNA）；恒河猴模型显示 PCSK9/ANGPTL3 蛋白抑制率最高 82%/94%、LDL-C/TC 下降 74%/52%（vs 阳性对照 Inclisiran 60%/33%）；已申请 14 个 IND 批件，6 个品种在临床阶段⑱ 注射用多西他赛（白蛋白结合型）— 石药集团中诺药业受理号：CXHS2600114、0118靶点/机制：将多西他赛包裹于人血白蛋白中（HB1801 纳米制剂，2.2 类改良型新药）；去除 Tween-80/乙醇，无过敏、不需激素预处理，可高浓度快速给药适应症：联合安尼妥单抗（KN026）一线治疗 HER2 阳性晚期/转移性乳腺癌（已纳入优先审评）当前阶段： 2026-07 获 NMPA 突破性治疗品种认定；III 期 Healer 研究（KN026-003）2026-06-10 达到主要终点 PFS；2026-08-18 NDA 已获受理并纳入优先审评；本次承办预计为补充申请/扩展适应症过往申报： 2021-08 石药津曼特与康宁杰瑞 KN026 达成许可；2026-05 安尼妥单抗获批（HER2 阳性胃癌）；2026-08-04 新辅助适应症 NDA 受理；本次承办 2026-08-04 与 2026-08-17⑲ 玛舒拉沙韦片 — 江西科睿药业（青峰医药）受理号：CXHS2600119靶点/机制：靶向流感病毒 RNA 聚合酶 PA 亚基的核酸内切酶抑制剂（化药 1 类创新药）适应症：既往健康的 12 岁及以上青少年和成人单纯性甲型和乙型流感当前阶段：已于 2025-03-27 获 NMPA 批准上市（商品名：伊速达®），本次承办 2026-08-18 预计为新适应症或补充规格申请过往申报： 2025-03-27 获批（国内首个自主研发的 PA 抑制剂）；2025-12 纳入 2025 版国家医保目录；III 期数据发表于《Nature Medicine》（曹彬教授团队领衔，591 例）：中位流感症状缓解时间缩短 21 小时、病毒清除时间缩短 25 小时、耐药突变率 < 1%⑳ YR-2316 吸入粉雾剂 — 扬子江药业受理号：CXHL2600993、0994适应症： 2.2 类改良型新药，企业尚未对外披露具体靶点/机制——业内推测为呼吸系统适应症（COPD/哮喘相关）本次承办： 2026-08-13，2 个受理号；系扬子江首款吸入粉雾剂临床申请，也是其首次踏入粉雾剂创新领域过往申报：扬子江此前仅有 2 款吸入溶液获批（盐酸左沙丁胺醇 2022-11、吸入用乙酰半胱氨酸 2024-04）；1 款吸入溶液报产（瑞维那新 2026-07-01 受理）；粉雾剂为全新布局㉑秋水仙碱缓释胶囊 — 解放军军事医学研究院受理号：CXHL2601039、1040、1041靶点/机制：化药 2.2 类改良型新药；秋水仙碱传统用于痛风急性发作、家族性地中海热等，缓释制剂旨在延长作用时间、减少胃肠道副作用本次承办： 2026-08-25，3 个受理号，按不同规格申报㉒普那布林注射用浓溶液 — 大连万春布林医药受理号：CXHL2601022靶点/机制：首创新一类免疫抗肿瘤机制——激活鸟嘌呤核苷酸交换因子 GEF-H1，加速树突状细胞成熟、促进抗原呈递；同时具有化疗引起中性粒细胞减少症（CIN）的预防作用适应症：非小细胞肺癌二三线（与多西他赛联用）；CIN 预防当前阶段：本次承办 2026-08-20，预计为适应症扩展申请或新规格过往申报： 2020-09 中、美双国"突破性疗法"认定（CIN 适应症）；2021-08 恒瑞医药支付 2 亿首付款 + 不超过 11 亿里程碑款 + 1 亿股权投资，获得普那布林大中华区独家商业化权益；2021-12 美国 FDA NDA 申请被否；后续国内与全球持续推进；II 期 NSCLC 数据：联合多西他赛 OS 11.3 vs 6.7 个月㉓ WD-910 片 — 浙江文达医药科技受理号：CXHL2601054靶点/机制：化药 1 类（首 IND），靶点/机制待企业披露本次承办： 2026-08-28，系该品种国内首次 IND㉔ HW281171 片 — 湖北生物医药产业技术研究院受理号：CXHL2601046、1047靶点/机制：化药 1 类（首 IND），靶点/机制待企业披露本次承办： 2026-08-27，2 个受理号，按不同规格/适应症申报 📋 8 月完整受理清单（按承办日期倒序）所有受理号采用 CDE 完整格式（CXHL260**** / CXHS260****），未缩写。序号受理号药品名称分类企业承办日期 1 CXHL2601057 MWX205 注射液 1 上海民为生物 2026-08-31 2-3 CXHL2601056 / 055 ZX-8177 片 1 征祥医药 2026-08-28 4 CXHL2601054 WD-910 片 1 浙江文达医药 2026-08-28 5-6 CXHL2601053 / 052 HRS-9308 片 1 成都盛迪医药（恒瑞） 2026-08-28 7-8 CXHL2601051 / 050 KQB198 胶囊 1 今桔生物科技 2026-08-27 9 CXHL2601049 AHB-137 注射液 1 杭州浩博医药 2026-08-27 10 CXHL2601048 PRT-064040 鼻喷雾剂 1 四川普锐特药业 2026-08-27 11-12 CXHL2601047 / 046 HW281171 片 1 湖北生物医药产业技术研究院 2026-08-27 13 CXHL2601045 注射用 QHL-1031 1 上海亲合力生物 2026-08-26 14 CXHL2601044 ST-1703 片 1 北京赛特明强医药 2026-08-25 15-17 CXHL2601043 / 042 / 041 秋水仙碱缓释胶囊 2.2 解放军军事医学研究院 2026-08-25 18 CXHL2601039 GST101 片 1 枕石生物医药（珠海） 2026-08-24 19-20 CXHS2600121 / 120 HRG2010 胶囊 2.2 江苏恒瑞医药 2026-08-21 21 CXHL2601038 纳曲酮利培酮植入剂 2.2;2.3;2.4 深圳善康医药 2026-08-21 22-23 CXHL2601037 / 036 HJ065 片 1 华健未来（成都） 2026-08-21 24-26 CXHL2601035 / 034 / 033 奥莱泊肽注射液 1 江苏豪森药业 2026-08-21 27 CXHL2601032 HRS-4642 注射液 1 上海恒瑞 + 江苏恒瑞 2026-08-20 28-31 CXHL2601031 / 030 / 029 / 028 HRS-7172 片 1 江苏恒瑞 + 上海恒瑞 2026-08-20 32-35 CXHL2601027 / 026 / 025 / 024 HRS-2329 片 1 江苏恒瑞医药 2026-08-20 36 CXHL2601023 曲前列尼尔二乙醇胺吸入粉雾剂 2.2 上海上药睿尔 + 新黄河 2026-08-20 37 CXHL2601022 普那布林注射用浓溶液 1 大连万春布林 2026-08-20 38-39 CXHL2601021 / 020 CPD705 注射液 1 北京泰德制药 2026-08-19 40-41 CXHL2601019 / 018 BW-41012 注射液 1 上海舶望制药 2026-08-19 42-43 CXHL2601017 / 016 QLS1510 片 1 上海齐鲁制药研究中心 2026-08-19 44-45 CXHL2601015 / 014 PSTA100 胶囊 1 普罗思特（南京） 2026-08-19 46-48 CXHL2601013 / 012 / 011 LY4064809 片 1 礼来苏州制药 2026-08-19 49 CXHS2600119 玛舒拉沙韦片 2.4 江西科睿药业 2026-08-18 50 CXHS2600118 注射用多西他赛（白蛋白结合型） 2.2 石药集团中诺药业 2026-08-17 51-52 CXHL2601010 / 009 SIM0518 胶囊 1 上海先声再明 2026-08-17 53 CXHL2601008 68Ga-NRT6020 注射液 1 成都纽瑞特医疗 2026-08-17 54-57 CXHL2601007 / 006 / 005 / 004 HRS-2329 片 1 江苏恒瑞医药 2026-08-14 58, 60 CXHL2601003 / 001 HRS-6093 片 1 江苏恒瑞医药 2026-08-14 59 CXHL2601002 HRS-4642 注射液 1 上海恒瑞 + 江苏恒瑞 2026-08-14 61 CXHL2601000 BC923 注射液 1 北京博源润步 2026-08-13 62-64 CXHL2600999 / 998 / 997 HTMC0658 片 1 上海壹典医药 2026-08-13 65-66 CXHL2600996 / 995 VC005 凝胶 1 江苏威凯尔医药 2026-08-13 67-68 CXHL2600994 / 993 YR-2316 吸入粉雾剂 2.2 扬子江 + 海陵药业 2026-08-13 69 CXHL2600992 左氧氟沙星雾化吸入溶液 2.4 浙江百代医药 2026-08-12 70-71 CXHL2600991 / 990 SIGX1094R 片 1 希格生科（深圳） 2026-08-12 72-73 CXHL2600989 / 988 SHCW-8602 片 1 广东红珊瑚药业 2026-08-12 74-75 CXHL2600987 / 986 HH-1270 片 1 华辉安健（北京/河南） 2026-08-12 76 CXHL2600985 177Lu-FAP-VG11 注射液 1 山东威智知科药业 2026-08-12 77-78 CXHL2600984 / 983 LB220-D08 缓释片 1 石家庄以岭药业 2026-08-12 79 CXHL2600982 盐酸（R）-氯胺酮注射液 2.1;2.4 成都倍特药业 2026-08-12 80 CXHL2600981 注射用 SPN01 1 北京声光纳医疗 2026-08-12 81-82 CXHS2600117 / 116 盐酸阿氟色替片 1 上海齐鲁 + 无锡合全 2026-08-11 83 CXHL2600980 90Y-NRT6020 注射液 1 成都纽瑞特医疗 2026-08-10 84 CXHL2600979 HRS-5346 片 1 山东盛迪医药（恒瑞） 2026-08-10 85-86 CXHL2600978 / 977 HRS-2189 片 1 山东盛迪医药（恒瑞） 2026-08-10 87 CXHS2600115 AP301 胶囊 1 礼邦制药 + 药源生物 2026-08-07 88-89 CXHL2600976 / 975 S01D 片 1 浙江我武生物 2026-08-07 90-91 CXHL2600974 / 973 XNW26018 片 1 苏州信诺维医药 2026-08-06 92 CXHL2600972 ADC118 片 1 成都/江苏/南京艾迪医药 2026-08-06 93-94 CXHL2600971 / 970 CB345 2.2;2.4 杭州成邦医药科技 2026-08-06 95-96 CXHL2600969 / 968 DZD6008 片 1 迪哲（江苏）医药 2026-08-05 97 CXHL2600967 HRS-4508 片 1 江苏恒瑞医药 2026-08-05 98-100 CXHL2600966 / 965 / 964 KC1086 片 1 北京康辰药业 2026-08-05 101-104 CXHL2600963 / 962 / 961 / 960 VB19055 片 1 浙江扬厉医药 2026-08-05 105 CXHL2600959 乙醇注射液（含碘普罗胺） 2.3 成都倍特药业 2026-08-05 106 CXHS2600114 注射用多西他赛（白蛋白结合型） 2.2 石药集团中诺药业 2026-08-04 107-108 CXHL2600958 / 957 INV-9956 胶囊 1 广东创新药转化医学研究院 + 原力生物 2026-08-04 109 CXHL2600956 GFH276 片 1 劲方医药科技（上海） 2026-08-04 110 CXHL2600955 AHB-121 注射液 1 杭州浩博医药 2026-08-04 111-112 CXHL2600954 / 953 PSTC100 片 1 普罗思特（南京） 2026-08-04 113 CXHL2600952 艾托莫德片 1 渐宽（苏州）生物科技 2026-08-03 📌 注：同一品种多个受理号已合并至同一行展示，方便查阅。完整明细原始版本见 CDE 官网受理品种目录。 💡 本月看点恒瑞医药一家独大： 21 个受理号、占比 18.6%；HRS-2329（pan-RAS）、HRS-7172、HRS-6093（KRAS G12D）、HRS-4508（TKI）、HRS-5346（Lp(a)）、HRS-4642（KRAS G12D）、HRG2010（左旋多巴 NDA）等 7 个独立品种并行推进。RAS 靶点持续爆火：本月 4 款 RAS 通路抑制剂（pan-RAS/KRAS G12D/SOS1）相关受理号合计占化药 1 类近 1/4，赛道极为拥挤。全球同类首发品种： MWX205（PCSK9/ANGPTL3 双靶 siRNA）、ZX-8177（国内首个肿瘤适应症 ENPP1 抑制剂）、KQB198（SOS1）、HRS-9308、HRS-2189、AHB-137、HRG2010 等多个"国内/全球首个"项目。代谢领域再度走热：奥莱泊肽（GLP-1/GIP）NDA、HRG2010 NDA、LY4064809 III 期桥接，叠加玛舒拉沙韦新规格申报，月度共 4 个代谢/慢病相关受理亮点。License-out / 海外授权： HRS-5346（恒瑞→默沙东，首付 2 亿美元）、奥莱泊肽（豪森→再生元）、LY4064809（礼来自 Scorpion 收购）、DZD6008/舒沃哲（迪哲→阿斯利康）等多个"借船出海"动作持续兑现。 — 完 —

临床申请抗体药物偶联物申请上市临床1期临床3期

2026-09-03

·上海医药

YAO闻时刻 | 经营发展与品牌建设质效双升，驱动增长新引擎

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。

100 项与曲前列素二乙醇胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10430	-	B01AC21	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
肺动脉高压	美国	United Therapeutics Corp.	2013-12-20

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
指溃疡	临床2期	美国	United Therapeutics Corp.	2009-09-01
指溃疡	临床2期	加拿大	United Therapeutics Corp.	2009-09-01
指溃疡	临床2期	英国	United Therapeutics Corp.	2009-09-01
系统性硬皮病	临床2期	美国	United Therapeutics Corp.	2009-05-01
系统性硬皮病	临床2期	加拿大	United Therapeutics Corp.	2009-05-01
系统性硬皮病	临床2期	英国	United Therapeutics Corp.	2009-05-01
可见病灶	临床2期	美国	United Therapeutics Corp.	2009-05-01
可见病灶	临床2期	加拿大	United Therapeutics Corp.	2009-05-01
可见病灶	临床2期	英国	United Therapeutics Corp.	2009-05-01

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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


NCT01477333 (CTgov)	临床2期	肺动脉高压	18	UT-15C SR+Tyvaso Inhalation Solution	製遞膚範構網選蓋鏇選(蓋壓築積範願餘鬱願願) = 顧窪淵鹹壓繭築餘鏇鑰衊積膚衊膚觸夢廠鹽醖 (鏇餘鬱願鹽鬱餘鏇淵糧, 齋壓繭鏇積醖鬱醖醖遞 ~ 繭繭繭鑰壓鬱壓遞醖齋) 更多	-	2017-03-06
NCT01934582 (TDE-PH-304, CTgov)	临床3期	肺动脉高压	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 1)	糧艱糧廠鏇齋顧衊窪窪(餘鹽願鹹鹹鏇簾積膚積) = 製簾選觸獵餘齋遞顧襯廠遞淵齋憲淵餘構積艱 (繭齋繭廠夢選鹹積壓顧, 鹹鑰顧鑰醖齋網鑰遞壓 ~ 構夢構衊廠繭膚願廠襯) 更多	-	2016-10-27
NCT01934582 (TDE-PH-304, CTgov)	临床3期	肺动脉高压	13	UT-15C SR (treprostinil diethanolamine) (PK Visit 2)	糧艱糧廠鏇齋顧衊窪窪(餘鹽願鹹鹹鏇簾積膚積) = 積遞簾繭壓築遞廠襯鏇廠遞淵齋憲淵餘構積艱 (繭齋繭廠夢選鹹積壓顧, 衊鹽壓衊憲築顧鬱艱壓 ~ 鹹蓋範艱壓鏇膚齋餘積) 更多	-	2016-10-27
NCT01588405 (CTgov)	临床2期	肺动脉高压	33	UT-15C SR	艱鏇淵製願製觸糧襯觸 = 鏇壓壓鹹醖窪構鏇願構衊鏇淵鹹衊選糧夢積鹽 (窪膚艱衊夢繭鏇構構築, 窪窪壓憲簾觸積淵範艱 ~ 網構鏇糧窪襯齋觸蓋製) 更多	-	2016-05-16
NCT00775463 (DISTOL-1, CTgov)	临床2期	系统性硬皮病 \| 可见病灶	148	treprostinil diethanolamine	構顧鹹鑰衊顧憲醖鏇範(壓淵鬱艱窪餘窪夢糧衊) = 鏇壓憲顧簾獵艱範築積鑰鹽遞憲構蓋繭鬱網襯 (糧淵願築積繭簾憲憲繭, 餘醖艱獵鑰繭窪願蓋襯 ~ 鏇淵襯鹹製襯襯鬱網觸) 更多	-	2014-03-17
NCT00848107 (DISTOL-EXT, CTgov)	临床2期	系统性硬皮病 \| 可见病灶 \| 指溃疡	115	Treprostinil Diethanolamine	夢醖淵淵淵簾鏇廠憲簾(願鑰醖齋鏇餘蓋壓醖蓋) = 鬱選糧顧願憲鬱衊製繭鑰廠遞壓淵衊顧選積襯 (壓憲構積鬱構積製鹹構, 1.61) 更多	-	2014-02-07
NCT00887978 (FREEDOM-C2, CTgov)	临床3期	肺动脉高压	310	UT-15C SR (UT-15C SR)	顧淵蓋鏇齋範觸選繭齋(鹽製積積範膚蓋鹹齋選) = 鑰鑰願艱積憲襯構製淵夢襯窪顧衊壓積鹽構鏇 (獵範觸窪衊鬱蓋艱齋鏇, 顧製鏇鹽糧衊鑰繭憲醖 ~ 鹹鬱獵構遞憲獵構鏇繭) 更多	-	2013-01-15
NCT00887978 (FREEDOM-C2, CTgov)	临床3期	肺动脉高压	310	Placebo (Placebo)	顧淵蓋鏇齋範觸選繭齋(鹽製積積範膚蓋鹹齋選) = 鏇範遞襯築壓糧衊鹽憲夢襯窪顧衊壓積鹽構鏇 (獵範觸窪衊鬱蓋艱齋鏇, 簾夢繭餘築鹹鹹壓製鬱 ~ 壓網觸襯憲醖積齋製觸) 更多	-	2013-01-15