预约演示

更新于：2026-04-06

Pirfenidone

吡非尼酮

更新于：2026-04-06

概要

基本信息

药物类型

小分子化药

别名

Pirfenidone (JAN/USAN/INN)、AMR-69、AP-01

+ [19]

靶点-

作用方式-

作用机制-

治疗领域

呼吸系统疾病其他疾病肿瘤+ [7]

在研适应症

特发性肺纤维化系统性硬化相关的间质性肺病尘肺病+ [21]

非在研适应症

同种异体移植排斥反应抗中性粒细胞胞质抗体相关性血管炎石棉肺+ [16]

原研机构

InterMune, Inc.

在研机构

Avalyn Pharma, Inc.Viatris Ltd. (New Zealand)

北京康蒂尼药业股份有限公司

+ [9]

非在研机构

Roche Holding AG

Genentech, Inc.Hoffmann-La Roche, Inc.

+ [3]

权益机构

Marnac, Inc.

AFT Pharmaceuticals Ltd.

The Georgia Neurosurgical Institute

+ [5]

最高研发阶段批准上市

首次获批日期

日本 (2008-10-16),

特发性肺纤维化

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)、孤儿药 (韩国)、快速通道 (美国)

登录后查看时间轴

结构/序列

分子式C12H11NO

InChIKeyISWRGOKTTBVCFA-UHFFFAOYSA-N

CAS号53179-13-8

关联

220

项与吡非尼酮相关的临床试验

NCT06241560

/ Recruiting临床2期

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another.
Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.
Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.

开始日期2026-03-05

申办/合作机构

Boehringer Ingelheim GmbH

NCT07454291

/ Not yet recruiting临床1期

A Phase 1, Open-Label Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 in Healthy Participants

The purposes of this study are to:
1. evaluate potential interactions between taladegib (ENV-101) and current standard-of-care (SOC) therapies for idiopathic pulmonary fibrosis (IPF), including nintedanib and pirfenidone, and
2. more fully characterize the pharmacokinetics (PK) of taladegib (i.e., how the body absorbs, distributes, metabolizes and excretes taladegib).
This study will enroll 4 cohorts (groups) of participants. Each cohort will experience a different duration of treatment and sequestering (being housed) at the clinical site, followed by a 14-day follow-up period for safety evaluation. The longest duration of treatment for any cohort is 30 days.

开始日期2026-03-01

申办/合作机构

Endeavor BioMedicines, Inc

NCT07388680

/ Not yet recruiting临床2/3期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Trial on the Efficacy and Safety of Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune-related Pneumonia

Radiation-induced lung injury (RILI) is one of the most common thoracic-radiotherapy complications, with an incidence as high as 31.4 %. Multiple studies have shown that RILI can adversely affect patient prognosis by disrupting treatment schedules. Moreover, the widespread clinical use of immune-checkpoint inhibitors (ICIs) has further increased pulmonary toxicity when radiotherapy (RT) is combined with ICIs. Checkpoint-inhibitor-related pneumonitis (CIP)-i.e., immune-mediated lung injury-may necessitate permanent discontinuation of ICIs, diminish survival benefit, and, in severe cases, directly threaten life. The diagnosis of both RILI and CIP is based on an integrated assessment of subjective symptoms and imaging findings.RILI typically occurs 1-3 months after completion of radiotherapy, whereas CIP may emerge at any point during treatment. The two entities share similar clinical presentations: fever, dry cough, chest tightness, dyspnoea, and pleuritic chest pain. Computed tomography (CT) is the most sensitive imaging modality. Pulmonary-function testing is another routinely used clinical metric; vital capacity, total lung capacity, forced expiratory volume in 1 s (FEV₁), and diffusing capacity of the lung for carbon monoxide (DLCO) may all decline, with DLCO being the most sensitive parameter. In advanced cases, arterial oxygen and carbon-dioxide tensions may also deteriorate.Currently, RILI is managed empirically with systemic corticosteroids and supportive care; however, this approach yields limited improvement in diffusing capacity or ventilatory function, and its ability to prevent radiation-induced pulmonary fibrosis (RPF) remains undefined. Corticosteroids also remain the mainstay of CIP therapy. Pirfenidone, a potent cytokine inhibitor, attenuates fibroblast activity by reducing production of transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF), thereby suppressing fibroblast proliferation and extracellular-matrix collagen synthesis. Pre-clinical efficacy studies have demonstrated robust anti-inflammatory, anti-oxidant, and anti-fibrotic effects in the lung.Because RILI and pneumonitis arising from combined radio-immunotherapy are often indistinguishable in clinical practice, and because both share pathogenetic features with idiopathic pulmonary fibrosis (IPF), the investigators initiated this phase II/III trial to address the unmet medical need for effective therapy. Building on prior pre-clinical and clinical data, the study aims to establish the optimal dose of pirfenidone capsules for RILI with or without concomitant CIP and to confirm efficacy and safety.Phase II (dose-finding): The study consists of a screening period (Day -28 to Day -1), a 168-day treatment-observation period (Day 1-Day 168), a safety follow-up (28 ± 7 days after the last dose), and subsequent disease-progression and survival follow-up. Ninety subjects with RILI, with or without CIP, who meet all eligibility criteria will be randomly assigned 1:1:1 to low-dose pirfenidone (400 mg TID), high-dose pirfenidone (600 mg TID), or matching placebo.Phase III (confirmatory): The dose of pirfenidone capsules for phase III will be determined jointly by the sponsor and investigators based on accumulated efficacy and safety data. The trial structure mirrors phase II: screening (Day -28 to Day -1), 168-day treatment-observation (Day 1-Day 168), safety follow-up (28 ± 7 days after the last dose), and disease-progression and survival follow-up. Eligible subjects with RILI ± CIP will be randomized 1:1 to receive either pirfenidone capsules (400 mg or 600 mg TID, taken with meals) or identical placebo. After completion of the 28-day post-treatment follow-up, all phase III participants will enter an extension phase for long-term survival assessment every 3 months (± 7 days).This trial will investigate the progression-free survival (PFS) and overall survival (OS) associated with pirfenidone capsules in patients with Grade 2 and 3 radiation-induced lung injury (RILI), with or without chemotherapy-induced pneumonitis (CIP).

开始日期2026-02-28

申办/合作机构

北京康蒂尼药业股份有限公司

[+1]

100 项与吡非尼酮相关的临床结果

登录后查看更多信息

100 项与吡非尼酮相关的转化医学

登录后查看更多信息

100 项与吡非尼酮相关的专利（医药）

登录后查看更多信息

2,254

项与吡非尼酮相关的文献（医药）

2026-12-01·MOLECULAR BIOLOGY REPORTS

Association of Pirfenidone and its Cardioprotective effects in Pentylenetetrazole-induced kindling model of Epilepsy through the High mobility group Box-1/Toll-Like Receptor-4 pathway

Article

作者: Vohora, Divya ; Majid, Haya ; Nidhi ; Dahalia, Mansi

2026-06-01·ARCHIVES OF MEDICAL RESEARCH

Pirfenidone as a Pleiotropic Antifibrotic Agent in Metabolic Steatohepatitis: From Mechanisms to Clinical Evidence

Review

作者: Méndez-Sánchez, Nahum ; Ramírez-Mejía, Mariana M ; Poo, Jorge L ; Ponciano-Rodríguez, Guadalupe

Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive phenotype of steatotic liver disease that can lead to advanced fibrosis, cirrhosis and liver-related complications. Pirfenidone is a small synthetic molecule that was originally approved for idiopathic pulmonary fibrosis. It has pleiotropic antifibrotic, anti-inflammatory, antioxidant, and immunomodulatory properties. In preclinical liver models, pirfenidone reduces hepatic stellate cell activation, collagen deposition, oxidative stress and proinflammatory cytokine expression, largely through the modulation of transforming growth factor β (TGF-β), platelet-derived growth factor (PDGF), mitogen-activated protein kinases, and the Nrf2 axis. Early clinical trials, including the large prospective cohort PROMETEO, the randomized controlled trial in compensated cirrhosis ODISEA, and the translational trial in post-sustained viral response fibrosis MINERVA, show improvements in noninvasive fibrosis markers, liver function tests, quality of life, and parallel epigenetic remodeling. These data suggest that pirfenidone acts on central fibrogenic biology and may contribute to histological regression in advanced disease. Larger and longer trials, as well as rational combinations with metabolic agents, are needed to define its therapeutic role in MASH.

2026-05-01·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Optimization and aerodynamic performance of nebulizable pirfenidone-loaded human serum albumin nanoparticles for targeted pulmonary delivery

Article

作者: Chen, Chih-Kuang ; Liu, Jia-Yu ; Cheng, Meng-Hsuan ; Lin, Zheng-Ian ; Fang, Yi-Ping ; Chien, Chu-Chun ; Chen, Shiou-Lan ; Chen, I-Ling

Idiopathic pulmonary fibrosis (IPF) is a severe fibrotic lung disease associated with poor survival and limited therapeutic efficacy. Oral pirfenidone (PFD), though clinically used, exhibits poor lung accumulation and systemic adverse effects. Human serum albumin (HSA) is a promising drug carrier due to its biocompatibility and ability to enhance solubility and lung targeting. This study developed nebulizable PFD-loaded HSA nanoparticles (PFD-HNPs) to improve pulmonary delivery and antifibrotic efficacy while minimizing systemic toxicity. Formulation parameters, including HSA concentration, pH, and drug loading, were optimized. The resulting PFD-HNPs (∼100 nm, PDI < 0.25, -50 mV) exhibited high entrapment efficiency (63-68%) and maintained physicochemical stability after nebulization. Next-Generation Impactor (NGI) analysis confirmed efficient aerosolization with preferential deposition in stages 5 and 6, indicating favorable lung retention. Cellular studies showed efficient PFD-HNP uptake by NR8383 macrophages and cytoplasmic retention, supporting localized drug reservoir formation. In MRC-5 cells, PFD-HNPs significantly inhibited TGF-β1-induced profibrotic marker expression, demonstrating anti-fibrotic efficacy comparable to that of free PFD. In vivo studies via nebulized inhalation showed no detectable toxicity in major organs. With their stability, efficient aerosol performance, potent antifibrotic effects, and favorable safety profile, PFD-HNPs represent a promising platform for inhaled PFD therapy and offer a potentially safer, more effective strategy for IPF treatment than conventional oral administration.

642

项与吡非尼酮相关的新闻（医药）

2026-04-06

·BioSpace

Avalyn Appoints Jon Congleton, Seasoned Biopharmaceutical Executive, to its Board of Directors

BOSTON, April 06, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., (“Avalyn” or the “Company”), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced the appointment of Jon Congleton, an accomplished biopharmaceutical executive, to its Board of Directors (the “Board”). Mr. Congleton currently serves as Chief Executive Officer and Board Member of Mineralys Therapeutics, Inc. (“Mineralys”), which he has led from its founding as a private, early-stage organization through its evolution into a publicly traded, pre-commercial stage biotechnology company. “We are delighted to welcome Jon to Avalyn’s Board, adding another accomplished biopharmaceutical leader with proven experience building and scaling both private and public companies,” said Lyn Baranowski, Chief Executive Officer of Avalyn. “His distinguished track record in commercial strategy and organizational leadership will be instrumental as we advance our Phase 2 programs, MIST for AP01 and AURA for AP02, and prepare for late-stage development and commercialization. Jon’s insights will help us efficiently execute our mission to deliver a new standard of care for patients with pulmonary fibrosis through targeted, better-tolerated inhaled therapies.” “I am thrilled to join Avalyn’s Board and collaborate with such a talented and mission-driven team,” said Mr. Congleton. “Pulmonary fibrosis remains a devastating disease with limited treatment options and significant unmet need. It is truly distressing to understand how few patients with this deadly diagnosis are able to tolerate the existing oral medicines, underscoring the potential Avalyn has to transform standard of care in pulmonary fibrosis given the encouraging clinical data across its two lead programs.” Mr. Congleton brings nearly 40 years of biopharmaceutical experience, with deep expertise in cardiovascular, gastrointestinal, and central nervous system (“CNS”) therapeutic areas, and a consistent focus on delivering innovative solutions for patients and their care partners. He has served as Chief Executive Officer for both private and public companies, demonstrating success in general management, global strategic marketing, brand development, corporate financing, and organizational leadership. Mr. Congleton currently serves as Chief Executive Officer and Board Member of Mineralys, a publicly traded biotechnology company focused on aldosterone-driven cardiorenal conditions. Prior to Mineralys, he served as Chief Executive Officer and Board Member of Impel Pharmaceuticals, a CNS-focused biotechnology company advancing novel upper nasal cavity drug delivery. He was also previously the Chief Executive Officer and a Board Member at Nivalis Therapeutics. Earlier in his career, he held roles of increasing responsibility at Teva Pharmaceuticals, where he was a member of the original U.S. launch team for Copaxone ® in multiple sclerosis, led the Canadian and U.S. Teva Neuroscience businesses, and ultimately oversaw the global CNS franchise. Mr. Congleton holds a B.S. in marketing from Kansas State University. About Avalyn Pharma Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (“PPF”). AP01 has demonstrated encouraging tolerability and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone data. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (“IPF”). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver dual antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn . Investor Contact: Cassie Saitow, Avalyn Pharma Inc. Sr. Director, IR and Corporate Communications ir@avalynpharma.com Media Contact: Kat Lippincott, Deerfield Group kat.lippincott@deerfieldgroup.com media@avalynpharma.com

临床2期高管变更

2026-04-03

·浦东科创集团

【医创浦东】从罗氏“弃药”到全球首药：一个张江博士的13年“逆行”豪赌

本文阅读时长约8分钟生物医药创新是“十年磨一剑”的长期实践，既考验企业耐力，更依赖区域生态支撑。浦东科创集团公众号推出“医创浦东”专题，聚焦生物医药创新力量。本期走进上海爱科百发生物医药技术股份有限公司（以下简称“爱科百发”），探寻其十余年长跑背后，顶尖人才、耐心资本与全链条生态如何共同托举，书写中国医创的浦东答卷。 2026年3月，一笔4.7亿元的授权交易，让市场重新审视这家张江药企的价值——爱科百发将ADHD药物爱智达®（AK0901）的中国大陆商业化权利授予齐鲁制药。这不仅是公司创立以来最大的单笔商业合作，更释放出两个关键信号：核心管线的资产价值获得产业认可，以及战略聚焦儿科与呼吸领域的清醒判断。这家由前罗氏病毒部负责人邬征博士创立的创新药企，在过去十三年里始终专注于呼吸系统与儿科疾病领域：从接手罗氏暂停的研发项目，到如今手握全球领先的RSV管线、成功上市ADHD新药、稳步推进IPF全球临床，已站在从Biotech向Pharma蜕变的商业化关键节点。而作为其重要投资方，浦东科创集团凭借国资创投的资源优势与产业赋能，助力公司在研发、临床、商业化全链条加速突破，共同书写中国创新药在儿科与呼吸领域的突围篇章。 “逆行”中的远见：从罗氏“弃药”到全球首药在生物医药领域，儿童药研发长期面临周期长、投入高、市场体量相对有限等挑战，多数跨国药企将其置于非优先布局地位。然而，呼吸道合胞病毒（RSV）相关疾病在全球儿童健康领域却是不容忽视的重大威胁。根据权威医学期刊《柳叶刀》等多项研究数据，RSV是全球5岁以下儿童下呼吸道感染的首要病因，全球每年约有3300万例感染病例。在中国，每年因RSV住院的患儿超过200万例。长期以来，这个领域缺乏特异性口服治疗药物，临床主要依赖对症支持治疗，存在着巨大的临床空白。 2013年，时任罗氏中国生物部与病毒部负责人、拥有三十余年抗病毒药物研发经验且为齐瑞索韦（AK0529）共同发明人的邬征，遭遇了罗氏因集团战略调整而暂停针对婴幼儿RSV研发项目的困境。在跨国药企的评估体系里，儿童药并非优先方向。然而，邬征从临床一线看到了巨大的未被满足的需求。正是这种对临床价值的深刻洞察，促使邬征在做出“逆行”决定。他辞去罗氏高管职务，在上海张江创立爱科百发，并从罗氏获得齐瑞索韦的全球独家开发与商业化权益。选择张江并非偶然——在邬征看来，这里集聚从科研人才、CRO服务到临床资源的完整产业链，为爱科百发的快速成长提供了重要支撑。邬征的目标清晰而坚定：将这颗被搁置的“明珠”，打造为全球首个婴幼儿RSV特异性治疗药物。这一决策的前瞻性在随后几年得到充分验证。RSV领域近年来重新成为跨国药企（MNC）的布局热点，但多数管线聚焦于疫苗与预防性抗体——GSK和辉瑞的RSV疫苗、赛诺菲的预防性单抗尼塞韦单抗相继上市，治疗领域却仍属空白。据行业预测，中国RSV治疗药物市场预计将从2024年的4300万元增长至2030年的20亿元，复合年增长率高达52.7%。在这一蓝海市场中，齐瑞索韦是目前全球唯一完成婴幼儿III期临床并提交新药上市申请（NDA）的特效抗病毒药物。在随后的发展过程中，爱科百发并未止步于单一产品。公司通过授权引进与自主研发双轮驱动，从基因泰克等机构引进高潜力资产，并搭建了儿科药物开发、抗病毒筛选等五大技术平台。精准切入三大赛道：构建儿科与呼吸领域的差异化壁垒历经十三年沉淀，爱科百发已构建起由6款候选药物组成的管线矩阵，精准切入RSV、特发性肺纤维化（IPF）和儿童多动症（ADHD）三大高景气赛道，核心产品均对标全球临床空白，具备显著的差异化优势。核心资产齐瑞索韦：填补全球婴幼儿RSV治疗空白作为公司的核心资产，齐瑞索韦是国内首款获得国家药监局突破性疗法认定的非肿瘤药物。其作用机制是通过特异性靶向RSV F蛋白的融合前构象，从而抑制病毒感染，这一靶点已获得低温电子显微镜结构验证。临床数据是产品价值的基石。齐瑞索韦的III期临床试验涉及超过400名RSV感染住院婴儿，结果显示，与安慰剂相比，该产品可使病毒载量显著降低75%，并使危重患儿的住院时间减少2.5天。更值得关注的是，该研究结果于2024年发表于《新英格兰医学杂志》（NEJM），并于2025年发表于《柳叶刀·儿童青少年健康》（The Lancet Child & Adolescent Health），充分证明了其临床价值与学术影响力。2025年8月，公司提交了针对1至24个月婴幼儿适应症的NDA并获受理，预计2026年有望获批。在全球竞争格局中，吉利德、Enanta、默沙东等MNC的竞品仍处于临床中后期，爱科百发凭借先发优势，有望率先卡位百亿蓝海市场。潜力品种AK3280：打造安全性更优的抗纤维化新选择 AK3280是从罗氏与基因泰克引进的另一款重要资产，目前处于II期概念验证后阶段。该药物对标已上市IPF药物，旨在改善现有疗法存在的胃肠道不耐受、光毒性等安全性问题，以更优的治疗窗实现差异化竞争。特发性肺纤维化（IPF）是一种病因不明的罕见病，患者生存率极低，临床需求未被充分满足。全球和中国市场规模稳步增长，但已上市药物如吡非尼酮和尼达尼布均存在明显副作用。AK3280在临床试验中展现出改善肺部功能的能力，更重要的是，它显示出比吡非尼酮更好的胃肠道耐受性，且无光毒性或肝毒性迹象。 2026年2月，AK3280已获得美国FDA批准开展II期临床，并计划于2028年完成中国III期试验。凭借其安全性优势，AK3280有望在IPF治疗领域开辟出一片新天地。已上市产品AK0901：Best-in-class的ADHD复方制剂 AK0901（商品名：爱智达®，复方丝右哌甲酯胶囊）是爱科百发商业化进程中的关键一步。该药于2025年12月获国家药监局批准上市，并于2026年1月正式推向市场，适用于6岁及以上注意缺陷多动障碍（ADHD）患者。 ADHD是一种影响个体全生命周期的慢性神经发育障碍。根据灼识咨询数据，中国儿童和青少年ADHD患病率达6.4%，患者群体庞大，但就诊率仅10%，市场渗透率极低，长效原研药供给不足。爱智达的临床价值在于其创新性的复方设计：每粒胶囊包含70%的前药丝右哌甲酯（SDX）和30%的速释右哌甲酯（d-MPH）。这种设计实现了30分钟内快速起效，并能持续控制症状长达12小时。更关键的是，SDX作为一种前药，仅在抵达下消化道后才被激活，这显著降低了药物的滥用风险。在美国，SDX已被DEA列为管制等级最低的Schedule IV物质，而其他哌甲酯类多为Schedule II。 2021年，爱科百发以最高1.055亿美元的里程碑付款从Commave公司引进其大中华区权益。2026年3月，在产品获批上市仅两个月后，公司便与齐鲁制药达成授权合作——这正是开篇所述的4.7亿元交易。关键一跃的考验：资本助力下的商业化冲刺与价值兑现十三载深耕，爱科百发的长期主义研发路径获得了资本市场的广泛认可。启明创投、高瓴、浦东科创等知名机构持续加注，为公司研发攻坚注入充足动力。2022年6月，爱科百发完成最新一轮1.9亿元融资，投后估值达46.9亿元，彰显了资本对其细分赛道布局与临床价值的高度信任。在这批投资方中，浦东科创集团的战略性投资值得关注。作为上海本土核心国资创投平台，浦东科创集团以精准产业判断著称，此次注资正是基于对儿科与呼吸系统临床需求的深度洞察，以及对爱科百发坚守长期研发价值的认可。投资之外，浦东科创集团更发挥国资平台资源整合优势，为爱科百发链接临床与监管资源、对接产业生态伙伴、协助政策落地，成为公司从初创走向临床后期的重要助力。资本的持续赋能，为爱科百发铺平了前路。而真正检验企业价值的，是商业化能力——与齐鲁制药达成的4.7亿元授权合作，正是爱科百发从“研发驱动”向“商业驱动”跨越的关键一跃。这笔合作的意义远超短期的现金回报：验证了核心管线的资产价值——爱智达®从引进、获批到成功授权，完整走通了“引进-开发-商业化变现”的路径，证明公司具备识别和兑现高价值资产的能力。实现了战略聚焦的清醒判断——公司并未分散精力自建ADHD销售团队，而是将非核心领域的商业化权利交给头部伙伴，从而将有限资源集中投入到RSV和IPF等更具差异化优势的研发管线中。为核心产品商业化积累资金——4.7亿元的里程碑付款不仅充实了现金流，更为齐瑞索韦等核心产品的上市准备、市场开拓和产能建设储备了关键弹药，确保公司在商业化关键阶段拥有充足的资源支撑。为后续产品树立了商业化范式——随着齐瑞索韦有望于2026年获批上市，爱科百发未来在RSV治疗领域同样可以灵活采用合作分销或自建团队的模式，授权合作的成功经验提供了可复用的方法论。爱科百发是“医创浦东”的缩影——以齐瑞索韦等原研产品填补临床空白，依托张江全链条生态实现研产贯通，更以邬征博士等顶尖人才归国创业凸显全球科研聚合效应。一家企业的发展，浓缩了浦东生物医药产业从创新策源到生态落地的完整能力。在这条路上，浦东科创集团始终相伴，以国资创投的耐心与资源，托举起一家本土创新药企的蜕变。未来，浦东科创集团将继续陪伴更多创新企业稳步前行，进一步推动浦东生物医药产业向高端化、国际化迈进。编辑｜雨田校对｜雪山审核｜集团战略发展部

2026-04-02

·小红书

特发性肺纤维化新药来了，靶点研发及进展✨

💊药物：TDI01混悬液（泰德制药，1类新药，全球首个进入IPF 3期的高选择性ROCK2抑制剂）适应症：特发性肺纤维化（IPF）临床研究阶段：3期（多中心、随机、双盲、安慰剂对照、适应性设计）登记号：CTR20254871 启动时间：2025-12-10；首例入组：2025-12-24 目标入组：508例（第一阶段80例，第二阶段428例）用法：400mg，每日1次，空腹口服，摇匀 💊研究设计（两阶段）第一阶段：筛选4周 + 治疗24周 → 评估疗效/安全性第二阶段：筛选4周 + 治疗52周 + 延展52周 + 随访2周 → 确证疗效主要终点：FVC（用力肺活量）较基线变化。 💊针对特发性肺纤维化的1类新药TDI01混悬液 3期临床已启动，高选择性ROCK2抑制剂，多中心招募中，符合条件的病友可多一个治疗选择，一起等新药上市～ ❗本文仅分享IPF 新药研发进展，不作为药品销售和广告用途。 #药物科普 #特发性肺纤维化 #IPF #间质性肺纤维化 #肺纤维化 #特发性肺纤维化新药 #那米司特 #医药 #尼达尼布 #吡非尼酮

100 项与吡非尼酮相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D01583	吡非尼酮	L04AX05	DB04951

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
特发性肺纤维化	日本	Shionogi & Co., Ltd.	2008-10-16

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
肺炎	临床3期	中国	北京康蒂尼药业股份有限公司	2026-02-28
辐射损伤	临床3期	中国	北京康蒂尼药业股份有限公司	2026-02-28
系统性硬化相关的间质性肺病	临床3期	中国	GNI Group Ltd.	2023-05-29
尘肺病	临床3期	中国	GNI Group Ltd.	2023-05-29
煤肺病	临床3期	中国	北京康蒂尼药业股份有限公司	2022-06-07
矽肺	临床3期	中国	北京康蒂尼药业股份有限公司	2022-05-09
硬化肼胝症	临床3期	中国	北京康蒂尼药业股份有限公司	2018-06-08
皮肌炎	临床3期	中国	北京康蒂尼药业股份有限公司	2018-06-01
间质性肺疾病	临床3期	中国	北京康蒂尼药业股份有限公司	2018-06-01
肺损伤	临床2期	中国	北京康蒂尼药业股份有限公司	2026-01-12

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06484153 (ASCO_GI2026)	临床1/2期	转移性结直肠癌 pMMR \| MSS	24	Fruquintinib+pirfenidone+anti-PD-1 antibody	顧餘鹽觸襯壓願膚艱顧(糧廠淵鑰觸顧夢廠糧窪) = 鹽構繭製願醖獵製鹽鏇簾鹹鏇簾窪簾繭築夢選 (壓繭鑰壓網積鏇遞繭構 ) 更多	积极	2026-01-08
NCT03902509 (Pubmed \| Lancet Oncol)	临床2期	-	134	Pirfenidone plus glucocorticoids	鹽鬱廠膚鹽膚築淵蓋鑰(構鹽繭觸蓋艱鬱衊膚廠) = pneumonia (four [6%] of 67 patients in the pirfenidone group vs eight [12%] of 67 patients in the control group), and rash (two [3%] of 67 patients in the pirfenidone group vs none in the control group). 構壓鏇糧鬱鑰範繭繭鑰 (鏇範窪範築襯顧網鹽選 )	积极	2025-12-01
				Glucocorticoids
NCT06329401 (MIST, Pubmed \| BMJ Open Respir Res)	临床2期	进展性肺纤维化	300	AP01 50 mg two times per day	艱範遞遞壓構淵簾壓獵(網窪鏇顧網淵衊製壓淵) = 鏇糧衊製糧簾膚構構夢鹽餘艱願顧獵餘顧觸網 (鬱範鹽鹹壓選製鏇製顧 )	积极	2025-12-01
				Placebo two times per day	淵夢壓製壓艱鏇鑰窪壓(願艱齋遞築鏇觸製觸鑰) = 顧觸醖構憲齋齋獵窪醖構顧餘淵選蓋築繭鬱醖 (築壓願壓製鏇觸鏇窪醖 )
ACR2025	N/A	原发性干燥综合征 anti-SSA/Ro \| anti-SSB/La	45	Glucocorticoids	憲遞蓋夢壓艱衊衊窪餘(構鹹築夢窪繭鑰顧餘憲) = 鑰壓繭繭憲膚構鏇願蓋醖壓壓構製鏇壓築蓋願 (夢網鹹窪網壓夢簾顧膚, 114.0) 更多	积极	2025-10-24
ACR2025	N/A	自身免疫性疾病 \| 系统性硬皮病 \| 类风湿性关节炎伴有类风湿性肺病	132	nintedanib (RA-ILD + SSc-ILD + SADs-ILD)	蓋膚窪獵鬱淵衊顧衊鏇(鏇繭鹹繭襯壓壓壓構蓋) = 製窪遞鏇衊廠窪鹹網糧簾積鏇觸憲遞襯憲繭鏇 (淵齋齋襯糧觸餘顧積醖 ) 更多	积极	2025-10-24
				pirfenidone (RA-ILD + SSc-ILD + SADs-ILD)	蓋膚窪獵鬱淵衊顧衊鏇(鏇繭鹹繭襯壓壓壓構蓋) = 範膚蓋範鬱築淵醖膚製簾積鏇觸憲遞襯憲繭鏇 (淵齋齋襯糧觸餘顧積醖 ) 更多
ChiCTR2400081900 (ESMO2025)	临床2期	放射性口腔黏膜炎	87	Pirfenidone	鑰蓋醖積積糧艱餘鑰鑰(窪膚糧願構蓋鏇願簾顧) = 廠襯醖鬱網醖積醖蓋襯蓋壓夢膚壓願廠齋製鹽 (憲簾鹽膚獵製積顧構獵 )	积极	2025-10-17
				Pirfenidone (Historical controls)	鑰蓋醖積積糧艱餘鑰鑰(窪膚糧願構蓋鏇願簾顧) = 築壓壓衊鹹網襯蓋淵窪蓋壓夢膚壓願廠齋製鹽 (憲簾鹽膚獵製積顧構獵 )
ASCO2025	N/A	特发性肺纤维化	4,529	Pirfenidone	鹽窪廠蓋鬱廠餘鑰夢獵(構齋願淵壓夢糧醖範範) = 觸衊窪積膚齋艱鏇憲衊醖獵夢廠膚鏇艱醖艱鬱 (網膚廠簾顧簾壓製鹹壓 )	积极	2025-05-30
				Non-Pirfenidone	鹽窪廠蓋鬱廠餘鑰夢獵(構齋願淵壓夢糧醖範範) = 窪願願膚鑰築艱鹹觸遞醖獵夢廠膚鏇艱醖艱鬱 (網膚廠簾顧簾壓製鹹壓 )
AP01-002 (ATLAS) (ATS2025)	N/A	-	91	50 mg AP01 once daily	糧壓夢襯壓蓋齋簾衊壓(遞襯積鹹壓糧獵願衊糧) = 壓夢膚鑰膚廠窪鏇齋網窪選網蓋鏇齋襯憲獵構 (襯選鏇醖廠窪膚廠糧餘 )	积极	2025-05-16
				100 mg AP01 twice daily	糧壓夢襯壓蓋齋簾衊壓(遞襯積鹹壓糧獵願衊糧) = 壓鏇齋艱鬱蓋衊窪衊築窪選網蓋鏇齋襯憲獵構 (襯選鏇醖廠窪膚廠糧餘 ) 更多
ATLAS Phase 1b Trial (ATS2025)	临床1期	-	28	AP01 50mg QD	夢鏇鏇鹹衊積夢鏇積齋(糧壓鬱繭顧鏇憲築襯窪) = 蓋鑰選淵衊選願鹹獵壓糧繭鏇壓鑰構窪築襯製 (繭製膚網構蓋膚糧蓋範, 5.61)	积极	2025-05-16
				AP01 100mg BID	夢鏇鏇鹹衊積夢鏇積齋(糧壓鬱繭顧鏇憲築襯窪) = 膚齋襯鏇憲構觸鹽觸鹽糧繭鏇壓鑰構窪築襯製 (繭製膚網構蓋膚糧蓋範, 7.87)
ATLAS Phase 1b Trial (ATS2025)	临床1期	特发性肺纤维化	64	Nebulised AP01 50mg QD	顧衊餘構鹽鹹糧鏇繭膚(範網蓋鏇膚顧構鏇繭蓋) = 淵簾鑰繭製選顧醖觸鏇齋膚壓鏇遞衊蓋繭淵蓋 (顧觸憲醖鬱鬱廠鏇鹹壓 ) 更多	积极	2025-05-16
				Nebulised AP01 100mg BID	顧衊餘構鹽鹹糧鏇繭膚(範網蓋鏇膚顧構鏇繭蓋) = 淵餘範壓鬱膚艱糧壓繭齋膚壓鏇遞衊蓋繭淵蓋 (顧觸憲醖鬱鬱廠鏇鹹壓 ) 更多