乙磺酸尼达尼布(Nintedanib esylate) - 药物靶点：CSF-1R x FGFRs x FLT3_在研适应症：局部晚期非小细胞肺癌，转移性非小细胞肺癌，复发性非小细胞肺癌_专利_临床

概要

基本信息

药物类型

小分子化药

别名

CYNEDIV、Intedanib、NDNB

+ [27]

靶点

CSF-1R x FGFRs x FLT3

作用方式

拮抗剂、抑制剂

作用机制

CSF-1R拮抗剂(集落刺激因子1受体拮抗剂)、FGFRs拮抗剂(成纤维细胞生长因子受体家族拮抗剂)、FLT3抑制剂(酪氨酸蛋白激酶受体FLT3抑制剂)

治疗领域

肿瘤呼吸系统疾病其他疾病+ [6]

在研适应症

局部晚期非小细胞肺癌转移性非小细胞肺癌复发性非小细胞肺癌+ [23]

非在研适应症

急性红细胞白血病急性早幼粒细胞白血病大肠腺癌+ [58]

原研机构

Boehringer Ingelheim International GmbH

在研机构

Boehringer Ingelheim GmbHBoehringer Ingelheim Pty Ltd.Boehringer Ingelheim International GmbH

+ [15]

非在研机构

美莱普（北京）医药研究有限公司

Boehringer Ingelheim España SABoehringer Ingelheim Ltd.

权益机构

远大医药（中国）有限公司

Santen Pharmaceutical Co., Ltd.

Mount Sinai Medical Center of Florida, Inc.

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2014-10-15),

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)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (韩国)、特殊审批 (中国)、孤儿药 (澳大利亚)、快速通道 (美国)

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结构/序列

分子式C33H39N5O7S

InChIKeyMMMVNAGRWOJNMW-FJBFXRHMSA-N

CAS号656247-18-6

关联

248

项与乙磺酸尼达尼布相关的临床试验

NCT07485920

/ Not yet recruiting临床4期IIT

A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer

This study is a prospective, single-arm, multicenter, exploratory clinical trial. It aims to evaluate the efficacy and safety of tislelizumab combined with nintedanib as consolidation therapy for patients with limited-stage small cell lung cancer after concurrent chemoradiotherapy, and to explore the prognostic markers related to the therapeutic effect.

开始日期2026-05-01

申办/合作机构

青岛大学附属医院

NCT07335562

/ Not yet recruiting临床3期

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

开始日期2026-04-30

申办/合作机构

Juno Therapeutics, Inc.

[+1]

NCT07194382

/ Recruiting临床2期

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability.
Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, and if treated with oral nintedanib or pirfenidone, have stopped the medication for at least 3 months.
Researchers will compare two different doses of AP02 to a placebo (a look-alike substance that contains no drug) to see if AP02 works to treat IPF. Participants are put into 1 of 3 groups randomly, which means by chance and will take AP02 or a placebo two times every day for 12 weeks by using a nebulizer, which is a device that provides medicine to the lungs via inhalation.
Participants will visit the office 6 times and receive 1 phone call over a 16-week period. At site visits doctors regularly perform breathing tests that measure how well the lungs are working, give the patient questionnaires and will check the participants' health.

开始日期2026-03-10

申办/合作机构

Avalyn Pharma, Inc.

100 项与乙磺酸尼达尼布相关的临床结果

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100 项与乙磺酸尼达尼布相关的转化医学

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100 项与乙磺酸尼达尼布相关的专利（医药）

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2,179

项与乙磺酸尼达尼布相关的文献（医药）

2026-06-01·Nanomedicine-Nanotechnology Biology and Medicine

Nebulized delivery of multi-modular stem cell-derived exosomes for the treatment of pulmonary fibrosis

Article

作者: Du, Hongwu ; Li, Luping ; Wang, Lei ; Sha, Shuang ; Li, Liang ; Gao, Xiaoyu ; Hang, Zhongci ; Xing, Cencan ; Yang, Yang ; Sun, Chunbin ; Cai, Shanglin

Pulmonary fibrosis (PF) is a terminal pathological manifestation of a group of lung diseases characterized by fibroblast proliferation, excessive extracellular matrix deposition, inflammatory damage, and structural destruction of lung tissue. The lung damage caused by PF is typically irreversible. Current medications and therapies can slow disease progression but fail to fully repair the damaged lung tissue. In this study, we developed a composite nanoparticle system from PNP@Exo using Poly(lactic-co-glycolic) acid (PLGA) as a carrier, which is capable of co-delivering the anti-fibrotic drug nintedanib and coated with polydopamine for adhering human umbilical cord mesenchymal stem cell-derived exosomes (hUC-MSCs-Exo) to synergistically harness their therapeutic effects. In vitro experiments demonstrated that the composite drug-loaded nanoparticles PNP@Exo significantly reduced the expression of inflammatory factors, COLI, and COL-III in bleomycin (BLM) induced A549 cells. Furthermore, administration of PNP@Exo into BLM-induced PF mice via nebulization significantly inhibited the production of extracellular matrix components and improved lung function without inducing systemic toxicity. Additionally, PNP@Exo inhibited the ferroptosis process in both PF cells and mice models. In conclusion, the composite drug-loaded nanoparticles synthesized in this study demonstrated a significant therapeutic efficacy in both PF cells and animal models, providing a novel strategy for the treatment of pulmonary fibrosis.

2026-05-01·CELLULAR SIGNALLING

Anti-fibrotic activity of nobiletin and nintedanib: In vitro and in vivo evidence in pulmonary fibrosis models

Article

作者: Wang, Yuanru ; Li, Luyao ; Yang, Xue ; Li, Xuejun ; Li, Huifang ; Zhang, Xiaoqian ; Cao, Yajun ; Lei, Qiqi ; Liu, Jie ; Xiang, Liuyan

BACKGROUND:

Pulmonary fibrosis, a well-known chronic and progressive lung disease, primarily impacts the interstitial tissues of the lungs, with a lack of effective therapies. Nobiletin is a polymethoxyflavonoid that exhibits characteristics of BH3 mimetics. It is mainly extracted from citrus peels and is known for its diverse pharmacological activities. Given the unsatisfactory clinical trial results of nintedanib, a combined treatment approach may represent a viable strategy for combating pulmonary fibrosis.

METHODS:

An in vitro pulmonary fibrosis model was established by inducing MRC-5 cells with transforming growth factor-β1 (TGF-β1). The impact of nobiletin combined with nintedanib on the migration of MRC-5 cells was assessed by wound healing and Transwell assays. Immunofluorescence and Western blot analyses were employed to assess the effect of drug combination on fibrosis-related markers, while Co-Immunoprecipitation (Co-IP) experiments were performed to assess the effects on autophagy. The anti-fibrotic effects and potential mechanisms of the combination of nobiletin and nintedanib were further explored using a bleomycin-induced pulmonary fibrosis model in C57BL/6 J mice.

RESULTS:

In vitro, the combination of nobiletin and nintedanib significantly inhibited MRC-5 cells' migration and extracellular matrix deposition, while simultaneously promoting apoptosis and autophagy. In addition, this combination exerted an anti-pulmonary fibrosis effect by regulating epigenetic mechanisms and the PI3K-AKT-mTOR signaling pathway. In vivo studies further revealed that the combination of nobiletin and nintedanib significantly reduced hydroxyproline levels in mice, attenuated lung inflammation, and helped to limit or prevent collagen accumulation.

CONCLUSIONS:

Our study demonstrates that the combination of nobiletin and nintedanib exhibits promising anti-fibrotic effects both in vitro and in vivo.

2026-05-01·JOURNAL OF ETHNOPHARMACOLOGY

Study on the anti-pulmonary fibrosis mechanism of Renshen Pingfei formula by inhibiting M2 macrophage polarization and regulating TGF - β/SMAD signaling pathway

Article

作者: Yang, Yaojing ; Hong, Lingling ; Fan, Xinsheng ; Zhang, Jingjing ; Sun, Yubo ; Zhu, Jinfeng ; Hou, Haihui ; Shi, Weiwei

ETHNOPHARMACOLOGICAL RELEVANCE:

Renshen Pingfei formula (RSPF), a traditional Chinese medicine (TCM) formulation,has been historically prescribed in China for treating "Fei Bi" (pulmonary stagnation syndrome), which symptoms and pathogenesis aligns with those of idiopathic pulmonary fibrosis (IPF).

AIM OF STUDY:

This study aimed to investigate the effects of RSPF on bleomycin-induced pulmonary fibrosis in mice and explore its regulatory effects on the TGF-β/SMAD signaling pathway and M2 macrophages polarization.

MATERIALS AND METHODS:

LC-MS/MS was used to detect and identify the main active components of RSPF. In vivo studies were conducted using forty-eight C57BL/6 mice divided into six groups (n = 8): control, BLM, low, medium, or high RSPF dose (8.8, 17.5, or 35 g/kg, respectively), and Nintedanib (60 mg/kg/d). A pulmonary fibrosis mouse model was established by intratracheal instillation of bleomycin at 5 mg kg-1. Histopathological changes in the lung tissue were assessed using hematoxylin-eosin (HE), Masson, and Sirius red staining. Enzyme-linked immunosorbent assay (ELISA) was employed to measure IL-1β and TNF-α levels in bronchoalveolar lavage fluid (BALF). Immunofluorescence analysis was performed to determine the expression levels of Arg-1⁺/F4/80⁺ and CD206⁺/F4/80⁺ cells. Flow cytometry was used to detect the expression of CD206 in interstitial macrophages (IMs) and alveolar macrophages (AMs). Furthermore, in vitro studies were employed using RSPF applied to IL-4-stimulated bone marrow-derived macrophages (BMDMs), co-cultured with alveolar epithelial cells. Flow cytometry was used to quantify M1 (CD86) and M2 (CD206) polarization. RT-qPCR, Western blot, and immunofluorescence were used to evaluate the fibrosis/EMT markers (E-cadherin, Vimentin, α-smooth muscle actin [α-SMA], fibronectin [FN], type I collagen [Collagen I], TGF-β1, and Smad2/3 phosphorylation).

RESULTS:

Seventy-eight active components were identified in RSPF. In vivo studies, RSPF increased the body weight of mice, improved collagen deposition and fibrosis in IPF, upregulated E-cadherin protein levels, and downregulated the expression of fibrosis-related markers such as Vimentin, α-SMA, FN, and Collagen I. Additionally, RSPF inhibited IL-1β and TNF-α levels in BALF and suppressed the protein expression levels of TGF-β, p-Smad2/Smad2, and p-Smad3/Smad3. Further mechanistic studies indicated that RSPF downregulated the expression of Arg-1⁺/F4/80⁺ and CD206⁺/F4/80⁺ and decreased CD206 expression in IMs. In vitro studies, RSPF suppressed M2 polarization (CD206, Arg1), downregulated fibrotic markers (Collagen 1α1, α-SMA), and inhibited TGF-β1/Smad signaling.

CONCLUSION:

RSPF alleviated pathological damage and fibrosis in the lung tissue of IPF mice, thereby delaying the progression of IPF. Its anti-fibrotic mechanism involved dual suppression of TGF-β1/Smad signaling and M2 macrophage polarization.

867

项与乙磺酸尼达尼布相关的新闻（医药）

2026-04-06

·PRNewswire

Cipla Expands U.S. Respiratory Portfolio with Approval of Nintedanib Capsules (100mg & 150mg) for Idiopathic Pulmonary Fibrosis

April 3, 2026 -- Cipla USA Inc. the wholly owned subsidiary of Cipla Limited(BSE: 500087) (NSE: CIPLA) (hereafter referred to as "Cipla") today announced final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nintedanib Capsules, 100 mg and 150 mg, indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Cipla's Nintedanib Capsules are the generic therapeutic equivalent of Ofev®, marketed by Boehringer Ingelheim. IPF is a chronic, progressive lung disease characterized by irreversible scarring of lung tissue, leading to declining lung function and significant impact on patients' quality of life. Commenting on the approval Marc Falkin, CEO, Cipla North America, said, "This approval strengthens our respiratory franchise and reflects our continued commitment to delivering high–quality therapies to patients. We are well prepared with a robust supply plan to support a successful launch." The product will be available through appropriate pharmacy distribution channels, including specialty distribution According to IQVIA, MAT January 2026, Ofev® generated approximately $3.76 billion in U.S. sales, underscoring the importance of reliable, high–quality treatment options in this category. Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec'25), 2nd Largest in the pharma prescription market in South Africa (IQVIA MAT Nov'25), and 3rd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Dec'25). For nine decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. The content above comes from the network. if any infringement, please contact us to modify.

上市批准生物类似药

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

2026-04-04

·医麦客

最快上半年 BLA！自免 CAR-T 疗法步入关键期，哪款率先撞线？

免费早鸟票，200 张限量领取 2026 年 4 月 5 日医麦客新闻 eMedClub News 继在治疗肿瘤取得突破后，CAR-T 疗法正将治疗革命推向自身免疫疾病领域。与传统需长期维持的免疫抑制方案不同，该疗法旨在通过精准清除引发免疫攻击的 B 细胞或浆细胞，从根本上重建免疫耐受，有望为患者带来「功能性治愈」的希望。随着技术迭代与临床证据的持续积累，全球已有多家企业将自免 CAR-T 项目推进至 Ⅲ 期临床阶段，围绕多个适应症展开「首创疗法」的竞速角逐。 Kyverna Kyverna Therapeutics 于今年 JMP 年会上宣布，鉴于其 CD19 CAR-T miv-cel（KYV-101）治疗僵人综合征（SPS）在注册性 Ⅱ 期临床试验 KYSA-8 中取得的前所未有的积极结果，预计于 2026 年上半年提交 SPS 适应症的生物制品许可申请（BLA）。公司已任命前吉利德 Kite 首席执行官 Christi Shaw 为董事会执行主席，全面推动 SPS 适应症的上市进程，力争成为全球首个获批上市的 SPS 疗法。此外，Kyverna 已启动 miv-cel 治疗全身性重症肌无力（gMG）的注册性 Ⅲ 期临床试验。公司还将进一步探索该疗法在无淋巴细胞耗竭方案及门诊给药模式中的应用潜力，以提升患者用药可及性。 Miv-cel 采用全人源化设计及 CD28 共刺激结构域，通过单次输注实现深度 B 细胞清除与免疫系统重置，有望为自身免疫性疾病患者带来持久且无需持续用药的临床缓解。推荐：提前锁定「全球首款自免 CAR-T」，CD19 CAR-T 治疗僵人综合征疗效「史无前例」 BMS 1 月，美国临床试验收录网显示，百时美施贵宝（BMS）的 CD19 CAR-T 细胞疗法 Zola-cel（Zolacaptagene Autoleucel，BMS-986353，CC-97540）启动了首个 Ⅲ 期临床试验，针对活动性系统性硬化症（SSc）。该研究旨在评估 Zola-cel 联合磷酸氟达拉滨和环磷酰胺对比标准治疗（托珠单抗、利妥昔单抗、尼达尼布）治疗 SSc 的有效性和安全性。此前公布的 Ⅰ 期研究 Breakfree-1 结果显示，系统性硬化症相关间质性肺病（SSc-ILD）患者接受一次 Zola-cel 治疗后，肺功能实现了前所未有的改善。在 6 例基线患有 ILD 的患者中，治疗 6 个月后中位相对预测 FVC（pFVC）较基线增加了 10%。这一数据意义重大——其它疗法并未报告过 pFVC 显著改善的效果。 Zola-cel 采用与 BMS 已上市 CAR-T 产品 Breyanzi 一致的 CD19 CAR 结构，依托 NEX-T 平台生产，有望缩短制备时间（体外制备周期约为 5 天）、提高生产率并提高 CAR-T 细胞质量。 Cabaletta Bio 1 月 12 日，Cabaletta Bio 公布 2026 年战略规划，核心聚焦推进其自体 CAR-T 疗法 rese-cel 在自免疫疾病领域的注册临床与商业化准备。该疗法采用全人源 CD19 结合域及 4-1BB 共刺激结构域，通过基于体重的单剂量输注给药。当下，该公司已于 2025 年 12 月启动了与 FDA 达成共识的皮肌炎（DM）和抗合成酶综合征（ASyS）注册队列研究，计划纳入 17 名患者，以支持 2027 年提交 BLA 申请（包括门诊单剂量剂量方案）。 2025 年 ACR 年会公布的 I/II 期 RESET-肌炎试验数据显示，所有符合注册入组标准的 DM 患者均达到主要终点，且疗效持久性长达一年。此外，FDA 已批准其 IND 补充申请，允许采用自动化、可扩展的 Cellares Cell Shuttle 平台生产 rese-cel，预计 2026 年上半年确认 GMP 达标情况，并有望推广至全产品线。该平台整合 IDMO 智能工厂，可实现低资本投入、快速全球扩产、及商业化后生产排期灵活调整的多重优势，助力规模化供应。公司还将重点推进 RESET-SLE 试验新增的无预处理剂量递增队列研究，后续将基于临床数据，评估与 FDA 就该队列注册路径达成共识的可行性，进一步探索门诊给药潜力，提升患者治疗可及性。 Cartesian Therapeutics Cartesian Therapeutics 开发的 Descartes-08 是一种潜在 FIC mRNA 工程化 CAR-T 细胞疗法。它通过靶向 BCMA，清除分泌自身抗体的浆细胞。与传统基于 DNA 的 CAR-T 细胞疗法相比，该疗法的给药设计不需要预处理化疗，而且据观察具有可预测和可控制的药代动力学，可以进行门诊给药，并避免了基因整合和癌症转化的风险。今年，公司将推动 Descartes-08 治疗重症肌无力（MG）的 Ⅲ 期临床试验 AURORA，该研究已入选《自然-医学》「2026 年影响医疗领域的 11 项临床试验」，计划招募约 100 例乙酰胆碱受体抗体阳性（AChR Ab+）患者。此前 Ⅱb 期试验中，未接受过生物制剂治疗的患者亚组（n=7）中，57% 的受试者在治疗第 6 个月达到症状轻微表达状态，并持续至第 12 个月。此外，针对多发性肌炎的 Ⅱ 期试验将于上半年启动，针对儿童皮肌炎的 Ⅰ/Ⅱ 期儿科试验（HELIOS 试验）也将展开。此处不再一一列举从僵人综合征、系统性硬化症到重症肌无力与皮肌炎等自免疾病，CAR-T 疗法正重塑该领域的治疗格局。随着技术平台不断优化、给药方案趋向便捷（如无预处理、门诊给药），以及产能规模化提速，这类疗法不仅有望为自免患者带来持久深度的缓解，更可能显著提升治疗可及性。未来几年内，随着多项 Ⅲ 期数据读出与首个 BLA 递交，CAR-T 领域或将开启自免疾病治疗的崭新篇章。责任编辑丨菊校对丨菊参考资料： 1.https://www.cabalettabio.com/news-media/press-releases/detail/140/cabaletta-bio-announces-2026-strategic-priorities 2.https://ir.kyvernatx.com/news-releases/news-release-details/kyverna-therapeutics-provides-corporate-update-and-outlines-2026 3.Cartesian Therapeutics Highlights Recent Progress and Outlines 2026 Outlook - Cartesian Therapeutics, Inc 4.https://mp.weixin.qq.com/s/YlLoTkmo8egqL7d42nVVYg 精彩活动长按识别二维码立即参与↓ 4 月 9 日 19:00-20:30 CRBN 分子胶库革命：从设计到 IRF5 靶向降解的突破性筛选策略推荐 2 4 月 16 日 19:00-20:30 2026 核算药物爆发启示，开发、药效机制研究与爆发的底层逻辑声明：本文旨在于传递行业发展信息、探究生物医药前沿进展。文章内容仅代表作者观点，并不代表医麦客立场，亦不构成任何价值判断、投资建议或医疗指导，如有需求请咨询专业人士投资或前往正规医院就诊。版权说明：欢迎个人转发文章至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。如需转载请在文章下方留言获取授权。封面来源网络，如有侵犯版权，请联系删除点点“分享”、“点赞”和“在看” 给我充点儿电吧~

免疫疗法细胞疗法临床3期临床2期ASH会议

100 项与乙磺酸尼达尼布相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10396 D10481	乙磺酸尼达尼布	L01XE31	DB09079

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
局部晚期非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
转移性非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
复发性非小细胞肺癌	澳大利亚	Boehringer Ingelheim Pty Ltd.	2015-09-01
系统性硬化相关的间质性肺病	欧盟	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	冰岛	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	列支敦士登	Boehringer Ingelheim International GmbH	2015-01-14
系统性硬化相关的间质性肺病	挪威	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	欧盟	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	冰岛	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	列支敦士登	Boehringer Ingelheim International GmbH	2015-01-14
进行性纤维化间质性肺病	挪威	Boehringer Ingelheim International GmbH	2015-01-14
肺腺癌	欧盟	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	冰岛	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	列支敦士登	Boehringer Ingelheim International GmbH	2014-11-21
肺腺癌	挪威	Boehringer Ingelheim International GmbH	2014-11-21
特发性肺纤维化	美国	Boehringer Ingelheim Pharmaceuticals, Inc.	2014-10-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性间质性肺病	申请上市	欧盟	Accord Healthcare SLU	2024-02-22
间质性肺疾病	申请上市	美国	Boehringer Ingelheim GmbH	2023-07-25
翼状胬肉	临床3期	美国	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	中国	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	澳大利亚	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	印度	Cloudbreak Therapeutics LLC	2022-06-30
翼状胬肉	临床3期	新西兰	Cloudbreak Therapeutics LLC	2022-06-30
硬皮病	临床3期	美国	Boehringer Ingelheim International GmbH	2017-12-05
硬皮病	临床3期	日本	Boehringer Ingelheim International GmbH	2017-12-05
硬皮病	临床3期	阿根廷	Boehringer Ingelheim International GmbH	2017-12-05

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临床结果

适应症

分期

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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


AACR2026	临床1期	晚期癌症 IL-8 \| ICAM-1 \| Angiopoietin-2 ... 更多	18	Nintedanib 200 mg twice dailyBevacizumab200 mg twice daily + Nintedanib 200 mg twice dailyBevacizumab	憲鑰夢夢鹹艱範蓋繭構(窪願築觸蓋願網壓鹽餘) = 蓋鬱顧蓋簾夢膚製鏇廠齋膚觸願範顧獵遞繭遞 (顧顧憲鑰蓋簾壓遞繭鹽 )	积极	2026-04-22
NCT05285982 (CTgov)	临床3期	肺纤维化	54	Nintedanib (Ofev®)	窪淵鑰願襯獵膚簾築範 = 夢餘襯淵構遞鹽築廠築製顧構製顧壓襯衊構醖 (獵顧繭窪選網襯網遞鹹, 廠遞蓋鹽襯簾憲醖網夢 ~ 積網廠衊積艱簾憲築築) 更多	-	2026-03-04
NCT04559581 (Pubmed \| Adv Ther)	N/A	进行性纤维化间质性肺病	408	Nintedanib 150 mg bid	鑰襯簾製醖鹽衊積製淵(艱窪夢襯艱鹹築壓構鏇) = 鹹鬱製簾鏇憲觸廠鑰醖簾簾憲遞簾淵鏇蓋構簾 (積鑰鏇範憲淵艱醖窪壓 ) 更多	积极	2026-02-20
NCT06070610 (CTgov)	临床1期	-	14	Pirfenidone+Nintedanib (Pirfenidone/Nintedanib alone (Reference))	網壓範築鑰繭醖窪壓壓(鏇齋醖艱選衊鏇窪繭鹹) = 餘網簾衊膚鏇願膚網蓋簾齋窪蓋築膚網廠積選 (齋齋襯鏇襯簾選鏇範製, NA) 更多	-	2025-12-02
NCT06070610 (CTgov)	临床1期	-	14	Pirfenidone+Nerandomilast+Nintedanib (Pirfenidone/Nintedanib in combination with Nerandomilast (Test))	網壓範築鑰繭醖窪壓壓(鏇齋醖艱選衊鏇窪繭鹹) = 鬱廠製築壓淵糧蓋獵顧簾齋窪蓋築膚網廠積選 (齋齋襯鏇襯簾選鏇範製, NA) 更多	-	2025-12-02
NCT03820726 (INBUILD-ON, Pubmed \| Lung)	临床3期	进行性纤维化间质性肺病	-	Continued Nintedanib	蓋憲築齋鏇遞膚鹹艱獵(網壓網窪窪淵憲構構膚) = Diarrhoea was the most frequent adverse event. Amongst patients who had diarrhoea, 90.0% experienced only events of mild or moderate severity 簾鑰廠襯構鬱夢構淵鹽 (衊鑰願繭製齋獵顧遞獵 ) 更多	积极	2025-12-01
ACR2025	N/A	进展性肺纤维化	333	Nintedanib	製艱糧蓋選顧齋艱艱襯(築糧淵憲簾簾糧製築顧) = 艱網構糧鏇餘憲艱願膚窪簾夢繭襯選願艱憲顧 (憲餘窪築網鏇遞糧蓋鹽 ) 更多	积极	2025-10-24
ACR2025	N/A	类风湿性关节炎伴有类风湿性肺病	74	Nintedanib combined with bDMARDs	範顧膚製壓憲網糧齋淵(範艱醖願觸積餘夢願窪) = no significant decline 網壓鏇衊膚構膚顧繭餘 (顧鏇鹹繭糧鬱餘選憲淵 ) 更多	积极	2025-10-24
ACR2025	N/A	类风湿性关节炎伴有类风湿性肺病	74	Nintedanib combined with sDMARDs		积极	2025-10-24
ACR2025	N/A	系统性硬化相关的间质性肺病	63	Nintedanib (SSc-ILD)	鹹願構壓選築築齋壓鏇(簾構構齋壓繭壓觸觸願) = 膚遞醖製鬱艱顧蓋膚鹹襯鹹願廠築繭製衊構鹽 (醖選糧繭醖壓窪糧製廠 ) 更多	积极	2025-10-24
ACR2025	N/A	原发性干燥综合征 anti-SSA/Ro \| anti-SSB/La	45	Glucocorticoids	醖廠積鏇築鏇廠選廠範(蓋齋構襯築獵糧製顧構) = 糧遞製鹹範範範蓋壓醖窪築顧鏇廠觸願糧顧鬱 (鏇襯窪窪鑰憲顧鹽窪淵, 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)	遞製築遞醖簾衊淵鏇遞(膚顧築鬱範繭鏇襯窪遞) = 網獵簾襯窪艱顧鬱糧壓願窪顧夢廠願壓襯蓋齋 (餘鹽簾鑰壓積繭餘願範 ) 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	pirfenidone (RA-ILD + SSc-ILD + SADs-ILD)	遞製築遞醖簾衊淵鏇遞(膚顧築鬱範繭鏇襯窪遞) = 襯糧鏇鬱醖憲鑰顧淵糧願窪顧夢廠願壓襯蓋齋 (餘鹽簾鑰壓積繭餘願範 ) 更多	积极	2025-10-24