A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2030-01-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT04910386

/ Not yet recruiting临床2期

A Randomized, Open-Label, Multicenter Phase 2 Study of Envafolimab in Combination With Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients With Locally Advanced or Metastatic Biliary Tract Cancers

This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients with Locally Advanced or Metastatic Biliary Tract Cancers

开始日期2027-06-01

申办/合作机构

四川思路康瑞药业有限公司

NCT07365306

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible DLBCL

This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

开始日期2026-12-30

申办/合作机构

City of Hope National Medical Center

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100 项与盐酸吉西他滨相关的临床结果

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100 项与盐酸吉西他滨相关的转化医学

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100 项与盐酸吉西他滨相关的专利（医药）

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13,164

项与盐酸吉西他滨相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

作者: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Zhao, Angela ; Lotan, Yair

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

2026-02-24·CURRENT TOPICS IN MEDICINAL CHEMISTRY

An Expedition of FDA-Approved Anticancer Drugs in 2024: Synthetic Routes, Mechanisms of Action, and Clinical Indications.

Article

作者: Kurmi, Balak Das ; Priya, Sakshi ; Soni, Reena ; Cherian, Issac V ; Kasana, Shivani ; Islam, Md Mustahidul ; Das, Km Supriya ; Patel, Preeti

The year 2024 witnessed significant advancements in cancer therapy, with the U.S. Food and Drug Administration (FDA) approving 56 anticancer drugs for various malignancies. These approvals encompass 36 organic small molecules and 20 macromolecular monoclonal antibody conjugates, each with distinct mechanisms of action targeting key oncogenic pathways. Among the small molecules, kinase inhibitors such as Ribociclib, Imatinib Mesylate, and Nilotinib Hydrochloride Dihydrate modulate critical signaling cascades, while antimetabolites like Fluorouracil and Pemetrexed Disodium disrupt nucleotide biosynthesis. Other classes include DNA-damaging agents (Mitomycin, Gemcitabine Hydrochloride), immune modulators (Pomalidomide, Lenalidomide), and hormonal antagonists (Abiraterone Acetate, Erleada). The macromolecular therapeutics primarily consist of monoclonal antibody-based agents, such as Keytruda, Tecentriq, and Imfinzi, which enhance immune checkpoint inhibition, and antibody-drug conjugates like Enhertu and Elahere, which deliver cytotoxic payloads with high specificity. This review systematically examines the chemical synthesis, mechanisms of action, and therapeutic indications of these FDAapproved agents, emphasizing their role in improving patient outcomes. By analyzing their structural frameworks and biological targets, we aim to provide insights into current trends in anticancer drug development and potential future directions.

2026-01-01·Gan to kagaku ryoho. Cancer & chemotherapy

[Evolving Pharmacotherapy for Bladder Cancer-From Non-Muscle-Invasive to Metastatic Disease-Development of Novel Therapies for BCG-Unresponsive NMIBC].

Article

作者: Inoue, Keiji ; Shigehisa, Ryu ; Fukata, Satoshi

Bladder cancer is a common malignancy in the elderly, with approximately 75% of cases diagnosed as non-muscle-invasive bladder cancer(NMIBC).Although transurethral resection of bladder tumor(TURBT)is the standard initial treatment, recurrence rates remain high, and intravesical Bacillus Calmette-Guérin(BCG)instillation has long been used as an adjuvant therapy.However, about 30% of patients develop BCG-unresponsive disease despite adequate BCG administration.Radical cystectomy is recommended in such cases, but its invasiveness and impact on quality of life(QOL)often make it impractical in real-world settings.Thus, the development of novel bladder-preserving treatments is urgently needed.In recent years, diverse approaches including immune checkpoint inhibitors(ICI), gene therapy, drug delivery systems(DDS), and oncolytic virus-based therapies have been actively investigated, with numerous clinical trials ongoing worldwide.Importantly, pembrolizumab, nadofaragene firadenovec, and N-803 in combination with BCG have received FDA approval, representing major advances in the management of BCG-unresponsive NMIBC.In addition, promising agents such as TAR-200, cretostimogene grenadenorepvec, and detalimogene voraplasmid are under clinical evaluation.These advances indicate the potential for novel strategies that enable bladder preservation while achieving tumor control.Future challenges include validation of long-term outcomes, establishment of evidence through randomized controlled trials, and regulatory approval and reimbursement in Japan.Expansion of therapeutic options is expected to improve both prognosis and QOL in this high-risk population.

1,342

项与盐酸吉西他滨相关的新闻（医药）

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·维亚生物

VIVA朋友圈丨维亚生物投资孵化公司近期发展动态一览（1-3月）

2026年1月至3月，维亚生物参与投资及孵化的多家企业持续取得重要进展。包括Iterion Therapeutics、合源医疗、Kainova Therapeutics、Grove Biopharma、QurAlis、勤浩医药、启愈生物、璧辰医药及辐联科技在内的多家公司，在管线研发推进、融资进展及重大合作等方面均取得了一系列新动态。 Iterion Therapeutics宣布其Tegavivint在结直肠癌及复发/难治性骨肉瘤临床试验中均已完成首例患者给药美国休斯顿，2026年3月25日——维亚生物参与投资的临床阶段生物制药公司Iterion Therapeutics宣布，在一项于HonorHealth Research Institute开展的I/II期临床试验（NCT07463599）中，已完成首例患者给药。该研究旨在评估其首创小分子Wnt/β-连环蛋白通路抑制剂Tegavivint在转移性结直肠癌（mCRC）中的治疗潜力。这一里程碑标志着Iterion的临床开发正式拓展至mCRC领域，该疾病仍存在显著未满足的临床需求，且靶向治疗进展相对有限。此前，2026年2月10日，Iterion Therapeutics曾宣布Tegavivint联合吉西他滨（Gemcitabine）治疗复发或难治性骨肉瘤患者的临床研究已完成首例患者给药。合源医疗NOVAtria™系统首例临床成功入组，并荣获“上海市专精特新中小企业”及“上海市创新型中小企业”双项认定 2026年3月20日，维亚生物参与投资的合源医疗宣布，其自主研发的NOVAtria™系统成功完成上市前临床试验HARMONYTrial（RCT）的首例临床试验入组。此次入组标志着这款由合源医疗®自主研发的创新器械——NOVAtria™系统，正式迈入验证其安全性与有效性的关键临床阶段，为慢性心力衰竭患者带来革命性的“中国方案”——即一次手术，实现“心衰治疗+术后疗法评估+长期慢病管理”。此外，合源医疗于3月荣获“上海市专精特新中小企业”及“上海市创新型中小企业”双项认定，进一步彰显其在创新能力与发展潜力方面的综合优势。 Kainova Therapeutics口服EP4受体拮抗剂DT-9081在晚期实体瘤I期临床取得积极结果，并完成3,200万加元B轮融资加拿大蒙特利尔、法国斯特拉斯堡及美国波士顿，2026年3月10日——维亚生物参与投资的Kainova Therapeutics宣布，其EPRAD I期临床研究取得了积极的临床试验结果。该研究评估了公司自主研发的口服小分子EP4受体（EP4R）拮抗剂DT-9081在晚期、复发性及转移性实体瘤患者中的安全性和初步疗效。此外，Kainova Therapeutics于2026年2月10日宣布顺利完成B轮融资首轮交割，融资总额达3,200万加元，Viva BioInnovator亦参与投资。 Grove Biopharma在《Nature Communications》发表临床前研究成果，展示MYC与KRAS降解的创新策略芝加哥，2026年2月24日——维亚生物投资企业Grove Biopharma宣布，其基于Bionic Biologics™平台的最新临床前研究成果已发表于国际权威期刊《Nature Communications》。该研究展示了一种创新策略，实现了对两大关键致癌驱动蛋白MYC与KRAS的靶向降解，标志着公司平台技术取得重要进展。 QurAlis在QRL-201治疗散发性ALS的ANQUR临床试验中展示对疾病进展和靶点结合的积极效果马萨诸塞州剑桥市，2026年2月23日——维亚生物参与投资孵化的临床阶段的生物技术公司QurAlis，宣布了其QRL-201治疗肌萎缩侧索硬化症（ALS）的概念验证性1/2期ANQUR临床试验的中期数据。这项研究的结果表明，QRL-201对ALS患者的疾病进展产生了积极影响；这一效果已通过临床疗效标志物、具有临床相关性的生物标志物的变化以及靶点结合得到了证实。勤浩医药多项里程碑齐发力，加速全球抗肿瘤新药布局中国苏州，2026年2月13日——维亚生物参与投资孵化的勤浩医药宣布，其合成致死疗法MAT2A抑制剂GH31与吉利德达成达成全球合作协议。此前，GH31于2026年1月获得中国国家药品监督管理局（NMPA）及美国FDA的临床试验申请。在资本与发展布局方面，勤浩医药于1月16日向香港联合交易所提交上市申请，冲刺港股IPO；此前1月13日，公司完成超3亿元人民币Crossover轮融资，为研发进程与战略布局提供有力支撑。启愈生物将在2026年ASCO年会上公布其Q-1802项目II期临床结果 2026年1月29日——维亚生物参与投资孵化的启愈生物，一家专注于开发用于治疗癌症、炎症及其他严重疾病的双特异性抗体及其他工程化生物制剂的临床阶段生物科技公司，近期在提交的2026年美国临床肿瘤学会（ASCO）摘要中公布了其Q-1802项目的Ib/II期临床数据。璧辰医药与Mosaica Medicines就MEK抑制剂ABM-168签署全球授权协议美国圣地亚哥、中国上海，2026 年1月14日——维亚生物参与投资孵化的璧辰医药（ABM Therapeutics）宣布，公司已与总部位于波士顿的生物技术公司Mosaica Medicines就其自主研发的MEK1/2抑制剂 ABM-168 达成全球授权与合作协议。根据该协议条款，璧辰医药将获得首付款，并有资格获得后续研发、监管及销售里程碑付款。辐联科技合作伙伴SK Biopharmaceuticals的α核素放射性候选药物获美国FDA IND批准，加速全球临床开发中国成都，2026年1月12日——维亚生物持股企业辐联科技祝贺其合作伙伴SK Biopharmaceuticals获得FDA对其放射性治疗候选药物SKL35501及影像剂SKL35502的IND批准。治疗候选药物SKL35501由SK Biopharmaceuticals于2024年7月从辐联科技引进。影像剂SKL35502采用与SKL35501相同的NTSR1靶点。关于 Iterion Therapeutics Iterion Therapeutics是一家临床阶段肿瘤学公司，致力于开发针对异常Wnt/β-连环蛋白信号驱动癌症的首创疗法。公司核心产品Tegavivint是目前首个也是唯一一个靶向 TBL1的小分子抑制剂。TBL1是维持核内β-连环蛋白稳定性及致癌基因表达的关键转录调控因子。Tegavivint已在多种复杂实体瘤（包括晚期肝细胞癌）中展现出良好的临床耐受性、明确的靶点结合及单药活性，使Iterion处于 Wnt/β-连环蛋白药物开发的前沿。关于合源医疗® 合源医疗®（United InnoMed®）成立于2020年，专注于创新型三类有源植入产品的开发，致力于为全球心衰患者提供高性价比的“闭环”心衰管理解决方案。现阶段，在研产品覆盖急性和慢性心衰患者的管理，主要包括①针对慢性心衰患者，集“治疗+诊断”于一体的长期植入类产品，②针对急性心衰住院患者，短期使用的电刺激循环辅助产品（Electrical Circulatory Support）。关于Kainova Therapeutics Kainova Therapeutics是一家处于临床阶段的生物制药公司，总部位于加拿大蒙特利尔，致力于开发能够精准调控G蛋白偶联受体（GPCR）的突破性疗法，重点聚焦免疫肿瘤学和炎症疾病领域。公司核心研发项目包括一款具有差异化竞争优势、能够清除调节性T细胞（Treg）的抗CCR8抗体，目前已进入临床阶段；以及一款处于IND申报前阶段、具有全新作用模式的PAR2偏向性拮抗剂。关于Grove Biopharma Grove Biopharma是一家源自美国西北大学的创新生物技术公司，致力于开发基于蛋白仿生聚合物（PLPs）的新一类治疗方式。通过其Bionic Biologics™平台，公司整合合成化学、精准聚合技术、蛋白与多肽工程以及药物化学，构建能够靶向历史上难以通过传统药物模式干预的疾病驱动因子的蛋白尺度分子架构。PLPs兼具抗体的关键特性，同时具备进入细胞并参与细胞内蛋白—蛋白相互作用的能力。该平台具有模块化特点，可快速工程化为双功能设计，以支持包括靶向蛋白降解在内的邻近驱动化学机制。公司总部位于芝加哥，是该市新兴生命科学生态系统的重要组成部分。更多信息请访问grovebiopharma.com。关于QurAlis QurAlis是肌萎缩侧索硬化症（ALS）精准疗法开发的领导者。除ALS外，QurAlis还在推进一个强大的精准药物管线，为由基因和临床生物标志物定义的严重疾病患者带来有效的疾病修饰疗法。关于勤浩医药勤浩医药成立于2014年，是一家专注于肿瘤领域突破性疗法的生物制药公司。公司拥有围绕RAS信号通路及合成致死机制打造的差异化创新药物管线。凭借四个自主开发的技术平台，勤浩医药已建立起涵盖早期发现到临床开发的完整研发体系。关于启愈生物启愈生物是一家临床阶段的生物科技公司，专注于为急迫且未满足的临床需求如难治性癌症、炎症及其他严重疾病的治疗开发创新生物药物。公司由相关领域的资深科学家创立，已构建了一系列针对工程化生物大分子的专有技术平台，包括创新的双特异性和三特异性抗体平台。启愈生物成立于2017年，获得维亚基金种子轮投资，此后陆续获得君度投资、沃生投资、深创投、新恒利达投资、宁波雅罗、交银产投（杭州）股权投资基金、苏州元禾控股、杭州国舜战兴、珠海隆门资本、上海浦东科创集团、深圳力合泓鑫、三江资本以及倚锋资本等多家机构的持续投资。关于璧辰医药璧辰医药（ABM Therapeutics）是一家处于临床阶段的生物制药公司，专注于创新小分子抗肿瘤药物的研发，重点布局具有血脑屏障穿透能力、可用于治疗脑转移及中枢神经系统肿瘤的治疗方案。公司目前拥有多个处于不同研发阶段的管线项目，致力于解决脑部肿瘤及脑转移领域中尚未满足的重大临床需求。关于辐联科技辐联科技是一家全面整合的临床阶段国际化放射性药物治疗公司，在比利时、德国和中国均设有办事处。辐联科技以全球患者为中心，致力于构建集放射性药物研发、生产和商业化为一体的全产业链核药公司，并通过领先的创新型研究解决现今放射性药物面临的根本性挑战，推动未来疗法发展。辐联科技团队由一支运作高效的企业家团队和经验丰富的科学家组成，他们在生命科学、放射性同位素研究和临床开发方面拥有丰富的成功经验。免责声明与孵化企业相关的信息由孵化企业提供, 未经本公司独立验证任何情况下, 本公司不对由于本新闻稿资料不准确或疏漏或使用本新闻稿资料引致的损失和损害承担任何直接和间接的责任(不论是民事侵权行为、合约责任或其他)。维亚生物（01873. HK）成立于2008年，向全球创新药研发企业提供从早期基于结构的药物研发到商业化药物生产的一站式综合服务。凭借在基于结构的药物研发（SBDD）技术领域的领先优势，我们向全球合作伙伴提供新药研究阶段的CRO服务，搭建了X射线蛋白晶体技术、冷冻电镜技术（Cryo-EM）、DNA编码化合物库技术（DEL）、亲和力质谱筛选技术（ASMS）、表面等离子共振技术（SPR）、氢氘交换质谱技术（HDX-MS）、AIDD/CADD等多个先进技术平台，并有资深药物化学家与药物发现生物专家领军的团队提供药物设计、药物化学（H2L，LO）、化合物合成、化学分析及纯化、公斤级放大及多肽合成及相应的生物活性测试服务。通过子公司朗华制药，我们提供从临床前开发到商业化生产的一站式CMC/CDMO解决方案。同时，我们专注于发现、投资高潜力生物医药初创公司，以独创的技术服务换取股权（EFS）的商业模式，解决未满足的临床需求。联系我们：info@vivabiotech.com

23 小时之前

·BioSpace

Revolution Medicines Begins Treating Patients in Phase 3 RASolute 303 Trial Evaluating Daraxonrasib as First Line Treatment for Patients with Metastatic Pancreatic Cancer

REDWOOD CITY, Calif., April 02, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it has begun treating patients in RASolute 303, a global Phase 3 clinical trial evaluating daraxonrasib as monotherapy and in combination with chemotherapy in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC), a disease predominantly driven by oncogenic RAS variants. RASolute 303 is designed to enroll patients irrespective of tumor RAS genotype. “Starting treatment of study participants in the RASolute 303 trial represents an important milestone for our daraxonrasib program and for patients with metastatic pancreatic cancer, a disease with substantial unmet medical need,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “In this trial, we are testing two biologically rational approaches—daraxonrasib as monotherapy and daraxonrasib in combination with chemotherapy—as two distinct, promising strategies to potentially improve patient outcomes. This trial underscores our commitment to advancing RAS(ON) inhibition into earlier lines of therapy, where we believe it can deliver significant benefit.” RASolute 303 ( NCT07491445) is a global, randomized, open-label Phase 3 trial evaluating daraxonrasib as monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard-of-care gemcitabine and nab-paclitaxel in patients with previously untreated metastatic PDAC. In this trial, the company is enrolling patients who have not received prior systemic therapy for metastatic disease. The primary endpoints are progression-free survival and overall survival. Key secondary endpoints include additional measures of antitumor activity, safety and tolerability, and patient reported outcomes. Daraxonrasib is currently being evaluated in four global Phase 3 registrational trials, including three trials in patients with PDAC and one in patients with non-small cell lung cancer (NSCLC). About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people are diagnosed annually with pancreatic cancer, and about 50,000 people will die from this aggressive disease. 1 Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-driven malignancy of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations. 2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%. 3 , 4 About Daraxonrasib Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a broad range of cancers driven by oncogenic RAS, including PDAC, NSCLC and colorectal cancer. Daraxonrasib suppresses RAS signaling by blocking the interaction of wild-type and mutant RAS(ON) with its downstream effectors. About Revolution Medicines, Inc. Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit and follow us on LinkedIn . Forward Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding progression of clinical studies and findings from these studies, including the safety, tolerability and antitumor activity of the company’s candidates being studied and the durability of these results; dosing and enrollment in the company’s clinical trials; and the company’s ability to improve patient outcomes or advance RAS(ON) inhibition into earlier lines of therapy. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 25, 2026, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Revolution Medicines Media & Investor Contact: media@revmed.com investors@revmed.com 1 Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin . 2024;74(1):12-49. doi:10.3322/caac.21820 2 Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1);91. doi:10.1038/s41698-022-00334-z 3 Halbrook CJ, Lyssiotis CA, Pasca di Magliano M, Maitra A. Pancreatic cancer: Advances and challenges. Cell. 2023;186(8):1729-1754. doi:10.1016/j.cell.2023.02.014 4 American Cancer Society. Survival rates for pancreatic cancer. Available at: Accessed February 2026.

临床3期

2026-04-01

·圆阳技术转移中心

BioLineRx公布全年财报，多项具备前景的癌症治疗临床试验持续推进！

数项多中心临床研究加速推进为公司未来增长提供了潜在的催化剂 BioLineRx 国家：以色列聚焦领域：生物制药致力于开发能够改变生活的肿瘤学和罕见病疗法的以色列商业化阶段生物科技公司BioLineRx Ltd.（纳斯达克代码：BLRX）近日公布了公司2025年财报。以下为该份财报的核心摘要。财务动态截至2025年12月31日，BioLineRx的资产负债表上持有2,090万美元现金，公司维持其现金储备可维持至2027年上半年这一预期。公司已获批上市的核心产品 APHEXDA（治疗多发性骨髓瘤）全年销售额为670万美元，为本公司带来了120万美元的专利使用费收入（来源于商业化合作方Ayrmid）。年度净亏损为200万美元，相较2024底的920万美元亏损有大幅改善。临床管线进展图：BioLineRx管线 1、GLIX1 – 适应症：胶质母细胞瘤公司核心管线GLIX1用于胶质母细胞瘤的I/IIa期临床试验预计将于26年3月底启动。计划有三家知名学术中心参与此次临床试验：由Roger Stupp博士和Ditte Primdahl博士领导的美国西北大学、由Alexandra M. Miller博士领导的纽约大学朗格尼医学中心，以及由Patrick Grogan博士领导的莫菲特癌症中心。临床研究的I期部分预计将招募最多30名复发性和进展性胶质母细胞瘤（GBM）及其他高级别胶质瘤患者。该阶段的目标是根据安全性、药代动力学/药效学（PK/PD）及初步疗效，确定最大耐受剂量（MTD）和/或推荐剂量。预计2027年上半年将获得I期试验的数据。该试验的IIa期扩展部分计划纳入多个患者亚组，包括GBM（新诊断和/或复发）以及其他接受或未接受标准治疗（如PARP抑制剂）的癌症患者。这些亚组预计将提供初步疗效、药效学评估及剂量优化数据，为快速、有效的后期临床开发奠定基础。此外，为支持GLIX1在其他癌症适应症上的临床开发，相关临床前研究正在进行中。 2、Motixafortide- 适应症：胰腺导管腺癌（mPDAC）由哥伦比亚大学牵头、Regeneron和BioLineRx共同支持的CheMo4METPANC IIb期临床试验正在加速招募患者。该试验旨在评估Motixafortide联合PD-1抑制剂Cemiplimab及标准化疗（Gemcitabine 和Nab-paclitaxel）的疗效。研究计划在观察到40%的无进展生存期（PFS）事件时进行预先设定的中期/无效性分析，公司仍预计该节点将在2026年达成。 3、Motixafortide- 适应症：镰状细胞病（SCD）与基因治疗一份展示 I 期临床试验（NCT05618301）最终结果的海报已在去年12月举行的第67届美国血液学会（ASH）第67届年会暨展览会上展出。由圣裘德儿童研究医院赞助的另一项镰状细胞病研究目前仍在招募患者。该研究是一项多中心I期临床试验，旨在评估Motixafortide用于动员CD34+造血干细胞（HSC），以用于镰状细胞病患者的基因治疗（NCT06442761）。 CEO 评论针对财报，BioLineRx首席执行官Philip Serlin表示：“GLIX1是我们通过与Hemispherian的合作获得的主要资产，是一种具有新颖作用机制的独特分子，能够靶向癌细胞的DNA修复机制，并在多个临床前模型中显示出令人信服的疗效，具有出色的血脑屏障穿透性，并在毒理学研究中表现出良好的安全性。我们希望通过确立安全性、推荐剂量和概念验证，将这一有前景的候选药物高效推进开发路径。与此同时，我们继续进行临床前研究，以支持GLIX1在其他高未满足需求癌症适应症中的进一步开发，同时，我们也在进行研究，以进一步探讨并确认GLIX1与PARP抑制剂联合的潜在协同效应，在努力最大化GLIX1机遇的价值。在转移性胰腺癌方面，由哥伦比亚大学牵头、Regeneron和BioLineRx支持的motixafortide正在进行的CheMo4METPANC二期b临床试验的入组速度加快，我们仍然预计2026年将公布预定的中期/无效性分析结果。我们相信，胰腺导管腺癌为患者提供急需的新治疗选择提供了机会，同时也为公司创造了持续的价值。” 关于 BioLineRx BioLineRx （纳斯达克代码：BLRX）是一家致力于开发能够改变生活的肿瘤学和罕见病治疗方案的生物制药公司。公司领先的研发项目是GLIX1，这是一种首创的口服小分子药物，针对胶质母细胞瘤及其他实体瘤中的DNA损伤应答机制，预计将于2026年第一季度启动I/IIa期临床试验。GLIX1正在与Hemispherian AS合作开发。公司首个获批产品APHEXDA®（motixafortide）在美国获批用于多发性骨髓瘤自体移植的干细胞动员，目前由Ayrmid Ltd.负责全球（亚洲除外）的商业化，并由Gloria Biosciences负责亚洲地区的开发。BioLineRx 保留了 motixafortide 在实体瘤（包括转移性胰腺癌（PDAC））领域进行开发的权利，目前正与哥伦比亚大学合作开展一项针对 PDAC 的 2b 期临床试验。延伸阅读 1 用于多发性骨髓瘤的 BioLineRx 干细胞药物获得 FDA 批准关注圆阳，我们将定期为您带来创新医药与医疗领域的全球最新动态关于圆阳圆阳技术转移中心专注于将以色列领先的医药科技项目引入国内，并对接政府、资本方和产业方，持续推进以色列先进医药科技项目在中国的转化与落地，最终形成产品应用和产业化布局。圆阳技术转移中心由以色列诺贝尔奖获得者、中国科学院外籍院士Aaron Ciechanover担任公司名誉主席，并已与希伯来大学Yissum合作中心、以色列理工学院T³合作中心、魏茨曼科学研究所Yeda合作中心、Clalit医院管理集团Mor Research合作中心、Sheba医院等以色列顶尖机构达成战略合作。圆阳官微扫描二维码｜关注我们您的点赞和在看，是圆阳进步的动力! ↘↘↘

财报临床1期临床2期临床终止

100 项与盐酸吉西他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01155	盐酸吉西他滨	L01BC05	DB00441

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
非肌层浸润性膀胱肿瘤	美国	Janssen Biotech, Inc.	2025-09-09
局部晚期非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
局部晚期胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
复发性卵巢癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
尿路上皮癌	日本	Eli Lilly & Co.	2008-11-25
膀胱癌	巴西	Libbs Farmacêutica Ltda.	2008-05-26
胆道癌	日本	Eli Lilly & Co.	2001-08-31
淋巴瘤	日本	Eli Lilly & Co.	2001-08-31
卵巢癌	日本	Eli Lilly & Co.	2001-08-31
乳腺癌	美国	Eli Lilly & Co.	1996-05-15
转移性乳腺癌	美国	Eli Lilly & Co.	1996-05-15
非小细胞肺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺腺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺癌	美国	Eli Lilly & Co.	1996-05-15

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
晚期胆道癌	临床3期	中国台湾	因华生技制药股份有限公司	2025-07-01
复发性膀胱癌	临床3期	美国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	中国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	日本	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	阿根廷	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	比利时	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	巴西	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	法国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	德国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	意大利	Janssen Research & Development LLC	2024-04-09

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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


ESMO_SRC2026	N/A	平滑肌肉瘤	336	Gemcitabine combined with docetaxel	鬱鑰範憲築顧蓋範蓋鹹(膚鹹鬱膚築餘醖鏇窪構) = 獵襯鑰衊願膚簾艱願廠鹽選廠糧積憲積鏇壓淵 (網構鏇夢築範蓋憲繭構 ) 更多	积极	2026-03-09
ESMO_SRC2026	N/A	血管周围上皮样细胞肿瘤	3	sirolimus + exemestane + gemcitabine	簾範壓遞構餘鹽艱願觸(範製繭製糧襯選顧憲顧) = 壓淵齋壓餘醖選醖製選範襯淵構觸蓋膚鏇選獵 (鬱製簾鹽鏇餘夢夢窪獵 ) 更多	积极	2026-03-09
ESMO_SRC2026	N/A	软骨肉瘤	10	Gemcitabine 1000 mg/m2 plus Oxaliplatin 100 mg/m2	築憲淵獵夢齋繭憲廠醖(衊襯鹽鹹餘鬱繭積膚築) = Treatment was generally well tolerated, with limited grade 3 toxicity and one case of grade 5 thrombotic microangiopathy-associated to gemcitabine 齋獵壓獵鹹憲範衊選鏇 (觸願願夢積蓋繭範廠製 )	积极	2026-03-09
ESMO_SRC2026	N/A	平滑肌肉瘤二线	108	Trabectedin	願選製窪獵製壓觸餘窪(憲夢繭獵簾膚顧製齋蓋) = 積觸鑰糧網獵鏇築範簾壓糧膚築蓋製壓憲壓鹹 (觸糧範鑰鬱築糧築鬱憲, 5.5 ~ 15.2) 更多	积极	2026-03-09
				gemcitabine-based chemotherapy	願選製窪獵製壓觸餘窪(憲夢繭獵簾膚顧製齋蓋) = 顧鬱鑰鑰築鬱艱繭網窪壓糧膚築蓋製壓憲壓鹹 (觸糧範鑰鬱築糧築鬱憲, 3.8 ~ 6.4) 更多
ASCO_GU2026	N/A	非肌层浸润性膀胱肿瘤	133	BCG	鑰繭夢鑰鬱糧遞廠淵繭(襯壓築餘齋範構鏇餘鹹) = 鹽顧廠窪廠網醖鏇鑰遞獵蓋憲憲窪齋淵範衊蓋 (遞糧夢網夢鏇齋艱選醖 ) 更多	不佳	2026-02-26
				sequential gemcitabine and docetaxel (Gem/Doce)	鑰繭夢鑰鬱糧遞廠淵繭(襯壓築餘齋範構鏇餘鹹) = 網觸網襯鑰鏇範積膚憲獵蓋憲憲窪齋淵範衊蓋 (遞糧夢網夢鏇齋艱選醖 ) 更多
ASCO_GU2026	N/A	肌层浸润性膀胱癌	98	Cisplatin	壓醖衊膚鬱獵構網醖觸(憲壓製築膚網餘繭鬱壓) = 艱鏇遞憲製廠鹹築鏇鹹餘衊膚壓構積積簾壓選 (壓廠廠遞廠製鏇鏇壓鹹 ) 更多	积极	2026-02-26
				5-FU+MMC	壓醖衊膚鬱獵構網醖觸(憲壓製築膚網餘繭鬱壓) = 衊窪襯簾鏇醖鑰獵範壓餘衊膚壓構積積簾壓選 (壓廠廠遞廠製鏇鏇壓鹹 ) 更多
NCT04179162 (ALLIANCE A032303, ASCO_GU2026)	临床1/2期	复发性膀胱癌	52	Gemcitabine + BCG	築夢鑰鏇鹹憲艱夢鑰選(範構餘選醖範醖窪鏇繭) = 選鹹範鹹築餘遞醖糧獵鏇觸憲觸艱顧觸範獵廠 (鑰壓艱膚齋範構構憲築 ) 更多	积极	2026-02-26
ASCO_GU2026	N/A	肌层浸润性膀胱癌新辅助	517	Gemcitabine 800 mg/m2	衊廠壓願壓鏇淵齋觸廠(糧鏇襯遞範餘憲簾繭積): P-Value = 0.012 更多	积极	2026-02-26
				Gemcitabine 1000 mg/m2
NCT04628767 (EA8192, ASCO_GU2026)	临床2期	肾盂和输尿管尿路上皮癌新辅助	30	Gemcitabine/Durvalumab	鏇範遞觸蓋簾顧鏇夢壓(齋鹹簾築範願獵製製觸) = 願觸範襯衊膚鹽蓋築憲觸夢淵構範鬱積蓋積範 (餘築衊鏇夢憲壓鏇壓憲, 3.0 ~ 25.2) 更多	积极	2026-02-26
NCT03366766 (CTgov)	临床2期	非小细胞肺癌Ⅰ期 \| 可切除非小细胞肺癌 \| 非小细胞肺癌IIIA期 ... 更多	14	Nivolumab+cisplatin+Pemetrexed Disodium (Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium))	鹽繭膚鏇觸鹹壓糧鏇願 = 築蓋願齋範廠夢膚顧憲製鏇餘膚鬱鬱鑰醖壓築 (鹽構鑰鹽鬱淵遞網鏇願, 範艱積膚艱選獵築繭壓 ~ 憲糧憲遞願鬱憲夢網衊) 更多	-	2026-02-20
				nivolumab+Gemcitabine Hydrochloride (Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride))	餘遞衊範鏇夢廠醖製鹹 = 餘鹹齋選糧餘願顧觸艱糧淵夢製壓襯鏇積淵鏇 (夢繭艱襯糧糧夢廠壓願, 範蓋鑰窪醖齋構鹹網衊 ~ 鬱選膚蓋淵蓋積艱選壓)