Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

This phase III trial compares the effect of adding panitumumab to standard chemotherapy (with nanoliposomal Irinotecan, leucovorin, and 5-fluorouracil [5-FU] or irinotecan, leucovorin, and 5-FU or nab-paclitaxel and gemcitabine) versus standard chemotherapy alone in treating patients with KRAS wild type (WT) pancreatic ductal adenocarcinoma that cannot be removed by sugery (unresectable) or that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Panitumumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as nanoliposomal irinotecan, leucovorin, 5-FU, irinotecan, nab-paclitaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding panitumumab to standard chemotherapy may be effective in treating patients with unresectable, locally advanced, or metastatic KRAS WT pancreatic ductal adenocarcinoma.

开始日期2026-01-06

申办/合作机构

SWOG

[+1]

NCT07076212

/ Not yet recruiting临床2期

Phase II Study Evaluating NALIRIFOX Versus Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).

开始日期2026-01-01

申办/合作机构

The Medical University of South Carolina

NCT07033689

/ Not yet recruiting早期临床1期

Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

开始日期2025-12-01

申办/合作机构

Sonire Therapeutics Inc

100 项与盐酸伊立替康脂质体相关的临床结果

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100 项与盐酸伊立替康脂质体相关的转化医学

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100 项与盐酸伊立替康脂质体相关的专利（医药）

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7,587

项与盐酸伊立替康脂质体相关的文献（医药）

2025-12-31·AUTOIMMUNITY

Deciphering distinct pathogenic mechanisms of ankylosing spondylitis and systemic sclerosis via shared biomarkers ZSWIM6 and CCL3L3: Insights from an integrative bioinformatics approach

Article

作者: Zhou, Chenxing ; Chen, Jiarui ; Zhan, Xinli ; Xue, Jiang ; Shi, Jianjun ; Zhou, Zhongxian ; Yang, Renbang ; Huang, Liangyu ; Huang, Chengqian ; Liu, Chong ; Chen, Tianyou ; Feng, Sitan ; Huang, Jieping ; Wu, Shaofeng ; Zhu, Jichong

Ankylosing Spondylitis (AS) and Systemic Sclerosis (SSc) are both autoimmune diseases, albeit with distinct anatomical targets. AS primarily affects the spine and sacroiliac joints, triggering inflammation and eventual fusion of the vertebrae. SSc predominantly impacts the skin and connective tissues, leading to skin fibrosis, thickening, and potential damage to vital organs such as the lungs, heart, and kidneys. Despite their differing anatomical manifestations, inflammation serves as a pivotal factor in both conditions. Exploring the causes of the different pathogenesis of inflammation in AS and SSc could provide new insights into their treatment. We selected RNA-seq profiles of peripheral blood mononuclear cells (PBMCs) from the GEO datasets GSE73754 and GSE19617. DEGs were identified using the Limma R package with an adjusted p-value cutoff of < 0.05. Gene Ontology pathway analysis, SVM recursive feature elimination, and Gene Set Enrichment Analysis (GSEA) were conducted to analyze the DEGs. CIBERSORT was applied to estimate immune cell composition and its correlation with hub genes. Single-cell RNA sequencing data from peripheral blood mononuclear cells in the GSE194315 dataset were included to support differential expression analysis and biomarker identification. Additionally, single-cell RNA sequencing data from bone marrow blood samples were utilized to further validate these findings, offering complementary insights into biomarker expression across distinct sample types. A total of 762 DEGs were identified between AS patients and controls, and 441 DEGs between SSc patients and controls. Both conditions showed enrichment in the Natural killer cell mediated cytotoxicity pathway. ZSWIM6 and CCL3L3 were identified as potential biomarkers in AS and SSc, with significant diagnostic capabilities demonstrated by ROC analysis. Correlation analysis revealed associations between these biomarkers and specific immune cell types. The study utilizing ZSWIM6 and CCL3L3 as potential biomarkers provides deep insights into the distinct molecular mechanisms of SSc and AS. These findings lay the foundation for future research on targeted therapies and enhance our understanding of immune cell interactions in these autoimmune diseases.

2025-10-01·EUROPEAN JOURNAL OF CANCER

Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (PRODIGE 62-FFCD 1701-OESIRI)

Article

作者: Kadi, Melissa ; Bouché, Olivier ; Fadin, Aurélie ; Dubreuil, Olivier ; Martin-Babau, Jérôme ; Lepage, Côme ; Zaanan, Aziz ; Jestin le Tallec, Véronique ; Lecomte, Thierry ; Hautefeuille, Vincent ; Lièvre, Astrid ; Bourgeois, Vincent ; Khemissa Akouz, Faiza ; Thimonier, Elsa ; Mineur, Laurent ; Poisson Ligeza, Catherine ; Di Fiore, Frédéric ; Ly Lebrun, Valérie ; Tougeron, David

BACKGROUND:

Metastatic esophageal squamous cell carcinoma (mESCC) patients with disease progression after platinum-based first-line chemotherapy (CT) +/- immune checkpoint inhibitors (ICI) may benefit from second-line CT, mostly based on paclitaxel and irinotecan, but no randomized trial has compared these regimens.

PATIENTS AND METHODS:

PRODIGE 62-OESIRI is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of nanoliposomal irinotecan (Nal-IRI) plus 5FU versus paclitaxel as second-line CT in mESCC. The primary endpoint was to achieve overall survival (OS) of 60 % at 9 months.

RESULTS:

Between March 2019 and July 2023, 106 pts were randomized. Median age was 65.6 years, 83.0 % men and 29.2 %/58.5 %/12.3 % of ECOG PS 0/1/2, respectively. As prior treatment, 48.6 % had chemoradiation, 41.9 % CT alone and 9.5 % CT plus ICI. OS at 9 months was 34.0 % [90 %CI: 22.9-46.5] and 39.2 % [90 %CI: 27.7-51.7] in the 5FU Nal-IRI and paclitaxel arms, respectively. The primary endpoint was not met. Median progression-free survival was 2.4 [95 %CI: 2.1-3.6] and 2.1 [95 %CI: 1.9-3.3] months, and median OS 7.1 [95 %CI: 5.2-8.3] and 6.6 [95 %CI: 4.8-10.3] months, respectively. Overall, 51.0 % and 38.5 % of patients experienced at least one grade 3-4 treatment-related adverse events (neuropathy: 2.0 vs. 7.7 %, diarrhea: 16.3 % vs. 0 % and vomiting: 10.2 vs. 0 %), in the 5FU Nal-IRI and paclitaxel arms, respectively. Treatment was discontinued for toxicity in 10.4 % versus 3.9 % in the 5FU Nal-IRI and paclitaxel arm, respectively.

CONCLUSIONS:

PRODIGE 62-OESIRI trial showed low efficacy of paclitaxel and 5FU Nal-IRI in the 2nd line treatment of mESCC, though paclitaxel provided a better safety profile. Trial registration NCT03719924.

2025-10-01·Clinical Journal of Gastroenterology

Successful conversion surgery for patients with pancreatic cancer, positive peritoneal cytology, and liver metastasis who were treated with chemotherapy involving nanoliposomal irinotecan with fluorouracil and folinic acid

Article

作者: Itoh, Ayaka ; Watanabe, Toru ; Fujii, Tsutomu ; Kawai, Shunsuke ; Igarashi, Takamichi ; Kimura, Nana ; Shibuya, Kazuto ; Yoshioka, Isaku ; Fukasawa, Mina ; Hirano, Katsuhisa

A 67-year-old woman was diagnosed with pancreatic head cancer. Staging laparoscopy (SL) was performed, peritoneal cytology (CY) was positive (CY1), and a peritoneal access port was created. The patient was started on nab-paclitaxel plus gemcitabine therapy (GnP). After 6 courses of GnP therapy, computed tomography revealed a single metastatic tumour in the liver. The disease was considered advanced, and nal-IRI + 5-FU/LV therapy was initiated as second-line treatment. After 13 courses of treatment, both the liver nodule and the primary tumour decreased in size, and CY became negative (CY0). A second-look SL and partial resection of the metastatic liver were performed. Thereafter, after 7 additional courses of nal-IRI + 5-FU/LV therapy. A third-look SL revealed no distant metastasis, and CY0. Then, pancreatoduodenectomy was performed as the conversion surgery. Histological examination revealed Grade 1a disease. She resumed adjuvant chemotherapy and is alive 7 months postoperatively without any signs of recurrence. In our rare case, a patient with CY1 pancreatic cancer and liver metastasis was successfully treated with nal-IRI + 5-FU/LV and was able to undergo radical resection. To our knowledge, this is the first report on conversion surgery with this regimen, which is not considered to have a high response rate.

202

项与盐酸伊立替康脂质体相关的新闻（医药）

2025-09-08

·美通社

晶泰科技助力智擎生技新一代"合成致死"新药获临床实验审批，AI 制药再迎里程碑

深圳 2025年9月8日 /美通社/ -- 晶泰科技（2228.HK）今日宣布，由其助力智擎生技制药（PharmaEngine, Inc.）发现的新一代PRMT5抑制剂PEP08已达成重要临床研发里程碑。PEP08近日分别获得澳大利亚人类临床研究伦理委员会（HREC）、澳洲药物管理局（TGA）及中国台湾地区"卫生福利部食品药物管理署"（TFDA）的临床试验批准，标志着该药物即将启动I期临床试验。基于此进展，晶泰科技确认获得该项目的里程碑付款。 PRMT5（蛋白质精氨酸甲基转移酶5）是在多种癌症中过表达并促进肿瘤生长的关键酶，也是热门的癌症合成致死靶点。在MTAP（甲硫腺苷磷酸化酶）纯合缺失的肿瘤中（约占10-15% 的人类癌症），抑制PRMT5活性可产生"合成致死"效应，有望实现高效安全的癌症靶向治疗。这类肿瘤常见于非小细胞肺癌（NSCLC）、间皮瘤、胰腺癌、胶质母细胞瘤（GBM）、头颈癌、食管癌和膀胱癌等癌种，然而传统 PRMT5 抑制剂常因选择性不佳而导致毒性问题，有巨大的未满足临床需求。项目开启后，晶泰科技凭借其融合物理模型、AI 算法与机器人实验的智能药物研发平台，结合智擎生技团队的专家经验，快速开展药物理性设计。晶泰科技为该项目生成了百万级别的分子库，并从中精确筛选出一批药物活性与选择性表现突出、分子骨架新颖的先导化合物。在多轮物理模型与 AI 模型结合的 ADMET 性质评估与迭代优化后，最终确定PEP08为临床前候选化合物（PCC）并由智擎生技完成临床前研发。 PEP08作为第二代PRMT5 抑制劑，结构新颖，具有高活性和高选择性，能够通过 MTA 协同结合模式与 PRMT5 结合，形成稳定的三元复合物，从而实现对PRMT5的高选择性抑制，特异性杀伤MTAP缺失型肿瘤细胞，并最大限度减轻对正常细胞的影响，临床开发潜力巨大。临床前研究数据表明，与第一代非选择性PRMT5抑制剂相比，PEP08的毒性及安全性优势显著，拥有良好的血脑屏障穿透能力与理想的综合成药性质。在多个动物药效模型中的更低剂量下，PEP08展示了强大的体内疗效。与目前处于临床开发阶段的其他二代PRMT5抑制剂相比，PEP08的综合药学性质展现出潜在同类最佳（Best-in-Class）效果及与其他疗法联合使用的广阔潜力。相关成果海报已由智擎生技发表于 2025年美国癌症研究协会 (AACR) 年会。 PEP08顺利获得两地监管机构的临床试验许可并达成里程碑付款，是晶泰科技与智擎生技合作取得的重要阶段性成果，再一次验证了晶泰科技平台高效赋能药物创新的交付能力。晶泰科技将持续支持合作伙伴，为更多患者带来优质高效的治疗选择。关于智擎生技制药股份有限公司智擎生技制药公司于2003年2月开始营运。智擎成立的概念是以国际策略联盟之方式，借由 "Virtual Pharmaceutical Company Business Model" 专注于新药研发，降低新药开发的风险。智擎之上市抗癌药品安能得® (ONIVYDE®)，已于美国、欧洲、韩国、新加坡、日本及中国等多个国家和地区上市。智擎之在研新药当中，其中一项新药专案 PEP07，系为细胞损伤调控酵素抑制剂，目前正进行第一期临床试验。另一项新药专案PEP08，系为MTA-Cooperative PRMT5抑制剂，目前也即将开始进行第一期临床试验。此外，智擎以国际合作或授权引进方式，执行多项早期药物开发专案，以智擎执行专案管理的丰富经验，推进及扩增在研产品线，加速药物开发与新药商业化的时间。

2025-09-03

·ETPharma

GST waiver for 36 drugs; formulations under 5% slab

New Delhi: Executing the much-awaited overhaul of the Goods and Services Tax (GST) regime, the GST Council has brought a major relief for patients by reducing the indirect tax on medicines to 5 per cent, along with exempting as many as 36 life-saving medicines and other critical drugs. The GST council—a statutory body highest decision making body on indirect taxes led by the Union Finance Ministry at its 56th meeting in the national capital has recommended to reduce the GST on all drugs and medicines (finished formulations) from 12 per cent to 5 per cent under the new two-tier tax structure of 5 and 18 per cent slabs to be effective from September 22. Additionally the body has also recommended to exempt GST on 33 lifesaving drugs and on 3 other medicines used for treatment of cancer, rare diseases and other severe chronic diseases. Speaking at a press briefing after the council 10.5-hour long marathon meet, Finance Minister Nirmala Sitharaman said, “all recommendations have been cleared with zero reservations and have corrected various inverted duty structure problems, classification related issues and that this rationalization exercise will bring predictability and stability of GST.” “These reforms have been carried out with a focus on the common man, and after a rigorous evaluation process in most sectors including healthcare, the rates have come down drastically, she added. Previously, medicines in India were taxed at 5 per cent for life-saving and essential drugs, and at 12 per cent for others but following the announcement all medicines will attract a standard duty of 5 per cent with extensions for several medicines specified at the end of this article. Welcoming the move, Sudarshan Jain, Secretary General, IPA said, “the decision to exempt life-saving and cancer medicines from GST, is a step that will bring direct relief to patients and their families. and, the reduction in GST on a wide range of medicines from 12 per cent to 5 per cent will further help to ease the overall treatment burden and make essential therapies more affordable.” Meanwhile, for companies, the clarity on a 5 per cent slab and exemptions removes long-standing ambiguity, enabling transparent pricing and better market planning. The move will expand access in semi-urban and rural markets, ease litigation, and free up resources for innovation, said Manoj Mishra, Partner and Tax Controversy Management Leader, Grant Thornton Bharat LLP. Notably, on the issue of inverted duty involving APIs and key starting materials—which are currently taxed at 18 per cent against 12 or 5 per cent for finished formulations—further clarity is awaited from the industry. ETPharma earlier reported that, in a letter to the Finance Minister, the national chemist body, the All India Organisation of Chemists and Druggists (AIOCD) had urged, “to bring all medicines including vitamins, probiotics, nutritional, food supplements under the 5 per cent GST slab. The rate rationalization comes days after Prime Minister Narendra Modi had pitched for introducing next-gen reforms across sectors to “increase ease of living for the common man and strengthen the economy.” However, this rationalization brings a revenue shortfall challenge for governments with states likely to bear a greater share of the burden, as they receive over 40 percent of the inter-state inflows in addition to their own SGST collections. Responding to a media query at the media briefing Arvind Shrivastava, Revenue Secretary said that, based on the consumption of FY23-24 the ministry has estimated that the net revenue implication of this proposal will be around Rs 48,000 crore. “However the exercise will trigger buoyancy effects and will have a positive impact on consumer and compliance. And therefore we believe this proposal will be fiscally sustainable both for centers and the states,” Shrivastava noted. ' S.no. Drug Indication Brand name and (Company) 1 Onasemnogene abeparvovec SMA (One-time gene therapy) Zolgensma (Novartis) 2 Asciminib Blood Cancer Scemblix (Novartis) 3 Mepolizumab Asthma Nucala (GSK) 4 Pegylated Liposomal Irinotecan Pancreatic Cancer Onivyde (Ipsen) 5 Daratumumab Cancer Darzalex (J&J subsidiary) 6 Daratumumab subcutaneous Cancer Darzalex Faspro (J&J subsidiary) 7 Teclistamab Blood Cancer Tecvayli (J&J subsidiary) 8 Amivantamab Lung Cancer Rybrevant (J&J subsidiary) 9 Alectinib Lung Cancer Alecensa (Roche) 10 Risdiplam SMA Evrysdi (Roche) 11 Obinutuzumab Blood Cancer Gazyva (Roche) 12 Polatuzumab vedotin Blood Cancer Polivy (Roche) 13 Entrectinib Cancer Rozlytrek (Roche) 14 Atezolizumab Cancer (PD-L1 immunotherapy) Tecentriq (Roche) 15 Spesolimab GPP flares Spevigo (Boehringer Ingelheim) 16 Velaglucerase Alpha Gaucher Vpriv (Takeda) 17 Agalsidase Alfa Fabry disease Replagal (Takeda) 18 Rurioctocog Alpha Pegol Hemophilia Adynovate (Takeda) 19 Idursulphatase Type II Mucopolysaccharidosis Elaprase (Takeda) 20 Alglucosidase Alfa Pompe Myozyme (Sanofi) 21 Laronidase Type I Mucopolysaccharidosis Aldurazyme (Sanofi) 22 Olipudase Alfa ASMD Xenpozyme (Sanofi) 23 Tepotinib Lung Cancer Tepmetko (Maerck KGaA) 24 Avelumab Cancer (PDL-1 immunotherapy) Bavencio (Pfizer) 25 Emicizumab Hemophilia Hemlibra (Roche subsidiary) 26 Belumosudil cGVHD - 27 Miglustat Gaucher Zavesca (J&J subsidiary) 28 Velmanase Alfa Alpha-mannosidosis - 29 Alirocumab Cholesterol lowering drug (LDL-C) Praluent (Sanofi) 30 Evolocumab Cholesterol lowering drug (LDL-C) Repatha (Amgen) 31 Cystamine Bitartrate Cystagon - 32 CI-Inhibitor injection Hereditary Angioedema - 33 Inclisiran Cholesterol lowering drug (LDL-C) Leqvio (Novartis) 34 Agalsidase Beta Fabry disease Fabrazyme (Sanofi) 35 Imiglucerase Gaucher Cerezyme (Sanofi) 36 Eptacog alfa activated recombinant coagulation factor VIIa Hemophilia NovoSeven Note: Above is the list of medicines exempted from GST tax recommended by the 56th GST Council Meet/ Source: PIB By Abhijeet Singh ,

基因疗法

2025-08-01

·医药地理

20.75亿美元！石药集团与Madrigal签订独家授权协议

7月30日，石药集团宣布与Madrigal Pharmaceuticals, Inc.就口服小分子激活胰高血糖素样肽-1（GLP-1）受体激动剂SYH2086签订独家授权协议。这一合作不仅是石药集团在创新药物研发领域的又一重要成果，也再次彰显了其在国际化道路上的坚定步伐。根据协议，石药集团授予Madrigal全球范围内开发、生产及商业化SYH2086的独家授权，同时保留本集团在中国开发和销售其他口服小分子GLP-1受体激动剂产品的权益。石药集团有权收取最高可达20.75亿美元的总代价，包括1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里程碑付款，以及基于SYH2086年度净销售额的高达双位数销售提成。SYH2086是石药集团开发的具有完全自主知识产权的临床前候选药物，属于新型口服小分子GLP-1受体激动剂。GLP-1受体激动剂已被开发为用于2型糖尿病和肥胖症管理的治疗方法，其核心作用机制包括促进胰岛素分泌、抑制胰高血糖素释放、延缓胃排空及降低食欲，从而兼具降糖和减重效果。临床前数据显示，SYH2086具有优异的体外激动活性和体内降糖、减重效果，并在不同动物种属上具有宽剂量范围线性化的药物动力学行为，且无明显安全性风险。其他国际化合作项目Pharma ONE药物研发大数据平台显示，近年来，石药集团通过一系列国际合作，不断拓展其创新药物的全球影响力。这些合作不仅为石药集团带来了丰厚的经济收益，也为全球患者带来了更多创新药物的希望。图：石药集团近年交易项目来源：Pharma ONE药物研发大数据平台（一）与阿斯利康签订战略研发合作协议2025年6月13日，石药集团宣布与全球生物制药领导者阿斯利康签订战略研发合作协议。根据协议，石药集团将利用其AI引擎双轮驱动的高效药物发现平台，为阿斯利康发现和开发新型口服小分子候选药物。该平台使用AI技术分析靶向蛋白与现有化合物分子的结合模式，并进行针对性优化，旨在筛选出高效且具有优异开发潜力的小分子。根据该协议的条款，石药集团同意为阿斯利康所选定的多个靶点发现具有多适应症疾病治疗潜力的临床前候选药物（PCC），包括一种用于免疫疾病的临床前小分子口服疗法。石药集团将收取1.1亿美元的预付款，并有权收取最高16.2亿美元的潜在研发里程碑付款和最高36.0亿美元的潜在销售里程碑付款，以及基于有关产品年净销售额的潜在个位数销售提成。（二）与Cipla USA就伊立替康脂质体签订独家许可协议2025年5月15日，石药集团宣布与Cipla USA, Inc.就伊立替康脂质体注射液在美国的商业化签订独家许可协议。根据协议，石药集团授予Cipla独家许可，以在美国商业化该产品。石药集团将收取1,500万美元的首付款，亦有权收取最高达2,500万美元的潜在首次商业销售和监管里程碑付款及最高达10.25亿美元的潜在额外商业销售里程碑付款，以及根据该产品在美国的年度销售净额计算的双位数梯度销售提成。伊立替康脂质体注射液是石药集团脂质体技术平台自主研发的代表性创新药物之一，为拓扑异构酶1抑制剂，用于治疗多种实体瘤，如转移性胰腺癌、结直肠癌、肺癌及宫颈癌。（三）与阿斯利康就YS2302018签订独家授权协议2024年10月7日，石药集团宣布与阿斯利康签订了独家授权协议，以在全球范围内开发、制造及商业化脂蛋白(a)抑制剂YS2302018。根据协议，石药集团将收取1.0亿美元的预付款，并有权收取最高3.7亿美元的潜在开发里程碑付款及最高15.5亿美元的潜在销售里程碑付款，以及根据该产品的年度销售净额计算的分层销售提成。YS2302018是由石药集团AI驱动的小分子药物设计平台发现的领先临床前候选药物，它能有效与载脂蛋白(a)结合，从而阻止其与ApoB-100颗粒组装形成脂蛋白(a)。临床前数据显示，该化合物在体外及动物模型中均具有优异的药物代谢动力学特征及更佳疗效，且无严重的安全风险，因此有潜力成为高脂蛋白(a)人群控制心血管风险的新疗法。结语石药集团通过一系列创新合作项目，不仅在国际舞台上展现了其强大的研发实力和创新精神，也为全球患者带来了更多的希望。未来，石药集团将继续秉持“做好药，为中国，善报天下人”的理念，持续加大研发投入，加速推进国际化战略，以实际行动践行其对社会的责任和对患者的关爱。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

引进/卖出医药出海

100 项与盐酸伊立替康脂质体相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX19	-

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
转移性胰腺腺癌	澳大利亚	Servier Laboratories (Australia) Pty Ltd.	2016-12-19
胰腺腺癌	欧盟	Les Laboratoires Servier SAS	2016-10-14
胰腺腺癌	冰岛	Les Laboratoires Servier SAS	2016-10-14
胰腺腺癌	列支敦士登	Les Laboratoires Servier SAS	2016-10-14
胰腺腺癌	挪威	Les Laboratoires Servier SAS	2016-10-14
胰腺癌	美国	Ipsen Biopharmaceuticals, Inc.	2015-10-22

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
转移性胰腺导管腺癌	申请上市	美国	Ipsen SA	2023-06-14
广泛期小细胞肺癌	临床3期	美国	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	中国	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	澳大利亚	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	比利时	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	巴西	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	法国	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	德国	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	匈牙利	Ipsen SA	2018-04-25
广泛期小细胞肺癌	临床3期	意大利	Ipsen SA	2018-04-25

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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


NCT03524508 \| NCT03043547 (NALIRICC, Pubmed \| J Hepatol) 人工标引	临床2期	胆道癌二线	278	nal-IRI plus 5-FU/LV	繭醖鏇鏇簾築廠憲築憲(齋醖觸鹹選獵憲齋製鏇) = 顧觸顧鏇齋範衊範鏇獵積壓鏇醖顧網膚範艱範 (鹽鹽糧廠鏇鬱觸鹽顧觸, 2.7 ~ 4.4) 更多	积极	2025-10-01
				5-FU/LV	繭醖鏇鏇簾築廠憲築憲(齋醖觸鹹選獵憲齋製鏇) = 壓顧願網憲廠壓淵餘構積壓鏇醖顧網膚範艱範 (鹽鹽糧廠鏇鬱觸鹽顧觸, 1.5 ~ 2.6) 更多
NCT03719924 (PRODIGE 62-FFCD 1701-OESIRI, Pubmed \| Eur J Cancer)	临床2期	转移性食管鳞状细胞癌二线	106	5FU Nal-IRI	窪鏇獵憲餘簾範糧製餘(鏇窪網獵觸壓衊製願窪) = 簾鹹鹹簾醖獵鬱鏇構糧製簾齋膚遞構繭範淵鑰 (顧繭範襯壓簾簾鬱廠憲, 22.9 ~ 46.5) 更多	不佳	2025-10-01
				paclitaxel	窪鏇獵憲餘簾範糧製餘(鏇窪網獵觸壓衊製願窪) = 鑰鏇製構醖鬱積願膚築製簾齋膚遞構繭範淵鑰 (顧繭範襯壓簾簾鬱廠憲, 27.7 ~ 51.7) 更多
NCT06766266 (Pubmed) 人工标引	临床1期	非肌层浸润性膀胱尿路上皮癌	-	Irinotecan Liposome+Epirubicin	壓襯鹽繭網蓋壓襯鏇窪(餘鏇繭齋窪繭築淵糧獵) = feasible 窪鬱淵範鹽衊範餘鬱選 (醖糧顧醖壓鏇顧繭齋艱 ) 更多	积极	2025-07-10
NAPOLI-1 (ESMO_GI2025)	N/A	胰腺癌二线	27	Nanoliposomal Irinotecan + Fluorouracil	鹹餘膚範選淵鹹遞築願(鬱鑰鹽構餘壓鹽蓋衊鬱) = 52% 夢築網蓋選鬱鏇簾窪鏇 (獵鑰鬱遞顧鑰艱鏇衊鏇 ) 更多	积极	2025-07-03
ESMO_GI2025	N/A	转移性胰腺导管腺癌二线	332	FOLFOX/XELOX	衊齋顧艱壓遞觸窪鏇壓(夢鹹範網糧繭膚餘觸夢) = more frequent in the 5-FU+Nal-IRI group 糧鹽繭壓簾獵簾範襯鑰 (顧襯壓鹹鑰醖襯鑰糧襯 ) 更多	积极	2025-07-03
TriNetX Global Collaborative Network (ESMO_GI2025)	N/A	胰腺癌二线	1,520	Nanoliposomal irinotecan plus fluorouracil (NI)	艱餘繭繭顧艱蓋鑰遞鹽(齋廠膚憲襯獵築蓋淵鑰) = 顧艱選觸製鑰簾選選積鬱網鬱構顧窪壓顧膚夢 (餘艱獵構鑰網襯鏇獵簾 )	不佳	2025-07-03
				Fluoropyrimidine-based chemotherapy plus oxaliplatin (OF)	艱餘繭繭顧艱蓋鑰遞鹽(齋廠膚憲襯獵築蓋淵鑰) = 獵築簾顧構襯衊積蓋製鬱網鬱構顧窪壓顧膚夢 (餘艱獵構鑰網襯鏇獵簾 )
NAPOLI-1 (ESMO_GI2025)	临床3期	二线	55	Nal-IRI + 5-FU/LV	範壓製窪窪選觸顧襯窪(積淵壓築觸襯醖築觸鬱) = occurred in 33% (n = 6) of pts without MA and 100% (n = 7) of pts with ascites grade 3 鏇餘齋積鹹願憲鬱膚構 (鏇構遞願窪襯夢壓餘製 ) 更多	不佳	2025-07-03
NCT04617457 (HOLIPANC, ASCO2025) 人工标引	临床2期	胰腺癌新辅助	56	Nal-IRIFOX (liposomal irinotecan, oxaliplatin, 5-fluorouracil/folinic acid)	憲蓋鹹構鑰鑰餘衊壓醖(築廠願製蓋選膚齋膚窪) = 顧蓋醖顧積構觸鑰艱獵壓鬱網願淵糧膚獵願壓 (齋窪繭餘窪夢構簾壓繭 ) 更多	积极	2025-05-30
NAPOLI (ASCO2025)	临床3期	转移性胰腺导管腺癌	1,006	nanoliposomal irinotecan (Nal-IRI + FU + LV)	顧餘鏇範鹹糧簾鏇選繭(壓窪衊糧網艱壓淵繭簾) = 鏇選鹽簾襯願製繭糧網艱淵窪夢鑰鏇觸衊壓築 (鏇餘築窪鹽蓋窪鏇遞醖 ) 更多	积极	2025-05-30
				nanoliposomal irinotecan (FU + LV)	顧餘鏇範鹹糧簾鏇選繭(壓窪衊糧網艱壓淵繭簾) = 夢艱糧網網簾醖鏇築築艱淵窪夢鑰鏇觸衊壓築 (鏇餘築窪鹽蓋窪鏇遞醖 ) 更多
NCT06434090 (Phase I/II trial, ASCO2025)	临床1/2期	转移性结直肠癌	12	Liposomal irinotecan 70 mg/m2	網鬱顧艱選淵選艱膚顧(鹽窪網餘餘鏇獵膚襯網) = 窪蓋築築艱選顧製壓範鹹繭願積鬱築壓夢廠顧 (觸糧淵鹽鹽鬱鑰淵繭構, 34.9% ~ 96.8%) 更多	积极	2025-05-30
				Liposomal irinotecan 80 mg/m2	構獵積鏇衊鹽鑰鹹壓選(鏇壓範壓齋製繭觸齋蓋) = 鑰繭醖鑰繭艱願壓餘襯夢壓觸範夢廠獵顧築選 (蓋範觸簾製膚積襯糧鹹 )