This is a single arm, proof of concept phase II clinical trial to evaluate the combination of Pembrolizumab and Carboplatin plus Paclitaxel in patients with localized TNBC (tumor size ≥10 mm and up to 25 mm), node-negative status (by clinical exam and local radiological evaluation) and who have not previously received chemotherapy, targeted therapy, and/or radiotherapy for invasive breast cancer.

开始日期2025-04-01

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

NCT06656598

/ Not yet recruiting临床2期IIT

A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer

The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.

开始日期2025-04-01

申办/合作机构

Intergroupe Francophone Cancerologie Thoracique

NCT06793917

/ Not yet recruiting临床3期IIT

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1

开始日期2025-04-01

申办/合作机构

福建省肿瘤医院（福建省肿瘤研究所、福建省癌症防治中心）

100 项与 Paclitaxel ceribate 相关的临床结果

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100 项与 Paclitaxel ceribate 相关的转化医学

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100 项与 Paclitaxel ceribate 相关的专利（医药）

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项与 Paclitaxel ceribate 相关的文献（医药）

2003-08-01·European heart journal1区 · 医学

Contrast media as carriers for local drug delivery Successful inhibition of neointimal proliferation in the porcine coronary stent model

1区 · 医学

Article

作者: Scheller, Bruno ; Romeike, Bernd ; Bohm, Michael ; Speck, Ulrich ; Sovak, Milos ; Schmitt, Alexander ; Stoll, Hans-Peter

BACKGROUND:

Lipophilic taxanes can be dissolved in contrast media at significantly higher concentration than in saline. As contrast media have occasionally been observed to delineate the contour of coronary arteries for some seconds they may serve as a matrix for an antiproliferative drug aimed at preventing restenosis. The aim of this study was to test a novel taxane-contrast agent formulation for this new approach in the setting of coronary stenting.

METHODS AND RESULTS:

In cell culture experiments (bovine vascular smooth muscle cells), 60-min incubation with contrast agent-taxane formulations (iopromide-paclitaxel, iopromide-protaxel) induced a significant, concentration-dependent inhibition of vascular smooth muscle cell (VSMC) proliferation over 12 days. Shorter incubation times of 10 and 3 min showed the same efficacy. For in vivo investigation, 16 stents were implanted into the coronary arteries of eight pigs using a 1.3 to 1 overstretch ratio. A control group received iopromide 370 alone while the treatment group was injected with a iopromide-protaxel formulation at a dose of 74 micromol/l, which is far below protaxel levels inducing systemic toxicity. Quantitative angiography and histomorphometry of the stented arteries asserted statistic equality of the baseline parameters between the control and treatment groups. After 28 days, the treatment group showed a marked reduction of the parameters characterizing in-stent restenosis, especially a 34% reduction of the neointimal area.

CONCLUSIONS:

First evidence is provided that using a contrast agent as solvent for a taxane constitutes a new drug delivery mechanism able to inhibit in-stent restenosis in the porcine restenosis model.

2002-01-01·Investigative radiology1区 · 医学

Acute Cardiac Tolerance of Current Contrast Media and the New Taxane Protaxel Using Iopromide as Carrier During Porcine Coronary Angiography and Stenting

1区 · 医学

Article

作者: Scheller, Bruno ; Clauss, Wolfram ; Bohm, Michael ; Speck, Ulrich ; Sovak, Milos ; Stoll, Hans-Peter ; Schmitt, Alexander

RATIONALE AND OBJECTIVES:

The systemic tolerance thresholds of modern low-osmolar x-ray contrast media (CM) are similarly high, but their effects on the cardiovascular system and on the coagulation differ. The aim of this study was to comparatively evaluate the cardiovascular tolerability of iopromide, ioxaglate, and iosmin, and of a novel taxane protaxel, dissolved in iopromide, as a carrier, by coronary angiography and stenting.

METHODS:

Sixteen pigs were randomized into four groups: iosmin (350 mg iodine/mL, n = 4, nonionic dimer), iopromide (370 mg iodine/mL, n = 4, nonionic monomer), ioxaglate (320 mg iodine/mL, n = 4, ionic dimer), and 70-micromol protaxel dissolved in iopromide 370 mg iodine/mL, intended to prevent restenosis. Coronary angiography was performed via the left carotid artery followed by implantation of stents into the left anterior descending and the circumflex arteries. About 80 mL per animal was used in each group.

RESULTS:

There were no thrombotic complications and no significant adverse events of electrocardiography, blood pressure, or contractility during or after CM injections. There were no differences among the CM tested except that ioxaglate was the only agent showing a significant reduction in dp/dt after 50 seconds compared to iosmin. The values of preinjection parameters were most rapidly regained after iosmin, compared with other CM tested.

CONCLUSIONS:

The novel iso-osmolar nonionic CM iosmin is well tolerated in porcine coronary angiography and subsequent stenting. The cardiac tolerance of iopromide has not been adversely affected by addition of the cytostatic protaxel.

2001-04-01·Anti-cancer drugs4区 · 医学

A new prodrug of paclitaxel: synthesis of Protaxel

4区 · 医学

Article

作者: Seligson, Allen L. ; Terry, Ronald C. ; Douglass, James G. III ; Sovak, Milos ; Bressi, Jerome C.

2' and 7 Polyol carbonates of paclitaxel were synthesized and screened as potential paclitaxel prodrugs. Paclitaxel is released from 7-(2",3"-dihydroxypropylcarbonato) paclitaxel (Protaxel) at rates inversely proportional to pH, by an intramolecular cyclization. Compared to paclitaxel, maximum tolerated i.v. or i.p. doses (MTD) of Protaxel are about 2.5- to 3-fold higher; its efficacy is substantially higher in human cancer line xenografts in athymic mice, especially in prostate PC-3, breast MDA-MB 468 and ovary OVCAR-1.

项与 Paclitaxel ceribate 相关的新闻（医药）

2025-05-06

·investors.imunon.com

IMUNON Announces Data from Phase 1/2 Trial Evaluating Intraperitoneal IMNN-001 in Combination with Neoadjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian Cancer to be Published in Gynecologic Oncology

Data from OVATION 2 trial will also be reviewed in an oral presentation at ASCO Annual Meeting on June 3, 2025 LAWRENCEVILLE, N.J. , May 06, 2025 (GLOBE NEWSWIRE) -- IMUNON , Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced that data from the company’s Phase 1/2 OVATION 2 trial evaluating intraperitoneal IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy in newly diagnosed patients with advanced epithelial ovarian cancer will be published in the peer-reviewed journal Gynecologic Oncology. The review of full data, entitled: OVATION-2: A Randomized Phase I/II study Evaluating the Safety and Efficacy of IMNN-001 (IL-12 gene therapy) with Neo/Adjuvant Chemotherapy in Patients Newly- Diagnosed with Advanced Epithelial Ovarian Cancer, is scheduled for publication on June 3, 2025 . As previously announced, data from the OVATION 2 study will also be reviewed in an oral presentation during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2025 in Chicago, Illinois . Premal H. Thaker , M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, is lead author on the publication and will lead the discussion in the oral presentation at the ASCO meeting. “We are very pleased that the data from our OVATION 2 study will be presented in the highly esteemed peer-reviewed journal Gynecologic Oncology and in an oral presentation at the ASCO meeting,” said Stacy Lindborg , Ph.D., president and chief executive officer of IMUNON . “Having our data presented in two of the premier global platforms in gynecologic oncology underscores both the critical need to develop new therapies to treat ovarian cancer and the strength and potential of IMUNON’s TheraPlas® platform technology.” About the Phase 2 OVATION 2 Study OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response. About IMNN-001 Immunotherapy Designed using IMUNON's proprietary TheraPlas® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer. About Epithelial Ovarian Cancer Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation. About IMUNON IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response. The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer that has completed Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. The Company has completed enrollment for a first-in-human study of its COVID-19 booster vaccine (IMNN-101) which remains ongoing. IMUNON will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions, and to further strengthen IMUNON’s balance sheet through attractive business development opportunities. For more information, please visit www.imunon.com. Forward-Looking Statements IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement and potential outcome of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission . IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. Contacts: Source: Imunon, Inc.

临床结果临床2期免疫疗法ASCO会议疫苗

2025-05-05

·ioncology

IGCC前瞻丨中国专家20项口头报告摘要闪耀国际舞台

IGCC 2025微专辑扫描二维码可查看更多内容编者按由国际胃癌学会（IGCA）主办的第16届国际胃癌大会（IGCC 2025）将于2025年5月7~10日在荷兰阿姆斯特丹隆重召开。作为全球胃癌研究领域具影响力的学术盛会，本届大会将汇聚来自世界各地的顶尖专家学者，聚焦胃癌诊疗前沿进展。值得关注的是，中国专家将在多个专题会场发表重要研究成果，展现我国在该领域的学术影响力。经《肿瘤瞭望消化时讯》系统梳理会议日程，现共整理出20项中国专家入选的口头报告摘要标题（中英文对照）供读者预览。若有遗漏或表述偏差，诚挚欢迎学界同仁批评指正。一、5月8日专题报告Session 1a：分期专场时间：11:45中文标题：多参数MRI与双能CT在胃癌局部区域分期中的对比研究英文标题：Multiparametric MRI versus Dual-Energy CT in Gastric Cancer Locoregional Staging专家：Qiong Li，南京医科大学第一附属医院时间：12:05中文标题：基于优化淋巴结分期的胃癌新辅助治疗后ypTNM分期细化英文标题：Refined ypTNM Staging for Gastric Cancer After Neoadjuvant Therapy Based on Optimal Lymph Node Staging专家：Baolong Li，福建医科大学附属协和医院Session 1b：肿瘤内科-免疫治疗专场时间：11:45中文标题：术前免疫治疗与dMMR/MSI-H胃癌病理反应改善相关英文标题：Preoperative immunotherapy is associated with better pathological response in dMMR/MSI-H gastric cancer专家：Hong Zeng，复旦大学附属中山医院时间：12:05中文标题：蛋白质组学分析预测胃癌新辅助放化疗免疫疗效英文标题：Proteomic Analysis Predicts Therapeutic Outcomes of Neoadjuvant Chemo-immunotherapy in Gastric Cancer Patients专家：崔昊，中国人民解放军总医院第一医学中心Session 1c：胃肠病学/内镜/早期胃癌专场时间：11:55中文标题：全腹腔镜与腹腔镜辅助远端胃癌根治术对早期胃癌患者生活质量的影响分析英文标题：Morbidity and quality of totally laparoscopic versus laparoscopy-assisted distal gastrectomy for early gastric cancer’s life专家：黄华，复旦大学附属肿瘤医院Session 2a：肿瘤内科-靶向治疗专场时间：16:40中文标题：T细胞激活增强抗HER2介导的胃癌抗体依赖性细胞毒性英文标题：T-cell activation enhances anti-HER2-mediated antibody-dependent cellular cytotoxicity in gastric cancer专家：薛子睿，复旦大学附属中山医院Session 2b：放射肿瘤学专场时间：16:30中文标题：可切除食管胃结合部腺癌新辅助斯鲁利单抗联合放化疗的Ⅱ期更新结果英文标题：Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results专家：赵林，北京协和医院时间：16:40中文标题：可切除食管胃腺癌放化疗价值的Meta分析英文标题：The value of chemoradiation therapy for resectable esopho-gastric adenocarcinomas: A meta-analysis of randomized clinical trials专家：Tao Fu，中日友好医院Session 2c：胃癌手术创新专场时间：16:40中文标题：D2+CME根治术对局部进展期胃癌的肿瘤学疗效：RCT三年随访结果英文标题：The oncological efficacy of D2+CME for locally advanced gastric cancer: 3-year outcomes of a RCT专家：龚建平，华中科技大学同济医学院附属同济医院二、5月9日专题报告3x接受口头摘要全体会议：HDGC/预康复专场时间：9:40中文标题：多学科预康复改善老年虚弱胃癌患者临床结局英文标题：Supervised multimodal prehabilitation to improve the clinical outcomes of frail elderly patients with gastric cancer专家：Yuqi Sun，青岛大学附属医院Session 3a：病理学/转化研究专场时间：11:55中文标题：FGFBP2+NK细胞作为胃癌免疫治疗预测性生物标志物的角色解析英文标题：Unraveling the Role of FGFBP2+NK Cells as Predictive Biomarkers in Gastric Adenocarcinoma Immunotherapy专家：潘宏达，复旦大学附属肿瘤医院Session 3b：人工智能与精准手术专场时间：11:45中文标题：机器学习模型预测胃癌患者术后并发症英文标题：Machine Learning Models for Predicting Postoperative Surgical Complications in Gastric Cancer Patients专家：Xiaohan Cui，山东大学齐鲁医院时间：12:05中文标题：基于多场景血管识别的AI驱动胃癌微创手术导航系统英文标题：AI-driven Surgical Navigation System based on Multi-scene Vessel Recognition for Minimally Invasive Gastric Cancer Surgery专家：Hao Chen，南方医科大学南方医院Session 3c：生活质量/支持治疗专场时间：11:55中文标题：中国胃癌手术质量与经济学评价：基于PACAGE研究分析英文标题：Surgical Quality and Economic Evaluation of Gastric Cancer Surgery in China: Analysis of PACAGE study专家：吴舟桥，北京大学肿瘤医院Session 4b：多模态治疗专场时间：16:30中文标题：AS与CAPOX在Ⅲ期胃腺癌术后化疗中的生存与安全性更新英文标题：AS versus CAPOX in postoperative chemotherapy for stage Ⅲ gastric adenocarcinoma patients: survival and safety update专家：俞鹏飞，浙江省肿瘤医院Session 4c：手术拓展-局限性Ⅳ期胃癌治疗专场时间：16:40中文标题：腹腔联合静脉化疗对比静脉紫杉醇+S-1治疗腹膜转移胃癌：DRAGON-01试验结果英文标题：Intraperitoneal+intravenous vs. intravenous paclitaxel+S-1 in gastric cancer with peritoneal metastasis: Results from DRAGON-01 trial专家：严超，上海交通大学医学院附属瑞金医院三、5月10日专题报告3x接受口头摘要全体会会议：手术专场时间：9:30中文标题：食管胃结合部腺癌纵隔淋巴结清扫的多中心队列研究中期分析英文标题：Lower mediastinal lymphadenectomy for adenocarcinoma of esophagogastric junction: interim analysis of a multicenter cohort study专家：李子禹，北京大学肿瘤医院时间：9:40中文标题：全腹腔镜与腹腔镜辅助全胃切除术疗效比较：CLASS08多中心RCT研究英文标题：The Efficacy of Totally Laparoscopic versus Laparoscopic-Assisted Total Gastrectomy: The CLASS08 Multicentre Randomized Controlled Trial专家：Qingya Li，南京医科大学第一附属医院Session 5a：肿瘤内科-新药与技术专场时间：11:55中文标题：替雷利珠单抗联合安罗替尼与XELOX一线治疗晚期胃/胃食管结合部腺癌（TALENT研究）英文标题：Tislelizumab Combined with Anlotinib and XELOX as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (TALENT)专家：Ling Ma，南京医科大学第一附属医院Session 5c：视频专场：如何应对治疗失败时间：11:45中文标题：D2+CME手术技术演示英文标题：D2+CME surgery专家：龚建平，华中科技大学同济医学院附属同济医院综上，本届IGCC大会中，中国专家在胃癌的分期诊断、免疫治疗、微创手术、多学科预康复等领域贡献多项突破性研究成果，涵盖临床分期优化、新型靶向药物联合方案、AI手术辅助系统等技术进展。特别关注领域包括：免疫治疗标志物探索（如dMMR/MSI-H分型与FGFBP2+NK细胞）、手术技术创新（如D2+CME根治术、全腹腔镜操作安全性）、多学科综合治疗（新辅助放化疗、多学科预康复模式）等。这些研究不仅展现中国在胃癌诊疗领域的国际影响力，更为全球患者带来潜在诊疗方案优化契机。期待中国专家在阿姆斯特丹的学术舞台上发出更强音！（来源：肿瘤瞭望消化时讯）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床2期免疫疗法

2025-04-30

·GlobeNewswire-Health Care

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

生物类似药上市批准临床3期临床1期并购

100 项与 Paclitaxel ceribate 相关的药物交易

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肿瘤	临床1期	捷克	-	-
肿瘤	临床1期	-	Interpharma Praha as	-

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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


NCT03107182 (OPTIMA II \| OPTIMA-II, CTgov)	临床2期	头颈部鳞状细胞癌 \| HPV阳性的口咽鳞状细胞癌 \| HPV相关鳞状细胞癌 ... 更多	72	Adjuvant RT+Nivolumab (Single Modality De-escalation Arm (SDA))	餘鬱壓蓋壓積積鬱窪鹽 = 窪築鬱蓋簾鬱襯蓋遞構糧簾願鹽膚蓋襯餘積醖 (糧鬱範淵膚築獵窪鹽選, 願蓋積餘蓋齋製窪襯醖 ~ 觸鑰遞鹹鏇網鹹鏇顧衊) 更多	-	2025-05-06
				Chemoradiotherapy+Nivolumab+Paclitaxel+Hydroxyurea+cisplatin+Famotidine+Diphenhydramine+Dexamethasone+5-FU (Intermediate De-escalation Arm (IDA))	餘鬱壓蓋壓積積鬱窪鹽 = 襯餘顧製醖鏇齋鹹鹽鏇糧簾願鹽膚蓋襯餘積醖 (糧鬱範淵膚築獵窪鹽選, 膚鏇廠壓築鏇積繭鹹淵 ~ 壓願廠糧淵鏇構觸艱鹽) 更多
AACR2025	N/A	转移性乳腺癌 ctDNA ESR1 mutations	158	Paclitaxel-resistant group	餘顧觸衊簾膚壓齋網齋(繭鹹糧齋顧鹽蓋鏇鑰製) = 願夢築廠積顧壓簾壓鑰選積簾鹹壓構築憲餘鏇 (窪製醖淵糧獵鏇獵餘簾 )	积极	2025-04-28
				Paclitaxel-sensitive group	餘顧觸衊簾膚壓齋網齋(繭鹹糧齋顧鹽蓋鏇鑰製) = 廠憲廠積願製餘衊獵齋選積簾鹹壓構築憲餘鏇 (窪製醖淵糧獵鏇獵餘簾 )