Gemcitabine Hydrochloride

2025年9月10日~14日，由中国临床肿瘤学会（CSCO）和北京市希思科临床肿瘤学研究基金会共同主办的第28届CSCO学术年会在山东济南盛大开幕，本届年会以“规范诊疗，创新引领”为主题，汇聚全球肿瘤领域知名专家学者，分享前沿研究成果与临床经验，促进学术交流与合作，通过肿瘤学继续教育推动临床诊疗规范的普及。胆道肿瘤专场作为大会重要组成部分，特邀顶尖专家学者参与，通过专题报告、共识解读和临床研究分享，全方位展现胆道肿瘤领域的最新成果与发展方向，为推动中国胆道肿瘤的规范化、精准化与国际化进程注入强劲动力 。开场致辞海军军医大学第三附属医院沈锋教授、陆军军医大学西南医院梁后杰教授对本届CSCO年会的召开表示热烈祝贺，并对与会专家同道的到来致以诚挚欢迎。他们强调，本次胆道肿瘤专场凝聚了国内顶尖学术力量，旨在共商诊疗新策略、共谋规范新未来，期待通过高水平的交流互鉴，进一步推动我国胆道恶性肿瘤（BTC）领域的创新与协同发展，预祝大会圆满成功。Session 1 围术期治疗本环节由复旦大学附属华山医院钦伦秀教授、上海交通大学医学院附属仁济医院王理伟教授共同主持。西安交通大学第一附属医院吴胤瑛教授以《从HER2视角看胆管癌的精准治疗策略》为题进行分享。HER2扩增或突变主要发生在胆囊癌和肝外胆管癌，且与胆管癌预后不良相关，HER2扩增患者复发及死亡风险更高。报告指出，需优化精准靶向治疗策略，包括联合治疗、探索化疗角色、靶向治疗前移等，还需探索耐药机制，如HER2基因突变、蛋白表达异质性等，可通过联合治疗、研发新型HER2靶向药物、应用个体化治疗策略及液体活检实时监测等手段克服耐药，此外还涉及ADC到细胞免疫治疗等新型药物研发。华中科技大学同济医学院附属协和医院马虹教授围绕《精准放疗在BTC新辅助治疗中进展》展开精彩分享。马虹教授围绕BTC新辅助治疗中放疗的作用展开，探讨了放疗在新辅助/转化治疗策略中的可行性及实施的精准性，分析了放疗在新辅助治疗中的作用及争议，还涉及新辅助治疗的精准化实施，包括依据肿瘤特性选择放疗方式及剂量、建立临床评价体系辅助治疗决策等，强调新兴影像学、基因组学检测的必要性，以及基于肿瘤特征选择放疗技术和剂量方案，同时指出在靶免治疗时代放疗可能成为药物治疗的增敏方式。武汉大学中南医院周福祥教授、陆军军医大学第一附属医院唐腾骞教授、东部战区总医院成远教授、湖南省肿瘤医院罗嘉教授围绕上述专题报告展开深入研讨与观点交锋。Session 2 靶向治疗 本环节由中国人民解放军总医院戴广海教授、大连医科大学附属第一医院刘基巍教授共同主持。中山大学附属第一医院许丽霞教授分享了《从IDH1/FGFR视角看胆管癌的精准治疗策略》。BTC分子特征复杂，存在多种基因变异，具有高度异质性，基因突变率高，IDH1与FGFR是BTC重要的驱动基因。免疫一线治疗地位确立，对部分基因突变BTC免疫治疗有效；二线治疗中，IDH1与FGFR抑制剂显示出不错的疗效。虽然现有方案为BTC患者带来生存获益，但更优方案仍在探索中，未来靶向联合是重要的发展方向。浙江省肿瘤医院应杰儿教授针对《胆道恶性肿瘤免疫检查点抑制剂中国专家共识（2025版）》进行了深入解读。近年，随着以PD-1/PD-L1为代表的免疫检查点抑制剂（ICI）的出现，为BTC治疗带来新的希望。为了促进ICI在BTC领域的推广和规范化应用，CSCO胆道肿瘤专家委员会撰写了《CSCO胆道恶性肿瘤免疫检查点抑制剂专家共识（2025版）》，基于现行诊疗标准，整合最新研究成果，就BTC一线治疗、二线及后线治疗、围术期治疗、免疫联合局部治疗、免疫治疗疗效预测标记物等核心板块提出了详细的建议，对治疗方案进行分级推荐，覆盖BTC的全病程管理路径，为临床实践提供了兼具科学性与可操作性的指导框架。四川大学华西医院曹丹教授以《BTC少见/罕见靶点的治疗与思考》为题进行分享。BTC是高侵袭性、异质性强的肿瘤，疾病负担重且预后差，靶向治疗和分子分型是改善预后的新方向。虽罕见靶点基因变异率低，但精准靶向治疗单疗法已显显著疗效，前景广阔。针对NTRK、RET、BRAF、MDM2等靶点及新靶点Claudin18.2的研究在BTC领域持续推进。TOPAZ-1研究显示免疫联合化疗仍是多数患者一线优选，未来精准靶向药物的应用需进一步探索。同时，阐明耐药机制对改善治疗策略至关重要，BTC治疗已进入精准化、个体化时代，需优化治疗选择以最大化患者获益。青岛大学附属医院邱文生教授、河南省肿瘤医院杨树军教授、哈尔滨医科大学附属肿瘤医院王广雨教授、解放军联勤保障部队第900医院彭永海教授围绕议题进行了热烈讨论，在思想碰撞中激发了诸多新见解。Session 3 专家共识本环节由西安交通大学医学院第一附属医院李恩孝教授、北京大学肿瘤医院郝纯毅教授共同主持。北京大学肿瘤医院周军教授针对《胆道恶性肿瘤精准检测与分子诊断专家共识》进行了深入解读。周军教授分析了胆道癌各亚型的分子改变，指出中国患者分子图谱与他国存在差异。可靶向突变的晚期胆道肿瘤经靶向治疗生存显著改善，匹配靶向治疗患者总生存期（OS）优于未接受靶向治疗以及无法接受靶向治疗的患者。共识方面，强调FGFR2、IDH1、HER-2等常见靶点的检测与治疗推荐，同时积极推荐BRAF V600E、NTRK/NRG1/RET融合等少罕见靶点的靶向治疗。检测方法上，IDH1变异可采用Sanger/PCR或NGS，HER-2检测参考胃癌/乳腺癌标准。2025年更新增加RAS、CLDN等新靶点，删除免疫相关检测内容，为胆道恶性肿瘤的精准检测与分子诊断及个体化治疗提供了重要指导。海军军医大学第三附属医院杨田教授以《从外科视角看BTC围术期的治疗策略》为题进行分享。BTC手术复杂，术后复发率高，决定其预后的关键外科因素包括切缘、阳性淋巴结数量及淋巴结清扫情况，不同亚型清扫淋巴结数量要求不同。术后辅助治疗仍有未满足的临床需求，虽然卡培他滨、S-1已列入指南推荐，但效果仍有不足，相关研究有待进一步开展。杨田教授指出，BTC预后差且发病率上升，手术切除是主要的治愈手段，不同亚型手术指征有差异，需切除所有可见灶、尽量清扫足够数量淋巴结，不推荐姑息性切除，手术向精准化和微创化发展。兰州大学第一医院赵达教授、中国药科大学附属南京天印山医院寻琛教授、大连医科大学附属第二医院吴涛教授、重庆大学附属涪陵医院周琪教授围绕上述专题分享展开深入讨论。 论文交流本环节由西南医院（陆军军医大学第一附属医院）谢峰丰教授主持。复旦大学附属中山医院黄晓勇博士分享论文《Primary Analysis of a Phase Ⅲb, Single-arm, Open-label, Multicenter Study of Durvalumab in Combination with Gemcitabine-based Chemotherapy for Chinese patients with Advanced Biliary Tract Cancer：TopDouble》。研究结果表明，度伐利尤单抗联合三种常用吉西他滨为基础的化疗方案安全性可管理、耐受性可接受，ECOG PS 0-1分患者疗效获益趋势与TOPAZ-1一致，ECOG PS 2分患者也有前景，联合GEMOX或GS1方案疗效与TOPAZ-1高度一致，联合GemCis方案有望成为体能较差患者新选择，不过因各组样本量有限，组间比较需谨慎解读。中山大学附属第一医院罗丽博士分享论文《Targeting YTHDF1 augments anti-PD-L1 efficacy in intrahepatic cholangiocarcinoma by inhibiting m6A-FOSL2-CXCL6-CXCR2 axis》。研究背景涉及晚期胆管癌治疗现状，聚焦两个科学问题：YTHDF1对肝内胆管癌免疫微环境的影响及机制，靶向YTHDF1能否改善其免疫治疗效果。结论表明，YTHDF1通过募集MDSCs、抑制CD8⁺T细胞功能促进肿瘤进展，其机制是通过m⁶A-FOSL2-CXCL6轴募集MDSCs；LNP-siYTHDF1可显著增强抗PD-L1对肝内胆管癌的抑制疗效。中国医学科学院北京协和医院李硕峰博士分享论文《Local-regional therapy plus immune checkpoint inhibitors and lenvatinib versus chemotherapy in advanced intrahepatic cholangiocarcinoma: a multicenter cohort study》。研究背景指出，晚期BTC一线治疗的化疗/免疫+化疗方案获益有限且不良反应大，需探索新策略。局部治疗联合系统治疗可控制病灶、促进肿瘤抗原释放以增强免疫原性。该研究纳入初治晚期ICC患者，排除其他BTC癌肿及前线治疗影响，同时纳入化疗对照组。结论表明，局部治疗联合ICIs和仑伐替尼疗效优越且毒性可控，是晚期肝内胆管癌一线治疗新选择。解放军总医院第五医学中心苟苗苗博士分享论文《Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer》。研究旨在评估度伐利尤单抗/帕博利珠单抗联合吉西他滨、顺铂及索凡替尼一线治疗晚期胆道恶性肿瘤的疗效与安全性。结果表明，中位无进展生存期（mPFS）6.86个月，客观缓解率（ORR）35.7%，疾病控制率（DCR）92.9%，1例患者达转化手术指征并成功切除，治疗相关不良事件整体可控。初步提示该方案为晚期BTC患者提供了新治疗选择。北京协和医院张楠博士分享论文《Evolutionary Divergence in HLA-B Genotype Predicts Efficacy of Immune Checkpoint Blockade in Advanced Biliary Tract Cancer》。该研究聚焦晚期胆道癌免疫治疗的关键科学问题，揭示了人类白细胞抗原-B（HLA-B）基因型的进化差异与免疫检查点抑制剂（ICB）疗效的关联性，聚焦免疫治疗关键靶点，极具探索与应用价值。浙江大学医学院附属第一医院方维佳教授、四川大学华西医院向丽莎教授、青岛大学附属医院吕红英教授、四川省肿瘤医院陈永昌教授围绕上述论文分享展开讨论。从围术期放化疗与靶向策略的优化，到免疫治疗共识的更新与罕见靶点突破，再到基础研究与临床转化的深度融合，专家学者们以前沿成果打破传统诊疗边界，为患者带来生存获益新可能。展望未来，胆道肿瘤领域仍需在耐药机制解析、跨学科诊疗协作及新型生物标志物开发中持续深耕。CSCO搭建的学术平台不仅凝聚了领域智慧，更以规范为基、以创新为翼，助力临床实践向“精准化、个体化、全程化”迈进，为改善胆道肿瘤患者预后开辟了切实可行的新路径。返回搜狐，查看更多

TME Pharma announces receipt of agreements in principle to extend certain bond agreements Berlin, Germany, November 17, 2025, 08.00am CET – TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, announced today that certain holders of the bonds issued in May and August, 2025 have agreed in principle to extend the maturity of the bonds for a one year period. These bond holders, Diede van den Ouden (CEO) and 2 members of the Supervisory Board, hold 29% of the regular bonds issued in May and August 2025 for a total face value amount of €718,946. TME Pharma will also discuss with other lenders who participated in the May and August 2025 bond issuance to try to procure similar extensions of their debt. TME Pharma believes now may be the right time, as the Company has gained traction with its newly implemented strategy and has seen its transition to a low-cost company successfully completed. A successful extension of the entire May and August bonds would extend the Company’s financial visibility to more than twelve months, into in Q2 2027. Taking into account the current reduction in costs to approximately €110k per month (where possible, costs will continue to be cut) and the cash position of around €2.1M at November 14, 2025. Current financial visibility ends at May 28, 2026 with the existing bond maturity dates. Under the bond extensions under discussion, the main conditions of the loans would not change, except for the extension by one year bringing the new maturity date to May 28, 2027, and the increase in total loan reimbursement amount, which would have to be repaid at 104.7% of the nominal value of the bond in cash at the new maturity date (as compared to 93.5% of the bond nominal value at May 28, 2026) or at 112% of the nominal value of the bond in the case of conversion to shares (formerly 100% of the bond nominal value). TME Pharma emphasizes that its primary goal remains to unlock the value of its biotech assets. The additional activities the Company is envisaging serves to support that goal. A sound operational foundation should help TME Pharma to find partners and limit the risk of shareholder dilution. Diede van den Ouden, CEO of TME Pharma, said: “Ever since I started working for TME Pharma, I've said I want to help the company move forward. I’m a shareholder myself, and I've done everything, and will do everything I can to limit shareholder dilution. Extending this debt could prevent dilution for even a much longer period. We are building a healthy future with TME Pharma and I think it is a positive sign that individuals closely involved with the Company are now once again willing to show their confidence in the Company’s future. I believe this will help us convince other bondholders as well, allowing us to visibly extend the financial performance and attract new investors interested in the complementary strategy.” For more information, please contact: TME Pharma N.V.Diede van den Ouden, CEOir@tmepharma.com About TME Pharma TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are: NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe. NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect. The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include: Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO)Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the CompanyLeveraging tax loss carry forwardsPotentially gaining exposure to digital assets Further information can be found at: www.tmepharma.com. About the GLORIA Study GLORIA (NCT04121455) is TME Pharma’s dose-escalation, Phase 1/2 study of NOX-A12 in combination with radiotherapy in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy). GLORIA further evaluates safety and efficacy of NOX-A12 in the expansion arm in which NOX-A12 is combined with radiotherapy and bevacizumab. About the OPTIMUS Study OPTIMUS (NCT04901741) is TME Pharma’s planned open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients. Disclaimer Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain "forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law. Management will now iParallel to its core biotechnology activities, the company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company's flagship products, NOXA12 and NOX-E36. Attachment ENG_TME Pharma announces receipt of agreements in principle to extend certain bond agreements