Tipiracil Hydrochloride/Trifluridine

Natera and its collaborators will present 20 abstracts, including 4 rapid oral presentations Signatera ™ Genome with Phased and Structural Variants, which has achieved detection below 1 part per 10 million and an LOD95 of 1 part per million, will be featured in Natera’s ESMO program AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that 20 abstracts featuring its technology will be presented at the 2026 European Society for Medical Oncology (ESMO) Annual Congress, taking place October 23–26 in Madrid, Spain. New evidence highlights the power of Natera’s latest ultrasensitive molecular residual disease (MRD) technology, Signatera Genome with Phased and Structural Variants, which has demonstrated an industry-leading analytical limit of detection (LOD95) below 1 part per million (ppm), and detection observed significantly below 1 part per 10 million. 1 Spanning tumor types and treatment modalities, multiple ESMO presentations will show that serial ctDNA testing provides meaningful clinical benefit: ICONIC trial in gastroesophageal cancer (abstract 2901P): Among patients treated with perioperative chemotherapy and immunotherapy, MRD clearance during neoadjuvant therapy was strongly associated with a lower risk of recurrence and a favorable pathologic response. Signatera Genome with Phased and Structural Variants detected all evaluable recurrences during surveillance, with a >7.3 month median lead time over standard imaging. SAGITTARIUS trial in colon cancer (abstract 808P): In this phase III trial, post-operative patients were randomized to a physician-choice adjuvant treatment plan prior to receiving MRD results to assess impact. The analysis showed that Signatera results influenced a change to providers’ pre-planned treatment for one in three patients, of which 87% were treatment de-escalated based on MRD negativity. Colorectal/Breast cancer (abstract 4258P): In a retrospective analysis of surveillance monitoring of stage I-III breast and colorectal cancer survivors, serial Signatera negativity was associated with an extremely low 2-year recurrence risk, which may help refine risk stratification and inform eligibility for solid organ transplant earlier than current methodologies. Breast cancer (abstract 1770RO): In HER2+ metastatic breast cancer, an analysis of exceptional responders on anti-HER2 therapy showed 81% with sustained MRD-negativity during serial monitoring, supporting the potential for Signatera-guided de-escalation. MDT-Bridge trial in non-small cell lung cancer (NSCLC) (abstract LBA62) : This phase II trial evaluated MRD clearance from baseline to pre-surgery/pre-CRT using the Clarity ™ assay with phased variant technology. MRD-guided reflex to liquid CGP drives actionable treatment decisions (abstract 4260P) : In a cohort of 50 patients across 10 tumor types, Signatera, complemented by reflex to blood-based comprehensive genomic profiling (liquid CGP), identified clinically relevant biomarkers in 18 patients, including ESR1, BRAF, FGFR3, and BRCA2 . “We are pleased to share data at ESMO that highlights our expanding diagnostics portfolio, which includes the newest version of our ultrasensitive Signatera Genome test,” said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection, Natera. “The incorporation of phased and structural variants results in the ability to detect ctDNA significantly below 1 part per 10 million and takes MRD sensitivity into a range we haven’t seen before.” The 2026 ESMO program featuring Natera’s technologies includes: October 23, 2026, 15:15 CET | Abstract 4258P Presenter: Hideaki Bando, M.D., Ph.D. Poster: Circulating tumor DNA (ctDNA)-informed risk prediction in breast (BC) and colorectal cancer (CRC) patients (pts): implications for solid organ transplant (SOT) October 23, 2026, 15:15 CET | Abstract 4265P Presenter: Luca Lazzari, Ph.D. Poster: Genomic alterations and association with post-surgery circulating tumor DNA status in early-stage colon cancer October 23, 2026, 15:15 CET | Abstract 4764P Presenter: Yousef Zakharia, M.D. Poster: Outcomes in patients with muscle-invasive bladder cancer with divergent differentiation or histologic subtypes from NIAGARA October 23, 2026, 15:15 CET | Abstract 3633P Presenter: Nicholas Bingham, BS Poster: Utility of circulating tumor DNA in patients with renal cell carcinoma at increased risk of recurrence after resection October 23, 2026, 16:15 CET | Abstract 542RO Presenter: Yukinori Ozaki, M.D., Ph.D. Rapid Oral: Prognostic impact of postoperative ctDNA surveillance on relapse-free survival and molecular lead time in high-risk breast cancer: JCOG1204A1 October 23, 2026, 15:15 CET | Abstract 4462P Presenter: Benjamin O. Herzberg, M.D. Poster: Genomic landscape of the SKI Complex in a large multi-cancer cohort of 260,000 tumors October 23, 2026, 15:15 CET | Abstract 4276P Presenter: Nicholas Hornstein, M.D., Ph.D. Poster: Quantification of circulating tumor DNA (ctDNA) in patients using a multi-cancer, methylation-based assay for tissue-free treatment response monitoring (tf-TRM) October 23, 2026, 15:15 CET | Abstract 4260P Presenter: Jason A. Mouabbi, M.D. Poster: Clinical utility of reflex liquid comprehensive genomic profiling (LCGP) to complement tumor-informed circulating tumor DNA (ctDNA) monitoring in solid tumors October 23, 2026, 15:15 CET | Abstract 4417P Presenter: Fizza Mughal, Ph.D. Poster: Plasma whole-exome sequencing (pWES) reveals somatic landscape and clonal dynamics in metastatic urothelial carcinoma October 24, 2026, 10:15 CET | Abstract 4741RO Presenter: Matthew D. Galsky, M.D. Rapid Oral: Exploratory analysis of molecular subtypes and association with treatment outcomes in patients (pts) with muscle-invasive bladder cancer (MIBC) from NIAGARA October 24, 2026, 12:00 CET | Abstract 574P Presenter: Adrianne L. Rolfes, M.D. Poster: Neoadjuvant anti-PD1 without chemotherapy in early-stage luminal B breast cancer October 24, 2026, 12:00 CET | Abstract 583P Presenter: Teck Long King Poster: ≥4 positive nodes identify a population enriched for ctDNA-guided adjuvant treatment escalation in ER+/HER2- early breast cancer October 25, 2026, 12:00 CET | Abstract 808P Presenter: Vicente Alonso-Orduna, M.D. Poster: ctDNA negativity influences adjuvant treatment decisions: a paired counterfactual analysis from the SAGITTARIUS trial October 25, 2026 | Abstract 870eP Presenter: Carlo Federici, Ph.D. e-Poster: Cost-effectiveness of a dynamic ctDNA-guided adjuvant strategy in stage II-III colon cancer, A SAGITTARIUS model-based analysis October 25, 2026, 12:00 CET | Abstract 810P Presenter: Stefano Tamberi, M.D., Ph.D. Poster: ctDNA-guided adjuvant trials may miss the molecular residual disease (MRD) window: evidence of early attrition during trial allocation October 25, 2026, 12:00 CET | Abstract 820P Presenter: Benjamin Weinberg, M.D. Poster: Leronlimab (LRM) in combination with trifluridine/tipiracil (TAS-102) plus bevacizumab (BEV) in metastatic colorectal cancer (mCRC): The phase 2 CLOVER study October 25, 2026, 12:00 CET | Abstract 3542P Presenter: Torben Van Zijp Poster: Organ preservation in rectal cancer after neoadjuvant radiotherapy, bevacizumab and atezolizumab: Translational analysis from the TARZAN study October 25, 2026, 12:00 CET | Abstract 2901P Presenter: Marco Gerlinger, M.D., FRCP Poster: Clinical performance of the Signatera Genome assay in patients with localized gastroesophageal adenocarcinomas (GEA) treated with peri-operative FLOT and immunotherapy: ICONIC trial October 26, 2026, 10:15 CET | Abstract 1770RO Presenter: Kazuki Nozawa, M.D. Rapid Oral: Ultra-sensitive MRD assessment in long-term complete responders to anti-HER2 therapy in HER2-positive metastatic breast cancer: Initial results from HER2-CR study October 26, 2026, 10:15 CET | Abstract LBA62 Presenter: Jonathan Spicer, M.D., Ph.D. Rapid Oral: ctDNA clearance (CL) during neoadjuvant treatment (neoadj Tx) and its association with outcomes in patients (pts) with resectable/borderline resectable stage IIB–IIIB NSCLC from MDT-BRIDGE References William B, Galanina N, Iqbal M, et al. ctDNA-Based MRD as a Dynamic Biomarker for Monitoring Treatment Response and Relapse in Lymphoma. SOHO 2026 Annual Meeting, Houston, TX, September 9-12, 2026. About Natera Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at and . Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

行业调研 · 篇三 医药 · CXO 与出海 CXO 的“错杀”逻辑，与创新药出海的真实进度。 10 月 16 日，商务部、科技部就《中国禁止出口限制出口技术目录》修订公开征求意见，拟新增 CGT、siRNA 底层工艺平台禁止出口条目。当天，CXO 板块盘中明显回调。 但同一批纪要里，还躺着另一组数字：药明康德把持续经营业务收入增速指引从 18%-22% 上调到 35%-39%；药明生物从 16%-20% 上调到 20%-23%；康龙化成从 12%-18% 上调到 15%-20%。 一个跌，一个涨，中间隔着的不是基本面，是有没有把条款读完。 这篇想把两件事讲清楚：政策到底管什么、不管什么；以及中国创新药出海，现在到底走到哪一步了。 01 管的是所有权，不是服务 这是全篇最关键的一句话。把禁止类条款拆开，控制要点其实只有两条： ① 具有自主知识产权的技术工艺平台所有权，对外转让。 ② 新靶点识别、先导化合物筛选等核心技术所有权，对外转让。 小核酸领域写得更具体：siRNA 药物技术工艺平台所有权对外转让，以及 siRNA 新靶点识别、序列筛选优化核心技术所有权对外转让。 注意两个关键词：所有权、转让。文件专门定义了什么叫“平台”——指可复用、标准化的成套底层技术体系，能持续产出多款管线，区别于单一药物品种的开发技术。 所以这套逻辑针对的是什么？是 biotech 打包卖平台、是 NewCo 这类交易。背景是学者预警的“卖青苗”风险——担心企业过早把早期核心资产和平台授权出去，导致中国被锁死在“高级研发外包”这个位置上。 而 CXO 恰恰就是“外包”本身。它输出的是平台使用权、提供委托研发生产服务并收取服务费，不是出售底层知识产权 IP——这正好落在政策明确豁免的范畴里。 换句话说：管的是“把技术所有权卖掉”，不管“用技术帮你做药”。这两件事在商业实质上天差地别，但在标题层面看起来很像，于是就有了那天的坑。 02 收窄：从四大领域到 5 项 第二个被忽略的细节是范围的变化。5 月流传的版本，覆盖抗体、小分子靶向、小核酸、细胞与基因治疗四大领域。而 10 月 16 日的正式稿，只剩 CGT、小核酸、病原微生物共 5 项。 抗体（含 ADC、双抗）和小分子（PROTAC、分子胶）都被拿掉了。 这个变化对药明康德的意义，比对任何一家公司都大——因为小分子 D&M 是它的基本盘。市场在恐慌的时候，往往不会注意“范围收窄”这件事；但从产业影响看，收窄比“有没有这份文件”重要得多。 另一个变量是程序：目前仍在征求意见阶段，正式条文还有微调可能。长期真正的核心变量，依旧是海外客户需求与地缘环境，而不是这份目录本身。 03 CDMO 正在上调指引 这是最硬的一组证据。中报季，多家 CDMO 不是“维持”，是上调： 公司 原指引 上调后 药明康德 18%-22%35%-39% 药明生物 16%-20%20%-23% 康龙化成 12%-18%15%-20% 注：药明康德为持续经营业务收入口径；药明生物为固定汇率口径。 上调背后是结构性的东西，不是一次性订单。三个增量来源值得记住： 多肽 / 小分子 GLP-1 产业链　这是近两年最明确的量增来源。 ADC 与核酸等新模态　逐步进入商业化阶段。 临床阶段项目向商业化项目转换　这是 CXO 商业模式里利润弹性最大的环节——临床期是小批量、高单价，商业化期是大批量、长周期，一旦转换成功，收入曲线会变陡。 内外需的分野也要分清：外需看确定性（中国公司在全球竞争优势下的渗透率提升），内需看景气度（国内投融资修复带动 biotech 研发需求回升，订单端先于收入端修复，然后按订单兑现周期逐步体现在报表上）。 04 出海进度：三个样本 如果只看新闻标题，会觉得“创新药出海”是一个宏观叙事。但拆到具体临床，进度是可以用数字数的。 样本一：科伦博泰的 ADC，被默沙东推进到了美国临床 默沙东围绕与科伦博泰合作开发的双抗 ADC 药物 MK-2750/SKB571（EGFR/c-Met）在美国启动 1/2 期临床，覆盖非小细胞肺癌、胰腺癌、胃癌和头颈癌。预计 2026 年 11 月启动，入组 300 例，分剂量比较队列与剂量寻找队列两部分。国内已开展多个 II 期，在同类 EGFR/c-Met ADC 中全球进展最快。 样本二：劲方医药的 KRAS G12D，做出了对历史数据的显著超越 这条数据值得单独看。GFH375 联合西妥昔单抗，在重度经治结直肠癌（CRC）中：54 例可评估患者，94% 接受过三线以上治疗、50% 接受过四线以上，肝转移占 50%、腹膜转移占 46%——是一群疾病负担很重的病人。结果：ORR 44%、DCR 89%、mPFS 7.3 个月，中位随访 5.4 个月，4 个月 PFS 率 78%。 研究 方案 ORR mPFS mOS FRESCO 呋喹替尼 4.7% 3.7 月 9.3 月 CONCUR 瑞戈非尼 约 4% 3.2 月 8.8 月 CORRECT 瑞戈非尼 1.0% 1.9 月 6.4 月 RECOURSE TAS-102 单药 1.6% 2.0 月 7.1 月 SUNLIGHT TAS-102＋贝伐 6.1% 5.6 月 10.8 月 GFH375＋西妥昔单抗 联合方案 44% 7.3 月 随访中 注：末行为可评估人群数值，公告未单列确认 ORR、PFS 置信区间及 OS 结果。 更值得注意的是跨瘤种：国内一线胰腺癌（PDAC）联合治疗，24 例可评估患者 ORR 71%、DCR 100%，21 例仍在治疗。海外 TARGET-D 101 研究中，900mg 单药治 2L+ PDAC 确认 ORR 41%（9/22），其中 2L 为 50%（4/8）；600mg 单药治 2L+ NSCLC 确认 ORR 43%（10/23）。 安全性也给了底：国内联合研究 78 例中，各单项 3 级 TRAE 发生率均不超过 5%，无 4-5 级 TRAE、无因 TRAE 终止给药；海外 900mg 单药 48 例，任意级别 TRAE 81%、≥3 级 10%，治疗相关 SAE 6%，因不良事件停药仅 2%，中位相对剂量强度 97%。 进度表也很明确：国内已进入 PDAC 与 NSCLC 两项单药注册 III 期，拿到 PDAC、NSCLC、CRC 三项突破性疗法认定；海外合作方 Verastem 已与 FDA 就 1L PDAC 的 TARGET-D 301 方案达成一致，拟 2026 年底启动，三组设计（联合抗 EGFR／联合吉西他滨＋白蛋白紫杉醇／标准化疗），PFS 与 ORR 双主要终点、OS 为次要终点——同时验证“无化疗联合”与“化疗联合”两条路。 后续催化剂：2026Q4 启动海外 1L PDAC III 期、更新海外 CRC 900mg 联合数据；2027Q2 披露 2L PDAC 注册导向 II 期初步数据；2027H2 披露 NSCLC 与 CRC 的 II 期初步数据。 样本三：阿斯利康用真金白银买中国的 AI 制药能力 10 月 15 日，阿斯利康与 AI 公司 Insitro 达成合作，在 MASH 与心肌疾病领域开发新疗法。Insitro 获 4000 万美元首付款，并有资格获得最高约 14.6 亿美元里程碑款及个位数百分比销售分成。Insitro 有 9 条管线，2021 年 C 轮 4 亿美元、投后估值 24.4 亿美元，投资方包括 a16z、淡马锡、Google Ventures。 这条不是中国企业，但它说明一个趋势：大药厂正在为“数据＋AI 平台”支付高额首付。国内拥有真实临床与健康数据资产的公司（比如体检场景），逻辑上同源。 05 两套尺子，别混用 把上面三件事放在一起，可以给出一条相对清晰的定价框架： 对 CXO，用“订单＋指引”定价，不用“政策标题”定价。判断依据是三条：指引是否上调、在手订单是否环比增长、临床转商业化的项目数是否增加。政策条款属于扰动项，且当前版本对主业不构成约束。 对创新药，用“临床数据＋注册进度”定价，不用“授权金额”定价。首付款是估值锚，但真正决定价值的是 III 期设计与主要终点、以及能否在海外拿到注册路径。 对二者的交集（CXO 承接创新药出海订单），用“产能利用率＋新模态占比”定价。多肽、ADC、核酸的产能是稀缺的，这部分定价权比传统小分子强。 补充两个今天的旁证：三鑫医疗前三季营收 13.05 亿元、同比 +11.78%，Q3 单季收入增速较上半年提升 5.18 个百分点，集采“以价换量”的路径在耗材端跑通了；麦科医药则用 10 年期 H 股股权激励＋回购不超过 10% H 股的授权，表达了对自身管线（MT1013 的 CaSR/OGP 双靶点、MT200605 的脑-肾双重保护）的信心。这类“公司自己用真金白银投票”的信号，比研报评级更值得看。 06 三条风险，写明面上 第一，条款仍在征求意见。正式条文有微调可能，尤其是“平台”的界定边界——如果口径放宽到“服务过程中形成的工艺”，影响面会完全不同。这是需要持续跟踪的第一变量。 第二，地缘环境是不可控项。出口管制的工具箱正在被更频繁地使用，同一天还有“中国拟限制生物技术出口、但允许许可协议”与“限制部分太阳能技术出口”的消息。任何基于“供应链永远畅通”的假设都不安全。 第三，临床失败与订单不及预期。创新药的数据再漂亮，也是可评估人群的早期结果；CXO 的指引再乐观，也要靠季度报表逐格兑现。 最后落一句判断：这两天 CXO 的下跌，本质上是“标题定价”压过了“条款定价”。这种情况在 A 股并不罕见，通常的修复路径也很固定——等第一份季报出来，或者等正式稿落地。中间这段时间，是情绪，不是基本面。 · · · 资料来源：商务部与科技部《中国禁止出口限制出口技术目录》修订征求意见稿相关解读、国泰海通医药、兴证医药、天风医药、东财医药团队纪要，药明康德/科伦博泰/劲方医药公开公告与临床数据，均为公开信息整理。 本文仅作产业研究交流，不构成任何投资建议；医药研发存在临床失败风险。