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更新于：2026-10-21

Albumin-Bound Paclitaxel

白蛋白结合型紫杉醇

更新于：2026-10-21

概要

基本信息

药物类型

化学药

别名

Nab-Paclitaxel、Nab-PTX、Paclitaxel Albumin Nanoparticles

+ [19]

靶点

Tubulin

作用方式

抑制剂

作用机制

微管蛋白抑制剂

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [11]

在研适应症

晚期乳腺癌肿瘤转移性胰腺癌+ [65]

非在研适应症

大肠腺癌小肠腺癌腺鳞癌+ [105]

原研机构

石药集团有限公司

Abraxis BioScience, Inc.

在研机构

Hoffmann-La Roche, Inc.

科兴生物制药股份有限公司Bristol-Myers Squibb Pharma EEIG

+ [17]

非在研机构

Pfizer Inc.

Novartis AG

Roche Holding AG

+ [15]

权益机构

浙江海昶生物医药股份有限公司

BeOne Medicines Ltd.

科兴生物制药股份有限公司

+ [8]

最高研发阶段批准上市

首次获批日期

美国 (2005-01-07),

转移性乳腺癌

最高研发阶段(中国)批准上市

特殊审评-

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结构/序列

分子式C47H51NO14

InChIKeyRCINICONZNJXQF-MZXODVADSA-N

CAS号33069-62-4

关联

2,939

项与白蛋白结合型紫杉醇相关的临床试验

NCT06592664

/ Withdrawn临床1/2期

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.

NCT07748611

/ Not yet recruiting临床2期IIT

SMART-PANC: SMAD4 Tailored Neoadjuvant Therapy for Pancreatic Cancer, A Phase ll Non-Randomized, Single Center Pilot Study

This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). PDAC is one of the most aggressive and fastest growing tumors. SMAD4, a tumor suppressor gene, acts like a brake on cell growth and helps to prevent tumor cells from growing. However, losing it makes the tumor more aggressive and often resistant to standard of care (SOC) treatments regimens, such as gemcitabine with nab-paclitaxel and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic (DNA) and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Instead of a one-sized fits all treatment approach with SOC therapies, matching therapy based on SMAD4 mutation status may use this specific genetic weakness against the tumor. This approach to neoadjuvant therapy may dramatically alter the path of treatment and improve outcomes, including complete resection rates, in patients with resectable or borderline resectable PDAC.

开始日期2027-02-03

申办/合作机构

Northwestern University

[+1]

NCT07265739

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Losartan in Combination With Weekly Paclitaxel in Platinum Resistant Ovarian Cancer

The purpose of this Phase II study is to measure the effects of a combination of study drugs, losartan and paclitaxel, on platinum resistant ovarian cancer.

开始日期2027-02-01

申办/合作机构

The Massachusetts General Hospital

[+1]

100 项与白蛋白结合型紫杉醇相关的临床结果

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100 项与白蛋白结合型紫杉醇相关的转化医学

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100 项与白蛋白结合型紫杉醇相关的专利（医药）

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27,400

项与白蛋白结合型紫杉醇相关的文献（医药）

2026-12-31·Future Science OA

Clinical efficacy of 2-week and 3-week albumin-bound paclitaxel therapy for advanced pancreatic cancer

Article

作者: Su, Zhimin ; Li, Zhiyong ; Shen, Feng ; Jiang, Jiana

OBJECTIVE:

We aim to compare the clinical efficacy and safety of albumin-bound paclitaxel (nab-PTX) (125 mg/m2, q2w) for two weeks and (125 mg/m2, d1, d8, q3w) for three weeks in the first-line treatment of advanced pancreatic cancer.

METHODS:

The medical records of patients with advanced pancreatic cancer who received nab-PTX for 2 weeks and 3 weeks, combined with gemcitabine, from July 2018 to January 2023, were retrospectively analyzed. The efficacy and adverse reactions of the two groups of patients were compared.

RESULT:

A total of 64 patients were included. The median progression-free survival (mPFS) of the 2-week group was 5.6 months, while the 3-week group was 7.8 months. The median overall survival (mOS) of the 2-week group was 14.0 months, while the 3-week group was 14.7 months. The multivariate analysis showed that a physical fitness status score of 0-1 was an independent factor with better OS, while metastatic sites ≥ 3 were related to poor OS. The incidence of leukopenia or neutropenia, neurotoxicity, fatigue, and poor appetite in the 2-week group was lower than that in the 3-week group.

CONCLUSION:

The clinical efficacy of nab-PTX in the 2-week and dose intensive 3 week did not show significant difference, but the 2-week treatment group had better tolerance and safety.

2026-12-31·Human Vaccines & Immunotherapeutics

Durable response of anaplastic thyroid cancer to pembrolizumab combined with chemotherapy: A case report

Article

作者: Zhuang, Yihan ; Chen, Qiongshan ; Lin, Wen ; Chen, Zipei

Anaplastic thyroid cancer is a notoriously aggressive malignancy with a dismal prognosis, typically associated with a median overall survival of less than one year. Therapeutic alternatives are particularly limited for patients without actionable driver mutations. Here, we report a case of BRAF V600E wild-type, PD-L1-positive (tumor proportion score of 80%) anaplastic thyroid cancer with residual/relapsed disease following surgery and subsequent progression on multi-targeted tyrosine kinase inhibitor therapy. The patient was thereafter treated with a combination of pembrolizumab, nab-paclitaxel and carboplatin, resulting in a sustained near-complete response lasting over 30 months, accompanied by a manageable safety profile. The favorable response in this case suggests that further evaluation of this triplet regimen could be considered for anaplastic thyroid cancer, though this remains a speculative premise requiring validation. Further studies are also needed to clarify the underlying mechanisms of this combination and to identify predictive biomarkers for patient selection.

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Estimating the cost-effectiveness of tumor treating fields for locally advanced pancreatic cancer patients

Article

作者: Wang, Bruce C. M. ; Picozzi, Vincent ; Guzauskas, Gregory F. ; Niño de Rivera Guzman, Jorge Fernando

BACKGROUND:

Locally advanced pancreatic cancer (LAPC) is associated with limited survival, high symptom burden, and few therapeutic innovations. The PANOVA-3 trial evaluated Tumor Treating Fields (TTFields) therapy applied with gemcitabine plus nab-paclitaxel (GnP) for first-line treatment of LAPC, demonstrating improved overall survival (OS), distant progression-free survival (PFS), and time to pain progression. We conducted a cost-utility analysis to evaluate the economic value of TTFields + GnP relative to GnP alone.

METHODS:

A partitioned survival model was developed using trial-based Kaplan-Meier curves for OS, distant progression-PFS, and time to pain progression. Model inputs reflected the intent-to-treat (ITT) population from PANOVA-3, with health utilities, resource use, and costs obtained from published U.S. sources. Disutility for pain was applied during time after pain worsening to capture quality-of-life decrement. Costs and outcomes were discounted at 3% annually, and analyses were conducted from a U.S. payer perspective. Deterministic, probabilistic, and scenario analyses explored uncertainty in key assumptions and model structure.

RESULTS:

TTFields + GnP increased discounted lifetime costs to $351,400 vs. $220,000 for GnP alone, with an incremental gain of 0.34 QALYs and an ICER of $387,300 per QALY. Approximately 0.03 QALYs were attributable to reduced time lived with pain. Sensitivity analyses identified TTFields therapy cost and treatment duration as primary drivers of the ICER. Scenario analyses produced ICERs ranging from $391,800 to $547,200 per QALY.

CONCLUSIONS:

TTFields + GnP improves survival and delays pain progression in LAPC, generating measurable gains in quality-adjusted survival. Resulting ICERs should be interpreted in the context of a disease with high unmet need, poor prognosis, and limited therapeutic options; factors that support a broader assessment of value beyond conventional cost-effectiveness thresholds. The multidimensional benefits observed, including quality-of-life gains, reinforce the case for TTFields therapy in LAPC and highlight the importance of incorporating such endpoints into economic evaluations of late-stage cancers.

4,312

项与白蛋白结合型紫杉醇相关的新闻（医药）

2026-10-20

·腾讯网

3 年 EFS 率超 90%，局晚期直肠癌再添「放化免」三联新辅助方案

2026 年欧洲肿瘤内科学会（ESMO）大会将于 10 月 23 日至 27 日在西班牙马德里举行。作为全球肿瘤学领域最具影响力的学术盛会之一，ESMO 每年汇聚世界各地的临床研究者与药物研发人员，集中发布肿瘤诊疗领域最具突破性的临床研究数据。消化道肿瘤是 ESMO 大会的核心议题之一。近年来，免疫治疗向围手术期前移、双特异性抗体与抗体偶联药物（ADC）的靶点拓展、KRAS 等「不可成药」靶点的突破，以及放疗与免疫联合策略的优化，正在重塑食管癌、胃癌、结直肠癌、胆道癌及肝细胞癌等疾病的治疗格局。丁香园肿瘤时间特选择以下几项消化道肿瘤领域具有代表性的口头报告进行整理，旨在与各位读者一同学习交流。摘要号：2875O英文标题：Pembrolizumab or placebo plus concurrent definitive chemoradiotherapy in esophageal and gastroesophageal junction (GEJ) cancer: The phase 3 randomized KEYNOTE-975 study中文标题：帕博利珠单抗或安慰剂联合根治性同步放化疗治疗食管癌及胃食管结合部（GEJ）癌：III 期随机 KEYNOTE-975 研究讲者：美国威尔康奈尔医学院 Manish A. Shah研究背景免疫治疗在接受根治性放化疗（dCRT）治疗的局部晚期食管癌（EC）患者中的作用尚未明确。KEYNOTE-975（NCT04210115）是一项国际多中心、III 期、随机、双盲、安慰剂（pbo）对照研究，旨在评估 dCRT ± 帕博利珠单抗在既往未经治疗的局部晚期不可切除食管癌及 GEJ 癌患者的疗效。本次报告了该研究第二次中期分析（IA2）的结果。研究方法该研究入组标准为：组织学确诊的 cTX N+ M0 或 cT2-T4a NX M0 食管鳞状细胞癌（ESCC）、食管腺癌（EAC）或 GEJ 癌患者，或仅伴锁骨上淋巴结转移的 cTX N+ M1 颈部或上胸段食管癌患者；ECOG PS 0-1；不适合根治性手术但适合 dCRT。入组患者按 1:1 随机分配至帕博利珠单抗组或安慰剂组，分别接受 200 mg 帕博利珠单抗或安慰剂每 3 周一次（Q3W）治疗，共 8 个周期，随后接受 400 mg 帕博利珠单抗或安慰剂治疗，每 6 周一次（Q6W），共 5 个周期，联合研究者选择的 dCRT（5- 氟尿嘧啶 + 顺铂 [FP] 联合放疗 [RT] 50 Gy 或 60 Gy，或 FOLFOX 联合 RT 50 Gy）。研究双主要终点为研究者评估的无事件生存期（EFS）和总生存期（OS），分别在程序性死亡配体 -1（PD-L1）综合阳性评分（CPS）≥10、CPS≥1 及全部患者中进行分析。数据截止日期为 2026 年 1 月 21 日。研究结果本研究共纳入 703 例患者，其中帕博利珠单抗组 349 例，对照组 354 例。整体患者中位随访时间为 47.1 个月。本次 IA2 分析显示，PD-L1 CPS≥10 患者中，帕博利珠单抗组较对照组未显著改善患者无事件生存期（EFS，中位 EFS 15.2 个月 vs 14.7 个月；HR 0.97，95% CI 0.77-1.23，P=0.3994，显著性 P 值界值为 0.0193）；中位 OS 为 32.2 个月 vs 35.0 个月（HR 1.00，95% CI 0.77-1.30，名义 P 值 0.5003）。由于 PD-L1 CPS≥10 患者未获 EFS 阳性结果，PD-L1 CPS≥1 及整体患者的 EFS 以及 OS 均未进行统计学显著性检验，按预设统计学计划停止进一步检验。两组 ≥3 级不良事件（AE）发生率均为 100%，5 级 AE 分别为 44 例（13%）vs 37 例（10%）。因任何 AE 导致停药者分别为 117 例（34%）vs 97 例（27%）。研究结论在 PD-L1 CPS≥10 且既往未经治疗不可切除食管癌或 GEJ 癌患者中，帕博利珠单抗 + dCRT 较安慰剂 + dCRT 未显著改善 EFS。研究未观察到新的安全性信号。摘要号：459O英文标题：A randomized trial of paclitaxel ± tovecimig in previously treated patients with advanced biliary tract cancer中文标题：一项紫杉醇 ± tovecimig 治疗经治晚期胆道癌的随机试验讲者：美国约翰 · 霍普金斯大学 Nilofer S. Azad研究背景既往经治的胆道癌（BTC）患者预后较差，中位 OS 约为 6 个月。Tovecimig [T] 是一种靶向 delta 样配体 4（DLL4）和血管内皮生长因子 A（VEGF-A）的双特异性抗体，可抑制 Notch 1 和血管内皮生长因子（VEGFR）信号通路。COMPANION-002 是一项开放标签、II/III 期随机对照研究，纳入既往接受过一线治疗的晚期或转移性 BTC 患者。研究方法研究纳入一线治疗后疾病进展的晚期 BTC 患者。所有患者均接受紫杉醇 [P] 治疗（80 mg/m²，每 28 天为一个周期，第 1、8、15 天给药）。联合治疗组患者在紫杉醇基础上接受 T 治疗（10 mg/kg，每 28 天为一个周期，第 1、15 天给药）。本研究主要终点为盲态独立中心审查（BICR）基于 RECIST v1.1 评估的客观缓解率（ORR）。关键次要终点包括无进展生存期（PFS）和 OS。P 组患者在 BICR 确认疾病进展（PD）后允许交叉接受 T+P 治疗。预设次要终点为交叉接受 T+P 治疗患者的第二次无进展生存期（PFS2）。研究结果2023 年 4 月至 2024 年 8 月期间，共 168 例患者按 2:1 随机分配至 T+P 组（n=111）或 P 组（n=57）。两组患者基线人口学特征均衡。与单药 P 组相比，T+P 组在 BICR 评估的 ORR（17.1% vs 5.3%，p=0.031）和 PFS（4.7 个月 vs 2.6 个月；HR=0.44，p<0.0001）方面均取得统计学显著改善。T+P 联合给药组中位 PFS2 较单药 P 组（中位 PFS1 为 1.9 个月）显著改善，达 3.5 个月（HR=0.36，p=0.0016）。值得注意的是，57 例 P 组患者中有 31 例（54%）交叉接受了 T+P 治疗。总体而言，两组 OS 无差异（HR=1.05，p=0.78）。安全性方面，T+P 组最常见的治疗中出现的不良事件（TEAE）为高血压（HTN，69%）和乏力（67%），相关 ≥3 级 TEAE 包括高血压（44%）和中性粒细胞减少（36%）。与 P 组相比，T+P 组的严重不良事件（SAE）发生率更高（40% vs 19%），导致停药的 TEAE 发生率亦更高（40% vs 15%）。此外，导致死亡的 TEAE 发生率在 T+P 组和 P 组相当，分别为 6% 和 2%。研究结论本研究证实，T+P 方案总体耐受性良好，在 BICR 评估的 ORR 和 PFS 方面显示出统计学显著优势。交叉治疗患者显示出 PFS2 获益。OS 分析受到高交叉率（全部患者中 85% 接受了 T+P 治疗）的混杂影响，无法进行有意义的比较。摘要号：1679O英文标题：Phase I study of BGB-B2033 (GPC3 x 4-1BB bispecific antibody) monotherapy: First disclosure of dose optimization (DO) and dose escalation (DE) update in advanced hepatocellular carcinoma (HCC)中文标题：BGB-B2033（GPC3×4-1BB 双特异性抗体）单药治疗 I 期研究：晚期肝细胞癌（HCC）剂量优化（DO）及剂量递增（DE）更新结果首次披露讲者：韩国 CHA 盆唐医疗中心 Hong Jae Chon研究背景BGB-B2033 是一种靶向肿瘤细胞表面磷脂酰肌醇蛋白聚糖 -3（GPC-3）和 4-1BB（表达于 T 细胞上的可诱导共刺激受体）的双特异性抗体。目前一项 I 期试验正在评估 BGB-B2033 单药或联合治疗晚期实体瘤患者的疗效（NCT06427941）。剂量递增 DE 队列的初步安全性和抗肿瘤活性此前已有报告。本文报告 HCC 患者剂量优化（DO）及 DE 更新结果（额外随访 3 个月）的首次分析数据。研究方法研究纳入既往接受过 ≥1 线治疗的 HCC 患者，并将其随机分配，分别接受 450 mg 或 900 mg BGB-B2033 治疗以进行 DO；来自 DE 和 DO 队列、接受 300-1000 mg 剂量治疗的 HCC 患者纳入汇总分析。研究主要终点为安全性和确定 II 期推荐剂量（RP2D）；次要终点为研究者基于 RECIST v1.1 评估的 ORR。研究结果截至 2026 年 4 月 26 日，研究纳入 110 例 HCC 患者（DE 队列 60 例；DO 队列 50 例）。总体而言，72% 的患者接受过 ≥2 线治疗，66% 的患者既往接受过抗 PD-(L)1 和酪氨酸激酶抑制剂（TKI）治疗。安全性方面，82 例（75%）患者发生不良事件（AE）；57 例（52%）患者发生治疗相关不良事件（TRAE）。6 例（5%）患者发生 3 级 TRAE；研究未报告 4 级或 5 级 TRAE。疗效方面，接受 300、600 和 1000 mg 剂量 BGB-B2033 治疗的患者中位随访时间为 6.4 个月（范围：0.3 个月 -13.3 个月），接受 450 和 900 mg BGB-B2033 治疗的患者中位随访时间为 4.1 个月（范围：0.4 个月 -5.9 个月）。DE 和 DO 队列中各剂量均显示出稳健的抗肿瘤活性（见表 1）；在 DE 队列中接受 ≥300 mg剂量入组的患者中，6 个月缓解持续时间（DOR）率为72.7%（37.1%-90.3%）。表 1、DO 及 DE 队列肿瘤缓解情况研究结论研究证实，BGB-B2033 在 HCC 患者中耐受性良好，AE 发生率有限且可控。其 RP2D 确定为 450 mg。随着随访时间延长（包括 DO 队列），BGB-B2033 仍表现出令人鼓舞的 ORR，并在经多线治疗的 HCC 中显示出早期疗效持久性证据。总体而言，上述结果支持 BGB-B2033 的进一步开发。摘要号：3530O英文标题：Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (LARC): The phase 3 UNION trial中文标题：新辅助短程放疗序贯卡瑞利珠单抗联合化疗治疗局部晚期直肠癌（LARC）：III 期 UNION 研究讲者：华中科技大学同济医学院附属协和医院林振宇研究背景尽管已采用新辅助放化疗，LARC 的复发和远处转移仍较为常见。针对以错配修复功能完整 / 微卫星稳定为主的人群，有效的免疫治疗策略仍有限。UNION 是首个在 LARC 中评估放疗、免疫治疗与化疗联合新辅助策略的 III 期试验。本文报告了该研究预设的 EFS 分析结果。研究方法本研究纳入 cT3-4 或 N+ 直肠腺癌患者（肿瘤距肛缘 ≤10 cm）。入组患者按 1:1 随机分配至接受短程放疗（试验组：SCRT；25 Gy/5 次；）或长程放化疗（标准治疗组：50.4 Gy/28 次，同步接受卡培他滨 825 mg/m² 每日两次治疗；），随后接受 2 个周期新辅助和 6 个周期辅助卡培他滨联合奥沙利铂（CAPOX）治疗。试验组自 CAPOX 治疗起额外接受新辅助和辅助卡瑞利珠单抗（200 mg，第 1 天）治疗，最多 17 个周期。本研究主要终点为 BICR 评估的病理完全缓解率。预设 α 分配的关键次要终点为研究者评估的 EFS 和 OS。研究结果2021 年 7 月至 2023 年 3 月期间，共 231 例患者入组并随机分配至试验组（n=113）和标准治疗组（n=118）。截至 2025 年 10 月 1 日，两组中位随访时间分别为 36.8 个月（95% CI 34.8 个月 -37.8 个月）和 35.6 个月（95% CI 34.3 个月 -36.9 个月）。结果显示，试验组 3 年 EFS 率显著高于标准治疗组（91.3% [95% CI 83.9%-95.4%] vs 77.4% [95% CI 67.9%-84.4%]，风险比为 0.33 [95% CI 0.15-0.71]，P=0.0029）。此外，经 BICR 评估的 EFS 结果与之一致。整个治疗期间，两组 ≥3 级 TRAE 发生率分别为 51.3%（59/115）和 48.2%（54/112）。研究结论UNION 是首个在 LARC 中证实基于免疫治疗的方案可显著改善 EFS 的 III 期试验，提供了一种潜在新的标准新辅助治疗策略。摘要号：2876RO英文标题：TQB2102, a novel HER2 bispecific antibody-drug conjugate, combined with bemotrizumab with or without capecitabine as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: A phase II study中文标题：TQB2102（新型人表皮生长因子受体 2[HER2] 双特异性抗体偶联药物）联合 Bemotrizumab ± 卡培他滨一线治疗 HER2 阳性晚期胃 / 胃食管结合部癌：一项 II 期研究讲者：中山大学肿瘤防治中心邱妙珍研究背景TQB2102 是一种靶向 HER2 结构域 2/4 的新型双特异性抗体偶联药物（ADC），偶联氘代 Topo I 抑制剂（DAR=6）。这是首个评估双特异性 HER2 ADC 联合方案一线治疗 HER2 阳性晚期 GC/GEJC 的 II 期研究。研究方法本多中心 II 期试验入组不可切除的局部晚期或转移性 HER2 阳性 GC/GEJC 患者，ECOG PS 0-1，既往未接受系统性治疗。患者分配至三个队列：A 组（TQB2102 7.5 mg/kg + Bemotrizumab）、B 组（7.5 mg/kg + Bemotrizumab + 卡培他滨 1000 mg/m²）、C 组（6 mg/kg + Bemotrizumab + 卡培他滨）。主要终点：ORR；次要终点包括疾病控制率（DCR）、至肿瘤缓解时间（TTR）、缓解持续时间（DOR）、PFS、OS 及安全性。研究结果截至 2026 年 2 月 28 日，共入组 86 例符合条件的患者（A 组：25 例；B 组：37 例；C 组：24 例），各组患者基线特征均衡。结果显示，三药联合方案（B/C 组）较双药方案（A 组）显示出更高的 ORR、DCR 和更短的 TTR。中位 PFS 和 OS 尚未达到，三药联合组在 6 个月 PFS 率和 9 个月 OS 率方面更优。在三药联合方案中，TQB2102 6 mg/kg 剂量较 7.5 mg/kg 显示出更有利的疗效，且无论 PD-L1 表达状态如何，均显示一致的抗肿瘤活性。表 2、各组患者疗效数据安全性方面，所有患者均发生 TRAE；≥3 级 TRAE 在双药组发生率为 56%，三药联合组为 60.66%（C 组 41.67%，B 组 72.97%）。值得注意的是，所有事件均可管理且可逆，且未发现新的安全性信号。研究结论本研究证实，TQB2102 联合 Bemotrizumab 及卡培他滨一线治疗 HER2 阳性晚期 GC/GEJC 显示出令人鼓舞的抗肿瘤活性和可控的安全性。TQB2102 6.0 mg/kg 剂量提供了最佳的获益 - 风险平衡，已被选定为 III 期推荐剂量，计划进一步开展 III 期试验。整理：丁香园；编辑：gulu投稿：gulujun@dxy.cn

2026-10-20

·PRNewswire

Hengrui Pharma Previews ESMO Congress 2026 with 64 Research Findings Across Its Innovative Oncology Portfolio

64 findings accepted, including three Proffered Paper and three Rapid Oral presentations, spanning more than ten oncology and supportive care areas. More than ten studies highlight HER2- and HER3-targeted antibody-drug conjugates (ADCs) in breast and lung cancers. Research advances established products and innovative therapies, including approaches for difficult-to-treat cancers such as pancreatic cancer. SHANGHAI, Oct. 20, 2026 /PRNewswire/ -- Hengrui Pharma will present 64 research findings at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, from October 23 to 27, 2026. These include three Proffered Paper presentations, three Rapid Oral presentations, 32 Posters and 26 e-Posters. Participating for the eleventh consecutive year, Hengrui Pharma will share progress across more than ten cancer areas and host an exhibition booth for the second consecutive year. Advancing ADC Innovation in Breast and Lung Cancers Two independently developed ADCs, HER2-targeted trastuzumab rezetecan (SHR-A1811) and HER3-targeted ruzaltatug rezetecan (SHR-A2009), have been selected for Proffered Paper presentations. These studies address treatment needs in breast and lung cancers. Trastuzumab rezetecan will feature in HORIZON-Breast06, a randomized phase 3 study in HER2-low advanced breast cancer led by Academician Binghe Xu of the Cancer Hospital at the Chinese Academy of Medical Sciences. The findings will further explore its therapeutic potential in this patient population. Trastuzumab rezetecan is being developed for more than ten indications, including breast, lung, gastric, colorectal and cervical cancers. HERON-Lung01, led by Professor Yi-Long Wu of Guangdong Provincial People's Hospital, will present interim analyses comparing ruzaltatug rezetecan with platinum-based chemotherapy in EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor (EGFR-TKI) treatment. China's National Medical Products Administration accepted its marketing application for review in July 2026. The ADC has also received US Food and Drug Administration Fast Track designation for EGFR-mutated metastatic NSCLC progressing after a third-generation EGFR-TKI and platinum-based chemotherapy. A phase 3 trial is also evaluating ruzaltatug rezetecan with an EGFR-TKI as first-line treatment for EGFR-mutated locally advanced or metastatic NSCLC. With HER2 and HER3 among its key targets, Hengrui Pharma has built an ADC development pipeline spanning multiple targets and continues to expand potential applications across cancer types and treatment settings. Its portfolio combines further development of established targets with exploration of emerging targets. Expanding Clinical Value Across Established and Emerging Therapies Hengrui Pharma's established PD-1 inhibitor camrelizumab will feature in UNION, a phase 3 trial of neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy for locally advanced rectal cancer. A Rapid Oral presentation will share phase 2 findings on Nectin-4-targeted ADC SHR-A2102 in recurrent or metastatic cervical cancer. Another Rapid Oral presentation will report preliminary phase 2 results for KRAS G12D inhibitor HRS-4642 plus chemotherapy, with or without adebrelimab, as perioperative therapy for KRAS G12D-mutant pancreatic cancer. HRS-4642 combined with gemcitabine and nab-paclitaxel has received breakthrough therapy designation in China for first-line treatment of advanced or metastatic KRAS G12D-mutant pancreatic cancer. Sharing Chinese Innovation with the Global Oncology Community Hengrui Pharma's R&D and innovation teams will join oncology experts and researchers at the congress, supporting international scientific exchange on its innovative products and research. Jo Feng, President and COO of Hengrui Pharma, said: "This year marks the eleventh time we have participated in ESMO, with 64 research presentations - a new record for Hengrui. We look forward to sharing our latest advances in innovative drug development, presenting clinical evidence demonstrating meaningful benefits for patients, and bringing more Chinese innovation to benefit patients worldwide. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. For more information, visit us at Hengrui.com and follow us on LinkedIn. 21% more press release views with Request a Demo

临床2期临床3期快速通道突破性疗法抗体药物偶联物

2026-10-20

·科兴制药

科兴制药出海产品阿达木单抗获多米尼加注册证

近日，公司引进的博锐生物阿达木单抗生物类似药正式获得多米尼加共和国药品监管机构(República Dominicana Ministerio de Salud Pública y Asistencia Social, Dirección General de Medicamentos, Alimentos y Productos Sanitarios)颁发的注册证书，正式开启北美洲医药市场征程。阿达木单抗是全球首个全人源抗肿瘤坏死因子α（TNF-α）单克隆抗体，适用于类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病等自身免疫性疾病的治疗，是自身免疫性疾病治疗领域的重要产品之一。博锐生物的阿达木单抗注射液为国内第二个获批上市的阿达木单抗生物类似药，市场份额在国产阿达木单抗中位居前列。此前，公司抗肿瘤产品注射用紫杉醇（白蛋白结合型）（Apexelsin®）已于今年4月在多米尼加获批，随着阿达木单抗的准入，科兴制药在多米尼加将形成“肿瘤+自免”双产品组合，海外商业化平台的协同效应进一步显现。未来，公司将继续坚持“创新+国际化”双轮驱动的发展战略，充分发挥自身出海平台优势，加速推进海外市场的注册获批与商业化落地，服务全球患者。关于科兴制药科兴制药（股票代码：688136）是一家专注于重组蛋白、多功能抗体、靶向递送疗法等研发、生产、销售一体化的创新型国际化生物制药企业。聚焦抗肿瘤、自身免疫、抗病毒等治疗领域，围绕未被满足的临床需求，打造新型蛋白、新型抗体等前沿生物技术平台，开发精准治疗及新型靶向递送药物，坚持“创新+国际化”双轮驱动的平台型发展模式，致力于成为高品质生物药领导者，服务全球患者。公司核心产品市场份额稳居国内同类品种前列，覆盖国内约2万家终端，已通过欧盟、巴西、菲律宾、印度尼西亚等全球约70个国家和地区的市场准入并实现销售。推荐阅读 *药出海分析 | 泰国医药市场 *药出海盘点 | 一文掌握2026年9月至今药企出海资讯 *越南医药市场分析

100 项与白蛋白结合型紫杉醇相关的药物交易

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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
晚期乳腺癌	中国	石药集团欧意药业有限公司	2026-06-10
肿瘤	乌拉圭	科兴生物制药股份有限公司	2025-10-31
转移性胰腺癌	秘鲁	浙江海昶生物医药股份有限公司	2025-05-14
胰腺癌	中国	Bristol Myers Squibb Co.	2024-01-05
转移性胰腺腺癌	美国	Teva Pharmaceuticals, Inc.	2023-05-11
不能切除性胰腺癌	日本	Taiho Pharmaceutical Co., Ltd.	2014-12-18
胃癌	日本	Taiho Pharmaceutical Co., Ltd.	2013-02-21
乳腺癌	中国	Abraxis BioScience, Inc.	2008-06-30
非小细胞肺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-01-11
非小细胞肺癌	挪威	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2008-01-11
胰腺腺癌	挪威	Bristol-Myers Squibb Pharma EEIG	2008-01-11
转移性乳腺癌	美国	Bristol Myers Squibb Co.	2005-01-07

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
脑转移瘤	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
肝转移	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
局部晚期不能切除的乳腺癌	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
淋巴管炎	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
胸膜炎	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
继发性肺恶性肿瘤	临床3期	日本	Chugai Pharmaceutical Co., Ltd.	2021-01-01
进展期胃腺癌	临床3期	中国	石药集团欧意药业有限公司	2020-03-01
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2019-12-10
PD-L1阳性三阴性乳腺癌	临床3期	智利	Hoffmann-La Roche, Inc.	2019-12-10
PD-L1阳性三阴性乳腺癌	临床3期	捷克	Hoffmann-La Roche, Inc.	2019-12-10

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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


ESMO2026	N/A	复发性头颈部鳞状细胞癌二线	102	Pembrolizumab-based therapy followed by paclitaxel-cetuximab	艱衊糧鏇艱製餘醖選繭(鹽廠廠積觸蓋製艱鏇蓋) = 齋糧願夢製襯襯構積艱繭壓憲艱獵獵觸廠觸築 (觸衊夢鑰淵糧鬱選鏇範 ) 更多	积极	2026-10-23
ESMO2026	N/A	血管肉瘤一线	33	Paclitaxel	糧積繭膚窪鏇積醖顧齋(繭壓顧糧憲淵鹹壓範範) = GMI analysis showed median values <1 for: doxorubicin 0.63 (0.12-6.30), with GMI ≥1.33 in 2/12; paclitaxel 0.64 (0.19-2.11), with GMI ≥1.33 in 1/5; gemcitabine monotherapy 0.56 (0.14-11.00), with GMI ≥1.33 in 1/4; and pazopanib, 0.36 (0.01-3.03), with no objective responses. Gemcitabine/dacarbazine showed a signal of activity, 2.38 (0.88-2.42), with GMI ≥1.33 in 2/3 patients. 憲鹹蓋蓋願蓋簾獵壓夢 (範顧築膚遞膚觸選淵範 ) 更多	不佳	2026-10-23
				Anthracycline-based regimens
NCT05170438 (T1222, ESMO2026)	临床2期	胆道癌	49	Lenvatinib 12 mg + Paclitaxel 80 mg/m²	觸範鑰襯餘糧鬱壓鏇蓋(膚顧膚繭積遞膚廠淵製) = 構餘艱願餘獵願蓋構艱餘壓齋醖廠蓋膚獵遞鬱 (鹹範遞網糧觸遞醖積願 ) 更多	积极	2026-10-23
ESMO2026	N/A	胰腺导管腺癌	58	Paclitaxel	糧構憲窪齋廠築築製獵(餘積獵鏇醖製鹽鑰鑰獵) = 範齋繭範鹹衊壓顧艱製鑰鏇選憲淵餘糧艱鹹餘 (構壓簾鏇廠蓋繭遞窪蓋 ) 更多	积极	2026-10-23
				Paclitaxel (BTC)	糧構憲窪齋廠築築製獵(餘積獵鏇醖製鹽鑰鑰獵) = 顧齋選廠廠淵鏇糧衊糧鑰鏇選憲淵餘糧艱鹹餘 (構壓簾鏇廠蓋繭遞窪蓋 )
NCT06494514 (ESMO2026)	临床2期	-	37	NALIRIFOX	艱繭糧壓衊製廠蓋製鬱(鹹範鑰鏇簾網憲選醖壓) = 繭鏇觸憲鑰繭憲壓網選鬱願淵餘壓製壓網鏇鏇 (憲憲壓壓願遞窪淵夢餘 ) 更多	积极	2026-10-23
				GnP	艱繭糧壓衊製廠蓋製鬱(鹹範鑰鏇簾網憲選醖壓) = 鏇鹹齋膚淵淵壓遞遞積鬱願淵餘壓製壓網鏇鏇 (憲憲壓壓願遞窪淵夢餘 ) 更多
NCT07549269 (ESMO2026)	N/A	食管鳞状细胞癌新辅助	387	Nab-paclitaxel	繭築壓鏇襯製憲製鏇構(構餘鬱網淵窪鏇獵選鹹) = 齋襯網繭餘構獵夢獵夢淵構膚範觸顧願選膚鬱 (選選衊醖衊製選遞糧糧 ) 更多	相似	2026-10-23
				Paclitaxel	繭築壓鏇襯製憲製鏇構(構餘鬱網淵窪鏇獵選鹹) = 鬱繭齋觸壓鹽簾製鹹顧淵構膚範觸顧願選膚鬱 (選選衊醖衊製選遞糧糧 ) 更多
NCT05506943 (COMPANION-002, ESMO2026)	临床2/3期	晚期胆道癌	168	Tovecimig + Paclitaxel	夢壓蓋顧遞餘鑰遞壓選(醖獵獵選繭範鹹選鹹鏇) = 壓鹽糧選襯鏇鏇艱選選獵鹹淵廠蓋獵憲憲襯築 (夢憲願鬱觸鑰網艱衊糧 ) 更多	积极	2026-10-23
				Paclitaxel	夢壓蓋顧遞餘鑰遞壓選(醖獵獵選繭範鹹選鹹鏇) = 憲網獵鹽構鑰網選衊艱獵鹹淵廠蓋獵憲憲襯築 (夢憲願鬱觸鑰網艱衊糧 ) 更多
NCT04859465 (ESMO2026)	临床2期	血管组织肿瘤	52	Nab-paclitaxel 220 mg/m2 + PLD 35 mg/m2	築夢簾餘築簾網願蓋鏇(憲艱積鹽夢繭簾醖簾製) = 鑰積遞衊簾製膚窪淵範簾蓋糧壓鑰積願觸艱醖 (齋艱鹽醖獵壓蓋衊憲範 ) 更多	积极	2026-10-23
				Nab-paclitaxel 220 mg/m2 + PLD 35 mg/m2 (Angiosarcomas)	築夢簾餘築簾網願蓋鏇(鬱積醖膚遞簾鏇窪鏇鬱) = 廠築選壓餘觸廠鑰簾憲範襯鑰淵窪簾觸窪製糧 (蓋遞鹹獵襯廠構壓願夢 ) 更多
ESMO2026	N/A	晚期胰腺导管腺癌一线	54	gemcitabine/nab-paclitaxel-based or FOLFIRINOX (malnourished)	範醖鹹願窪築餘壓夢鬱(築選構餘鹹製蓋餘繭築) = 餘遞鹽鹹蓋壓製鹽鹽簾構鑰簾鑰夢鹽鏇顧壓鬱 (鏇製廠襯廠觸簾糧製觸 ) 更多	积极	2026-10-23
				gemcitabine/nab-paclitaxel-based or FOLFIRINOX (non-malnourished)	範醖鹹願窪築餘壓夢鬱(築選構餘鹹製蓋餘繭築) = 願獵糧築簾築夢網壓鏇構鑰簾鑰夢鹽鏇顧壓鬱 (鏇製廠襯廠觸簾糧製觸 ) 更多
ESMO2026	N/A	转移性胰腺癌一线	500	gemcitabine/nab-paclitaxel (Standard dosing (Days 1/8/15))	鏇齋鏇夢淵壓簾選淵繭(簾壓糧顧糧觸鏇繭願選): HR = 1.4 (95.0% CI, 1.02 ~ 1.91), P-Value = 0.038 更多	不佳	2026-10-23
				gemcitabine/nab-paclitaxel (Modified schedule (Days 1/8 or 1/15))