培美曲塞二钠(Pemetrexed Disodium Hydrate) - 药物靶点：DHFR x GART x TYMS_在研适应症：局部晚期非鳞状非小细胞肺癌，转移性非鳞状非小细胞肺癌，不可切除的胸膜恶性间皮瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

MTA、Multitargeted antifolate、PEMETREXED

+ [32]

靶点

DHFR x GART x TYMS

作用方式

抑制剂

作用机制

DHFR抑制剂(二氢叶酸还原酶抑制剂)、GART抑制剂(GAR转化酶抑制剂)、TYMS抑制剂(胸苷酸合成酶抑制剂)

治疗领域

肿瘤呼吸系统疾病其他疾病

在研适应症

局部晚期非鳞状非小细胞肺癌转移性非鳞状非小细胞肺癌不可切除的胸膜恶性间皮瘤+ [15]

非在研适应症

晚期乳腺癌晚期癌症晚期结直肠腺癌+ [60]

原研机构

Eli Lilly & Co.

在研机构

AstraZeneca PLCPfizer Europe MA EEIG

Eli Lilly & Co.

+ [18]

非在研机构

Genentech, Inc.

Krka dd Novo Mesto

GSK Plc

+ [11]

权益机构

美时化学制药股份有限公司

Boryung Corp.

Eli Lilly & Co.

最高研发阶段批准上市

首次获批日期

美国 (2004-02-04),

恶性胸膜间皮瘤

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)

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结构/序列

分子式C20H35N5Na2O13

InChIKeyPXQGZQUWLRLNRX-MYXYZBIASA-N

CAS号357166-29-1

关联

523

项与培美曲塞二钠相关的临床试验

NCT06694454

/ Suspended临床1/2期IIT

Phase I/II Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)

Background:
Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine [AZA] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.
Objective:
To find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.
Eligibility:
Adults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.
Participants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.
AZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.
Participants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.
Participants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.

开始日期2026-08-23

申办/合作机构

National Cancer Institute

ChiCTR2600129562

/ Not yet recruiting临床2期IIT

Study on the efficacy and safety of Ametinib combined with Pemetrexed as neoadjuvant therapy in patients with EGFR-positive stage II–IIIB non-small cell lung cancer

开始日期2026-08-11

申办/合作机构

粤北人民医院

NCT07751536

/ RecruitingN/AIIT

Dynamic Adaptive Radiotherapy for Non-Small Cell Lung Cancer With Leptomeningeal Metastasis After Resistance to Third-Generation TKIs in the Consolidation Phase: A Multicenter Randomized Controlled Trial Comparing Outcomes Between Proton Craniospinal Irradiation and Intrathecal Pemetrexed (DART-LM)

**Brief Summary (English)**
The goal of this clinical trial is to learn if a risk-adaptive consolidation therapy, guided by cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) clearance kinetics after induction intrathecal pemetrexed, can improve intracranial progression-free survival (iPFS) compared to standard intrathecal pemetrexed consolidation in patients with leptomeningeal metastasis (LM) from EGFR-mutant non-small cell lung cancer (NSCLC) that has progressed on third-generation EGFR-TKIs. It will also learn about the safety and tolerability of proton craniospinal irradiation (pCSI) in this setting.
The main questions it aims to answer are:
* Does risk-adaptive consolidation therapy (pCSI with or without concurrent low-dose intrathecal pemetrexed) prolong iPFS compared to standard intrathecal pemetrexed consolidation?
* What medical problems do participants have when receiving pCSI or intrathecal pemetrexed?
Researchers will compare the experimental arm (risk-adaptive consolidation: pCSI for intermediate-risk, or pCSI with concurrent low-dose intrathecal pemetrexed for high-risk patients) to the control arm (standard intrathecal pemetrexed consolidation) to see if the adaptive strategy improves survival outcomes.
Participants will:
* Receive induction intrathecal pemetrexed (40 mg, biw, q3w for 2 cycles) via Ommaya reservoir.
* Undergo CSF collection at baseline and after induction for ctDNA (maxVAF) analysis to determine risk stratification (low, intermediate, high).
* If stratified as intermediate or high risk, be randomly assigned to either standard intrathecal pemetrexed consolidation or risk-adaptive consolidation (pCSI 30 GyE/10f for intermediate-risk; pCSI 30 GyE/10f with concurrent intrathecal pemetrexed 30 mg on d1, d8 for high-risk).
* Receive maintenance intrathecal pemetrexed (40 mg, q4w) until intracranial progression.
* Undergo regular efficacy assessments (contrast-enhanced MRI of brain and whole spine) every 8 weeks, and complete neurocognitive and quality-of-life questionnaires.

开始日期2026-08-05

申办/合作机构

安徽省肿瘤医院

100 项与培美曲塞二钠相关的临床结果

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100 项与培美曲塞二钠相关的转化医学

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100 项与培美曲塞二钠相关的专利（医药）

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3,686

项与培美曲塞二钠相关的文献（医药）

2026-06-01·JOURNAL OF ENDODONTICS

Long-term Survival and Outcomes of Direct Pulp Capping with Bioceramic iRoot BP Plus in Symptomatic Irreversible Pulpitis

Article

作者: Lv, Huixiang ; Cui, Haining ; Li, Yanfeng

OBJECTIVE:

To evaluate the long-term efficacy and safety of the bioceramic material iRoot BP Plus compared with mineral trioxide aggregate (MTA) in direct pulp capping for symptomatic irreversible pulpitis (SIP).

METHODS:

A single-center retrospective cohort study was conducted, including SIP patients who underwent direct pulp capping between January 2016 and December 2020, with a minimum follow-up of 36 months. Propensity score matching (PSM) with replacement was used to balance baseline characteristics, resulting in 92 teeth each in the iRoot BP Plus group and the MTA group The primary outcome was pulp survival, assessed by combined clinical and radiographic criteria. Statistical analyses for group comparisons incorporated weights from the PSM. Secondary outcomes included pain intensity changes, reparative dentin bridge formation, and complications. An exploratory multivariable Cox regression analysis with a reduced set of covariates was employed to identify prognostic factors, and sensitivity analyses were performed according to tooth position and preoperative pain level.

RESULTS:

At 36 months post-treatment, the pulp survival rate was 88.0% (95% confidence interval [CI]: 79.6-93.4%) in the iRoot BP Plus group and 86.9% (95% CI: 78.3-92.6%) in the MTA group, with no statistically significant difference (P = .730). The absolute difference was 1.1% (95% CI: -8.4% to 10.7%). No significant differences were observed between groups in reparative dentin bridge formation (78.3% vs. 75.0%), vitality response, or complication rates. Exploratory multivariate analysis identified higher preoperative pain level (visual analog scale ≥7) as an independent risk factor for treatment failure (hazard ratio = 2.35, 95% CI: 1.22-4.52, P = .010), whereas the type of capping material did not influence outcomes (hazard ratio = 0.98, 95% CI: 0.46-2.11, P = .962). Subgroup analyses further confirmed comparable performance of both materials across different tooth positions and pain strata.

CONCLUSION:

iRoot BP Plus demonstrates comparable long-term efficacy to MTA in direct pulp capping for SIP, with favorable clinical applicability and safety. Preoperative pain intensity, rather than the choice of capping material, appears to be a critical determinant of prognosis.

2026-06-01·Clinical and Experimental Dental Research

Clinical Evaluation of Three Direct Pulp Capping Materials in Caries‐Induced Pulpitis of Mature Permanent Teeth: A Randomized Controlled Trial

Article

作者: Pan, Yueping ; Huang, Lili ; Li, Yutong ; Ran, Shujun ; Xia, Wenwei ; Chen, Boshu ; Zeng, Kangrui ; Kang, Qiongyi ; Huang, Hong ; Li, Tingting

ABSTRACT:

Objectives:

Direct pulp capping (DPC) preserves pulp vitality in caries‐exposed permanent teeth, but clinical evidence comparing different capping materials and identifying prognostic factors remains limited. This study evaluated the success of DPC with iRoot BP Plus, mineral trioxide aggregate (MTA), and calcium hydroxide (CH), and explored factors associated with treatment outcomes.

Material and Methods:

In this single‐blind, parallel‐group, superiority randomized trial, 120 patients with caries‐induced reversible pulpitis were equally assigned to CH, MTA, or iRoot BP Plus. The primary outcome was 12‐month success, defined by combined clinical and radiographic criteria. Associations between baseline clinical factors and 12‐month success were evaluated. Secondary analyses included success at 3 and 6 months.

Results:

At 12 months, 81 of 120 randomized patients (67.5%) were available for evaluation. The overall success rate was 88.9%. Success rates were 88.5% for iRoot BP Plus ( n = 26), 93.1% for MTA ( n = 29), and 84.6% for CH ( n = 26), with no significant differences between groups ( p = 0.6). Failures were significantly associated with lesions confined to the proximal surface ( p = 0.001) at 12 months, while exposure size > 1 mm ( p = 0.024) and anterior teeth ( p = 0.018) were additional risk factors at 6 months. Kaplan–Meier analysis showed high survival across all groups (log‐rank p = 0.66) and confirmed the influence of these risk factors. No adverse events were reported.

Conclusions:

DPC achieved high short‐term success in mature permanent teeth in MTA, CH, and iRoot BP Plus. Prognostic factors such as caries location, tooth position, and exposure size remain critical for case selection.Trial Registration: number: ChiCTR2100047588; Chinese Clinical Trial Register.

2026-05-11·The journal of contemporary dental practice

Assessment of Shear Bond Strength of MTA and ApaCal ART Liners to a Universal Bonding Agent: An In Vitro Study

Article

作者: Thomas, Archana A ; Pullishery, Fawaz ; Anilkumar, Gautham ; Lahiri, Banibrata ; Kurian, Angel ; Raju, Reshma

Aim:

The current investigation sought to assess the shear bond strength (SBS) between two distinct liners and a universal bonding agent.

Materials and methods:

Eighty extracted premolars were cleaned using a periodontal scaler and stored in 0.9% saline until required. Teeth were cut to expose the dentinal surface at a depth of 1 mm using a straight fissure bur. For uniformity, grooves were marked at 1 mm. Then, use a straight fissure bur to create a 1.5 × 3 × 3 mm hollow on the surface. Apply the mineral trioxide aggregate (MTA) to 40 premolar cavities using an amalgam carrier. Apply the ApaCal ART to 40 premolar cavities, then allow it to cure for 40 seconds. Group IA consisted of 10 premolars bonded with MTA liner using a seventh-generation bonding agent; group IB consisted of 10 premolars bonded with ApaCal ART liner using a seventh-generation bonding agent; group IIA consisted of 10 premolars bonded with MTA liner using an eighth-generation bonding agent; and group IIB consisted of 10 premolars bonded with ApaCal ART liner using an eighth-generation bonding agent. Composite was applied to each sample's cavity lining using a two-layer incremental approach after the adhesive was applied. Each layer was cured. Shear bond strength was assessed by using a universal testing machine.

Results:

Group IIA had the greatest SBS value (14.9780 MPa), and group IB had the least SBS value (12.3110 MPa). Overall analysis of variance (ANOVA) showed significant differences (p = 0.036), though pairwise comparisons were not statistically significant.

Conclusion:

In both bioactive materials, the eighth-generation adhesives are superior to the seventh-generation adhesives, with MTA exhibiting greater values.

Clinical significance:

The lifespan and durability of the repair are guaranteed by a strong enough adhesion between the adhesive system and the liner. Stronger adhesion, which can enhance the stability of the restorative material, prevent marginal gaps, and reduce microleakage.

2,453

项与培美曲塞二钠相关的新闻（医药）

2026-08-18

·医药速览

sac-TMT在EGFR-TKI耐药、EGFR突变晚期非小细胞肺癌中的应用

EGFR突变在非小细胞肺癌（NSCLC）中比例很高，第三代EGFR-TKI（如奥希替尼）是标准一线治疗，但获得性耐药几乎不可避免。耐药后，含铂双药化疗是标准方案，但疗效有限。近年探索的联合方案（免疫+化疗、双抗+化疗、HER3-ADC等）虽有PFS获益，但OS获益尚不明确。 TROP2 在EGFR突变NSCLC中高表达，且与EGFR-TKI耐药相关。Sacituzumab tirumotecan（sac-TMT，芦康沙妥珠单抗）是一种靶向TROP2的ADC，载荷为拓扑异构酶I抑制剂。前期研究显示，EGFR突变可显著增加sac-TMT在NSCLC细胞中的内化和溶酶体摄取，且耐药细胞摄取更多。 sac-TMT在经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗及含铂化疗后进展的EGFR突变非小细胞肺癌（NSCLC）患者中，已显示出显著生存获益。在一项多中心、开发标签、随机对照Ⅲ期试验中，入组了经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性非鳞状NSCLC患者。患者按1:1比例随机分配，接受sac-TMT单药治疗或培美曲塞联合含铂化疗。主要终点为经盲态独立中心审查评估的无进展生存期。总生存期为按层级检验的关键次要终点。在经盲态独立中心审查评估的无进展生存期中期分析中，sac-TMT单药治疗达到了预设的显著性标准（双侧P<0.0001）。共376例患者接受随机分组，每组各188例。中位随访18.9个月后，sac-TMT组中位无进展生存期为8.3个月，化疗组为4.3个月（疾病进展或死亡的风险比为0.49；95%置信区间[CI]为0.39~0.62）。sac-TMT组的总生存期显著长于化疗组（死亡风险比为0.60；95% CI为0.44~0.82；双侧P=0.001）；18个月总生存率分别为65.8%和48.0%。主要结果 1、患者基线 2、无进展生存期PFS 3、亚组分析 4、总生存期OS 5、总生存期的中期分析 6、盲法独立评审评估的疗效终点（意向治疗人群） 7、治疗相关AE sac-TMT组和化疗组≥3级治疗相关不良事件发生率分别为58.0%和53.8%，最常见为中性粒细胞计数减少（39.9% vs. 33.0%）；治疗相关严重不良事件发生率分别为9.0%和17.6%。小结在既往EGFR-TKI治疗后进展的EGFR突变晚期或转移性NSCLC患者中，sac-TMT的无进展生存期和总生存期结局均显著优于含铂化疗。（由四川科伦博泰生物医药公司资助；OptiTROP-Lung04临床试验注册号：NCT05870319。）附NCT05870319入选标准签署知情同意书时年龄≥18周岁且≤75周岁的男性或女性；经组织学或细胞学证实的非鳞状非小细胞肺癌（NSCLC），且为局部晚期（IIIB/IIIC期）或转移性（IV期），不适合根治性手术和/或根治性同步/序贯放化疗；携带EGFR敏感突变；既往EGFR-TKI治疗失败；根据RECIST 1.1标准，经研究者评估至少有一个可测量的靶病灶；美国东部肿瘤协作组（ECOG）体能状态评分为0或1分；预期生存期≥12周；器官和骨髓功能良好；有生育能力的女性受试者及有育龄期女性伴侣的男性受试者，需从签署知情同意书之日起至末次给药后6个月内采取有效的医学避孕措施；受试者自愿参加研究，签署知情同意书，并能够遵守方案规定的访视及相关程序。排除标准经组织学或细胞学证实含有小细胞肺癌、神经内分泌癌、癌肉瘤成分，或鳞状细胞癌成分超过10%；首次给药前3年内患有其他恶性肿瘤；有需类固醇治疗的（非感染性）间质性肺病（ILD）/非感染性肺炎病史，或目前患有ILD/非感染性肺炎；患有活动性慢性炎症性肠病、胃肠道梗阻、严重溃疡、胃肠道穿孔、腹腔脓肿或急性胃肠道出血的受试者；既往抗肿瘤治疗的毒性反应未恢复至≤1级（按NCI CTCAE 5.0标准）或未恢复至入选资格标准中规定的水平；人类免疫缺陷病毒（HIV）检测阳性或有获得性免疫缺陷综合征（AIDS）病史的受试者；已知患有活动性梅毒感染；既往接受过TROP2靶向治疗；既往接受过任何靶向拓扑异构酶I抑制剂的药物治疗，包括抗体药物偶联物（ADCs）；首次给药前4周内接受过大手术，或预期在研究期间需要接受大手术；首次给药前30天内接种过活疫苗，或计划在研究期间接种活疫苗；妊娠期或哺乳期女性。 OptiTROP-Lung04研究的入组标准并未要求患者必须检测并确认TROP2表达阳性参考文献： Fang W, Wu L, Meng X, et al. Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026;394(1):13-26. doi:10.1056/NEJMoa2512071. 推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学

临床结果临床3期抗体药物偶联物临床2期

2026-08-18

·佰傲谷BioValley

阿斯利康/第一三共：Enhertu一线治疗肺癌III期研究成功

8月17日，阿斯利康和第一三共联合宣布Enhertu（德曲妥珠单抗）单药一线治疗非小细胞肺癌（NSCLC）的III期DESTINY-Lung04研究取得了高水平的积极结果。 Enhertu是一种靶向HER2的ADC药物，由第一三共和阿斯利康合作开发和商业化。Enhertu于2019年2月首次在美国获批上市，随后于2020年、2021年、2023年分别在日本、欧洲和中国获批上市。截至目前，Enhertu在美国已获批用于治疗HER2阳性乳腺癌、HER2低表达乳腺癌、HER2超低表达乳腺癌、HER2阳性胃癌或胃食管交界处癌、HER2激活突变NSCLC、HER2阳性实体瘤，其中NSCLC适应症为二线治疗。 DESTINY-Lung04是一项全球性、随机、开放标签的III期临床试验，旨在评估Enhertu（5.4 mg/kg）与标准治疗（铂类-培美曲塞双药化疗联合帕博利珠单抗）相比，在携带HER2第19、20号外显子突变的不可切除的局部晚期或转移性非鳞状NSCLC患者中的疗效和安全性。在DESTINY-Lung04研究中，患者按1:1的比例随机分组，分别接受Enhertu或标准治疗。随机分组按吸烟史和是否存在脑转移或既往脑转移进行分层。研究的主要终点是由BICR评估的无进展生存期（PFS）。次要终点包括总生存期（OS）、研究者评估的PFS、由BICR和研究者评估的总缓解率和缓解持续时间、药代动力学和安全性。研究结果显示：Enhertu组患者的PFS较标准治疗组实现了统计学显著且临床意义显著的改善。该研究将按计划继续进行，以评估包括总生存期（OS）在内的次要终点。值得一提的是，Enhertu是第一个在III期研究中成功证明单药相较标准治疗作为一线治疗方案能够改善NSCLC患者的PFS的ADC药物。在DESTINY-Lung04中观察到的Enhertu安全性特征与其已知特征基本一致，未发现新的安全问题。试验将按计划继续进行，以评估包括总体生存期在内的次要终点。 DESTINY-Lung04的数据将在即将召开的医学会议上公布，并与全球监管机构共享。作为药物偶联模式的成功范例，ADC充分带动了新型药物偶联模式的探索和开发。随着近年来偶联技术的不断优化升级，药物偶联的形式也是越来越新颖、越来越多样。2026年9月17日-19日，全球XDC创新峰会（Global XDC Innovation Conference）将于江苏无锡再度启航，本届大会以「融合与创新」为主题，共同探讨行业创新前沿技术，解锁生物偶联技术的无限可能。时间：2026年9月17-19日地点：中国·无锡君来洲际酒店主办：药明合联WuXi XDC、佰傲谷BioValley 主题：Convergence & Innovation: The New Frontiers of Bioconjugation Convergence（融合）——整合全球多元资源、凝聚行业势能 Innovation（创新）——战略深耕技术创新、突破行业既定边界参会报名备注XDC加入群聊参考资料： 1.https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-improved-pfs-in-1l-her2m-lung-cancer.html

抗体药物偶联物临床3期临床结果临床成功上市批准

2026-08-18

·财经财健道

每日医刻｜北京发布CGT促进措施9项举措；第一三共/阿斯利康重磅 ADC 又一 Ⅲ 期研究获得积极结果

将“财健道”设为星标★ 持续关注，不错过好看每日医刻 1 北京发布CGT促进措施9项举措 8月16日，北京市科委、中关村管委会发布《促进细胞与基因治疗领域高质量发展若干措施（征求意见稿）》，围绕创新、临床、平台、监管、产业五个维度推出9项举措。创新端对免疫细胞药物、干细胞药物、基因编辑等关键技术攻关按每项不超过500万元择优支持；临床端鼓励制剂制备与研究型病房建设。征求意见截至8月18日。这是继上海之后又一地方政府出台CGT专项支持政策。 2 第一三共/阿斯利康重磅 ADC 又一 Ⅲ 期研究获得积极结果 8 月 17 日，第一三共和阿斯利康联合宣布，DESTINY-Lung04 III 期临床试验的积极顶线结果显示，Enhertu（德曲妥珠单抗）作为一线治疗方案，在不可切除的局部晚期或转移性 HER2 突变型非鳞状非小细胞肺癌（NSCLC）患者中，与全球标准治疗方案（铂类-培美曲塞双药化疗联合帕博利珠单抗）相比，在无进展生存期（PFS）方面展现出具有统计学意义和临床意义的显著改善。该试验将按计划继续进行，以评估包括总生存期在内的次要终点。 3 湘雅二医院停采4家药企产品近日，中南大学湘雅二医院通报：艾力斯、康蒂尼、赛诺菲、安进四家药企的医药代表未经预约擅入诊疗区域，医院决定暂停采购伏美替尼、吡非尼酮、甘精胰岛素利司那肽、地舒单抗四款药品三个月，并将相关企业列入负面名单。这是新版《医药代表管理办法》发布后首批院内处罚落地案例。 4 贝达药业聘任张杰博士任副总裁 8月17日，贝达药业聘任张杰博士为公司副总裁，负责医学策略制定及临床开发规划。张杰博士毕业于北京大学医学部，曾任职于美国MD安德森癌症中心及强生、阿斯利康、默沙东等全球领先药企，拥有20余年跨瘤种肿瘤新药研发和临床开发经验，深度参与20余款创新药物的全球开发与注册，曾领导埃万妥单抗皮下制剂关键注册研究并推动FDA优先审评。贝达董事长丁列明表示，其加盟将加快重点创新项目进程，支撑公司"五年再造"战略目标。 5 复宏汉霖与山德士达成3.22亿美元授权合作 8月17日，复宏汉霖（02696.HK）宣布与全球仿制药巨头山德士（Sandoz）签订合作框架协议，双方将围绕至多10款单抗及ADC生物类似药建立战略合作。首批3款产品（西妥昔单抗HLX05-N、依洛尤单抗HLX16、贝利尤单抗生物类似药）已敲定条款，山德士将支付首付款、里程碑及选择权费共计最高3.22亿美元，2026年预计开票金额不超1.005亿美元。首批3款对应原药2025年全球销售额合计107.73亿美元。山德士称这是其"有史以来规模最大的生物类似药合作之一"。 6 英矽智能获纳入MSCI全球小盘股指数，8月31日收盘后生效 8月17日，英矽智能（03696.HK）发布港交所自愿公告，公司将获纳入MSCI全球小盘股指数，相关变更于8月31日收盘后生效。自2025年12月30日港交所主板上市以来，公司已获13家内外资头部机构覆盖（摩根士丹利、中金、瑞银、汇丰、摩根大通等），全部给予积极看好评级，目标价最高达100港元。此前公司已纳入中证港股通创新药、恒生综合、富时全球小盘股等系列指数；7月发布盈利预喜，预计上半年营收1.025至1.065亿美元。 7 阿斯利康特泽利尤单抗在华商业上市 8月17日，阿斯利康（LSE/STO/NYSE：AZN）宣布，泰适卓（英文商品名：Tezspire，通用名：特泽利尤单抗注射液）在中国正式上市。特泽利尤单抗是由阿斯利康与安进合作开发的全球首创（first-in-class）人源单克隆抗体，可抑制胸腺基质淋巴细胞生成素（TSLP）的活性。 2026年3月，特泽利尤单抗基于DIRECTION 及WAYPOINT两项Ⅲ期临床研究的阳性结果在中国获批两项适应证：用于成人和12岁及以上青少年重度哮喘的维持治疗；与鼻用糖皮质激素联合使用，治疗系统性糖皮质激素和/或手术治疗无法充分控制疾病的慢性鼻窦炎伴鼻息肉（CRSwNP）成人患者。独学而无友，则孤陋而寡闻。欢迎更多读者向《财经》财健道分享对于医药行业的困惑、见解或期待，添加《财经》财健道：13581763450，通过实名认证后加入读者群。更多商务合作请咨询：Sylvie-1123。扫描下方二维码添加小助手微信 - END - 大公司：好大夫 | 百济｜恒瑞｜再鼎｜爱尔眼科｜医联｜爱美客大事件：Biotech生死劫 | 医保谈判｜胰岛素｜心脏起搏器｜人工关节｜种植牙人物：毕井泉 | 詹积富｜钟东波｜刘国恩｜张强｜顾昕｜姚树坤｜王杉特稿：艾滋｜首席医学官｜协和百年｜AI简史｜抑郁症专访：传奇生物｜睿心医疗｜医渡云｜泰康拜博｜复星凯特｜君实生物点个“在看”不失联

100 项与培美曲塞二钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	培美曲塞二钠	L01BA04	DB00642

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
局部晚期非鳞状非小细胞肺癌	巴西	Libbs Farmacêutica Ltda.	2012-09-10
转移性非鳞状非小细胞肺癌	巴西	Libbs Farmacêutica Ltda.	2012-09-10
不可切除的胸膜恶性间皮瘤	巴西	Libbs Farmacêutica Ltda.	2012-09-10
非鳞状非小细胞肺癌	美国	Eli Lilly & Co.	2009-07-02
间皮瘤	美国	Eli Lilly & Co.	2004-08-19
非小细胞肺癌	美国	Eli Lilly & Co.	2004-08-19
局部晚期非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
转移性非小细胞肺癌	澳大利亚	Eli Lilly Australia Pty Ltd.	2004-06-30
恶性胸膜间皮瘤	美国	Eli Lilly & Co.	2004-02-04

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
KRAS G12C突变非小细胞肺癌	临床3期	美国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	中国	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	日本	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	澳大利亚	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	奥地利	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	比利时	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	巴西	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	加拿大	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	捷克	Eli Lilly & Co.	2023-12-21
KRAS G12C突变非小细胞肺癌	临床3期	丹麦	Eli Lilly & Co.	2023-12-21

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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


NCT04895735 (MC200708, CTgov)	临床2期	唾液腺癌复发 \| 转移性涎腺癌 \| 腺样囊性癌	45	pembrolizumab+pemetrexed disodium (Cohort A (Adenoid Cystic Carcinoma))	淵夢夢淵齋蓋壓鬱鏇觸 = 餘壓願構艱鑰廠醖衊網顧憲選獵糧壓選選鬱餘 (壓壓淵襯蓋選製鹹餘壓, 壓鏇膚積繭範糧範願蓋 ~ 鹹選糧構選構鹹淵窪齋) 更多	-	2026-06-04
				pembrolizumab+pemetrexed disodium (Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3))	淵夢夢淵齋蓋壓鬱鏇觸 = 鬱鑰艱簾膚網鏇鹹鹽築顧憲選獵糧壓選選鬱餘 (壓壓淵襯蓋選製鹹餘壓, 顧艱糧獵網鹹網築積醖 ~ 廠製選鹽餘窪蓋蓋簾構)
NCT04163432 (STAGGER, CTgov)	临床2期	转移性非小细胞肺癌 \| 转移性非鳞状非小细胞肺癌	43	Carboplatin+Durvalumab+Pemetrexed (Arm A: Chemo-Immuno)	壓齋餘蓋繭觸簾獵憲範 = 顧網憲積餘衊窪築蓋蓋鹽鑰糧積築積獵衊觸繭 (顧願醖鏇獵製艱構廠鑰, 憲糧鏇襯選鑰鬱廠選遞 ~ 網衊觸衊襯艱淵憲齋網) 更多	-	2026-05-19
				Carboplatin+Durvalumab+Pemetrexed (Arm B: Immuno-Chemo)	壓齋餘蓋繭觸簾獵憲範 = 積衊鬱齋衊選淵範積窪鹽鑰糧積築積獵衊觸繭 (顧願醖鏇獵製艱構廠鑰, 構遞膚鹹願構壓積簾觸 ~ 鹹範遞齋範鏇觸願網觸) 更多
NCT04245085 (ETOP 15-19 ABC-lung \| ETOP ABC-lung \| ABC-lung, CTgov)	临床2期	EGFR突变的非小细胞肺癌	95	Carboplatin+Paclitaxel+Atezolizumab+Bevacizumab (Arm A)	選廠壓艱繭鬱夢壓範鬱 = 衊壓壓鏇願觸窪構夢製築窪遞鏇醖願製淵築衊 (遞選選顧齋衊鹹夢遞蓋, 蓋衊糧簾範壓築壓糧範 ~ 築憲獵襯願繭淵築築願) 更多	-	2026-05-12
				Atezolizumab+Bevacizumab+Pemetrexed (Arm B)	選廠壓艱繭鬱夢壓範鬱 = 淵願鏇築壓襯淵夢鑰廠築窪遞鏇醖願製淵築衊 (遞選選顧齋衊鹹夢遞蓋, 憲齋獵網獵夢觸製艱鑰 ~ 製製範繭淵遞齋鏇鹽齋) 更多
NCT04042558 (GFPC 06-2018, CTgov)	临床2期	非小细胞肺癌IIIB期 \| 转移性非小细胞肺癌 \| 非鳞状非小细胞肺癌	150	Carboplatin+Atezolizumab+Bevacizumab+Pemetrexed (Cohort With Bevacizumab)	鹹願鏇範築積鹽餘膚簾 = 構積鏇積壓鏇顧鏇襯鑰製選蓋壓積鑰廠餘網齋 (壓壓夢構衊蓋鑰壓遞製, 醖蓋築觸鑰齋範鹽艱築 ~ 顧夢憲鑰鹹蓋遞積衊獵) 更多	-	2026-05-12
				Carboplatin+Atezolizumab+Pemetrexed (Cohort Without Bevacizumab)	鹹願鏇範築積鹽餘膚簾 = 鹹壓醖醖壓顧壓簾壓遞製選蓋壓積鑰廠餘網齋 (壓壓夢構衊蓋鑰壓遞製, 鬱餘夢築選窪觸鬱選構 ~ 廠構積觸鬱鬱鬱鏇積選) 更多
NCT06630325 (CTgov)	临床2期	卵巢癌 \| 晚期恶性实体瘤 \| 胰腺癌 ... 更多	6	Survey Administration+Abemaciclib+Gemcitabine (Arm I (Abemaciclib, Gemcitabine))	觸構顧襯糧網選鹹獵簾(築鬱憲淵廠遞積艱艱鹽) = 積積衊選鏇淵獵網壓鬱蓋壓衊獵醖鬱糧襯範憲 (願廠鑰襯願範糧簾膚鹹, 選齋願餘艱窪齋醖醖艱 ~ 蓋憲鹹艱選淵顧襯鏇遞) 更多	-	2026-04-28
				Survey Administration+abemaciclib+Pemetrexed (Arm II (Abemaciclib, Pemetrexed))	觸構顧襯糧網選鹹獵簾(築鬱憲淵廠遞積艱艱鹽) = 積衊蓋選積艱構獵鑰築蓋壓衊獵醖鬱糧襯範憲 (願廠鑰襯願範糧簾膚鹹, 顧鏇膚襯夢窪窪繭壓蓋 ~ 選鹽網鏇蓋蓋艱顧範鹹) 更多
NCT03366766 (CTgov)	临床2期	非小细胞肺癌Ⅰ期 \| 可切除非小细胞肺癌 \| 非小细胞肺癌IIIA期 ... 更多	14	Nivolumab+cisplatin+Pemetrexed Disodium (Cohort I (Nivolumab, Cisplatin, Pemetrexed Disodium))	遞鏇鑰繭製襯鏇築膚鏇 = 壓蓋獵餘窪膚獵膚齋鬱鏇獵繭襯顧獵範鏇窪淵 (範衊網獵構鏇齋簾遞鏇, 積艱遞選醖遞觸簾窪鑰 ~ 觸夢觸繭鹹衊顧範繭觸) 更多	-	2026-02-20
				nivolumab+Gemcitabine Hydrochloride (Cohort I (Nivolumab, Cisplatin, Gemcitabine Hydrochloride))	網選艱蓋衊鏇窪遞餘艱 = 觸製觸餘繭繭簾積顧蓋蓋繭衊鏇範壓鏇齋衊顧 (鹹選構網蓋鹽製鹹齋襯, 積鬱鹽蓋艱製憲壓醖鬱 ~ 壓壓鹽壓衊鏇製繭網壓)
NCT04765059 (COMPEL, CTgov)	临床3期	非小细胞肺癌 \| 鳞状非小细胞肺癌 \| 复发性非小细胞肺癌	98	Carboplatin+Pemetrexed+Cisplatin+Osimertinib (AZD9291) (Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin)	遞觸遞鏇顧繭蓋鹹襯鬱(簾夢獵簾憲繭簾範遞獵) = 淵網築網構餘積齋糧壓製簾遞壓壓構顧願艱願 (襯膚齋遞鏇糧廠淵夢網, 網齋鹽憲鏇繭製襯夢選 ~ 積餘鹽鬱鏇鬱築網遞憲) 更多	-	2026-01-13
				Placebo+Carboplatin+Pemetrexed+Cisplatin+Osimertinib (AZD9291) (Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin)	遞觸遞鏇顧繭蓋鹹襯鬱(簾夢獵簾憲繭簾範遞獵) = 淵襯廠餘糧範憲範範鬱製簾遞壓壓構顧願艱願 (襯膚齋遞鏇糧廠淵夢網, 遞襯願製壓齋積餘糧鑰 ~ 齋蓋夢鏇膚餘網製網憲) 更多
ESMO_ASIA2025	N/A	EGFR突变的非小细胞肺癌一线 EGFR-mutant	1,050	Gefitinib + pemetrexed-platinum chemotherapy	繭膚鏇築廠艱獵憲願廠(獵衊醖廠簾憲繭網範構): RR = 1.03 (95.0% CI, 0.79 ~ 1.34), P-Value = 0.81 更多	积极	2025-12-05
				Gefitinib monotherapy
NCT04967417 (PHOEBS, CTgov)	临床2期	非小细胞肺癌 \| 转移性非小细胞肺癌 \| 脑转移瘤	13	Carboplatin+Pembrolizumab+Pemetrexed (Non-squamous Cell Carcinoma)	遞製膚膚選積網膚艱蓋(蓋簾選願鹽淵膚製窪衊) = 夢鑰壓簾窪鬱襯壓願顧廠簾蓋觸襯憲窪醖顧簾 (鏇齋鏇齋窪範選繭糧鏇, 積蓋餘壓願鬱鏇獵簾鹹 ~ 襯築製繭窪壓簾廠築範) 更多	-	2025-05-09
				Carboplatin+Paclitaxel+Pembrolizumab (Squamous Cell Carcinoma)	遞製膚膚選積網膚艱蓋(蓋簾選願鹽淵膚製窪衊) = 鏇窪鬱鑰製醖憲鏇夢繭廠簾蓋觸襯憲窪醖顧簾 (鏇齋鏇齋窪範選繭糧鏇, 餘醖淵遞獵壓壓築鏇艱 ~ 鹽積鏇願糧醖鑰衊糧製) 更多
NCT03137771 (NRG-LU002, CTgov)	临床2期	转移性非小细胞肺癌 \| 复发性非小细胞肺癌	218	Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 1 (Systemic Maintenance Chemotherapy))	顧鏇衊選鹽鏇窪繭糧膚(顧齋窪鑰憲鑰艱鬱壓遞) = 淵製築膚鏇糧製醖衊襯製網獵網鹽夢衊艱廠蓋 (鑰積憲衊淵簾鬱積簾膚, 糧壓膚壓衊壓糧構積糧 ~ 夢衊餘獵廠鬱構鬱鑰範) 更多	-	2025-03-11
				Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + Systemic Maintenance Chemotherapy))	顧鏇衊選鹽鏇窪繭糧膚(顧齋窪鑰憲鑰艱鬱壓遞) = 壓憲鬱淵鹹繭夢願蓋鏇製網獵網鹽夢衊艱廠蓋 (鑰積憲衊淵簾鬱積簾膚, 艱積遞獵顧選膚廠觸蓋 ~ 築鹹構製夢製餘廠醖糧) 更多