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更新于：2026-09-17

Palbociclib

哌柏西利

更新于：2026-09-17

概要

基本信息

药物类型

小分子化药

别名

Iburance、Palbociclib (JAN/USAN)、Palbociclib Isethionate

+ [16]

靶点

CDK4 x CDK6

作用方式

抑制剂

作用机制

CDK4抑制剂(细胞周期蛋白依赖性激酶4抑制剂)、CDK6抑制剂(细胞周期蛋白依赖性激酶6抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病免疫系统疾病+ [8]

在研适应症

HR阳性/HER2阳性乳腺癌复发性乳腺癌HR阳性/HER2阴性乳腺癌+ [104]

非在研适应症

急性白血病伴有 11q23 异常的急性髓系白血病晚期癌症+ [59]

原研机构

Pfizer Inc.

在研机构

Invitae Corp.

Pfizer Inc.

Alliance Foundation Trials LLC

+ [19]

非在研机构

SWOGXynomic Pharmaceuticals, Inc.

The Vanderbilt-Ingram Cancer Center

+ [10]

权益机构

Dr. Reddy's Laboratories Ltd.

Amgen, Inc.

亞盛醫藥集團

+ [11]

最高研发阶段批准上市

首次获批日期

美国 (2015-02-03),

ER阳性/HER2阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评加速批准 (美国)、特殊审批 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

分子式C24H29N7O2

InChIKeyAHJRHEGDXFFMBM-UHFFFAOYSA-N

CAS号571190-30-2

关联

437

项与哌柏西利相关的临床试验

NCT07748208

/ Not yet recruiting临床2期

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.

开始日期2026-10-30

申办/合作机构

Hoffmann-La Roche Ltd.

NCT07683754

/ Not yet recruiting临床3期

A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+/ HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

开始日期2026-09-04

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

ChiCTR2600129847

/ Not yet recruiting临床2期IIT

Becotatug Vedotin combined with Palbociclib for advanced head and neck squamous cell carcinoma after failure of first-line treatment: a single-arm, single-center phase II exploratory study

开始日期2026-09-01

申办/合作机构

上海交通大学医学院附属第九人民医院

100 项与哌柏西利相关的临床结果

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100 项与哌柏西利相关的转化医学

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100 项与哌柏西利相关的专利（医药）

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3,470

项与哌柏西利相关的文献（医药）

2026-12-31·Journal of Pharmaceutical Policy and Practice

Economic evaluation of cyclin-dependent kinases 4 and 6 inhibitors in advanced hormonal receptor-positive and human epidermal growth factor receptor 2 negative breast cancer: a nationwide budget impact analysis

Article

作者: Hamad, Anas ; Shafei, Laila ; Hisham Al-Ziftawi, Nour ; Mohamed Ibrahim, Mohamed Izham ; Bojassoum, Salha ; Elazzazy, Shereen

Background:

Several trials demonstrated improvements in clinical outcomes associated with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors in breast cancer patients. The challenge remains regarding their high costs. Ribociclib and Abemaciclib are cost-effective in Qatar. Yet, their affordability was not studied. This budget impact analysis (BIA) is to assess the affordability of adopting CDK4/6 inhibitors in Qatar over five years duration (2024-2028).

Methods:

We ran a BIA to evaluate two scenarios: (1) Increasing abemaciclib's market share from 20% to 60%, replacing both palbociclib and ribociclib. (2) Assuming equal market share for both ribociclib and abemaciclib up to 80%, reducing palbociclib's share. The analysis considered treatment costs, patient population, and disease prevalence. All data were retrieved from the National Center for Cancer Care and Research, and costs were presented in Qatari Riyals (QAR). Sensitivity analyses were run to ensure the robustness of the conclusion. All results were compared to Qatar's budget threshold, which is QAR 453,822.

Results:

Based on a total of 173 patients using CDK4/6 inhibitors, increasing abemaciclib's market share to 60% yielded cumulative savings of QAR 14 million over five years, which is around QAR 14,613 per patient per year. However, equally increasing ribociclib's and abemaciclib's market share to 80% resulted in a modest budget increase, remaining within acceptable thresholds. Sensitivity analyses confirmed the robustness of these findings, showing that cost reductions and higher uptake rates further enhanced savings.

Conclusion:

Abemaciclib is a budget-saving option for HR+/HER2- breast cancer in Qatar, should it replace the market share by up to 60% over five years. In addition, ribociclib and abemaciclib are affordable treatment options if they equally contributes to up to 80% of the market share for the eligible advanced breast cancer patients. The results supported the concept of allocating CDK4/6 inhibitors as they were found to be affordable to the Qatari healthcare system.

2026-12-01·MOLECULAR BIOLOGY REPORTS

Possible TLR-mediated immunostimulatory effect of Palbociclib in breast cancer

Article

作者: Sağ, Sevda ; Tomatir, Ayse Gaye ; Ergezgin, Huriye ; Bayav, Ibrahim ; Dodurga, Yavuz

BACKGROUND:

Palbociclib, which exerts its effect by inhibiting the cell cycle in cancer cells, is a CDK inhibitor used in the treatment of ER+/HER- breast cancer. In this study, we aimed to investigate the effect of Pablosiklib on TLR, which plays an important role in the immune response, in MCF-7 (ER+/HER2-) and MDA-MB-231 (ER-/PR-/HER2-) cell lines.

METHODS AND RESULTS:

The expression levels of TLR 1-10 genes, cell cycle-related genes (CDK4/6), and genes involved in the apoptotic pathway (Bcl-2, Bax, Cas-3) in MCF-7 and MDA-MB-231 cells treated with palbociclib were evaluated using the real-time PCR (qRT-PCR) method. Additionally, the levels of total retinoblastoma (RB) and phosphorylated retinoblastoma (pRB) proteins were analyzed using the Western blot method. CDK4/6 and pRB expression decreased in MCF-7 and MDA-MB-231 cells treated with palbociclib. Bax and Cas-3 expression increased, while Bcl-2 expression decreased. Changes in TLR expression were also observed.

CONCLUSIONS:

We believe that palbociclib not only stops the cell cycle and induces apoptosis in breast cancer cells, but also activates the immune response via TLRs.

2026-11-01·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

A PROTAC-inspired bifunctional small molecule recruits CDK6 to target EYA2 degradation and suppress breast tumor growth

Article

作者: Qin, Xiaoyu ; Wu, Zhaofeng ; Wang, Yu ; Yuan, Bin ; Kan, Chenchen ; Ma, Junting ; Zhou, Rui ; Liu, Mingming ; Luo, Qichao ; Zhang, Yanhui ; Zhao, Qun ; Gao, Jiahui ; Ai, Jiaxin

Cyclin-dependent kinase 6 (CDK6) has been reported to exert tumor-suppressive functions through its non-enzymatic activity and promotes the degradation of the oncogenic driver EYA2. This suggests a potential strategy for targeted protein degradation by exploiting endogenous protein-protein interactions. Here, we report the design and synthesis of a bifunctional small molecule, EC21, capable of simultaneously engaging CDK6 and EYA2. Structure-guided design based on the reported binding modes of palbociclib and the EYA2 inhibitor ETC-616 enabled the identification of EC21 as a lead compound. Biological studies demonstrated that EC21 effectively reduced EYA2 protein levels in breast cancer cells in a time- and concentration-dependent manner through a ubiquitin-proteasome-dependent process. Mechanistic investigations indicated that EC21 enhances the interaction between CDK6 and EYA2, thereby promoting EYA2 degradation. Functional analyses further revealed that EC21 disrupts DNA damage repair pathways and significantly suppresses breast cancer cell proliferation. Importantly, EC21 exhibited pronounced antitumor activity in a syngeneic breast cancer mouse model and reduced EYA2 protein levels in tumor tissues without apparent toxicity. Collectively, these findings demonstrate that pharmacological stabilization of the CDK6-EYA2 interaction represents a feasible strategy for inducing EYA2 degradation and provides a potential therapeutic approach for EYA2-driven breast cancer.

2,322

项与哌柏西利相关的新闻（医药）

23 小时之前

·FiercePharma

AstraZeneca’s Etcamah flunks first-line breast cancer trial, adding to oral SERDs’ failure record

The ink was barely dry on the FDA approval letter for AstraZeneca’s Etcamah before the oral SERD suffered a key clinical setback. Etcamah failed to significantly improve patients’ time before tumor progression or death compared with the aromatase inhibitor anastrozole for the first-line treatment of ER-positive, HER2-negative breast cancer, AZ said Friday. The readout comes from the Serena-4 phase 3 trial, in which all patients also received Pfizer’s CDK4/6 inhibitor Ibrance. AZ noted a numerical progression-free survival improvement for the Etcamah regimen, but the outcome didn’t meet statistical significance on that trial’s primary endpoint. Etcamah now joins Roche’s rival oral SERD, giredestrant, in missing the mark in first-line HR+/HER2- breast cancer. Previously, in the phase 3 persevERA trial, giredestrant plus Ibrance only showed a numerical 11% improvement over Novartis’ aromatase inhibitor letrozole and Ibrance. Trying to infuse confidence into Serena-4 on AZ’s second-quarter earnings call back in July, AZ’s oncology and hematology R&D chief, Susan Galbraith, Ph.D., pointed to the study’s larger patient pool than persevERA, as well as a population enriched for endocrine sensitivity. Because oral SERDs exert their therapeutic effect through estrogen receptor signaling, they need tumors that remain vulnerable to endocrine manipulation to work. The two failures now spell trouble for other oral SERD efforts in the first-line setting, such as Olema Oncology’s Opera-02 trial that combines its palazestrant with Ibrance. The Serena-4 announcement came merely a week after the FDA’s surprise approval for Etcamah in another first-line setting. Rather than giving Etcamah from the outset, the accelerated approval allows the AZ drug to be used in combination with a CDK4/6 inhibitor upon detection of ESR1 mutation during first-line aromatase inhibitor and CDK4/6 therapy—prior to traditional radiographic disease progression. In a Friday statement, Galbraith said the Serena-4 readout “reinforces the importance of ESR1 testing for patients on first-line therapy.” The FDA had initially resisted that novel first-line switch approach because of a design flaw in AZ’s Serena-6 trial, but the agency came around to overrule a similarly negative advisory committee opinion. However, there’s a twist: In clearing Etcamah, the FDA has required AZ to run a separate randomized trial, essentially asking the company to re-do Serena-6 but with an optimal design. The agency specifically asked that AZ compare changing therapy to Etcamah during first-line treatment to using the oral SERD upon progression in the second-line setting, according to the FDA’s approval letter. That trial, along with the final overall survival results from Serena-6, form the FDA’s accelerated approval requirements to verify Etcamah’s benefit in its current indication. According to the FDA’s letter, AZ plans to finalize the new study’s protocol by April 2027. That means at least the current Serena-4 flop will not affect Etcamah’s accelerated approval status. Prior to Etcamah, oral SERDs have been approved as second-line HR+/HER2- breast cancer treatments but only for those whose tumors carry ESR1 mutations, as they’ve shown no clear benefit in those without the abnormalities. Untreated HR+/HER2- breast cancers rarely carry ESR1 mutations that could give oral SERDs a biological advantage over standard therapies. Over time, cancer cells adapt to anti-estrogen treatment by developing ESR1 mutations, making standard aromatase inhibitors ineffective. Existing CDK4/6 inhibitors are already very potent, and “you don’t see early on what is really an effect of an endocrine manipulation,” Roche’s deputy chief medical officer, Stefan Frings, M.D., Ph.D., told Fierce when explaining giredestrant’s first-line fail during ASCO 2026. Despite the first-line setback, Roche’s pharma chief, Teresa Graham, has argued that giredestrant’s multibillion-dollar peak sales potential remains intact by pointing to its opportunity as an adjuvant therapy for early-stage cancer. Similarly, Eli Lilly’s oncology chief, Jake Van Naarden, has also called the adjuvant setting what “this entire class of medicines was ever resourced” for. The Indianapolis pharma has its oral SERD, Inluriyo, currently approved as a second-line option. In its press release on Friday, AZ also highlighted its two phase 3 trials, Cambria-1 and -2, designed for patients at both intermediate and high risk of recurrence in the adjuvant setting. The two studies together encompass roughly 10,000 patients and are evaluating Etcamah as a monotherapy, in combination with CDK4/6 inhibitors and following CDK4/6 treatment in early HR+/HER2- breast cancer. The content above comes from the network. if any infringement, please contact us to modify.

临床结果加速审批上市批准

23 小时之前

·医学新视点

美国FDA加速批准阿斯利康口服SERD组合疗法

美国FDA近期宣布，加速批准阿斯利康（AstraZeneca）开发的Etcamah（camizestrant）联合CDK4/6抑制剂（abemaciclib、palbociclib或ribociclib），用于治疗激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性乳腺癌成人患者。适用患者需在接受芳香化酶抑制剂和CDK4/6抑制剂治疗期间，通过FDA授权的检测发现雌激素受体1（ESR1）基因突变。 FDA新闻稿指出，这是FDA首次批准一种癌症疗法，其治疗决策依据是在影像学检查显示疾病进展之前，通过循环肿瘤DNA（ctDNA）检测到耐药突变。 ESR1突变是一种获得性耐药突变，可能在患者接受芳香化酶抑制剂治疗期间出现。芳香化酶抑制剂是局部晚期或转移性乳腺癌常用的一线内分泌治疗方式。根据FDA新闻稿，在HR阳性转移性乳腺癌确诊时，不到5%的患者存在ESR1突变；而在接受芳香化酶抑制剂治疗后疾病进展的患者中，近40%的患者存在这一突变。此次批准的一个重要特点，是在影像学确认疾病进展之前，通过血液检测发现ESR1耐药突变，并据此调整治疗。ctDNA由肿瘤释放进入血液中的微小DNA片段组成，可以帮助从分子层面发现肿瘤发生的变化。 Etcamah是一款强效、下一代口服选择性雌激素受体降解剂（SERD）和完全雌激素受体拮抗剂。此次疗效评价比较了两种治疗策略：在检测到ESR1突变后，将芳香化酶抑制剂切换为Etcamah，同时继续使用CDK4/6抑制剂；或继续使用原有芳香化酶抑制剂联合CDK4/6抑制剂。 FDA新闻稿显示，Etcamah联合CDK4/6抑制剂组的预计中位无进展生存期（PFS）为16个月，继续接受芳香化酶抑制剂联合CDK4/6抑制剂治疗的对照组为9.2个月。 FDA同时指出，目前尚未确认在检测到耐药突变时提前调整治疗，相比等待影像学确认疾病进展后再更换治疗，是否能够转化为具有临床意义的获益。因此，FDA要求开展确证性研究，以进一步验证并描述Etcamah的临床获益。参考资料： [1] FDA Grants Accelerated Approval to a New Breast Cancer Treatment. Retrieved September 4, 2026, from https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

2026-09-16

·医药地理

一周药讯：国家医保局全面完成40批立项指南编制工作

关注医药地理数据库 2026年9月第2期总第1067期目录行业政策 1.国家医保局发布：按病种付费3.0版分组方案配置信息 “开源”啦！ 2.国家医保局发布第二十一批智能监管“两库”规则和知识点 3.国家医保局全面完成40批立项指南编制工作全国医疗服务收费迈入统一新阶段 4.国家医保局发布：2023-2025年医保结算住院人次TOP10疾病费用结构分析 5.国家药品监督管理局发布中药保护品种公告（第38号）（2026年第89号） 6.国家药监局关于发布关于开展灵活就业人员、农民工、新就业形态人员参加基本医疗保险提质专项行动的通知 7.重庆市人民政府办公厅关于印发《重庆市建立健全长期护理保险制度实施方案》的通知行业动态 1. 药讯动态：重磅获批 2. 药讯动态：重磅临床 3. 药企动态：市场动态零售行业动态《横琴粤澳深度合作区药品零售单位风险分级管理办法（试行）》正式执行政策动态 1、国家医保局发布：按病种付费3.0版分组方案配置信息 “开源”啦！为推进按病种付费3.0版分组方案落地，国家医保局面向社会公开DRG3.0版分组配置信息与DIP3.0版Excel文件。DRG公开了分组规则及匹配路径；DIP支持诊断与手术操作匹配查询入组路径。此举以"开源"方式推动分组从"结果可查"迈向"规则可溯"，提升透明度。同时欢迎高校、科研院所及专家围绕3.0版实施开展研究，助力深化按病种付费改革。 2.国家医保局发布第二十一批智能监管“两库”规则和知识点国家医保局编写的《国家医保基金智能监管知识库、规则库（2025年版）》近日出版发行。按计划向社会公开"诊断与患者性别不符"规则中"某些传染病和寄生虫病"等9章知识点明细。各省级医保部门须据此动态更新省级平台智能监管子系统"两库"；定点医药机构可将"两库"嵌入本机构系统或对接医保部门事前提醒模块，对医保基金使用行为自动提醒、自查自纠，将违规行为消除在萌芽阶段。 3.国家医保局全面完成40批立项指南编制工作全国医疗服务收费迈入统一新阶段近期，国家医保局正式公布检验类医疗服务价格项目立项指南，历时近五年的立项指南编制工作圆满收官。国家医疗保障局贯彻落实党中央、国务院深化医疗服务价格改革试点的决策部署，将统一规范价格项目作为重要改革任务，全面完成40批医疗服务价格项目立项指南编制工作，将各地价格项目整合规范为2624个主项目、742个加收项、174个扩展项，医疗服务价格管理破解碎片化、差异化问题，迈入规范化标准化新发展阶段。 4.国家医保局发布：2023-2025年医保结算住院人次TOP10疾病费用结构分析本文基于国家医保信息平台结算数据，对2023年-2025年全国医保结算住院人次最多的Top10疾病的总体分布、费用结构等情况进行分析。 5.国家药品监督管理局发布中药保护品种公告（第38号）（2026年第89号）根据《中药品种保护条例》规定，国家药品监督管理局批准广州奇绩医药科技有限公司的金蓉颗粒、黑龙江汉鸿药业有限公司的复方刺五加颗粒、吉林敖东延边药业股份有限公司的小儿柴桂退热口服液、浙江康德药业集团股份有限公司的丹龙口服液、丽彩甘肃西峰制药有限公司的复方伤痛胶囊为首家中药二级保护品种，保护品种编号分别为：ZYB2072026021、ZYB2072026019、ZYB2072026020、ZYB2072026023、ZYB2072026022。保护期限自公告日起七年。 6.国家药监局关于发布关于开展灵活就业人员、农民工、新就业形态人员参加基本医疗保险提质专项行动的通知国家医保局等七部门2026年9月8日发布《关于开展灵活就业人员、农民工、新就业形态人员参加基本医疗保险提质专项行动的通知》（医保办发〔2026〕11号，文件落款9月2日）。目标是用3年左右，通过政策集成、部门联动、优化服务、技术赋能，持续提高上述群体参加基本医保人数，尤其是职工医保人数。主要措施：推动超大城市取消灵活就业人员就业地、常住地参保户籍限制；合理确定缴费基数；职工医保缴费年限按月累计，每满12个月计1年；关系转移接续缴费年限累计；不得将职工医保退休待遇与按月领养老金绑定。缴费可月缴，探索季、半年、全年预缴；鼓励平台企业对稳定接单人员采用“个人缴费+平台补贴”；鼓励纳入生育保险。服务上推行“灵活就业参保一件事”，推动个人账户跨省家庭共济；完善“一人一档”数据库，与人社、交通、税务、邮政、工会、商务等共享数据，精准动员未参保人员。 7.重庆市人民政府办公厅关于印发《重庆市建立健全长期护理保险制度实施方案》的通知重庆市2026年7月印发《建立健全长期护理保险制度实施方案》，明确2026年继续覆盖参保职工并启动居民筹资，2027年居民享待遇。职工与居民同步参保，单位职工费率0.3%（单位个人各半），居民费率5年内由0.15%过渡至0.3%（个人与政府1:1分担）。失能满6个月评估后可享待遇，职工支付约70%、居民约50%，无起付线，年度限额不超上年居民人均可支配收入50%。2027年起断保设等待期。基金财政专户管理，2028年起禁交第三方代管，多部门协同推进。行业动态 01 药讯动态：重磅获批最近重磅获批药捷安康自主研发的1类新药替恩戈替尼片获NMPA附条件批准上市，用于既往接受过系统性治疗和FGFR抑制剂治疗、且携带FGFR2融合或重排的晚期/转移性胆管癌成人患者。该产品曾纳入NMPA优先审评及突破性治疗品种。恒瑞公司自主研发的1类创新药海曲泊帕乙醇胺片新增两项适应症。海曲泊帕乙醇胺片是一种口服非肽类血小板生成素受体（TPO-R）激动剂，通过激活 TPO-R 介导的STAT 和MAPK 信号转导通路，促进血小板生成。诺和诺德司美格鲁肽注射液（商品名：诺和盈®）的代谢相关脂肪性肝炎（MASH）适应症上市申请获得中国国家药品监督管理局（NMPA）批准，适用于治疗代谢相关脂肪性肝炎（MASH）伴中重度肝纤维化（符合F2-F3期纤维化）的非肝硬化成人患者，成为首个且唯一获批用于治疗 MASH的GLP-1RA类药物。拜耳塞伐艾替尼（Sevabertinib）获 FDA 加速批准作为 HER2 突变型非小细胞肺癌（NSCLC）成人患者的一线治疗方案。Sevabertinib 是一种口服可逆酪氨酸激酶抑制剂（TKI），可有效抑制突变型 HER2，包括 HER2 外显子 20 插入和 HER2 点突变。美国FDA加速批准卡米司群(商品名：Camizestrant)联合细胞周期蛋白依赖性激酶(cyclin dependent kinase，CDK)4/6抑制剂(阿贝西利、哌柏西利或瑞博西尼)，用于在芳香化酶抑制剂和CDK4/6抑制剂治疗期间检测发现雌激素受体-1(estrogen receptor-1，ESR1)突变的激素受体(hormone receptor，HR)阳性、人表皮生长因子受体2(human epidermal growth factor receptor 2，HER2)阴性局部晚期或转移性乳腺癌成年患者。卡米司群是一种雌激素受体拮抗剂。拜耳宣布塞伐艾替尼（Sevabertinib）获 FDA 加速批准作为 HER2 突变型非小细胞肺癌（NSCLC）成人患者的一线治疗方案。Sevabertinib 是一种口服可逆酪氨酸激酶抑制剂（TKI），可有效抑制突变型 HER2，包括 HER2 外显子 20 插入和 HER2 点突变。 02 药讯动态：重磅临床最近重磅临床江苏恒瑞医药股份有限公司收到国家药品监督管理局（以下简称“国家药监局”）核准签发关于HRS-6209胶囊、HRS-4508片的《药物临床试验批准通知书》，将于近期开展临床试验。华兰生物疫苗股份有限公司于近日收到国家药品监督管理局核准签发的关于新型流感病毒mRNA疫苗的《药物临床试验批准通知书》，同意开展预防由疫苗相关型别的流感病毒引起的流行性感冒的临床试验。复星医药口服小分子JAK抑制剂（TYK2/JAK1双靶点抑制剂）FXS5626片用于治疗非节段型白癜风的II/III期适应性无缝设计临床试验获得国家药监局批准，公司将在各项条件齐备后，于中国境内推进该适应症的相关临床研究工作。长春高新技术产业（集团）股份有限公司控股子公司收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，金赛药业GenSci133注射液的境内生产药品注册临床试验申请获得批准。诺诚健华宣布中国国家医药品监督管理局药物评审中心（CDE）已批准ICP-B381试验申请（IND），启动针对PSMA和STEAP1的新型双特异性ADCICP-B381临床试验，用于治疗包括前列腺癌在内的实体肿瘤。ICP-B381是InnoCare首个进入临床的双特异性ADC，也是第三个进入临床试验的ADC。诺和诺德提前终止了 IL-6 单抗 ziltivekimab（泽韦奇单抗）的另外两项后期研究，原因是研究数据监测委员会认定这两项研究成功的可能性很小。Ziltivekimab 是一款全人源单克隆抗体，通过抑制 IL-6 来减少全身炎症，其经过长效化改造以延长半衰期，仅需每月一次皮下注射给药。2020 年 6 月，诺和诺德以 7.25 亿美元首付款、潜在总额超 21 亿美元收购阿斯利康子公司 Corvidia Therapeutics 囊获了该产品。 03 药企动态：市场动态数千万元！华拟智能完成天使轮融资仿生人形机器人企业华拟智能宣布完成数千万元天使轮融资，投资方为广东省科学院佛山产业技术研究院与国资产业资本东莞科创集团。本轮融资将主要用于核心技术的研发迭代、量产交付能力的提升及重点场景的渠道建设。相关数据显示，2025年中国陪伴机器人行业市场规模约900亿元，预计到2026年底将向1100 亿至1400亿元区间迈进。随着全球人口结构走向老龄化、少子化，独居人口持续增加，陪伴型人形机器人需求获得快速崛起的“陪伴经济”支撑。2025年全球陪伴机器人市场规模已突破180 亿美元，年复合增长率维持在34%以上。佳量脑科学完成两轮融资数据驱动全栈脑机接口平台企业——杭州佳量脑科学股份有限公司宣布连续完成C轮及 D轮两轮融资，累计融资金额达数亿元人民币。其中，C轮融资由启明创投领投，老股东余杭国投、辰德资本继续投资，泰珑投资、浦耀信晔、建源西证、临港蓝湾基金、渝富高质基金、禾合创投跟投。D轮融资由赛智伯乐、宽桥恒松及宁波国资等多家机构共同参与。融资完成后，佳量脑科学将围绕商业化、国际化持续投入：加快推进Epilcure™注册上市及商业化进程，持续推进Vivastep™等下一代神经接口产品的临床转化，进一步完善脑科学数据和算法平台建设；在海外市场，将推进FDA、CE等国际注册及全球临床合作，依托杭州与新加坡的双中心布局，逐步建立面向国际市场的产品和临床合作体系。数千万元！威图医疗完成Pre-A轮融资宠物医疗CT影像设备及AI诊断企业威图医疗宣布完成数千万元人民币Pre-A轮融资，本轮融资由邦勤创投投资。威图医疗是全球宠物多功能CT影像设备的开创者及领航者，本轮融资资金将用于AI影像诊断研发、新一代影像成像技术迭代，以及海外营销与全球市场拓展。作为全球宠物多功能CT影像设备的开创者，威图医疗的产品与服务已覆盖全球23个国家和地区，累计服务超4500+家动物医院及科研机构。数千万元！杰心医疗完成天使+轮融资杰心医疗科技（宁波）有限公司宣布完成数千万元天使+轮融资。本轮融资由承树投资领投，三江资本、乾融控股跟投。募集资金将主要用于厂房建设、市场推广以及新产品研发。杰心医疗成立于2024年1月，秉持“Better Tool, Beyond PVI”的产品理念，聚焦心脏电生理等心血管介入市场，为介入医生和患者提供手术创新性解决方案。成立以来，全资子公司北京维康达心科技有限公司已完成ISO 13485质量体系认证，并获评国家高新技术企业和中关村高新技术企业。在产品端，公司已建立起覆盖通道建立、标测、消融及复律等环节的产品布局，其中房间隔穿刺系统、球囊标测导管已相继获批上市。麦科田正式在港交所上市 2026年9月7日，深圳麦科田生物医疗技术股份有限公司在香港联合交易所主板正式挂牌上市，股票代码为02041.HK，发行价为15.42港元/股。根据招股书及港交所披露信息，麦科田本次全球发售共计约3891.06 万股（无超额配售权安排），募资净额约4.96亿港元。麦科田成立于2011年，总部位于深圳，是一家专注于生命支持、体外诊断及微创介入领域的医疗器械企业。公司核心产品包括输注泵、麻醉仪、全自动血栓弹力图分析仪等，尤其在输液工作站这一细分赛道，麦科田是国内少数能与国际巨头（如费森尤斯卡比等）正面竞争的本土企业。零售行业动态 01 《横琴粤澳深度合作区药品零售单位风险分级管理办法（试行）》正式执行横琴粤澳深度合作区商事服务局2026年8月11日印发《药品零售单位风险分级管理办法》，9月10日起施行，有效期五年。适用于合作区药品零售单位（含连锁门店）。按经营规模、经营范围、药师配置及在岗、质量管理、追溯、信息化、药学服务、数据上报、网售等定风险，系统连续60日动态评分，初始100分。85分及以上A级，75—85分B级，65—75分C级，低于65分D级。A/B/C/D级每年至少检查1/2/3/4次；等级提高或单项零分，10个工作日内专项检查。目的为强化管理、落实主体责任、提高监管效能。来源：由中国医药工业信息中心整理 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

100 项与哌柏西利相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10372	哌柏西利	L01XE33	DB09073

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
HR阳性/HER2阳性乳腺癌	美国	Pfizer Inc.	2026-06-24
复发性乳腺癌	日本	Pfizer Japan, Inc.	2017-09-27
HR阳性/HER2阴性乳腺癌	美国	Pfizer Inc.	2016-02-19
ER阳性/HER2阴性乳腺癌	美国	Pfizer Inc.	2015-02-03

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
HPV相关鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
头颈部鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
转移性头颈部鳞状细胞癌	临床3期	美国	Pfizer Inc.	2022-04-06
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	奥地利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	法国	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	匈牙利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	意大利	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	西班牙	Pfizer Inc.	2019-08-27
HR阳性HER2阴性淋巴结阳性乳腺癌	临床3期	瑞士	Pfizer Inc.	2019-08-27
HER2 阴性乳腺癌	临床3期	日本	Pfizer Inc.	2019-07-16

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临床结果

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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


NCT03423199 (PATHWAY, Pubmed \| Breast Cancer)	临床3期	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	328	Palbociclib plus Tamoxifen	觸襯蓋夢簾齋衊選構壓(齋願鑰遞醖窪淵憲構膚) = cycle 4: 0.70 [95% CI: -5.00, 6.41]; cycle 7: 2.17 [95% CI: -4.14, 8.48]; EOT: -5.19 [95% CI: -11.64, 1.26] 艱範鏇衊繭顧鏇觸衊鹽 (選顧憲鹽選窪窪廠選膚 ) 更多	积极	2026-06-24
				Placebo plus Tamoxifen
ESMO_GCC2026	临床2期	转移性子宫内膜恶性肿瘤 estrogen receptor-positive	29	Palbociclib and anastrozole	鏇製襯糧襯顧齋窪簾窪(憲廠鏇築憲遞獵糧壓膚) = 糧蓋選衊餘鏇醖窪鏇糧製壓顧簾簾鬱鏇鑰壓簾 (壓齋築鑰蓋齋繭遞網糧 ) 更多	积极	2026-06-18
NCT04767594 (PERFORM, ASCO2026)	N/A	HR阳性/HER2阴性乳腺癌一线 HR+/HER2−	1,010	Palbociclib + ET (TFI >12 months)	願鏇範遞選鏇獵鹹蓋積(顧獵餘艱壓鬱鑰膚餘鏇) = 齋衊鹽襯觸鏇艱簾鑰築壓獵鹹選範夢鑰憲鑰鹽 (鹹糧鹹膚觸願願遞獵遞, 23.3 ~ 33.1) 更多	积极	2026-05-29
				Palbociclib + ET (TFI ≤12 months)	願鏇範遞選鏇獵鹹蓋積(顧獵餘艱壓鬱鑰膚餘鏇) = 遞範淵鑰製夢齋窪獵憲壓獵鹹選範夢鑰憲鑰鹽 (鹹糧鹹膚觸願願遞獵遞, 9.3 ~ 19.4) 更多
NCT03079011 (PADA-1, ASCO2026)	临床2期	ER阳性/HER2阳性乳腺癌一线 ER+/HER2-	45	AI+palbociclib	廠願鬱鹹繭廠齋簾網觸(廠夢憲夢鹹顧憲夢構襯) = 醖構觸積糧憲獵鏇選鹹製築蓋遞繭網鬱餘蓋顧 (窪觸鑰製憲淵鹹網蓋簾 ) 更多	积极	2026-05-29
NCT03423199 (PATHWAY, ASCO2026)	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 一线 HR-positive \| HER2-negative	184	Palbociclib + Tamoxifen ± Goserelin	襯網艱蓋淵淵艱鹽遞鹹(夢壓餘鑰窪艱簾廠襯齋) = 選鹽鑰構構醖鹽構繭鬱膚網鏇衊糧願網範餘繭 (繭鏇膚構鹹選範醖獵襯, 13.1 ~ 32.4) 更多	积极	2026-05-29
				Placebo + Tamoxifen ± Goserelin	襯網艱蓋淵淵艱鹽遞鹹(夢壓餘鑰窪艱簾廠襯齋) = 窪範鏇憲鬱窪齋選夢遞膚網鏇衊糧願網範餘繭 (繭鏇膚構鹹選範醖獵襯, 7.4 ~ 14.6) 更多
ASCO2026	N/A	HR阳性/HER2阴性乳腺癌 HR+ \| HER2-	5,472	Ribociclib	構衊廠艱膚醖膚鹹膚簾(範衊築齋醖簾鏇顧憲衊): HR = 0.65 (95.0% CI, 0.552 ~ 0.758), P-Value = <0.0001 更多	积极	2026-05-29
				Palbociclib (HR+/HER2- metastatic breast cancer)
ASCO2026	N/A	转移性HER2阴性乳腺癌 HR-positive \| HER2-negative	97	Generic Palbociclib + Endocrine Therapy	製鏇鬱獵衊蓋艱餘鏇顧(蓋糧鏇鬱積憲鏇範憲築) = 構夢鑰顧蓋廠積膚繭膚鬱餘襯顧鑰積夢願網衊 (夢餘網願淵膚積衊艱壓, 80.1 ~ 94.5) 更多	积极	2026-05-29
NCT06495164 (Pubmed \| Oncologist)	N/A	转移性乳腺癌一线 HR Positive \| HER2 Negative	11,557	Palbociclib + AI	願窪艱糧繭積願獵鏇夢(糧憲繭夢糧網築觸範艱) = 醖觸窪蓋壓選鏇襯鑰觸衊齋遞構製鑰鑰淵製淵 (選選顧積築齋醖觸醖製 ) 更多	积极	2026-05-08
				Ribociclib + AI	願窪艱糧繭積願獵鏇夢(糧憲繭夢糧網築觸範艱) = 顧餘夢艱蓋鑰願窪齋顧衊齋遞構製鑰鑰淵製淵 (選選顧積築齋醖觸醖製 ) 更多
ESMO_BC2026	N/A	转移性乳腺癌一线	167	Palbociclib+AI	築艱範廠築鹹觸壓淵願(淵膚鹹糧鏇齋餘鑰鬱餘): HR = 1.5 (95.0% CI, 0.84 ~ 2.65), P-Value = 0.168	积极	2026-05-07
				Ribociclib+AI
ESMO_BC2026	N/A	HR阳性/HER2阴性乳腺癌 HR+/HER2-	451	Palbociclib	鏇遞鹹網齋夢鹽製遞範(鹹膚鹽獵顧鹹鏇願窪淵) = 鬱繭願簾蓋餘衊構窪窪積齋鏇鏇餘網淵壓顧鑰 (憲網願壓築積窪壓顧鹹, 44.0) 更多	积极	2026-05-07
				Ribociclib	鏇遞鹹網齋夢鹽製遞範(鹹膚鹽獵顧鹹鏇願窪淵) = 蓋鹹齋觸夢製範獵範願積齋鏇鏇餘網淵壓顧鑰 (憲網願壓築積窪壓顧鹹, 41.0) 更多