A Prospective, Multicenter, Open-Label, Randomized, Comparative, Phase 4 Trial to Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.

开始日期2025-08-14

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT06658093

/ Not yet recruiting早期临床1期IIT

RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK/PD Study of mTOR Inhibition in Older Human Subjects

As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.

开始日期2025-08-01

申办/合作机构

University of Texas Health Science Center At San Antonio

[+1]

NCT06972758

/ Not yet recruiting临床2期IIT

A Phase II Study of EVEerolimus as Adjuvant Therapy After Surgical Resection for Hepatocellular cArcinoma at High Risk of RecurreNCE [SEVERANCE Trial]

"Hepatic resection is the primary curative treatment for patients with a single, liver-confined hepatocellular carcinoma (HCC) without cirrhosis and is also considered in patients with cirrhosis if residual liver function is sufficient. Despite curative resection, HCC has a high recurrence rate, with 5-year recurrence reported in approximately 50-70% of patients. Notably, in cases with microvascular invasion, the 2-year recurrence rate reaches 55-75%. As early recurrence strongly impacts overall survival, there is a critical need for effective adjuvant therapies; however, no adjuvant treatment has yet been established or officially recommended.
Everolimus is an mTOR inhibitor that has both immunosuppressive and antitumor effects. Approximately half of HCC cases exhibit activation of the mTOR pathway. In liver transplant recipients, everolimus is used as an immunosuppressive agent and has been associated with reduced recurrence and improved survival, particularly in patients with elevated tumor markers prior to transplantation. Preclinical studies at our institution have shown that mTOR inhibitors may be more effective in preventing tumor development than in treating established tumors, suggesting a potential benefit for everolimus in an adjuvant setting.
To date, no clinical trials have assessed the efficacy of everolimus as adjuvant therapy after curative hepatic resection, especially in high-risk HCC characterized by microvascular invasion or satellite nodules. This study aims to evaluate the efficacy and safety of everolimus (Certirobell®) as adjuvant therapy in high-risk HCC patients following curative resection.
This is a single-center, single-arm Phase II trial conducted at Severance Hospital. A total of 60 patients with pathologically confirmed HCC who underwent R0 resection and exhibit high-risk features for recurrence will be enrolled. Everolimus will be administered orally, twice daily for 92 weeks, starting 4 to 6 weeks postoperatively. Initial dosing will be 1.0 mg twice daily, adjusted to 0.75 mg for patients with a Child-Pugh score of 6. Dosage adjustments will be made based on everolimus trough levels, targeting 3-8 ng/mL. Treatment will be discontinued upon confirmation of HCC recurrence.
The primary endpoint is 2-year recurrence-free survival (RFS). Secondary endpoints include 1-year RFS, 2-year recurrence rate, overall survival (OS), time to recurrence, and safety outcomes.
An interim analysis will be conducted after the first 30 patients have been enrolled and followed for 2 years. Based on the interim assessment of efficacy or futility, the study will either be terminated early or proceed with enrollment of an additional 30 patients.

开始日期2025-07-01

申办/合作机构

Yonsei University

100 项与依维莫司相关的临床结果

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100 项与依维莫司相关的转化医学

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100 项与依维莫司相关的专利（医药）

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8,551

项与依维莫司相关的文献（医药）

2025-12-01·IMMUNOLOGIC RESEARCH

RAD001-mediated mTOR targeting in human monocyte-derived dendritic cells shifts them toward an immunogenic phenotype

Article

作者: Masoumi, Javad ; Hatami-Sadr, Amirhossein ; Baradaran, Behzad ; Hemmat, Nima ; Alipour, Shiva ; Alizadeh, Nazila ; Vaysi, Edris ; Naseri, Bahar

Dendritic cells (DCs) are essential for promoting T lymphocyte responses since they are specialist antigen-presenting cells. In order to maintain tolerance or initiate immune responses, DCs must be activated in a balanced and regulated manner via diverse signaling pathways. By using a variety of pharmacological components, we can interfere with their different signaling pathways such as the mammalian target of rapamycin (mTOR) to appropriately modulate DC activity. In the current study, we administered RAD001 to DCs to examine the impact of mTOR inhibition on both the maturation stage and the expression of inflammatory and anti-inflammatory molecules in DCs. Pure monocytes were cultivated and stimulated with GM-CSF and IL-4 to generate immature DCs, which were then treated with RAD001. The phenotype of the DCs was determined by labeling surface markers and analyzing them using flow cytometry. Afterward, real-time PCR was carried out to evaluate the expression of inflammatory and anti-inflammatory genes. The administration of RAD001 to DCs led to a significant upregulation in the gene expression of inflammatory molecules such as IL-12, IL-1β, tumor necrosis factor (TNF)-α, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-KB). Conversely, RAD001 treatment resulted in a decrease in the gene expression of anti-inflammatory factors IL-10 and indoleamine 2,3-dioxygenase (IDO). However, the expression of differentiation and antigen presentation-related markers CD11c and human leukocyte antigens (HLA)-DR in RAD001-treated DCs was lower and higher compared to the control group that did not receive the treatment, respectively. Taken together, our findings indicated that RAD001 treatment of DCs can be a promising therapeutic approach for the generation of immunogenic DCs in order to barricade tumor growth. However, there is a need for further investigation to evaluate the impacts of mTOR inhibition by RAD001 in DCs on cellular immune responses in vitro and in vivo.

2025-08-01·CELLULAR SIGNALLING

MTDH∆7-mediated mTOR activation drives doxorubicin resistance in triple-negative breast cancer: Relevance of mTORC1 inhibition on chemosensitization

Article

作者: Kotamraju, Srigiridhar ; Neeli, Praveen Kumar ; Pulipaka, Sriravali ; Kumari, Sunita ; Chandra, Yogesh ; Sahoo, Shashikanta ; Annamaneni, Sandhya ; Kuncha, Madhusudana

Cancer chemoresistance poses a major hurdle in the management of several cancers, including breast cancer. Herein, we identified MTDH∆7, a splice variant of an oncogene, metadherin (MTDH), promotes doxorubicin (Dox)-induced chemoresistance in triple-negative breast cancer (TNBC) cells. Increased MTDH∆7 levels were positively correlated with the elevated levels of ABC transporters like ABCB1, ABCC1, and ABCG2, which in turn caused reduced intracellular Dox accumulation. Interestingly, everolimus, an mTORC1 inhibitor, potentiated Dox-induced cytotoxicity by inhibiting MTDH∆7-mediated increase in the aforementioned ABC transporters. Moreover, MTDH∆7 overexpression increased mTORC1 levels, possibly due to MTDH∆7-induced accentuation of mitochondrial respiration, ATP production, and AMPK inactivation. Mechanistically, enhanced phosphorylation of mTORC1 caused NF-κB-dependent activation of cAMP-regulatory element-binding protein (CREB). Further, activated CREB led to an increase in the levels of ABCB1, ABCC1, and ABCG2. Inhibition of either mTORC1 by everolimus or NF-κB by BAY-11-7082 or CREB by H89 reversed these effects and mitigated MTDH∆7-mediated Dox efflux. Accordingly, while Dox administration alone marginally caused tumor regression in SCID mice bearing LV.MTDH∆7-MDA-MB-231 cells, administration of everolimus greatly sensitized these mice to Dox-induced tumor regression. In agreement, intriguingly, a positive correlation was observed between elevated MTDH∆7, mTORC1 activation, and ABC transporters level in human breast cancer patient cohort tumor samples. Collectively, MTDH∆7, by promoting mTOR signaling causes breast cancer chemoresistance, and that targeting MTDH∆7-mTOR signaling axis effectively enhances chemosensitization.

2025-07-01·PEDIATRIC NEUROLOGY

Long-Term Efficacy and Safety of Mammalian Target of Rapamycin Inhibitor Treatment for Subependymal Giant Cell Astrocytoma in Tuberous Sclerosis

Article

作者: Becker, Lena-Luise ; Ritter, David M ; Agricola, Karen ; Krueger, Darcy A ; Franz, David Neal ; Caré, Marguerite M

BACKGROUND:

Subependymal giant cell astrocytoma (SEGA) is a low-grade astrocytoma occurring in approximately 5%-20% of persons affected with tuberous sclerosis complex (TSC). Therapy options include surgical resection or medical treatment with mammalian target of rapamycin (mTOR) inhibitors ([mTORis] everolimus or sirolimus) to prevent further growth and neurosurgical interventions due to life-threatening hydrocephalus. Short-term follow-up of mTORi treatment has been described in earlier studies; however, data on long-term efficacy and safety are limited.

METHODS:

Patients from SEGA studies at Cincinnati Children's Hospital Medical Center with ongoing care at our center and consented to ongoing retrospective records collection were included in the study. Data was compiled from medical records.

RESULTS:

Our cohort consisted of 25 patients with TSC. All but one were currently receiving mTORi treatment with either sirolimus (N = 4, 20%) or everolimus (N = 20, 80%) at the time of evaluation. Median mTORi treatment duration was 15.5 years (range: 9.8-16.8 years, interquartile range: 0.9 years). One patient underwent SEGA resection after starting mTORi. None required cerebrospinal fluid diversion. In 19 patients (76%), SEGA was stable or decreased over time. In six patients, it increased slightly from pretreatment baseline. Ongoing adverse drug reactions (ADR) at their last visit were reported in the medical record of eight patients (33%) with intermittent aphthous ulcers being the most frequent (N = 7). Long-term ADRs were observed in 17 patients (68%), including hypercholesterolemia (N = 10), diabetes mellitus type 2 (N = 6), prediabetes (N = 1), hypertension (N = 6), and osteoporosis (N = 3).

CONCLUSIONS:

Long-term TSC-associated SEGA treatment with mTORi is safe, effective and well tolerated. Knowledge of adverse reactions is important for successful long-term therapy.

662

项与依维莫司相关的新闻（医药）

15 小时之前

·医药观澜

速递丨信达生物「信迪利单抗」+和黄医药「呋喹替尼」癌症联合疗法新适应症申报上市

6月5日，和黄医药和信达生物联合宣布，呋喹替尼（fruquintinib）和信迪利单抗（sintilimab）联合疗法用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性的肾细胞癌患者的新药上市申请已获中国国家药品监督管理局（NMPA）受理。FRUSICA-2研究的数据支持了此项新药上市申请。FRUSICA-2是一项随机、开放标签、阳性对照的注册研究，旨在评估呋喹替尼和信迪利单抗联合疗法对比阿昔替尼（axitinib）或依维莫司（everolimus）单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。该研究已达到盲态独立中心阅片（BICR）根据RECIST 1.1标准评估的无进展生存期（"PFS"）的主要终点。该联合疗法亦在包括客观缓解率（"ORR"）和缓解持续时间（"DoR"）在内的次要终点上亦取得改善。安全性特征可耐受，亦没有观察到新的安全信号。FRUSICA‑2研究的数据将提交于近期的学术会议上发表。呋喹替尼和信迪利单抗的联合疗法于2024年12月取得NMPA附条件批准，用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。该批准是基于FRUSICA-1研究的数据。呋喹替尼和信迪利单抗联合疗法的一项1b/2期概念验证研究结果于2025年1月在《靶向肿瘤学》（Targeted Oncology）期刊发表。该联合疗法在此类疾病中展示出了良好的疗效和可耐受的安全性。至数据截止日2024年10月9日，该研究中所有20例入组的经治患者均可评估疗效，中位随访时间为45.7个月。确认的ORR为60.0%，DCR为85.0%。中位DoR为13.9个月，中位PFS为15.9个月。中位总生存期（OS）尚未达到，36个月的OS率为58.3%。参考资料：[1]和黄医药与信达生物宣布呋喹替尼联合信迪利单抗用于治疗晚期肾细胞癌的中国新药上市申请获受理. From https://www.prnasia.com/story/491801-1.shtml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。

临床结果上市批准

2025-06-05

·Insight数据库

信达生物「信迪利单抗」+和黄医药「呋喹替尼」联合疗法新适应症国内报上市

6 月 5 日，信达生物与和黄医药联合宣布，信迪利单抗和呋喹替尼联合疗法用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性的肾细胞癌患者的新药上市申请已获 NMPA 受理。截图来源：企业公告此次上市申请是基于 FRUSICA-2 研究的数据。FRUSICA-2 是一项随机、开放标签、阳性对照的注册研究，旨在评估信迪利单抗和呋喹替尼联合疗法对比阿昔替尼或依维莫司单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。结果显示，该研究已达到盲态独立中心阅片（BICR）根据 RECIST 1.1 标准评估的 PFS 的主要终点。该联合疗法亦在包括 ORR 和 DoR 在内的次要终点上亦取得改善。安全性特征可耐受，亦未观察到新的安全性信号。该研究的数据将提交于近期的学术会议上发表。信迪利单抗是信达生物制药和礼来公司共同合作研发及商业化的创新 PD-1 抑制剂药物。目前信迪利单抗的 2 项新药上市申请正在 NMPA 审评中，包括：联合伊匹木单抗用于可切除的微卫星高度不稳定型（MSI-H）/错配修复缺陷（dMMR）结肠癌患者的新辅助治疗；联合呋喹替尼用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性肾细胞癌患者。截图来源：Insight 数据库呋喹替尼是血管内皮生长因子受体（VEGFR）-1、-2 和-3 的选择性口服抑制剂。在中国，呋喹替尼由和黄医药及礼来公司合作研发和商业化，武田拥有在中国内地、香港和澳门以外进一步开发、商业化和生产呋喹替尼的全球独家许可。截图来源：Insight 数据库值得一提的是，信迪利单抗和呋喹替尼的联合疗法已于 2024 年 12 月取得 NMPA 附条件批准，用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。如本次上市申请成功获批，将成为该联合疗法获批的第 2 项适应症。封面来源：站酷海洛免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccaiPR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn

2025-06-05

·美通社

和黄医药与信达生物宣布呋喹替尼联合信迪利单抗用于治疗晚期肾细胞癌的中国新药上市申请获受理

香港、上海和新泽西州弗洛勒姆公园 2025年6月5日 /美通社/ -- 和黄医药（中国）有限公司（简称" 和黄医药 "或"HUTCHMED"）（纳斯达克/伦敦证交所：HCM；香港交易所：13）和信达生物制药集团（Innovent Biologics, Inc.，简称"信达生物"或"Innovent"）今日联合宣布呋喹替尼（fruquintinib）和信迪利单抗（sintilimab）联合疗法用于治疗既往接受过一种酪氨酸激酶抑制剂治疗失败的局部晚期或转移性的肾细胞癌患者的新药上市申请已获中国国家药品监督管理局（"国家药监局"）受理。 FRUSICA-2研究的数据支持了此项新药上市申请。FRUSICA-2是一项随机、开放标签、阳性对照的注册研究，旨在评估呋喹替尼和信迪利单抗联合疗法对比阿昔替尼（axitinib）或依维莫司（everolimus）单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。该研究已达到盲态独立中心阅片（BICR）根据RECIST 1.1标准评估的无进展生存期（"PFS"）的主要终点。该联合疗法亦在包括客观缓解率（"ORR"）和缓解持续时间（"DoR"）在内的次要终点上亦取得改善。安全性特征可耐受，亦没有观察到新的安全信号。FRUSICA‑2研究的数据将提交于近期的学术会议上发表。该项研究的其他详情可登录clinicaltrials.gov，检索注册号 NCT05522231 查看。和黄医药研发负责人兼首席医学官石明博士表示："肾癌在中国仍是一项重大挑战，对于一线治疗失败的患者而言，治疗选择十分有限。此次提交呋喹替尼联合信迪利单抗用于晚期肾细胞癌的新药上市申请，是我们解决这一未被满足医疗需求的重要一步。我们致力推动这一联合疗法惠及肾细胞癌患者。与此同时，我们将持续研究以挖掘该联合疗法更大的潜力，并推进我们管线中其他产品在多个癌症领域的应用，为更多患者带来创新且有效的治疗选择。" 信达生物高级副总裁周辉博士表示："很高兴看到信迪利单抗联合呋喹替尼的第二项新药上市申请获受理，有望为中国晚期肾细胞癌患者提供更有效二线治疗选择。这也是信迪利单抗（达伯舒®）的第10 项受理的新药上市申请，进一步巩固了其作为免疫肿瘤（IO）治疗的基石药物的领先地位，同时也是信达生物对于该品种在生命周期管理和最大化其临床价值方面的重要里程碑。" 呋喹替尼和信迪利单抗的联合疗法于2024年12月取得国家药监局附条件批准，用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。该批准是基于FRUSICA-1研究的数据（ NCT03903705 ）。关于肾癌及肾细胞癌 2022年全球估计约新增43.5万例肾癌患者。 [1] 在中国，2022年估计新增7.4万例肾癌患者。 [2] 在所有肾癌病例中，肾细胞癌约占90%。关于呋喹替尼呋喹替尼是一种针对所有三种血管内皮生长因子受体（"VEGFR"）-1、-2和-3的选择性口服抑制剂。 VEGFR抑制剂在抑制肿瘤的血管生成中起到至关重要的作用。呋喹替尼被设计为拥有更高的激酶选择性，旨在降低脱靶激酶活性，从而实现药物暴露、对靶点的持续覆盖以及当潜在作为联合疗法时拥有更高的灵活度。 [3] 关于呋喹替尼获批在中国，呋喹替尼由和黄医药及礼来公司合作研发和商业化，并以商品名爱优特®（ELUNATE®）上市。呋喹替尼已于中国获批用于既往接受过氟尿嘧啶类、奥沙利铂和伊立替康为基础的化疗，以及既往接受过或不适合接受抗血管内皮生长因子（"VEGF"）治疗、抗表皮生长因子受体（"EGFR"）治疗（RAS野生型）的转移性结直肠癌患者。其于2020年1月获纳入中国国家医保药品目录。自呋喹替尼在中国上市以来已惠及超过10万名结直肠癌患者。爱优特®（呋喹替尼）和达伯舒®（信迪利单抗注射液）的联合疗法已于中国获附条件批准用于既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）子宫内膜癌患者。武田拥有在中国内地、香港和澳门以外进一步开发、商业化和生产呋喹替尼的全球独家许可，并以商品名FRUZAQLA®上市销售。呋喹替尼已于美国、欧洲、日本及全球其他多个国家获批用于治疗经治的转移性结直肠癌。呋喹替尼用于以下研究用途的安全性及疗效尚不明确，不能保证其将在任何国家的研究用途能获得卫生部门批准或商业上市关于呋喹替尼用于二线治疗肾细胞癌目前单药靶向疗法仍然是中国晚期肾细胞癌一线治疗的主要选择之一。然而，对于既往单药靶向疗法失败的晚期肾细胞癌患者，仍然存在未被满足的医疗需求。呋喹替尼和信迪利单抗联合疗法的一项Ib/II期概念验证研究结果于2025年1月在《靶向肿瘤学（Targeted Oncology）》期刊发表。该联合疗法在此类疾病中展示出了良好的疗效和可耐受的安全性。至数据截止日2024年10月9日，该研究中所有20例入组的经治患者均可评估疗效，中位随访时间为45.7个月。确认的ORR为60.0%，DCR为85.0%。中位DoR为13.9个月，中位PFS为15.9个月。中位总生存期（OS）尚未达到，36个月的OS率为58.3%。 [4] 关于信迪利单抗信迪利单抗，中国商品名为达伯舒®（信迪利单抗注射液），是信达生物制药和礼来公司共同合作研发及商业化的创新PD-1 免疫球蛋白G4（IgG4）单克隆抗体，能特异性结合T细胞表面的PD-1分子，从而阻断导致肿瘤免疫耐受的 PD-1/ PD-L1通路，重新启动淋巴细胞的抗肿瘤活性，从而达到治疗肿瘤的目的。 [5] 信迪利单抗已在中国获批并纳入新版国家医保目录七项适应症，协议期内医保目录描述的限定支付范围包括：至少经过二线系统化疗的复发或难治性经典型霍奇金淋巴瘤的治疗；表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶(ALK)阴性、不可手术切除的局部晚期或转移性非鳞状非小细胞肺癌的一线治疗；表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗失败的 EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌患者的治疗；不可手术切除的局部晚期或转移性鳞状非小细胞肺癌的一线治疗；既往未接受过系统治疗的不可切除或转移性肝细胞癌的一线治疗；不可切除的局部晚期、复发或转移性食管鳞癌的一线治疗；不可切除的局部晚期、复发或转移性胃及胃食管交界处腺癌的一线治疗。此外，信迪利单抗的第八项适应症，即与呋喹替尼的联合疗法用于治疗既往系统性抗肿瘤治疗后失败且不适合进行根治性手术治疗或根治性放疗的晚期错配修复完整（pMMR）的子宫内膜癌患者的新药上市申请已于2024年12月取得国家药监局附条件批准。目前，信迪利单抗的两项新药上市申请正在国家药监局审评中，包括：信迪利单抗联合伊匹木单抗用于可切除的微卫星高度不稳定型（MSI-H）/错配修复缺陷（dMMR）结肠癌患者的新辅助治疗，正在国家药监局审评中，并获纳入优先审评；信迪利单抗联合呋喹替尼用于治疗既往接受过TKI治疗失败的局部晚期或转移性肾细胞癌患者。另外，信迪利单抗的两项临床试验达到研究终点，包括：单药用于晚期/转移性食管鳞癌二线治疗的II期临床研究；单药用于含铂化疗失败的晚期鳞状非小细胞肺癌二线治疗的III期临床研究。声明：信达不推荐任何未获批的药品 / 适应症使用。关于和黄医药和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问： www.hutch‑med.com 或关注我们的领英专页。关于信达生物 "始于信，达于行"，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。信达生物已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®）, 氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在国家药监局审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。信达生物已与礼来、罗氏、赛诺菲、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守"以患者为中心"，心系患者并关注患者家庭，积极履行社会责任。信达生物陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问信达生物网站： www.innoventbio.com 或信达生物领英账号 www.linkedin.com/company/innovent-biologics/ 。声明：信达生物不推荐未获批的药品 / 适应症的使用雷莫西尤单抗注射液（希冉择 ® ）、塞普替尼胶囊（睿妥 ® ）和匹妥布替尼片（捷帕力 ® ）由礼来公司研发。前瞻性陈述本新闻稿包含 1995 年《美国私人证券诉讼改革法案》 " 安全港 " 条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对呋喹替尼与信迪利单抗联合疗法用于治疗晚期肾细胞癌患者的治疗潜力的预期，以及呋喹替尼与信迪利单抗联合疗法针对此适应症及其他适应症的进一步临床研究计划。前瞻性陈述涉及风险和不确定性。此类风险和不确定性包括下列假设：支持呋喹替尼与信迪利单抗联合疗法在中国或其他地区获批用于治疗晚期肾细胞癌患者的新药上市申请的数据充足性、获得监管部门快速审批或审批的潜力、呋喹替尼的安全性、和黄医药为呋喹替尼与信迪利单抗联合疗法进一步临床开发计划及商业化提供资金并实现及完成的能力，以及此类事件发生的时间。此外，由于部分研究赖于把其他药物产品如信迪利单抗与呋喹替尼联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、 AIM 以及香港联合交易所有限公司提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。 [1] The Global Cancer Observatory, kidney cancer fact sheet. https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf . Accessed February 19, 2025. [2] The Global Cancer Observatory, China fact sheet. https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/populations/160-china-fact-sheet.pdf . Accessed February 19, 2025. [3] Sun Q, et al. Discovery of fruquintinib, a potent and highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy. Cancer Biol Ther . 2014;15(12):1635-45. doi: 10.4161/15384047.2014.964087. [4] Xu H, et al. Fruquintinib Plus Sintilimab in Patients with Treatment‑Naïve and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Targeted Oncolog y. 2025; 20:113–125. doi.org/10.1007/s11523-024-01120-6. [5] Wang J, et al . Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. doi: 10.1080/19420862.2019.1654303.

申请上市

100 项与依维莫司相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02714	依维莫司	L04AA18 L01XE10	DB01590

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
癫痫	美国	Novartis Pharmaceuticals Corp.	2021-12-30
癫痫部分性发作	美国	Novartis Pharmaceuticals Corp.	2018-04-10
结节性硬化症相关的肾血管平滑肌脂肪瘤	中国	Novartis Pharma AG	2016-12-12
复发性乳腺癌	日本	Novartis Pharma AG	2014-03-17
胰神经内分泌瘤	中国	Novartis Pharma AG	2014-02-01
室管膜下巨细胞星形细胞瘤	中国	Novartis Pharma AG	2014-02-01
HR阳性/HER2阴性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2012-07-20
胃肠胰神经内分泌肿瘤	日本	Novartis Pharma AG	2011-12-22
结节性硬化症	欧盟	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	冰岛	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	列支敦士登	Novartis Europharm Ltd.	2011-09-02
结节性硬化症	挪威	Novartis Europharm Ltd.	2011-09-02
星形细胞瘤	美国	Novartis Pharmaceuticals Corp.	2010-10-29
血管平滑肌脂肪瘤	加拿大	Novartis Pharmaceuticals Canada, Inc.	2010-03-15
HR阳性乳腺癌	欧盟	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	冰岛	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	列支敦士登	Novartis Europharm Ltd.	2009-08-02
HR阳性乳腺癌	挪威	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	欧盟	Novartis Europharm Ltd.	2009-08-02
神经内分泌肿瘤	冰岛	Novartis Europharm Ltd.	2009-08-02

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
癫痫发作	临床3期	美国	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	日本	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	澳大利亚	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	比利时	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	加拿大	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	哥伦比亚	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	法国	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	匈牙利	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	意大利	Novartis Pharmaceuticals Canada, Inc.	2017-06-08
癫痫发作	临床3期	墨西哥	Novartis Pharmaceuticals Canada, Inc.	2017-06-08

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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


NCT03697408 (CTgov)	临床1/2期	复发性经典霍奇金淋巴瘤 \| 典型霍奇金淋巴瘤	23	Itacitinib+Everolimus (Cohort 1 (Starting Dose))	夢構鏇醖鏇網齋蓋醖鬱 = 網鹹廠壓積醖廠衊醖構積選遞壓願範餘積鬱顧 (夢積醖醖獵選觸鬱鹹膚, 鹹衊廠鹽積鑰窪齋膚遞 ~ 艱衊築鏇選獵選範簾遞) 更多	-	2025-05-30
				Itacitinib+Everolimus (Cohort -1)	廠獵襯簾範鏇鑰製衊窪(鹹夢衊廠遞繭製鹽鬱選) = 選選鏇鏇鑰積鑰鏇觸廠夢繭糧壓網觸齋鏇繭壓 (鬱膚憲憲製醖淵鹹艱蓋, 鏇觸憲鬱鹽膚憲餘觸顧 ~ 獵鹽構淵願觸選膚蓋蓋) 更多
ESMO_ELCC2025	临床2期	胸腺上皮肿瘤二线	37	Everolimus	壓顧遞鬱築觸窪糧夢網(淵夢淵鑰構鏇壓鏇鬱範) = occurring in 8 (21.6%) pts 鏇窪顧憲醖餘餘構簾築 (鑰顧廠選餘衊窪遞製遞 ) 更多	积极	2025-03-26
NCT03032406 (CTgov)	临床2期	复发性乳腺癌	53	hydroxychloroquine (HCQ Alone (Arm A))	鬱齋製廠鏇獵鏇膚襯憲 = 淵積襯遞膚製襯廠壓衊顧淵糧淵鑰齋願憲獵艱 (鑰鏇獵廠壓憲遞鹽膚壓, 壓築襯糧衊構鹽廠襯膚 ~ 遞構簾製憲鹽鏇廠夢鬱) 更多	-	2025-03-05
				everolimus (EVE Alone (Arm B))	鬱齋製廠鏇獵鏇膚襯憲 = 窪齋鬱蓋衊淵願鏇淵醖顧淵糧淵鑰齋願憲獵艱 (鑰鏇獵廠壓憲遞鹽膚壓, 襯艱窪構衊範夢鏇蓋選 ~ 遞獵顧顧壓築淵觸顧窪) 更多
NCT02991807 (CTgov)	临床1/2期	PTEN 错构瘤综合征	46	RAD001 (RAD001)	範製構築鑰齋鏇鹹憲遞 = 簾選顧積壓膚製夢遞鹽齋淵艱餘憲夢願遞壓餘 (觸簾觸觸淵簾餘鏇顧遞, 顧糧蓋製襯襯鏇醖餘襯 ~ 鏇壓範網觸醖壓簾衊鏇) 更多	-	2025-02-17
				Placebo (Placebo)	範製構築鑰齋鏇鹹憲遞 = 顧構願醖製醖顧鏇淵廠齋淵艱餘憲夢願遞壓餘 (觸簾觸觸淵簾餘鏇顧遞, 積廠築鬱蓋構淵鏇獵廠 ~ 網壓膚糧窪襯憲鬱衊顧) 更多
NCT02842749 (CTgov)	临床4期	胰腺神经内分泌肿瘤	61	Everolimus (Everolimus)	範獵築構夢膚餘齋構遞 = 蓋衊築遞窪築製鹽襯蓋糧製憲築構範鑰鑰淵獵 (積簾淵廠觸遞糧壓廠蓋, 廠鏇壓窪積齋鹹製鬱構 ~ 衊繭衊壓願鏇衊顧製簾) 更多	-	2025-02-10
				Everolimus (Everolimus-on Treatment)	構顧淵壓膚壓廠艱齋蓋(窪餘觸鹽壓構構鬱構製) = 顧艱簾憲願襯築夢築鏇顧憲憲襯選獵艱構齋構 (積選積製夢獵範廠廠鬱, 膚製醖觸築構觸蓋鹽壓 ~ 願積獵夢選鬱蓋遞醖構) 更多
NCT03070301 (CTgov)	临床2期	晚期神经内分泌肿瘤	21	LEE011+Everolimus	顧齋選窪夢鑰憲餘網鬱 = 艱襯觸膚鹹製遞蓋願鹽築壓淵襯鑰遞築衊鑰夢 (顧構網壓廠夢網遞鹽觸, 憲艱餘鏇鏇鹽齋築製網 ~ 鑰鏇齋壓廠顧簾醖襯簾) 更多	-	2024-10-10
NCT01678664 (EVACEL \| FFCD 1104-EVACEL-GTE, CTgov)	临床2期	内分泌腺肿瘤 \| 肝转移 \| 神经内分泌肿瘤	74	embolization+Doxorubicin+Everolimus	鹽顧憲觸膚鬱窪願蓋夢(窪範壓壓網製艱糧憲獵) = 顧選鹽選蓋積顧觸網齋繭窪膚鏇鹹鬱鑰顧窪願 (廠鬱衊顧淵鹽範鹹築觸, 顧鹽鑰願艱繭衊壓鏇鹽 ~ 顧鏇膚餘衊蓋鏇壓選壓) 更多	-	2024-09-25
EVERGREEN (ESMO2024)	N/A	ER阳性/HER2阴性乳腺癌 PIK3CA-AKT1-PTEN pathway alterations	207	Everolimus-based endocrine therapy (EVE)	鬱遞鏇範糧醖願願齋淵(鑰觸膚製廠繭選製鹹鬱) = 夢壓鬱築遞艱鬱糧網襯廠憲築廠網夢範鬱願積 (鏇選鬱觸襯願簾願鹹網 ) 更多	不佳	2024-09-16
				Endocrine therapy alone (ETa)	鬱遞鏇範糧醖願願齋淵(鑰觸膚製廠繭選製鹹鬱) = 鑰襯製積網網壓廠選鬱廠憲築廠網夢範鬱願積 (鏇選鬱觸襯願簾願鹹網 ) 更多
ESMO2024	临床1期	晚期神经内分泌肿瘤	92	Everolimus 6.1 - 10mg	鏇選夢窪繭製鏇艱網衊(艱築衊鑰蓋遞壓憲網繭) = 餘鹽鹽鹽遞遞簾糧觸繭積築構觸製齋鹽簾夢獵 (齋鑰範衊窪觸顧淵鹽願, 3.7 ~ 32) 更多	积极	2024-09-16
				Everolimus 6mg or less	鏇選夢窪繭製鏇艱網衊(艱築衊鑰蓋遞壓憲網繭) = 願鑰壓蓋鬱鹽顧積壓選積築構觸製齋鹽簾夢獵 (齋鑰範衊窪觸顧淵鹽願, 3.9 ~ 27) 更多
NCT02338609 (EXIST-LT, CTgov)	临床4期	-	15	Everolimus	窪鏇齋壓獵製壓觸網壓 = 構網網獵淵糧鏇鑰膚醖鹹獵簾糧網襯艱製膚壓 (憲憲範窪艱願鹽鬱願衊, 壓獵壓鬱鏇膚襯構願餘 ~ 糧製窪糧範襯顧網觸積) 更多	-	2024-08-09