预约演示

更新于：2025-01-29

Temozolomide

替莫唑胺

更新于：2025-01-29

概要

基本信息

药物类型

小分子化药

别名

3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide、3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide、3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide

+ [26]

靶点

DNA

作用机制

DNA抑制剂(DNA抑制剂)、DNA烷化剂

治疗领域

肿瘤神经系统疾病皮肤和肌肉骨骼疾病+ [9]

在研适应症

尤文肉瘤脑恶性胶质瘤转移性恶性黑色素瘤+ [79]

非在研适应症

听神经瘤伴有 11q23 异常的急性髓系白血病肾上腺嗜铬细胞瘤+ [98]

原研机构

Merck Sharp & Dohme Corp.

在研机构

Sun Pharmaceutical Industries (Europe) BV

National Cancer InstituteAccord Healthcare SLU

+ [15]

非在研机构

Novartis AG

Hexal AG

Barbara Ann Karmanos Cancer Institute

+ [15]

最高研发阶段批准上市

首次获批日期

欧盟 (1999-01-26),

星形细胞瘤多形性胶质母细胞瘤胶质瘤

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)、孤儿药 (欧盟)、优先审评 (中国)

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结构/序列

分子式C6H6N6O2

InChIKeyBPEGJWRSRHCHSN-UHFFFAOYSA-N

CAS号85622-93-1

关联

1,030

项与替莫唑胺相关的临床试验

NCT06202066

/ Not yet recruiting临床2期IIT

A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Tumors (NETs)

This phase II trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67/M57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.

开始日期2025-06-15

申办/合作机构

Roswell Park Comprehensive Cancer Center

NCT06448286

/ Not yet recruiting临床3期IIT

PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma

This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

开始日期2025-06-01

申办/合作机构

Jonsson Comprehensive Cancer Center

NCT06681220

/ Not yet recruiting临床2期IIT

Biomarker Directed Trial of Temozolomide and PARP Inhibition in Relapsed SCLC

Randomized phase 2, multicenter, biomarker directed clinical trial to assess the efficacy of PARP inhibitor plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of PARP inhibitor plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of PARP inhibitor with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). Participants will be assigned to one of the two groups. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Niraparib plus Temozolomide (TMZ) or Lurbinectedin.

开始日期2025-06-01

申办/合作机构

VA Office of Research and Development

100 项与替莫唑胺相关的临床结果

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100 项与替莫唑胺相关的转化医学

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100 项与替莫唑胺相关的专利（医药）

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14,254

项与替莫唑胺相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

WT161, a selective HDAC6 inhibitor, decreases growth, enhances chemosensitivity, promotes apoptosis, and suppresses motility of melanoma cells

Article

作者: Castro-Gamero, Angel Mauricio ; Oliveira, Leilane Sales ; de Almeida Lima, Graziela Domingues ; Aissa, Alexandre Ferro ; Ionta, Marisa ; Fonseca, Rafael ; de Souza, Carlos Vinicius Expedito ; Oliveira-Silva, João Marcos ; Chiminazo, Carolina Berraut

PURPOSE:

Histone deacetylase 6 (HDAC6) plays a critical role in tumorigenesis and tumor progression, contributing to proliferation, chemoresistance, and cell motility by regulating microtubule architecture. Despite its upregulation in melanoma tissues and cell lines, the specific biological roles of HDAC6 in melanoma are not well understood. This study aims to explore the functional effects and underlying mechanisms of WT161, a selective HDAC6 inhibitor, in melanoma cell lines.

METHODS:

Cell proliferation was assessed using both 2D and 3D cell culture systems, including MTT assays, spheroid growth analyses, and colony formation assays. The interaction between WT161 and the chemotherapeutic agents temozolomide (TMZ) or dacarbazine (DTIC) was evaluated using the Chou-Talalay method. Apoptotic cell death was analyzed through flow cytometry, while migration, adhesion, and invasion assays were conducted to evaluate the motility capacities of melanoma cells. Western blot assays quantified α-tubulin acetylation (Lys40), PARP cleavage, and protein levels of β-catenin and E-cadherin.

RESULTS:

WT161 significantly reduced cell growth in both 2D and 3D cultures, decreased clonogenic capacity, and showed synergistic interactions with TMZ and DTIC. The inhibitor also induced apoptotic cell death and enhanced TMZ-induced apoptosis. Additionally, WT161 reduced cell migration and invasion while increasing cell adhesion. These effects were linked to changes in β-catenin and E-cadherin levels, depending on the specific cell type evaluated.

CONCLUSION:

Our study underscores the pivotal role of HDAC6 in melanoma progression, establishing it as a promising therapeutic target. We provide the first comprehensive evidence of WT161's anti-melanoma effects, setting the stage for further research into HDAC6 inhibitors as a potential strategy for melanoma treatment.

2025-04-01·COLLOIDS AND SURFACES B-BIOINTERFACES

Design of a versatile platform on nanostructured Ti-Mo-Zr alloy surface with photothermal, antibacterial and osteoinductive properties for biomedical application

Article

作者: Guo, Zhijun ; Yuan, Delin ; Huang, Yizhou ; Zhou, Xueke ; Xue, Mintao ; Cai, Bianyun

Bacterial infection and inadequate osseointegration represent significant challenges in the application of titanium (Ti)-based bone implants. Surface modification presents a promising strategy to address these obstacles. Taking advantage of silver ions, black phosphorus nanosheets (BPNs) and polydopamine (PDA), this study developed a versatile platform on the surface of Ti-12Mo-10Zr (TMZ) alloy through a multiple surface modification process, including the anodic oxidation treatment of TMZ alloy, the preparation and addition of silver-loaded BPNs (BPNs/Ag), and the coating with PDA. Our results demonstrated that silver enhanced the stability of BPNs/Ag, which were successfully loaded to the nanostructure of oxidized TMZ surface. PDA coating conferred a pH-responsive property to the surface, prolonged the release of silver ions, and improved the photothermal performance. In acidic conditions that mimic bone defect microenvironment, the platform exhibited good photothermal performance, accelerated Ag⁺ release, enhanced antibacterial efficacy, and increased osteoinductivity. Taken together, due to its advantageous characteristics, the versatile platform provides a valuable solution to improve the surface performance of TMZ alloys.

2025-03-01·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

Phytochemical strategies in glioblastoma therapy: Mechanisms, efficacy, and future perspectives

Review

作者: Sharma, Rajni ; Goyal, Shipra ; Chhabra, Ravindresh ; Baliyan, Deepanjali ; Singh, Baljinder

Glioblastoma (GBM) is foremost the most aggressive primary brain tumor, presenting extensive therapeutic challenges due to its high invasiveness, genetic complexity, and resistance to established treatments. Despite substantial advances in surgical and chemotherapeutic interventions, the median survival rate for patients is only 14.6 months, and the prognosis remains poor. This review focuses on the molecular hallmarks of GBM, including the activation of the PI3K/Akt pathway, genomic instability, and the deregulation of epidermal growth factor receptor (EGFR), all of which contribute to the tumor's aggressive behavior. Current therapies, such as Temozolomide and Bevacizumab, have limitations, highlighting the need for novel treatment strategies. Phytochemicals, bioactive compounds found in plants, have emerged as potential therapeutic agents by targeting multiple cellular pathways involved in GBM progression. This review provides an overview of key phytochemicals, including quercetin, curcumin, apigenin, and resveratrol. These compounds have shown promise in preclinical studies, with their anti-invasive, anti- angiogenic, pro-apoptotic, and anti-proliferative properties positioning them as strong candidates for GBM therapy. While phytochemicals offer a promising avenue for GBM treatment, further research is required to fully understand their mechanisms of action and to evaluate their efficiency in clinical settings. Developing multi-targeted, safer, and cost-effective anti-GBM therapies could significantly improve patient outcomes.

583

项与替莫唑胺相关的新闻（医药）

2025-01-29

·生物制品圈

癌症疫苗：平台介绍及进展

摘要：癌症疫苗作为免疫治疗的关键组成部分，分为预防性和治疗性两类。预防性疫苗（如HPV和HBV疫苗）通过阻断致癌病毒感染显著降低癌症发病率，而治疗性疫苗通过激活树突状细胞（DC）和细胞毒性T淋巴细胞（CTL）诱导持久的抗肿瘤免疫应答。近年来，合成肽、mRNA、DNA、细胞疫苗及纳米疫苗等平台的创新显著提升了抗原递送效率和免疫激活能力。尽管美国食品药品监督管理局（FDA）已批准多款疫苗，但由于肿瘤抗原异质性、免疫抑制微环境及递送系统优化等挑战，其治疗潜力尚未完全释放。本文系统综述了癌症疫苗的分类、新抗原发现、递送平台进展、佐剂作用机制及联合疗法的协同效应，并探讨了临床转化中的关键挑战与未来方向。癌症疫苗的研发始于19世纪末，William B. Coley观察到细菌毒素可诱导肿瘤消退，首次揭示了免疫系统与癌症的关系。20世纪80年代，BCG疫苗被用于膀胱癌治疗，成为首个获批的治疗性癌症疫苗。2010年，Sipuleucel-T的上市标志着个性化免疫治疗的突破。近年来，基因工程技术的进步（尤其是mRNA疫苗）在胶质母细胞瘤和黑色素瘤中展现出显著潜力。例如，靶向EB病毒的mRNA疫苗WGc-043和针对黑色素瘤的mRNA-4157已在临床试验中取得积极成果。然而，肿瘤抗原异质性、免疫抑制微环境及递送效率仍是主要挑战。图1 治疗性癌症疫苗的免疫反应机制描述：疫苗通过递送肿瘤抗原至DC，激活CTL和CD4+ Th1细胞，诱导肿瘤细胞杀伤。APC（抗原呈递细胞）通过MHC分子呈递抗原，触发T细胞受体（TCR）信号通路。预防性与治疗性疫苗预防性疫苗 HPV疫苗：覆盖HPV 16/18等高危亚型，降低宫颈癌、肛门癌及口咽癌发病率。临床数据显示，接种后宫颈癌前病变发生率下降60%-90%。需与常规细胞学筛查联合应用。 HBV疫苗：通过阻断乙肝病毒感染，降低肝细胞癌风险。全球范围内接种率提升使肝癌发病率显著下降。治疗性疫苗治疗性疫苗需满足以下关键特性：高效抗原递送：优先选择肿瘤特异性新抗原（如EGFRvIII、KRAS突变），避免自身免疫毒性。克服免疫抑制微环境：TME中的调节性T细胞（Treg）和髓源性抑制细胞（MDSC）可抑制DC功能，需联合佐剂（如TLR激动剂）增强DC活性。持续免疫记忆：通过激活记忆T细胞，防止肿瘤复发。肿瘤抗原的选择共享抗原（TAAs） TAAs在肿瘤和正常组织中均有表达，如CEA（结直肠癌）、PSA（前列腺癌）和MUC1（乳腺癌）。早期临床试验中，CEA疫苗在结直肠癌患者中诱导免疫应答，但疗效短暂。AFP肽疫苗在肝细胞癌中部分患者实现完全缓解，提示TAAs的潜力与局限性。肿瘤特异性抗原（TSAs） TSAs由肿瘤突变产生，如EGFRvIII（胶质母细胞瘤）、RAS突变（胰腺癌）及p53突变（多种实体瘤）。新抗原的筛选依赖于：全外显子测序（WES）和RNA测序：识别体细胞突变及表达水平。质谱技术（MS）：精确检测免疫肽段，减少预测算法误差。生物信息学工具：NetMHCpan等算法预测抗原与MHC结合亲和力。表1 新抗原疫苗临床案例疫苗平台1. 合成肽疫苗短肽疫苗（8-15氨基酸）：如gp100疫苗联合高剂量IL-2，客观缓解率（ORR）达42%。但需佐剂（如Poly-ICLC）增强免疫原性。长肽疫苗（20-30氨基酸）：如HPV E6/E7长肽疫苗在宫颈癌中耐受性良好，诱导强效T细胞应答。多价肽疫苗：NEO-PV-01联合PD-1抑制剂在黑色素瘤中ORR达35%，显著优于单药治疗。2. 核酸疫苗 DNA疫苗：INO-5401编码hTERT和WT1抗原，联合PD-1抑制剂在胶质瘤中延长生存期。 mRNA疫苗：mRNA-4157联合Pembrolizumab在黑色素瘤III期试验中降低44%复发风险。脂质纳米颗粒（LNP）递送系统提升稳定性，如BNT122在胰腺癌中激活多克隆T细胞。3. 细胞疫苗自体肿瘤细胞疫苗：GVAX通过分泌GM-CSF募集DC，但单药疗效有限。联合化疗或免疫检查点抑制剂可增强响应。 DC疫苗：Sipuleucel-T通过体外负载PAP抗原延长前列腺癌患者生存期（中位OS 25.8 vs 21.7个月）。DCVax-L负载肿瘤裂解物，在胶质瘤中5年生存率提升至13%。4. 病毒疫苗溶瘤病毒：T-VEC（表达GM-CSF）在黑色素瘤中客观缓解率25.2%，中位OS 41.1个月。病毒样颗粒（VLP）：VBI-1901靶向CMV抗原，在复发性胶质瘤中中位OS达12.9个月。5. 纳米疫苗脂质体/介孔二氧化硅：增强抗原递送至淋巴结，激活DC和CTL。如dClip-LNP/siRNA纳米疫苗通过沉默TIM-3增强抗肿瘤免疫。自组装纳米结构：CS-TEMPO-OVA纳米疫苗联合PD-1抑制剂抑制黑色素瘤转移。图2 纳米疫苗作用机制描述：纳米载体共递送抗原和佐剂至淋巴结，促进DC成熟及T细胞活化。佐剂的作用机制免疫刺激剂 TLR激动剂： TLR3激动剂（Poly-ICLC）诱导IFN-β和IL-12，增强抗原交叉呈递。 TLR4激动剂（MPL）激活NF-κB通路，促进Th1极化。细胞因子：IL-12和GM-CSF增强T细胞增殖，但需平衡疗效与毒性（如IL-2引发毛细血管渗漏综合征）。递送系统脂质纳米颗粒（LNP）：保护mRNA免受降解，如Moderna的mRNA-5671靶向KRAS突变。可降解聚合物（PLGA）：控释抗原，延长免疫应答。表2 佐剂分类及代表疫苗联合疗法1. 化疗联合化疗诱导免疫原性细胞死亡，释放肿瘤抗原。案例：SurVaxM（靶向Survivin）联合替莫唑胺在胶质母细胞瘤中延长无进展生存期（PFS 11.4个月）。2. 放疗联合放疗增强肿瘤抗原释放并改变TME。案例：PSA靶向疫苗联合放疗在前列腺癌中显著提升抗原特异性T细胞数量。3. 免疫检查点抑制剂（ICI）联合疫苗逆转T细胞耗竭，ICI阻断PD-1/PD-L1通路。案例：mRNA-4157联合Pembrolizumab在黑色素瘤中ORR达50%，降低复发风险44%。4. CAR-T联合疫苗增强CAR-T持久性与肿瘤浸润。案例：CLDN6 mRNA疫苗联合CAR-T在实体瘤中实现33%客观缓解率。图3 联合疗法机制示意图描述：疫苗与化疗、放疗、ICI或CAR-T协同，通过多通路激活抗肿瘤免疫。临床挑战 1.抗原筛选与个性化制备：新抗原预测需结合基因组学与免疫肽组学，成本高且周期长。动物模型局限性：人源化小鼠难以完全模拟人类免疫系统，需开发类器官或芯片替代模型。不良反应管理：常见：注射部位反应、发热、疲劳。严重：细胞因子释放综合征（CRS）、自身免疫性毒性。耐药机制：肿瘤抗原丢失或MHC下调可导致免疫逃逸。结论与展望癌症疫苗通过多平台创新与联合策略展现出变革性潜力。未来方向包括：精准新抗原筛选：结合AI优化预测算法，降低成本。新型递送系统：开发靶向淋巴结或穿透血脑屏障的纳米载体。克服免疫抑制：联合TME调控剂（如TGF-β抑制剂）或表观遗传药物。临床转化加速：利用器官芯片替代部分动物试验，缩短研发周期。随着mRNA技术和个性化医疗的突破，癌症疫苗有望成为“治愈性疗法”的重要组成部分，为实体瘤和血液肿瘤患者带来长期生存希望。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观，不代表本站立。

疫苗信使RNA免疫疗法临床研究

2025-01-29

·Business Wire

Imvax Announces Completion of $29 Million Financing and Confirms Timing for Topline Results of Phase 2b Trial of IGV-001 in Newly Diagnosed Glioblastoma

PHILADELPHIA--( BUSINESS WIRE )-- Imvax, Inc. , a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced the closing of a $29 million financing round from existing investors. Over the past 21 months, the Company has raised $86 million to support the completion of its randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). IGV-001 is derived from Imvax’s proprietary Goldspire® immuno-oncology platform, which is designed to use a patient’s own tumor cells to induce a broad and durable immune response against tumors. The primary endpoint of the Phase 2b trial is progression free survival (PFS). “ We are grateful for the support of our existing investors in this latest fundraising, which reflects their continued belief in the promise of IGV-001 for the thousands of patients facing a GBM diagnosis each year,” said John P. Furey, Chief Executive Officer. “ The financing provides us with operating flexibility well beyond the readout of the topline results of our Phase 2b trial, which we remain on track to report in mid-2025.” About the Phase 2b Trial of IGV-001 The Phase 2b clinical trial is a randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess the safety and efficacy of IGV-001, an autologous biologic-device combination product, in ndGBM patients. The trial enrolled approximately 100 participants in a 2:1 randomization across 20 sites in the United States. Approximately 48 hours after surgical resection, participants in the IGV-001 arm were implanted with biodiffusion chambers containing a combination of personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001); in the placebo arm, the chambers contained an inactive solution only. In both arms, the biodiffusion chambers were explanted approximately 48 hours later, and after six weeks all patients were treated with standard of care (adjuvant radiotherapy and temozolomide followed by maintenance temozolomide). The primary endpoint of the trial is PFS, and key secondary endpoints include overall survival (OS) and safety. About IGV-001 and Glioblastoma IGV-001 is an autologous biologic-device combination product derived from Imvax’s proprietary Goldspire® immuno-oncology platform for solid tumors, which involves a unique approach to inducing a broad and durable immune response against tumors. Phase 1 studies showed that IGV-001 was safe and well tolerated, and a Phase 1b ndGBM study also yielded several efficacy signals, including significant improvements in PFS, OS, radiographic evidence of tumor response, and multiple biomarker changes that supported the presence of an immune response (Andrews DW, et al., Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM patients in the highest dose cohort treated with IGV-001, median PFS was 17.1 months, compared with 6.5 months in historical standard-of-care (SOC) treatment, and median OS was 38.2 months, compared with 16.2 months in historical SOC. Glioblastoma is both the most common and most aggressive brain cancer and has resisted significant advances in treatment for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States and their average life expectancy 12 to 15 months. Just over 7 percent of patients survive five years after diagnosis. About Imvax, Inc. Imvax is a clinical-stage biotechnology company with a unique platform technology, Goldspire®, focused on delivering personalized, whole tumor-derived immunotherapies across a range of solid tumors. Imvax’s most advanced program, IGV-001, is currently being evaluated in a Phase 2b clinical trial in newly diagnosed glioblastoma patients. Imvax’s portfolio also includes several other programs designed to stimulate a patient’s immune system against the entire antigen signature of their tumor. Imvax is headquartered in Philadelphia, PA. For additional information, please visit www.imvax.com .

临床2期免疫疗法临床结果临床1期寡核苷酸

2025-01-23

·米内网

这家中药企业厉害了！手握17个中药独家品种，40亿大品种领跑，26款1类新药发力

精彩内容近日，天士力的中药1.1类新药安神滴丸申报上市、生物药1类新药P134细胞注射液申报IND。2024年至今公司已有4款新药申报上市，2款1类新药申报IND，4款仿制药获批上市，累计有23个品种过评（7个首家）。天士力坚持创新驱动，拥有17个中药独家品种，领跑心脑血管、神经系统疾病中成药市场；26款1类新药在研，8款处于NDA或Ⅲ期临床阶段，上市可期。手握17个中药独家品种！40亿大品种领跑天士力创立于1994年，公司聚焦心脑血管、消化代谢、肿瘤、中枢神经等重大疾病领域，致力于提供临床急需甚至填补中国临床市场空白的药物研发，利用现代中药、生物药、化学药协同发展优势进行创新药物的战略布局。天士力中药产品已覆盖心脑血管、神经系统、呼吸系统、消化系统、妇科、儿科等疾病领域，代表品种有复方丹参滴丸、养血清脑颗粒、芪参益气滴丸、注射用益气复脉(冻干)、养血清脑丸、穿心莲内酯滴丸、藿香正气滴丸等。目前，公司拥有中成药生产批件178个，其中中药独家品种有17个。天士力中药独家品种情况（含独家剂型品种）米内网数据显示，天士力的中药独家品种复方丹参滴丸2023年在中国三大终端六大市场（统计范围详见本文末）销售额接近40亿元，养血清脑颗粒销售额接近10亿元，芪参益气滴丸、注射用益气复脉(冻干)、注射用丹参多酚酸销售额均超过5亿元，还有藿香正气滴丸、荆花胃康胶丸等多个过亿大单品。在心脑血管疾病领域，天士力已有复方丹参滴丸、芪参益气滴丸、注射用丹参多酚酸、醒脑静注射液、牛黄清心丸(局方)、安宫牛黄丸等20个中成药获批上市。在神经系统疾病领域，天士力已有养血清脑颗粒、养血清脑丸、柏子养心丸、朱砂安神丸等11个中成药获批上市。凭借复方丹参滴丸、芪参益气滴丸、注射用益气复脉(冻干)、养血清脑颗粒/丸等主力品种，天士力在心脑血管、神经系统疾病中成药市场稳居龙头地位。米内网数据显示，2024H1中国三大终端六大市场心脑血管疾病中成药销售额TOP10一级集团中，天士力位列第三；神经系统疾病中成药销售额TOP10一级集团中，天士力自2019年以来持续位列第一。研发费用5.65亿元，中药创新药抢攻70亿市场 1月23日，CDE官网显示，天士力的中药1.1类新药安神滴丸上市申请获得CDE承办，用于治疗失眠症。这是公司2025年首款申报上市的1类新药。米内网数据显示，2023年中国三大终端六大市场安神补脑药销售额超过70亿元。 1月10日，CDE官网显示，天士力的生物药1类新药P134细胞注射液IND申请获得CDE承办。这是公司2025年首款申报IND的1类新药。米内网数据显示，2023年中国三大终端六大市场生物药销售额超过2300亿元。作为国内中药龙头企业之一，天士力坚定实施创新驱动战略，近年来持续加大研发投入。2023年公司研发投入13.15亿元，同比增长29.49%，占医药工业收入比例为17.73%。2024前三季度公司研发费用5.65亿元，同比增长1.15%。新药研发方面，2024年至今天士力有一款中药1.1类新药安神滴丸、一款2.2类改良型新药注射用重组人尿激酶原（新增适应症急性缺血性脑卒中）、2款中药3.1类新药枇杷清肺饮颗粒及温经汤颗粒申报上市；2款生物药1类新药同种异体脂肪间充质基质细胞注射液、P134细胞注射液申报IND。仿制药业务方面，2024年天士力共有4个品种盐酸达泊西汀片、利伐沙班片、盐酸丙卡特罗口服溶液、巴氯芬口服溶液获批上市并视同过评，以及2个品种尼可地尔片、富马酸酮替芬片通过仿制药一致性评价，进一步丰富了公司的产品管线，提高了市场竞争力。米内网数据显示，2023年中国三大终端六大市场利伐沙班片销售额超过28亿元、盐酸达泊西汀片销售额超过13亿元、尼可地尔片销售额超过8亿元、盐酸丙卡特罗口服溶液销售额超过1亿元。其中，尼可地尔片、盐酸丙卡特罗口服溶液已分别有11家、12家企业过评，有望被纳入第十一批集采。截至目前，天士力已有23个品种通过/视同通过一致性评价，其中7个品种赖诺普利氢氯噻嗪片、右佐匹克隆片、替莫唑胺胶囊、苯扎贝特缓释片、米诺膦酸片、舒必利片、盐酸苯海索片为国内首家过评。 26款1类新药蓄势待发！13款上市可期天士力通过自主研发、产品引进、合作研发、投资市场许可优先权的“四位一体”药物创新研发模式，扩充公司在研管线，稳步推动现代中药、生物药、化学药研发进展，目前已拥有涵盖100余款在研产品的研发管线。在中药新药研发方面，天士力重视创新中药研发与重点品种二次开发，近年来已有2款中药1类创新药芍麻止痉颗粒、坤心宁颗粒获批上市，以及复方丹参滴丸获批新增糖尿病视网膜病变适应症。目前，天士力有19款中药新药处于Ⅱ期临床及以上研究阶段，涉及心脑血管、呼吸系统、神经系统、消化系统、妇科、儿科、骨科等疾病领域。天士力主要在研中药新药 19款中药新药中，中药1类创新药安神滴丸及2款中药3.1类新药枇杷清肺饮颗粒、温经汤颗粒已申报上市，有望于2025年内获批上市；7款中药1类创新药肠康颗粒、青术颗粒、脊痛宁片、安体威颗粒、香橘乳癖宁胶囊、连夏消痞颗粒、苏苏小儿止咳颗粒已处于Ⅲ期临床研究阶段，上市可期。在化药、生物药研发方面，天士力有14款新药处于申报临床及以上研究阶段。其中，注射用重组人尿激酶原（治疗急性缺血性脑卒中）已申报上市、PXT3003（治疗腓骨肌萎缩症）处于Ⅲ期临床研究阶段，上市可期；4款1类新药B1962注射液、JS1-1-01片、TSL-1502胶囊、治疗用乙型肝炎腺病毒注射液均处于Ⅱ期临床研究阶段。天士力主要在研生物药、化学药在研仿制药方面，天士力有碳酸司维拉姆片、硫酸氨基葡萄糖胶囊、米诺地尔搽剂、富马酸伏诺拉生片等8个品种的注册申请在审中，获批生产后将视同通过一致性评价。8个品种2023年在中国三大终端六大市场销售额合计超过37亿元，其中碳酸司维拉姆片销售额超过10亿元。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准临床申请

100 项与替莫唑胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06067	替莫唑胺	L01AX03	DB00853

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
尤文肉瘤	日本	Ohara Pharmaceutical Co., Ltd.	2019-02-21
尤文肉瘤	日本	MSD KK	2019-02-21
脑恶性胶质瘤	欧盟	Teva Pharmaceuticals Europe BV	2010-01-28
脑恶性胶质瘤	冰岛	Teva Pharmaceuticals Europe BV	2010-01-28
脑恶性胶质瘤	列支敦士登	Teva Pharmaceuticals Europe BV	2010-01-28
脑恶性胶质瘤	挪威	Teva Pharmaceuticals Europe BV	2010-01-28
转移性恶性黑色素瘤	澳大利亚	Merck Sharp & Dohme (Australia) Pty Ltd.	2009-11-13
胶质母细胞瘤	中国	江苏天士力帝益药业有限公司	2004-04-30
星形细胞瘤	欧盟	Merck Sharp & Dohme BV	1999-01-26
星形细胞瘤	冰岛	Merck Sharp & Dohme BV	1999-01-26
星形细胞瘤	列支敦士登	Merck Sharp & Dohme BV	1999-01-26
星形细胞瘤	挪威	Merck Sharp & Dohme BV	1999-01-26
多形性胶质母细胞瘤	欧盟	Merck Sharp & Dohme BV	1999-01-26
多形性胶质母细胞瘤	冰岛	Merck Sharp & Dohme BV	1999-01-26
多形性胶质母细胞瘤	列支敦士登	Merck Sharp & Dohme BV	1999-01-26
多形性胶质母细胞瘤	挪威	Merck Sharp & Dohme BV	1999-01-26
胶质瘤	欧盟	Merck Sharp & Dohme BV	1999-01-26
胶质瘤	冰岛	Merck Sharp & Dohme BV	1999-01-26
胶质瘤	列支敦士登	Merck Sharp & Dohme BV	1999-01-26
胶质瘤	挪威	Merck Sharp & Dohme BV	1999-01-26

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
神经母细胞瘤	申请上市	欧盟	ORPHELIA Pharma SAS	2024-11-14
子宫平滑肌肉瘤	临床3期	美国	National Cancer Institute	2022-03-30
脑干胶质瘤	临床3期	美国	National Cancer Institute	2011-01-26
脑干胶质瘤	临床3期	加拿大	National Cancer Institute	2011-01-26
成人脑星形细胞瘤	临床3期	美国	National Cancer Institute	2011-01-26
成人脑星形细胞瘤	临床3期	加拿大	National Cancer Institute	2011-01-26
高级别胶质瘤	临床3期	美国	National Cancer Institute	2011-01-26
高级别胶质瘤	临床3期	加拿大	National Cancer Institute	2011-01-26
小儿小脑星形细胞瘤	临床3期	美国	National Cancer Institute	2011-01-26
小儿小脑星形细胞瘤	临床3期	加拿大	National Cancer Institute	2011-01-26

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO_ASIA2024 人工标引	临床2期	胶质母细胞瘤维持	40	Concurrent bevacizumab + standard radiotherapy + temozolomide + adjuvant treatment(temozolomide + bevacizumab + Surufatinib)Surufatinib)	齋獵憲鑰選繭獵蓋鹹顧(夢遞膚製顧範選壓醖鹹) = 築鹹鑰憲壓願選積顧簾衊艱餘積窪夢夢鑰夢鑰 (餘構衊淵膚範憲繭製糧, 4 ~ 8) 更多	积极	2024-12-07
phase II clinical study (SNO2024)	临床2期	胶质母细胞瘤维持 MGMT status	69	TTFields therapy concomitant with RT/TMZ	膚鹽蓋築鹹願繭衊積窪(餘選鹽鏇積築築選壓鑰) = 顧衊壓獵壓鑰繭製糧鑰鬱衊廠遞廠餘積簾觸網 (積膚窪觸廠鹽淵願鬱鏇 ) 更多	积极	2024-11-11
				RT/TMZ alone	膚鹽蓋築鹹願繭衊積窪(餘選鹽鏇積築築選壓鑰) = 衊夢鑰鹹簾網觸選製範鬱衊廠遞廠餘積簾觸網 (積膚窪觸廠鹽淵願鬱鏇 ) 更多
RADT-09 (SNO2024)	N/A	IDH wild-type \| TERT promoter mutation	21	Chemoradiotherapy with Temozolomide	壓衊艱鹹壓繭襯繭憲糧(製蓋積鹹範糧願糧醖壓) = 齋顧膚鏇積簾鹹遞憲遞憲構觸壓壓顧夢繭衊鑰 (積鹽鏇願廠醖憲醖構糧 ) 更多	积极	2024-11-11
				Radiotherapy alone	壓衊艱鹹壓繭襯繭憲糧(製蓋積鹹範糧願糧醖壓) = 顧壓網範鬱積夢選鬱襯憲構觸壓壓顧夢繭衊鑰 (積鹽鏇願廠醖憲醖構糧 ) 更多
CNSC-35 (SNO2024)	N/A	弥漫内生性脑桥神经胶质瘤辅助	28	Adjuvant Temozolomide	夢糧簾網襯醖積範襯製(膚糧鹽艱築衊願選鑰壓) = 簾鑰鏇夢蓋獵襯範築簾顧廠構廠夢鹽簾簾選鬱 (製壓簾簾觸遞壓鹹鏇顧, 5 ~ 10.7)	积极	2024-11-11
				No Adjuvant Temozolomide	夢糧簾網襯醖積範襯製(膚糧鹽艱築衊願選鑰壓) = 淵網鑰願網積餘鹹餘淵顧廠構廠夢鹽簾簾選鬱 (製壓簾簾觸遞壓鹹鏇顧, 2.3 ~ NA)
INNV-27 (SNO2024)	N/A	垂体肿瘤 MGMT methylation status	8	Temozolomide	窪願醖糧簾繭蓋築夢鬱(餘繭壓築簾衊廠築顧鹹) = 餘製積艱製繭鹹構範淵遞窪餘網衊鑰鹽觸鑰鹽 (壓鏇餘膚範範廠鏇夢範 )	积极	2024-11-11
INB-200 (SNO2024)	临床1期	多形性胶质母细胞瘤维持 IDH wild type \| mutant tumors \| MGMT unmethylated	23	Temozolomide (Cohort 1 (1 x 10^7 DRI cells/dose))	壓壓積製蓋憲鬱積鹽繭(遞鏇範鏇範製製繭夢顧) = The most common adverse events were decreased WBC/platelet count 糧襯淵遞醖鏇簾齋範蓋 (糧衊鹽獵襯遞齋選淵鹹 )	积极	2024-11-11
				Temozolomide (Cohort 2 (1 x 10^7 DRI cells/dose))
QLTI-22 (SNO2024)	N/A	胶质瘤	13	Patients who received Temozolomide chemotherapy	製積積鏇鬱衊壓獵鏇糧(膚觸獵鏇鹽積餘蓋壓膚) = 膚簾壓糧選衊鑰糧鏇鏇鏇憲淵鏇窪製網願鏇網 (鏇鬱鏇繭廠觸範鬱獵廠 ) 更多	-	2024-11-11
SNO2024	N/A	胶质母细胞瘤一线	-	Temozolomide Chemoradiation	構網夢鏇膚衊夢襯簾壓(積餘遞範製鹹製顧願鑰) = 遞製顧襯繭製製窪獵鬱醖壓壓衊窪蓋鹽積遞選 (鑰齋鹹積築衊淵積鬱夢 )	积极	2024-11-11
				Placebo	構網夢鏇膚衊夢襯簾壓(積餘遞範製鹹製顧願鑰) = 憲廠蓋觸鏇衊繭鹽憲衊醖壓壓衊窪蓋鹽積遞選 (鑰齋鹹積築衊淵積鬱夢 )
P26.12.A (EANO2024)	N/A	胶质母细胞瘤	8	Itraconazole	範繭顧築顧願觸獵鑰襯(夢餘窪築顧鹹廠糧繭鬱) = 範鹹餘憲範蓋鬱鹽壓襯鏇簾淵廠醖鬱製製範壓 (觸遞鑰淵艱憲觸夢鹽鹽 ) 更多	积极	2024-10-17
				Pyrimethamine	範繭顧築顧願觸獵鑰襯(夢餘窪築顧鹹廠糧繭鬱) = 願構簾選觸壓顧構膚製鏇簾淵廠醖鬱製製範壓 (觸遞鑰淵艱憲觸夢鹽鹽 )
CeTeG/NOA-09 (EANO2024)	N/A	胶质母细胞瘤 MGMT-methylated \| IDH-wildtype	17	CCNU/TMZ	憲齋製築鑰鏇壓壓觸遞(選鹽鬱鬱鹹廠憲廠積餘) = 衊夢網鹹夢構鬱蓋憲鏇製觸網築鏇網鹽窪築襯 (壓範鹹艱糧壓醖築壓築, 17.6 ~ not reached) 更多	积极	2024-10-17