A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.

开始日期2025-07-29

申办/合作机构

The University of Alabama at Birmingham

NCT05879484

/ Withdrawn临床1/2期IIT

A Phase Ib/II Multicenter Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS

Background:
Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide. These cancers have different causes, with smoking/tobacco exposure and human papilloma virus infection being the most common. . When HNSCC occurs in people who are not infected with HPV, the cancers are more likely to return after treatment; when this happens, overall survival is only about 10 months, thus better treatments are needed.
Objective:
To test a combination treatment using 2 drugs (valemetostat and pembrolizumab) in people with HNSCC. Phase 1b of the study will determine a recommended dose of the 2 drugs and evaluate how safe the combination is.; this will include patients with HPV-positive and HPV-negative HNSCC, as well as squamous cell NSCLC that have progressed on anti-PD-1/anti-PD-L1 therapies.Phase II will determine how effective the combination is and will focus on patients with HPV-negative HNSCC.
Eligibility:
People aged 18 years and older with HPV-negative HNSCC, sinonasal carcinoma of the head and neck, or squamous non-small cell lung cancer (NSCLC).
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have imaging scans. They may have a biopsy: A small sample of tissue will be removed from the tumor.
Treatment will be given in 21-day cycles.
Pembrolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will receive pembrolizumab on the first day of each cycle.
Valemetostat is a tablet taken by mouth. Participants will take the tablet once a day at home. They will record the date and time of each dose in a diary. They will also write down any adverse effects they experience.
Participants may remain in the study up to 2 years.

开始日期2025-07-09

申办/合作机构

National Cancer Institute

NCT06632977

/ Recruiting临床2期IIT

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

开始日期2025-02-06

申办/合作机构

Alliance for Clinical Trials in Oncology

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项与 Valemetostat Tosilate 相关的文献（医药）

2025-12-01·FUNCTIONAL & INTEGRATIVE GENOMICS

Polycomb repressive complex 2 (PRC2) pathway’s role in cancer cell plasticity and drug resistance

Review

作者: Tabari, Mohammad Amin Khazeei ; Khan, Haroon ; Javan, Alireza ; Larsen, Danaé S ; Rezaee, Aryan ; Heidari, Mohammad Mahdi ; Sanaye, Pantea Majma ; Hadipour, Mahboube ; Daglia, Maria ; Goleij, Pouya

Polycomb Repressive Complex 2 (PRC2) is a central regulator of gene expression via the trimethylation of histone H3 on lysine 27. This epigenetic modification plays a crucial role in maintaining cell identity and controlling differentiation, while its dysregulation is closely linked to cancer progression. PRC2 silences tumor suppressor genes, promoting cell proliferation, metastasis, epithelial-mesenchymal transition, and cancer stem cell plasticity. Enhancement of zeste homolog 2 (EZH2) overexpression or gain-of-function mutations have been observed in several cancers, including lymphoma, breast, and prostate cancers, driving aggressive tumor behavior and drug resistance. In addition to EZH2, other PRC2 components, such as embryonic ectoderm development (EED) and suppressor of zeste 12, are essential for complex stability and function. EED, in particular, enhances EZH2 activity and has emerged as a therapeutic target. Inhibitors like MAK683 and EED226 disrupt EED's ability to maintain PRC2 activity, thereby reducing H3K27me3 levels and reactivating tumor suppressor genes. Valemetostat, a dual inhibitor of both EZH2 and EED, has shown promising results in aggressive cancers like diffuse large B-cell lymphoma and small-cell lung cancer, underlining the therapeutic potential of targeting multiple PRC2 components. PRC2's role extends beyond gene repression, as it contributes to metabolic reprogramming in tumors, regulating glycolysis and lipid synthesis to fuel cancer growth. Furthermore, PRC2 is implicated in chemoresistance, particularly by modulating DNA damage response and immune evasion. Tazemetostat, a selective EZH2 inhibitor, has demonstrated significant clinical efficacy in EZH2-mutant cancers, such as non-Hodgkin lymphomas and epithelioid sarcoma. However, the compensatory function of enhancer of zeste homolog 1 (EZH1) in some cancers requires dual inhibition strategies, as seen with agents like UNC1999 and Tulmimetostat, which target both EZH1 and EZH2. Given PRC2's multifaceted role in cancer biology, its inhibition represents a promising avenue for therapeutic intervention. The continued development of PRC2 inhibitors and exploration of their use in combination with standard chemotherapy or immunotherapy has great potential for improving patient outcomes in cancers driven by PRC2 dysregulation.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetics, metabolism, and excretion of [14C]-valemetostat in healthy male participants, and in vitro plasma protein binding

Article

作者: Siebers, Nicholas ; Inaba, Shinichi ; Craveiro, Thuy Vu ; Ikeda, Tomoko ; Kazui, Miho ; Shimizu, Takako ; Tachibana, Masaya ; Abutarif, Malaz A

INTRODUCTION:

Valemetostat tosylate (valemetostat) is an oral, selective, dual inhibitor of enhancer of zeste homolog (EZH)2 and EZH1. This article reports findings on the mass balance and pharmacokinetics of valemetostat in a phase I study; valemetostat metabolite identification in plasma, urine, and fecal samples; and plasma-protein-binding of valemetostat in vitro.

METHODS:

Eight healthy participants received a single 200-mg oral dose of [¹⁴C]-valemetostat under fasting conditions. Blood, urine, and feces samples were collected to determine total radioactivity and/or unchanged valemetostat, and for metabolite identification. The binding of valemetostat 600-10,000 ng/mL to plasma, 4% human serum albumin (HSA), and 0.1% alpha-1-acid glycoprotein (AAG) was assessed in vitro.

RESULTS:

Mean cumulative recovery of administered radioactivity was 95.3% by 360 h post-dose, with a mean recovery of 15.6% in urine and 79.8% in feces. Valemetostat accounted for the most radioactivity in the excreta, at 10% and 64.9% of the administered dose in the urine and feces, respectively. CALZ-1809a was the most abundant metabolite, present in all biological samples, and accounted for 5.6% of total radioactivity in the feces. Valemetostat was minimally associated with red blood cells, with a blood-to-plasma total radioactivity ratio of 0.54. In vitro, valemetostat was highly plasma-bound (> 94%) at clinically relevant concentrations, with a higher affinity to AAG than to HSA.

CONCLUSION:

Valemetostat was rapidly absorbed into the systemic circulation, mainly excreted via the biliary/fecal route, primarily metabolized by CYP3A enzymes to CALZ-1809a, and highly bound to plasma proteins, with a greater affinity to AAG than HSA in vitro.

2025-10-01·CTS-Clinical and Translational Science

Physiologically Based Pharmacokinetic Modeling of Valemetostat to Inform Dose Recommendations When Coadministered With CYP3A /P‐gp Modulators

Article

作者: Watanabe, Akiko ; Kotsuma, Masakatsu ; Lau, Yvonne ; Kazui, Miho ; Shimizu, Takako ; Okudaira, Noriko ; Tachibana, Masaya

ABSTRACT:

Valemetostat tosylate (valemetostat) is an oral, potent, selective dual inhibitor of enhancer of zeste homolog (EZH)2 and EZH1, approved in Japan for the treatment of relapsed/refractory adult T‐cell leukemia/lymphoma and peripheral T‐cell lymphoma. Results from in vitro and clinical studies suggest that valemetostat is pre‐systemically metabolized by cytochrome P450 3A (CYP3A) in the gut and excreted into bile and urine via P‐glycoprotein (P‐gp) in its unchanged form and as an oxidative metabolite. In this study, a physiologically based pharmacokinetic (PBPK) model was developed by utilizing available in vitro and clinical pharmacokinetics (PK) data to predict the impact of CYP3A and P‐gp modulators on the PK of valemetostat. The developed PBPK model was validated against clinical drug–drug interaction studies with a moderate CYP3A inhibitor (fluconazole), a strong CYP3A/P‐gp dual inhibitor (itraconazole), and a strong CYP3A/P‐gp dual inducer (rifampicin), indicating that the contributions of CYP3A and P‐gp in the gut and liver to valemetostat PK were appropriately described in the PBPK model. The validated model was applied to assess the effect of either a CYP3A or a P‐gp inhibitor, or a moderate CYP3A inducer on valemetostat PK. The PBPK model incorporating the contribution of CYP3A and P‐gp in the gut and liver effectively estimated the effect of CYP3A/P‐gp modulators on valemetostat PK and can be used to inform dose recommendations for valemetostat upon coadministration with other treatments.

项与 Valemetostat Tosilate 相关的新闻（医药）

2025-10-14

·第一三共中国

第一三共将在2025ESMO年会上发布三项具有里程碑意义的乳腺癌研究成果及ADC产品组合的最新数据,为患者持续推动标准治疗的变革

●在主席专题研讨会上，接连发布DESTINY-Breast11和DESTINY-Breast05两项研究的最新成果，进一步展现德曲妥珠单抗在以治愈为目标的HER2阳性早期乳腺癌治疗中，成为基础性疗法的潜力。 ●TROPION-Breast02 Ⅲ期研究的重磅结果显示，德达博妥单抗成为目前首个且唯一的一款TROP2靶向抗体偶联药物，在免疫治疗不适用的转移性三阴性乳腺癌（TNBC）一线治疗中，相较化疗改善总生存期的疗法*。 ●此外，来自八项研究（DESTINY-Breast09、REJOICE-Ovarian01、IDeate-Lung01、TROPION-PanTumor03、DESTINY-Gastric04、DESTINY-CRC02、DESTINY-PanTumor02及DS-3939）的最新数据，进一步印证了第一三共DXd抗体偶联药物（ADC）产品管线在多癌种治疗领域的强劲实力。 ●公司将召开投资者电话会议，对在ESMO年会上公布的研究进展进行深入解读与讨论。东京和美国新泽西州巴斯金里奇——（2025年10月13日）——第一三共将在2025年欧洲肿瘤内科学会（#ESMO25）年会上发布旗下DXd抗体偶联药物（ADC）产品组合的最新临床研究成果，涵盖超过20篇摘要，其中包括4场重磅结果报告。 ESMO年会上发布的数据将重点展示公司在乳腺癌治疗领域推动新标准疗法的最新进展，包括在主席专题研讨会 I上连续呈现DESTINY-Breast11（291O）和DESTINY-Breast05（LBA1）两项Ⅲ期临床研究的数据。这两项具有里程碑意义的研究结果将展现注射用德曲妥珠单抗在HER2阳性早期乳腺癌以治愈为目标的治疗过程中成为基础性疗法的潜力。 TROPION-Breast02 Ⅲ期研究将在摘要发言专场作为最新突破性数据速递（LBA21）发布注射用德达博妥单抗的重磅研究结果。这也是目前首个在不适合免疫治疗的局部复发不可手术或转移性三阴性乳腺癌（TNBC）患者中，德达博妥单抗作为一线治疗较化疗改善总生存期的研究。相关数据将以优选论文报告形式呈现。 Ken Takeshita 博士第一三共全球研发负责人这三项具有里程碑意义的研究数据证明，第一三共的DXd 抗体偶联药物（ADC）产品组合正持续推动乳腺癌标准疗法的革新。DESTINY-Breast11和DESTINY-Breast05的研究结果凸显了德曲妥珠单抗在以治愈为目标的HER2阳性早期乳腺癌治疗中的潜力，有望成为基础治疗方案。此外，TROPION-Breast02中德达博妥单抗（Dato-DXd）的突破性成果首次证实：在不适合免疫治疗的转移性三阴性乳腺癌患者一线治疗中实现了总生存期获益。这一系列令人瞩目的成果，结合德曲妥珠单抗在HER2阳性、HER2低表达及HER2超低表达乳腺癌中的既往研究结果，使第一三共目前拥有两款有潜力覆盖大部分转移性乳腺癌患者的药物。在乳腺癌领域，BEGONIA I/II期研究（555MO）队列7的数据及队列8的数据在ESMO年会上以小型口头报告形式公布。该研究旨在评估德达博妥单抗联合度伐利尤单抗用于转移性三阴性乳腺癌（TNBC）患者的一线治疗。目前，三项III期研究（TROPION-Breast03、TROPION-Breast04和TROPION-Breast05）正进一步评估该组合策略在TNBC不同分期及治疗场景下的疗效与安全性。三项近期突破性疗法认定背后的研究成果亮相在ESMO年会上，第一三共还将展示支持近期在美国获批三项突破性疗法认定（BTD）的临床研究数据，分别为DESTINY-Breast09、REJOICE-Ovarian01和IDeate-Lung01，研究药物涉及德曲妥珠单抗、R-DXd及I-DXd。两场最新摘要专场会议将重点公布以下关键研究：一是REJOICE-Ovarian01 II/III期研究中II期部分（LBA42）针对既往经治的铂耐药卵巢癌患者使用raludotatug deruxtecan的初步分析，二是DESTINY-Breast09 III期试验（LBA18）：评估德曲妥珠单抗联合帕妥珠单抗对比THP方案（紫杉烷类+曲妥珠单抗+帕妥珠单抗）一线治疗HER2阳性转移性乳腺癌患者的重点亚组分析。DESTINY-Breast09的研究结果也成为德曲妥珠单抗在美国递交补充生物制品许可申请（sBLA）的依据，并已于近期通过实时肿瘤学审评（RTOR）项目获得优先审评资格。 IDeate-Lung01 II期研究（2760MO）针对I-DXd在既往经治且基线存在脑转移的广泛期小细胞肺癌（ES-SCLC）患者中的颅内疗效详细结果，将在ESMO年会上以小型口头报告形式公布。该研究的主要结果已于上月在2025年世界肺癌大会（#WCLC25）上发布。第一三共DXd ADC药物组合在多种肿瘤治疗研究中持续取得进展在ESMO年会上，还将通过小型口头报告首次展示第一三共DXd ADC药物组合的两项早期临床研究数据：一是DS-3939首个人体I/II期试验（917O）的初步结果，该药为公司在临床开发阶段的第六款DXd ADC，用于既往经治、对标准疗法耐药的晚期实体瘤患者；二是TROPION-PanTumor03 II期试验（3072MO）子研究的初步结果，该研究旨在评估德达博妥单抗联合阿斯利康的PD-1/TIGIT双抗rilvegostomig，用于局部晚期或转移性尿路上皮癌患者的一线或二线治疗。在ESMO年会上，将展示两项支持德曲妥珠单抗泛肿瘤适应症的临床试验DESTINY-CRC02 和 DESTINY-PanTumor02最终分析结果，该适应症目前已在全球超过10个国家和地区获批。小型口头报告将重点介绍DESTINY-CRC02 II期试验（737MO）的最终分析，该研究评估了德曲妥珠单抗在HER2阳性既往经治的转移性结直肠癌患者中的疗效和安全性。与此同时，两项海报展示将呈现DESTINY-PanTumor02 II期试验第一部分的最终分析结果（957P）及探索性生物标志物分析结果（145P），研究对象为既往经治的HER2表达实体瘤患者。德曲妥珠单抗针对HER2阳性转移性实体瘤患者的泛肿瘤适应症申请，目前已在欧盟和日本接受监管审评。在ESMO年会上，将以海报形式展示DESTINY-Gastric04 III期试验的亚组分析结果（2099P）。该研究比较了德曲妥珠单抗与雷莫西尤单抗联合紫杉醇，在HER2阳性、转移性胃癌或胃食管结合部（GEJ）腺癌患者二线治疗中的疗效和安全性。本次报告将包括中心实验室与地方实验室HER2检测结果的一致性分析，以及额外的疗效和安全性数据。此外，DESTINY-Gastric06 II期试验的数据将通过两项海报展示。该研究针对中国HER2表达的晚期胃癌或GEJ腺癌患者，这些患者既往已接受至少两种方案治疗，其中包括氟嘧啶类和铂类药物。第一项海报（2105P）将呈现既往接受过除曲妥珠单抗外的其他抗HER2治疗，或在曲妥珠单抗基础上联合其他抗HER2疗法的患者治疗分析结果。第二项海报（2175P）将报告接受德曲妥珠单抗治疗的既往或已清除乙型肝炎病毒（HBV）感染、或非活动性慢性HBV感染患者的HBV再激活风险。在ESMO年会上，肺癌研究的最新进展将通过小型口头报告和海报形式发布。小型口头报告将介绍由第一三共和默沙东联合开发的靶向DLL3的T细胞衔接器gocatamig（2758MO）在小细胞肺癌及其他神经内分泌肿瘤患者中的I/II期研究最新结果。另一项海报（2023P）将展示德达博妥单抗联合EZH1/2双重抑制剂valemetostat在既往经治的晚期非鳞状非小细胞肺癌（NSCLC）患者中的Ib期研究初步安全性数据。第一三共肿瘤产品线的在研试验进展在ESMO年会上，多项在研试验的海报展示进一步体现了第一三共持续拓展DXd抗体偶联药物（ADC）产品线的研发战略，旨在满足更广泛癌症患者的未尽医疗需求。一项在研试验海报将重点介绍DESTINY-Endometrial01 Ⅲ期研究（1223TiP）的设计。该研究评估德曲妥珠单抗联合rilvegostomig或帕博利珠单抗，与帕博利珠单抗联合铂类化疗方案（卡铂联合紫杉醇）相比，用于HER2表达（IHC 3+/2+）、错配修复功能正常（pMMR）的原发性晚期或复发性子宫内膜癌患者一线治疗的疗效。三项Ⅱ期在研试验包括：HERTHENA-Breast03研究（463eTiP），评估HER3-DXd联合帕博利珠单抗用于高危早期TNBC或激素受体（HR）低表达/人表皮生长因子受体2（HER2）阴性乳腺癌患者的新辅助治疗，在帕博利珠单抗联合化疗前后不同序列下的疗效；REJOICE-GI01研究（1001TiP），评估R-DXd在消化系统肿瘤患者（包括胰腺导管腺癌、胃食管腺癌、胆道癌及结直肠癌）中的疗效和安全性；以及KEYMAKER-U01子研究01H/01I（2081eTiP），评估I-DXd、R-DXd或多西他赛在Ⅳ期非小细胞肺癌（NSCLC）患者中的疗效。此外，还将公布两项早期研究设计，包括一项Ⅰ/Ⅱ期研究（2792TiP），评估I-DXd联合gocatamig用于复发/难治性ES-SCLC患者的疗效，以及一项Ⅰb期研究（977P），评估valemetostat联合伊匹木单抗（ipilimumab）用于难治性泌尿生殖系统肿瘤（包括前列腺癌、尿路上皮癌和肾透明细胞癌）患者的疗效。 ESMO大会期间投资者说明会第一三共将于2025年10月21日（星期二）美国东部时间上午8:00至9:30 / 日本时间晚上9:00至10:30举行线上投资者电话会议。届时，公司管理层将介绍本次ESMO大会公布的最新研究数据。第一三共在ESMO年会的口头报告第一三共在ESMO大会的海报展示关于第一三共ADC产品组合第一三共ADC产品组合包括7个处于临床开发阶段的ADC药物，所有药物均基于公司自研的两个ADC技术平台开发。第一三共拥有全球领先的DXd ADC技术平台。每款ADC药物由单克隆抗体通过可裂解四肽连接子与多个拓扑异构酶I抑制剂有效载荷（一种依喜替康衍生物，DXd）连接组成。目前DXd ADC产品组合包括T-DXd（靶向HER2 ADC）和Dato-DXd（靶向TROP2 ADC），由第一三共与阿斯利康共同开发并在全球范围内商业化。HER3-DXd（靶向HER3 ADC）、I-DXd（靶向B7-H3 ADC）、raludotatug deruxtecan（R-DXd，靶向CDH6 ADC）由第一三共与默沙东共同开发并在全球范围内商业化。DS-3939是一款靶向TA-MUC1的ADC，由第一三共开发。第一三共的第2个ADC平台由单克隆抗体与改良吡咯并苯并二氮杂卓（PBD）有效载荷连接组成。DS-9606是一种靶向CLDN6的ADC，是第一个通过该技术平台开发并处于临床阶段的ADC。 I-DXd、HER3-DXd、R-DXd、DS-3939和DS-9606均为在研药物，尚未在任何国家/地区获批用于任何适应症。安全性和有效性尚未确立。关于第一三共第一三共是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业125余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。如欲了解更多信息，请访问www.daiichisankyo.com。参考文献： *：首个是指目前首个TROP2 ADC 在用于不适合抗PD-1/PD-L1治疗的局部复发、不可无法手术或转移性三阴性乳腺癌（TNBC）患者的一线治疗中取得OS阳性结果，信息来源https://clinicaltrials.gov/ 声明: 1.本材料不用于任何推广目的，相关信息亦不应作为治疗或使用建议。如有相关问题请咨询医疗卫生专业人士。 2.本文涉及未在中国获批的产品或适应症，第一三共不推荐任何未获批药品/适应症的使用。

抗体药物偶联物临床3期临床结果临床2期

2025-10-13

·Business Wire

Daiichi Sankyo Continues to Transform Standards of Care for Patients with Three Landmark Breast Cancer Trials and Additional Data Across Industry-Leading ADC Portfolio at ESMO

Back-to-back Presidential Symposium presentations of ENHERTU from DESTINY-Breast11 and DESTINY-Breast05 demonstrate its potential to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer Late-breaking data from TROPION-Breast02 showcase that DATROWAY is the first and only therapy to significantly improve overall survival versus chemotherapy as first-line treatment for patients with first-line metastatic triple negative breast cancer for whom immunotherapy is not an option Data from eight additional trials – DESTINY-Breast09, REJOICE-Ovarian01, IDeate-Lung01, TROPION-PanTumor03, DESTINY-Gastric04, DESTINY-CRC02, DESTINY-PanTumor02 and DS-3939 – further support the strength of the DXd ADC portfolio of Daiichi Sankyo across multiple types of cancer Investor conference call to discuss ESMO TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio with four late-breaking presentations from more than 20 abstracts at the 2025 European Society for Medical Oncology (#ESMO25) Congress. Data at ESMO will spotlight the company’s advances towards creating new standards of care for patients with breast cancer, including back-to-back presentations during Presidential Symposium I featuring data from the DESTINY-Breast11 (291O) and DESTINY-Breast05 (LBA1) phase 3 trials. Results of these two landmark trials will showcase the potential of ENHERTU® (trastuzumab deruxtecan) to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer. Late-breaking DATROWAY® (datopotamab deruxtecan) data from the TROPION-Breast02 phase 3 trial (LBA21), representing the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option, will be featured in a proffered paper session. “Data from these three landmark trials demonstrate how the DXd ADC portfolio of Daiichi Sankyo continues to transform standards of care for patients with breast cancer. The findings from DESTINY-Breast11 and DESTINY-Breast05 highlight the potential of ENHERTU to become a foundational treatment in the curative-intent settings of HER2 positive early breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Additionally, the DATROWAY results from TROPION-Breast02 represent the first time ever that an overall survival benefit has been demonstrated in the first-line setting of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option. Couple these impressive results for DATROWAY with previous results seen with ENHERTU in the HER2 positive, HER2 low and HER2 ultralow disease settings, Daiichi Sankyo will now have two medicines with the potential to treat approximately 90 percent of patients with metastatic breast cancer.” Additional breast cancer data at ESMO includes a mini oral presentation of data from Arm 7 and Arm 8 of the BEGONIA phase 1/2 trial (555MO) evaluating DATROWAY plus durvalumab in patients with first-line metastatic TNBC. The efficacy and safety of this combination strategy is being further investigated in three phase 3 trials – TROPION-Breast03, TROPION-Breast04 and TROPION-Breast05 – across stages and treatment settings of TNBC. Trials Supporting Three Recent Breakthrough Therapy Designations Showcased Data from additional late-stage trials – DESTINY-Breast09, REJOICE-Ovarian01 and IDeate-Lung01 – that supported three recent Breakthrough Therapy Designations (BTD) in the U.S. for ENHERTU, raludotatug deruxtecan (R-DXd) and ifinatamab deruxtecan (I-DXd) will be showcased at ESMO. Two late-breaking proffered paper sessions will highlight the primary analysis from the phase 2 part of the REJOICE-Ovarian01 phase 2/3 trial (LBA42) of raludotatug deruxtecan in patients with previously treated platinum-resistant ovarian cancer, and additional analyses of key subgroups of interest from the DESTINY-Breast09 phase 3 trial (LBA18) evaluating ENHERTU plus pertuzumab versus THP (taxane, trastuzumab, pertuzumab) for the first-line treatment of patients with HER2 positive metastatic breast cancer. Results of DESTINY-Breast09 formed the basis for a supplemental Biologic License Application in the U.S. for ENHERTU, which was recently granted Priority Review under the Real-Time Oncology Review program. Detailed results highlighting the intracranial activity of ifinatamab deruxtecan from the IDeate-Lung01 phase 2 trial (2760MO) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) and baseline brain metastases will be highlighted during a mini oral session. The primary results of IDeate-Lung01 were presented last month at the 2025 World Conference on Lung Cancer (#WCLC25). Progress Continues in Multiple Cancers Across the DXd ADC Portfolio of Daiichi Sankyo Additional mini oral sessions at ESMO will feature the first presentation of data from two early phase trials from the DXd ADC portfolio of Daiichi Sankyo. These include preliminary results from the first-in-human phase 1/2 trial of DS-3939 (917O), the sixth DXd ADC in clinical development, in patients with previously treated advanced solid tumors refractory to standard treatment, as well as initial results from a sub-study of the TROPION-PanTumor03 phase 2 trial (3072MO) evaluating DATROWAY plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, in patients as first-line or second-line locally advanced or metastatic urothelial carcinoma. Final analyses from two trials – DESTINY-CRC02 and DESTINY-PanTumor02 – that supported the tumor agnostic indication of ENHERTU, which is now approved in more than 10 countries/regions worldwide, will be presented. A mini oral session will feature the final analysis from the DESTINY-CRC02 phase 2 trial (737MO) of ENHERTU in patients with previously treated HER2 positive metastatic colorectal cancer while two poster presentations will highlight the final results (957P) and an exploratory biomarker analysis (145P) from part 1 of the DESTINY-PanTumor02 phase 2 trial in patients with previously treated HER2 expressing solid tumors. Additional regulatory submissions seeking a tumor agnostic approval in patients with HER2 positive metastatic solid tumors currently are under review in the EU and Japan. Further sub-analyses from the DESTINY-Gastric04 phase 3 trial of ENHERTU versus ramucirumab plus paclitaxel in the second-line treatment of patients with HER2 positive metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma will be presented as a poster presentation (2099P) reporting the concordance of central HER2 testing with local HER2 testing along with additional efficacy and safety analyses. Data from DESTINY-Gastric06, a phase 2 trial in patients from China with HER2 expressing advanced gastric or GEJ adenocarcinoma who have received at least two prior regimens including a fluoropyrimidine agent and a platinum agent, will be presented in two poster presentations. The first poster (2105P) will feature an analysis of patients that received prior anti-HER2 treatment other than or in addition to trastuzumab. The second poster (2175P) will report the risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with ENHERTU. Updates of progress in lung cancer include a mini oral session reporting updated results from a phase 1/2 trial of gocatamig (2758MO), a DLL3 targeting T-cell engager being jointly developed by Merck, in patients with small cell lung cancer and other neuroendocrine cancers, as well as a poster presentation that will highlight the initial safety results from a phase 1b trial of valemetostat (2023P), a dual EZH1 and EZH2 inhibitor, in combination with DATROWAY in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC). Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio Several trials-in-progress poster presentations at ESMO further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with cancer. A trial-in-progress poster will highlight the design of the DESTINY-Endometrial01 phase 3 trial (1223TiP) evaluating ENHERTU in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. Three phase 2 trials-in-progress will include the HERTHENA-Breast03 trial (463eTiP) evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; the REJOICE-GI01 trial (1001TiP) evaluating the efficacy and safety of raludotatug deruxtecan in patients with gastrointestinal cancers, including pancreatic ductal adenocarcinoma, gastroesophageal adenocarcinoma, biliary tract and colorectal cancer; and, the KEYMAKER-U01 sub-studies 01H/01I (2081eTiP) evaluating ifinatamab deruxtecan, raludotatug deruxtecan or docetaxel in patients with stage IV NSCLC. The design of two additional early phase trials will be shared, including the phase 1/2 trial (2792TiP) evaluating ifinatamab deruxtecan and gocatamig in patients with relapsed/refractory ES-SCLC and a phase 1b trial (977P) of valemetostat in combination with ipilimumab in patients with refractory genitourinary tumors, including prostate cancer, urothelial carcinomas and renal clear cell carcinoma. Investor Briefing During ESMO Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 21, 2025 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO data. Daiichi Sankyo Oral Presentations at ESMO Presentation Title Author Abstract Presentation (CEST) Breast Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with high-risk human epidermal growth factor receptor 2-positive (HER2+) primary breast cancer with residual invasive disease after neoadjuvant therapy: interim analysis of DESTINY-Breast05 C. Geyer LBA1 Presidential Symposium I Saturday, October 18 4:30 – 6:15 pm DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer N. Harbeck 291O Presidential Symposium I Saturday, October 18 4:30 – 6:15 pm Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analyses of DESTINY-Breast09 in key subgroups of interest S. Loibl LBA18 Proffered Paper Session Sunday, October 19 8:30 – 10:00 am First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: primary results from the randomized, phase 3 TROPION-Breast02 trial R. Dent LBA21 Proffered Paper Session Sunday, October 19 8:30 – 10:00 am Datopotamab deruxtecan (Dato-DXd) + durvalumab as first-line treatment for unresectable locally advanced/ metastatic triple negative breast cancer: final results from the phase 1b/2 BEGONIA study P. Schmid 555MO Mini Oral Session Monday, October 20 10:15 – 11:45 am Lung Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer and baseline brain metastases: primary analysis of IDeate-Lung01 P. Rocha 2760MO Mini Oral Session Saturday, October 18 4:30 – 6:00 pm Updated results from a phase 1/2 study of gocatamig for small cell lung cancer and other neuroendocrine cancers H. Beltran 2758MO Mini Oral Session Saturday, October 18 4:30 – 6:00 pm Ovarian Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: primary analysis of the phase 2 dose- optimization part of the REJOICE-Ovarian01 study I. Ray-Coquard LBA42 Proffered Paper Session Sunday, October 19 2:45 – 4:15 pm Bladder Datopotamab deruxtecan (Dato-DXd) + rilvegostomig in patients with locally advanced or metastatic urothelial cancer: results from the phase 2 TROPION-PanTumor03 study S. Rha 3072MO Mini Oral Session Friday, October 17 4:00 – 5:30 pm CRC Trastuzumab deruxtecan (T‑DXd) in patients with HER2 positive (HER2+) metastatic colorectal cancer: final analysis of DESTINY-CRC02, a randomized, phase 2 trial K. Raghav 737MO Mini Oral Session Sunday, October 19 2:45 – 4:15 pm PanTumor DS-3939, a tumor-associated mucin 1 (TA-MUC1)-directed antibody drug conjugate (ADC), in patients with advanced/metastatic solid tumors: initial results from a first-in-human study M. Patel 917O Proffered Paper Session Sunday, October 19 2:45 – 4:20 pm Daiichi Sankyo Poster Presentations at ESMO Presentation Title Author Abstract Presentation (CDT) Breast Final real-world safety and effectiveness results of REALITY-01 study: trastuzumab deruxtecan (T-DXd) in patients received ≥2 prior treatment lines for HER2+ metastatic or unresectable breast cancer J. Pierga 539P Poster Session The effectiveness of post-trastuzumab deruxtecan (T-DXd) treatment regimens and the incidence of recurrent interstitial lung disease (ILD) in patients with HER2+ metastatic breast cancer who discontinued T-DXd due to ILD J. Tsurutani 540P Poster Session HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR low+/HER2− breast cancer M. Danso 463eTiP ePoster Lung Phase 1b study of valemetostat in combination with datopotamab deruxtecan (Dato-DXd) in advanced non-squamous non-small cell lung cancer: initial safety results A. Spira 2023P Poster Session A phase 1b/2 study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer J. Sun 2792TiP Poster Session KEYMAKER-U01 phase 2 substudies 01H/01I: ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) or docetaxel in stage IV non-small cell lung cancer E. Nadal 2081eTiP ePoster Gastrointestinal Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma: additional data from DESTINY-Gastric04 F. Pietrantonio 2099P Poster Session Trastuzumab deruxtecan (T-DXd) in patients with HER2+ gastric cancer or gastroesophageal junction adenocarcinoma who received prior anti-HER2 treatment other than/in addition to trastuzumab in DESTINY-Gastric06 Z. Peng 2105P Poster Session Risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06 L. Shen 2175P Poster Session Raludotatug deruxtecan in participants with gastrointestinal cancers: phase 2 REJOICE-GI01 trial M. Ueno 1001TiP Poster Session Endometrial A randomized phase 3 study of first-line trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2 expressing, mismatch repair-proficient, primary advanced or recurrent endometrial cancer: DESTINY-Endometrial01/GOG-3098/ENGOT-EN24 B. Slomovitz 1223TiP Poster Session PanTumor Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: DESTINY-PanTumor02 part 1 final analysis V. Makker 957P Poster Session Trastuzumab deruxtecan (T-DXd) in pretreated patients with HER2 expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 part 1 D. Oh 145P Poster Session DS3201 (valemetostat), an EZH1/2 inhibitor, with ipilimumab in patients with refractory genitourinary tumors S. Goswami 977P Poster Session About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

临床2期临床3期临床结果突破性疗法临床1期

2025-09-21

·信狐药迅

两个1类新药：徐诺药业艾贝司他和信立泰泰卡西单抗提交上市申请|新受理（9.15-9.21）

本周药品注册受理数据，分门别类呈现，一目了然。(9.15-9.21）新药上市申请药品名称企业注册分类受理号甲苯磺酸艾贝司他片徐诺药业(南京)有限公司 1 CXHS2500117 泰卡西单抗注射液深圳信立泰药业股份有限公司 1 CXSS2500097 泰卡西单抗注射液深圳信立泰药业股份有限公司 1 CXSS2500096 注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSS2500094 新药临床申请药品名称企业注册分类受理号 TQF3250胶囊正大天晴药业集团股份有限公司 1 CXHL2501018 TQF3250胶囊正大天晴药业集团股份有限公司 1 CXHL2501017 TQF3250胶囊正大天晴药业集团股份有限公司 1 CXHL2501016 177Lu-PSMA-VG01注射液山东威智知科药业有限公司 1 CXHL2501015 HRS-6208胶囊山东盛迪医药有限公司 1 CXHL2501014 HRS-6208胶囊山东盛迪医药有限公司 1 CXHL2501013 HRS-6208胶囊山东盛迪医药有限公司 1 CXHL2501012 注射用莱古比星上海亲合力生物医药科技股份有限公司 1 CXHL2501011 HRS-1358片山东盛迪医药有限公司 1 CXHL2501010 HRS-1358片山东盛迪医药有限公司 1 CXHL2501009 冻干带状疱疹病毒mRNA疫苗北京沃森创新生物技术有限公司 1.2 CXSL2500805 冻干带状疱疹病毒mRNA疫苗北京沃森创新生物技术有限公司 1.2 CXSL2500804 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液上海邦耀生物科技有限公司 1 CXSL2500810 注射用SSGJ-709 沈阳三生制药有限责任公司 1 CXSL2500806 HLX37注射液上海复宏瑞霖生物技术有限公司 1 CXSL2500802 VBC103 上海橙帆医药有限公司 1 CXSL2500801 注射用LBL-047 南京维立志博生物科技股份有限公司 1 CXSL2500797 HX15001注射液华深智药生物科技(苏州)有限公司 1 CXSL2500800 SHR-2906注射液北京盛迪医药有限公司 1 CXSL2500799 QM101细胞注射液北京奇迈永华生物科技有限公司 1 CXSL2500798 LM103注射液苏州蓝马医疗技术有限公司 1 CXSL2500796 JMT206注射液上海津曼特生物科技有限公司 1 CXSL2500795 WGP03 深圳市卫光生物制品股份有限公司 2.2 CXSL2500807 注射用苏维西塔单抗江苏先声生物制药有限公司 2.2 CXSL2500803 仿制药申请药品名称企业注册分类受理号甲苯磺酸艾贝司他片徐诺药业(南京)有限公司 1 CXHS2500117 米诺地尔搽剂海南钧华医疗科技有限公司 3 CYHS2503477 注射用盐酸多西环素湖北美林药业有限公司 3 CYHS2503467 利多卡因丁卡因乳膏江苏盈科生物制药有限公司 3 CYHS2503466 维生素K1注射液江苏九旭药业有限公司 3 CYHS2503464 地氯雷他定口服溶液广州聚力医药开发有限公司 3 CYHS2503469 盐酸奈福泮注射液海南全星制药有限公司 3 CYHS2503457 盐酸苯海拉明注射液四川天杏汇医药科技有限公司 3 CYHS2503453 布瑞哌唑口腔崩解片烟台巨先药业有限公司 3 CYHS2503451 布瑞哌唑口腔崩解片烟台巨先药业有限公司 3 CYHS2503450 盐酸苯海索片云鹏医药集团有限公司 3 CYHS2503445 硝普钠注射液四川奇裕医药科技有限公司 3 CYHS2503444 低钙腹膜透析液(碳酸氢盐-G1.5%) 安徽丰原药业股份有限公司 3 CYHS2503431 低钙腹膜透析液(碳酸氢盐-G2.5%) 安徽丰原药业股份有限公司 3 CYHS2503430 盐酸丁螺环酮片浙江赛默制药有限公司 3 CYHS2503423 盐酸丁螺环酮片浙江赛默制药有限公司 3 CYHS2503422 盐酸丁螺环酮片浙江赛默制药有限公司 3 CYHS2503421 醋酸钙片赤峰固得药业有限公司 3 CYHS2503416 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503483 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503482 哌柏西利胶囊广州科锐特药业有限公司 4 CYHS2503481 聚乙烯醇滴眼液广州大光制药有限公司 4 CYHS2503480 硫酸氨基葡萄糖胶囊河北九汇医药制造有限公司 4 CYHS2503479 甲磺酸溴隐亭片郑州泰丰制药有限公司 4 CYHS2503478 硫酸氨基葡萄糖胶囊河北三升药业有限公司 4 CYHS2503476 盐酸决奈达隆片石家庄市华新药业有限责任公司 4 CYHS2503475 洛索洛芬钠贴剂北京百奥药业有限责任公司 4 CYHS2503474 洛索洛芬钠贴剂北京百奥药业有限责任公司 4 CYHS2503473 阿帕他胺片重庆华森制药股份有限公司 4 CYHS2503468 富马酸伏诺拉生片广州白云山天心制药股份有限公司 4 CYHS2503465 孟鲁司特钠咀嚼片翎耀生物科技(上海)有限公司 4 CYHS2503463 孟鲁司特钠咀嚼片翎耀生物科技(上海)有限公司 4 CYHS2503462 布瑞哌唑片杭州和泽坤元药业有限公司 4 CYHS2503472 布瑞哌唑片杭州和泽坤元药业有限公司 4 CYHS2503471 硫酸羟氯喹片安若维他药业泰州有限公司 4 CYHS2503470 甲磺酸沙非胺片安徽泰恩康制药有限公司 4 CYHS2503456 甲磺酸沙非胺片安徽泰恩康制药有限公司 4 CYHS2503455 注射用盐酸地尔硫䓬江西科为制药有限公司 4 CYHS2503454 复方氨基酸注射液(18AA-IX) 远大医学营养科学(武汉)有限公司 4 CYHS2503452 复方氨基酸注射液(20AA) 武汉市小铂生物科技有限公司 4 CYHS2503448 吸入用丙酸倍氯米松混悬液四川普锐特药业有限公司 4 CYHS2503447 注射用头孢曲松钠/氯化钠注射液海南倍特药业有限公司 4 CYHS2503446 卡铂注射液广东星昊药业有限公司 4 CYHS2503443 格列齐特缓释片广东彼迪药业有限公司 4 CYHS2503461 甲钴胺片杭州民生药物研究院有限公司 4 CYHS2503460 地塞米松棕榈酸酯注射液汇禹远和(海南)药业有限公司 4 CYHS2503459 苯磺酸左氨氯地平片云鹏医药集团有限公司 4 CYHS2503458 盐酸曲唑酮缓释片福州基石医药科技有限公司 4 CYHS2503449 氨氯地平阿托伐他汀钙片安徽佳和药业有限公司 4 CYHS2503440 聚多卡醇注射液浙江赛默制药有限公司 4 CYHS2503439 聚多卡醇注射液浙江赛默制药有限公司 4 CYHS2503438 注射用氟氧头孢钠苏州二叶制药有限公司 4 CYHS2503437 注射用氟氧头孢钠苏州二叶制药有限公司 4 CYHS2503436 甘油磷酸钠注射液朗天药业(湖北)有限公司 4 CYHS2503432 四烯甲萘醌软胶囊北京柏雅联合药物研究所有限公司 4 CYHS2503429 丁溴东莨菪碱注射液上海理想制药有限公司 4 CYHS2503442 瑞格列奈片重庆药友制药有限责任公司 4 CYHS2503435 硫酸镁钠钾口服用浓溶液河南合智医药科技有限公司 4 CYHS2503434 瑞格列奈片重庆药友制药有限责任公司 4 CYHS2503433 注射用伏立康唑浙江创新生物有限公司 4 CYHS2503441 依折麦布片海南赛立克药业有限公司 4 CYHS2503424 环孢素滴眼液(III) 辅必成(上海)医药科技有限公司 4 CYHS2503420 盐酸氨溴索口服溶液黄山精制药业有限公司 4 CYHS2503419 盐酸氨溴索口服溶液黄山精制药业有限公司 4 CYHS2503418 布洛芬缓释胶囊通化万通药业股份有限公司 4 CYHS2503417 洛索洛芬钠贴剂山东汉方制药有限公司 4 CYHS2503415 洛索洛芬钠贴剂山东汉方制药有限公司 4 CYHS2503414 达格列净二甲双胍缓释片(IV) 山东诺禾康药业有限公司 4 CYHS2503413 苯磺酸美洛加巴林片广州大光制药有限公司 4 CYHS2503412 苯磺酸美洛加巴林片广州大光制药有限公司 4 CYHS2503411 甲苯磺酸艾多沙班片湖南方盛制药股份有限公司 4 CYHS2503410 盐酸米诺环素胶囊成都瑞尔医药科技有限公司 4 CYHS2503409 盐酸米诺环素胶囊成都瑞尔医药科技有限公司 4 CYHS2503408 达格列净二甲双胍缓释片(III) 江苏天士力帝益药业有限公司 4 CYHS2503407 达格列净二甲双胍缓释片(II) 江苏天士力帝益药业有限公司 4 CYHS2503406 达格列净二甲双胍缓释片(I) 江苏天士力帝益药业有限公司 4 CYHS2503405 碘比醇注射液重庆药友制药有限责任公司 4 CYHS2503426 碘比醇注射液重庆药友制药有限责任公司 4 CYHS2503425 麦考酚钠肠溶片山东新时代药业有限公司 4 CYHS2503427 盐酸阿莫罗芬搽剂广州乐宓医药科技有限公司 4 CYHS2503428 人细小病毒B19核酸检测试剂盒(PCR-荧光法) 北京万泰生物药业股份有限公司 CXSS2500095 泰卡西单抗注射液深圳信立泰药业股份有限公司 1 CXSS2500097 泰卡西单抗注射液深圳信立泰药业股份有限公司 1 CXSS2500096 注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSS2500094 阿柏西普眼内注射溶液迈威(上海)生物科技股份有限公司 3.3 CXSS2500098 芍药甘草颗粒河北万邦复临药业有限公司 3.1 CXZS2500039 半夏白术天麻颗粒海南斯达制药有限公司 3.1 CXZS2500040 注射用泼尼松龙琥珀酸钠南京恩泰医药科技有限公司 3 CYHL2500173 注射用泼尼松龙琥珀酸钠南京恩泰医药科技有限公司 3 CYHL2500172 注射用泼尼松龙琥珀酸钠南京恩泰医药科技有限公司 3 CYHL2500171 酮洛芬凝胶贴膏福元药业有限公司 3 CYHL2500169 盐酸羟甲唑啉滴眼液海南斯达制药有限公司 3 CYHL2500170 利多卡因丁卡因乳膏西藏中卫诚康药业有限公司 3 CYHL2500168 酮洛芬贴剂上海朝晖药业有限公司 3 CYHL2500167 米诺地尔泡沫剂科笛生物医药(无锡)有限公司 3 CYHL2500166 重组人促卵泡激素注射液成都景泽生物制药有限公司 3.3 CXSL2500809 重组人促卵泡激素注射液成都景泽生物制药有限公司 3.3 CXSL2500808 进口申请药品名称企业注册分类受理号 Gadoquatrane 注射液 Bayer AG 1 JXHS2500103 Gadoquatrane 注射液 Bayer AG 1 JXHS2500102 Gadoquatrane 注射液 Bayer AG 1 JXHS2500101 布地格福吸入气雾剂 AstraZeneca AB 2.4 JXHS2500105 布地格福吸入气雾剂 AstraZeneca AB 2.4 JXHS2500104 氟比洛芬凝胶贴膏 LEAD CHEMICAL CO., LTD. 5.1 JXHS2500106 Gadoquatrane 注射液 Bayer AG 1 JXHS2500103 Gadoquatrane 注射液 Bayer AG 1 JXHS2500102 Gadoquatrane 注射液 Bayer AG 1 JXHS2500101 布地格福吸入气雾剂 AstraZeneca AB 2.4 JXHS2500105 布地格福吸入气雾剂 AstraZeneca AB 2.4 JXHS2500104 氟比洛芬凝胶贴膏 LEAD CHEMICAL CO., LTD. 5.1 JXHS2500106 CVM-1118胶囊 TaiRx, Inc. 1 JXHL2500294 JSB462片 Novartis Pharma AG 1 JXHL2500288 Olomorasib胶囊 Eli Lilly and Company 1 JXHL2500291 Olomorasib胶囊 Eli Lilly and Company 1 JXHL2500290 DZR123片 Novartis Pharma AG 1 JXHL2500289 DZR123片 Novartis Pharma AG 1 JXHL2500287 DZR123片 Novartis Pharma AG 1 JXHL2500286 DZR123片 Novartis Pharma AG 1 JXHL2500285 双醋瑞因软膏 TWi Biotechnology, Inc. 2.2;2.4 JXHL2500293 达罗他胺片 Bayer HealthCare Pharmaceuticals Inc. 2.4 JXHL2500292 DS-3201b片 Daiichi Sankyo, Inc. 2.4 JXHL2500284 吸附无细胞百白破灭活脊髓灰质炎乙型肝炎(重组)和b型流感嗜血杆菌(结合)联合疫苗 Sanofi Winthrop Industrie 3.1 JXSL2500179 注射用AZD0292 AstraZeneca AB 1 JXSL2500182 prasinezumab注射液 F. Hoffmann-La Roche Ltd. 1 JXSL2500181 Tarperprumig注射液 Alexion Pharmaceuticals, Inc. 1 JXSL2500177 AZD4512 AstraZeneca AB 1 JXSL2500176 AZD4512 AstraZeneca AB 1 JXSL2500175 Amivantamab注射液(皮下注射) Janssen Research & Development, LLC 2.2 JXSL2500178 Amivantamab注射液(皮下注射) Janssen Research & Development, LLC 2.2 JXSL2500180 中药相关申请药品名称企业注册分类受理号柴芍解郁颗粒黑龙江省济仁药业有限公司 1.1 CXZL2500084 参苏止咳颗粒玉森(江西)新药研发有限公司 1.1 CXZL2500083 疏肝宁心颗粒中国中医科学院中药研究所 1.1 CXZL2500082 消腺止鼾口服液四川省现代中药创新技术有限公司 1.1 CXZL2500081 玛木然其尼软膏中科中山药物创新研究院 1.1 CXZL2500079 ZHY211贴膏杭州禾橼医药科技有限公司 1.1 CXZL2500078 鼾眠颗粒山东康众宏医药科技开发有限公司 1.1 CXZL2500077 桑枝总生物碱片北京五和博澳药业股份有限公司 2.3 CXZL2500080 芍药甘草颗粒河北万邦复临药业有限公司 3.1 CXZS2500039 半夏白术天麻颗粒海南斯达制药有限公司 3.1 CXZS2500040 注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗信使RNA临床申请临床1期申请上市

100 项与 Valemetostat Tosilate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11551 D16662	-	-	-

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
成人T细胞白血病/淋巴瘤	日本	Daiichi Sankyo Co., Ltd.	2022-09-26
外周T细胞淋巴瘤	日本	Daiichi Sankyo Co., Ltd.	2022-09-26

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床2期	美国	Daiichi Sankyo Co., Ltd.	2024-10-30
转移性非小细胞肺癌	临床2期	中国	Daiichi Sankyo Co., Ltd.	2024-10-30
转移性非小细胞肺癌	临床2期	日本	Daiichi Sankyo Co., Ltd.	2024-10-30
转移性非小细胞肺癌	临床2期	阿根廷	Daiichi Sankyo Co., Ltd.	2024-10-30
转移性非小细胞肺癌	临床2期	巴西	Daiichi Sankyo Co., Ltd.	2024-10-30
转移性非小细胞肺癌	临床2期	韩国	Daiichi Sankyo Co., Ltd.	2024-10-30
鳞状非小细胞肺癌	临床2期	美国	Daiichi Sankyo Co., Ltd.	2024-10-30
鳞状非小细胞肺癌	临床2期	中国	Daiichi Sankyo Co., Ltd.	2024-10-30
鳞状非小细胞肺癌	临床2期	日本	Daiichi Sankyo Co., Ltd.	2024-10-30
鳞状非小细胞肺癌	临床2期	阿根廷	Daiichi Sankyo Co., Ltd.	2024-10-30

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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


NCT06244485 (ESMO2025)	临床1期	非鳞状非小细胞肺癌	22	Datopotamab deruxtecan 6.0 mg/kg + Datopotamab deruxtecan 6.0 mg/kg	製醖獵壓鹽艱艱醖獵夢(醖蓋簾鹽製壓鏇淵艱醖) = no Vale MTD has been identified up to 200 mg 鏇衊衊鹽膚壓構襯獵襯 (膚鑰繭製憲夢餘夢壓衊 )	积极	2025-10-17
NCT04388852 (ESMO2025)	临床1期	泌尿生殖系统肿瘤	65	DS3201 (200 mg/day) plus ipilimumab (metastatic clear cell renal cell carcinoma)	顧齋壓選顧鬱襯獵範蓋(鏇壓顧鬱鏇範鹹壓夢遞) = 膚顧積築顧繭鹽選廠廠齋夢選憲鏇襯遞繭鹽範 (衊顧範願鏇獵淵鏇廠鑰 ) 更多	积极	2025-10-17
				DS3201 (200 mg/day) plus ipilimumab (aggressive variant prostate cancer)	鬱製憲艱鹽艱繭築夢顧(餘餘廠淵襯醖膚獵蓋醖) = 鏇鑰蓋顧鏇窪壓積淵蓋願鏇鏇齋壓鹽淵製繭衊 (淵糧餘繭夢鹽鹽選願鹹 ) 更多
JPRN-jRCT2031190268 (NCCH1904, ASCO2025)	临床1期	实体瘤 INI1-negative	30	Valemetostat tosylate (DS-3201b) 150 mg/1.7 m^2	襯鹽憲蓋積糧鹽顧鏇壓(艱鑰構範鹽衊餘膚鏇願) = One patient with NB developed acute lymphocytic leukemia as a secondary malignancy 構鹹鹹遞鑰糧願遞繭窪 (鑰蓋製獵鏇糧繭鬱齋網 ) 更多	积极	2025-05-30
				Valemetostat tosylate (DS-3201b) 200 mg/1.7 m^2
Phase II clinical trial (AACR2025)	临床2期	成人T细胞白血病/淋巴瘤 HTLV-1	-	Valemetostat (VAL)	鏇壓窪艱網繭鏇夢壓鹽(遞鹹繭鹹壓鑰壓艱餘積) = 鏇廠蓋艱願積齋鏇鹽餘蓋觸鬱糧構構鹹鏇顧鏇 (鹽選獵艱醖願糧選襯蓋 )	-	2025-04-29
NCT04703192 (VALENTINE-PTCL01, Pubmed \| Lancet Oncol)	临床2期	外周T细胞淋巴瘤	-	Valemetostat tosylate (valemetostat) 200 mg per day	襯蓋夢遞鏇鑰醖蓋衊觸(鏇蓋憲觸鬱餘鏇壓鬱築) = 選廠鏇鹽鬱製範鹽窪淵膚憲糧願鏇壓衊艱網餘 (膚糧顧廠蓋構齋廠衊獵, 35 ~ 53)	积极	2024-12-01
NCT04703192 (VALENTINE-PTCL01, CTgov)	临床2期	成人T细胞白血病/淋巴瘤 \| 外周T细胞淋巴瘤 \| 成人T细胞淋巴瘤/难治性白血病	155	Valemetostat Tosylate	觸範淵齋艱繭選築顧糧 = 築願衊艱襯艱淵窪壓襯憲獵構夢憲鏇齋製選範 (壓艱選衊積願製獵鹹積, 齋鬱獵壓鑰淵鹹糧夢製 ~ 蓋膚襯繭壓壓壓壓遞夢) 更多	-	2024-07-22
NCT02732275 (DS3201-A-J101, EHA2024) 人工标引	临床1期	非霍奇金淋巴瘤 EZH2 mutation	90	valemetostat tosylate 150-300 mg/d	艱鏇遞衊醖蓋淵夢鏇願(鬱鏇鹽糧膚壓齋積鹽艱) = 顧構夢製壓鬱鹽遞構鏇醖獵顧鏇觸蓋襯廠夢膚 (鹹餘願淵繭網網構鏇築 ) 更多	积极	2024-05-14
				valemetostat (ATLL)	願夢願製壓艱鹹網選積(構簾構蓋糧繭簾鏇網繭) = 觸簾夢壓憲築願構範簾艱壓窪構繭鏇壓繭淵鬱 (膚艱淵憲壓鬱壓積顧網, 1.4 ~ 38.7) 更多
NCT04703192 (VALENTINE-PTCL01, EHA2024) 人工标引	临床2期	外周T细胞淋巴瘤	119	Valemetostat tosylate 200 mg/day (pts with 1 prior LOT)	顧積範鏇鑰齋網醖鏇窪(壓選艱醖醖襯壓鹽廠鏇) = 鹽顧襯鹽廠齋鬱艱簾築壓選獵製鑰廠廠蓋淵夢 (衊構鏇壓衊鹽積願憲觸, 35.5 ~ 69.6)	积极	2024-05-14
				Valemetostat tosylate 200 mg/day (pts with 2 prior LOT)	顧積範鏇鑰齋網醖鏇窪(壓選艱醖醖襯壓鹽廠鏇) = 願構鑰積廠鑰襯壓獵鬱壓選獵製鑰廠廠蓋淵夢 (衊構鏇壓衊鹽積願憲觸, 28.3 ~ 65.7)
NCT03110354 (CTgov)	临床1期	急性髓性白血病 \| 急性淋巴细胞白血病	28	DS-3201b (DS-3201b 150 mg)	鏇壓鏇遞構網淵鹽積鏇 = 鑰觸艱餘鑰製糧餘構製簾範衊獵廠範築淵遞觸 (蓋簾觸糧鬱憲淵壓願顧, 簾糧範壓壓鏇夢範淵築 ~ 鏇簾鬱遞憲襯鏇淵鹹憲) 更多	-	2024-01-30
				DS-3201b (DS-3201b 250 mg)	鏇壓鏇遞構網淵鹽積鏇 = 築醖觸淵築網艱夢觸繭簾範衊獵廠範築淵遞觸 (蓋簾觸糧鬱憲淵壓願顧, 壓鹹糧艱選積蓋壓壓蓋 ~ 齋淵衊網餘選淵糧膚構) 更多
ASH2023	临床1期	外周T细胞淋巴瘤	71	Valemetostat	鬱窪顧鬱獵艱衊餘顧餘(艱憲膚鏇選構鬱製製壓) = 窪衊鹽夢齋膚積淵顧膚夢選蓋憲襯繭範糧築膚 (襯選積壓淵艱繭範獵艱 ) 更多	-	2023-12-09