A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.

开始日期2024-05-10

申办/合作机构

苏州泽璟生物制药股份有限公司

NCT06233994 / Not yet recruitingN/AIIT

A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.

开始日期2024-01-01

申办/合作机构-

NCT06244225 / Recruiting临床2期IIT

An Exploratory Study to Evaluate the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine With Sintilimab and Donafenib for Unresectable Hepatocellular Carcinoma

This is a single-arm exploratory clinical study to evaluate the efficacy and safety of HAIC in combination with Sintilimab and Donafenib in patients with BCLC-C stage who have not received prior systemic therapy

开始日期2024-01-01

申办/合作机构

武汉协和医院

100 项与甲苯磺酸多纳非尼相关的临床结果

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100 项与甲苯磺酸多纳非尼相关的转化医学

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100 项与甲苯磺酸多纳非尼相关的专利（医药）

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项与甲苯磺酸多纳非尼相关的文献（医药）

2023-09-01·Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

Simultaneous quantification of donafenib, sorafenib, and their N-oxide metabolites in rat plasma using a HPLC-MS/MS method.

Article

作者: Zhang, Yiwen ; Sun, Zhiyong ; Gu, Jinping ; Hu, Ying ; Lou, Yutao ; Liu, Yujia ; Bao, Meihua ; Chai, Yitao ; Qin, Hui ; Zheng, Xiaowei ; Hu, Qing

Donafenib and sorafenib are small molecule chemotherapy drugs for the management of hepatocellular carcinoma, with donafenib being a deuterated derivative of sorafenib. To date, a high liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method that quantify donafenib, sorafenib, and their main metabolites has not yet been developed. The objective of this study was to establish a HPLC-MS/MS method for the simultaneous detection of donafenib, donafenib-N-oxide, sorafenib, and sorafenib-N-oxide and for the pharmacokinetic studies in rat. The extraction of all analytes was achieved by simple protein precipitation utilizing acetonitrile. The Waters XBridge C₁₈ column (2.1 × 100 mm, 3.5 µm) was selected, and the analytes could be efficiently separated and quantitated during a 2.8 min gradient elution procedure. The method was linear within the predefined quantification ranges and provided acceptable precision (%CV < 9.4%), reproducible extraction recovery (99.4%-111.5%), and low matrix effect (88.1%-98.6%). The hemolysis effect did not interfere with the quantification of all analytes, and similar results were obtained by changing the anticoagulant K₂-EDTA to heparin or sodium citrate. Plasma pharmacokinetics revealed that the values of t_1/2, C_max, and AUC_0-t of donafenib were 1.4-, 6.2-, and 3.1-fold higher than those of sorafenib, respectively. In conclusion, the proposed bioassay was successfully applied to pharmacokinetic studies in rat after administration of donafenib and sorafenib. Our work not only improves the bioanalytical method for determining the plasma concentrations of donafenib, sorafenib, and their N-oxide metabolites, but also provides a scientific reference for clinical pharmacokinetic studies.

2023-06-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

In vivo assessment of the pharmacokinetic interactions between donafenib and dapagliflozin, donafenib and canagliflozin in rats

Article

作者: Guo, Caihui ; Li, Yajing ; Fu, Yuhao ; Li, Ying ; He, Xueru ; Wang, Zhi ; Xun, Xuejiao ; Dong, Zhanjun

Donafenib (DONA), a deuterium derivative of sorafenib, is used for advanced hepatocellular carcinoma (HCC). Dapagliflozin (DAPA) and canagliflozin (CANA) are sodium-glucose co-transporter 2 (SGLT2) inhibitors used for T2DM, which is frequently comorbid with HCC. Three drugs are substrates of UGT1A9 isoenzyme. This study aimed to evaluate donafenib-dapagliflozin and donafenib-canagliflozin pharmacokinetic interactions and explore the potential mechanisms. Rats were divided into seven groups (n = 6) that received donafenib (1), dapagliflozin (2), canagliflozin (3), dapagliflozin and donafenib (4), canagliflozin and donafenib (5), donafenib and dapagliflozin (6), donafenib and canagliflozin (7). The concentrations of drugs were determined by an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method. The messenger RNA (mRNA) expressions were measured by quantitative RT-PCR. Multiple doses of dapagliflozin caused donafenib maximum plasma concentration (C_max) to increase 37.01%. Canagliflozin increased donafenib C_max 1.77-fold and the area under the plasma concentration-time curves (AUC_0-t and AUC_inf) 1.39- and 1.41-fold, respectively, while reducing the apparent clearance (CL_z) 28.38%. Multiple doses of donafenib increased dapagliflozin AUC_0-t 1.61-fold, AUC_inf 1.77-fold, whereas its CL_z reduced 40.50%. Furthermore, donafenib caused similar changes in canagliflozin pharmacokinetics. The PCR results demonstrated that dapagliflozin inhibited the mRNA expression of Ugt1a7 in liver and donafenib decreased the expression of Ugt1a7 mRNA in liver and intestine. Increased exposure to these drugs may be due to their metabolism inhibition mediated by Ugt1a7. These pharmacokinetic interactions observed in this study may be of clinical significance, which may help adjust dose properly and avoid toxicity effects in patients with HCC and T2DM.

2023-01-01·Frontiers in pharmacology

Development of a UPLC-MS/MS method for simultaneous therapeutic drug monitoring of anti-hepatocellular carcinoma drugs and analgesics in human plasma.

Article

作者: Li, Guofei ; Zhao, Mingming ; Lu, Shijia ; Zhao, Limei

In hepatocellular carcinoma treatment, sorafenib, oxaliplatin, 5-fluorouracil, capecitabine, lenvatinib, and donafenib are first-line drugs; regorafenib, apatinib, and cabozantinib are second-line drugs; and oxycodone, morphine, and fentanyl are commonly used analgesics. However, the high degree of inter- and intra-individual variability in the efficacy and toxicity of these drugs remains an urgent issue. Therapeutic drug monitoring (TDM) is the most reliable technical means for evaluating drug safety and efficacy. Therefore, we developed an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for simultaneous TDM of three chemotherapy drugs (5-fluorouracil, oxaliplatin, and capecitabin), six targeted drugs (sorafenib, donafenib, apatinib, cabozantinib, regorafenib, and lenvatinib), and three analgesics (morphine, fentanyl, and oxycodone). We extracted 12 analytes and isotope internal standards (ISs) from plasma samples by magnetic solid phase extraction (mSPE) and separated them using a ZORBAX Eclipse Plus C18 column with water containing 0.1% formic acid and methanol containing 0.1% formic acid as the mobile phase. The analytical performance of our method in terms of sensitivity, linearity, specificity, carryover, precision, limit of quantification, matrix effect, accuracy, dilution integrity, extraction recovery, stability, and crosstalk of all the analytes under different conditions met all the criteria stipulated by the guidelines of the Chinese Pharmacopoeia and U.S. Food and Drug Administration. The response function was estimated at 10.0-10 000.0 ng/mL for sorafenib, donafenib, apatinib, cabozantinib, regorafenib, and lenvatinib, and 20.0-20 000.0 ng/mL for 5-fluorouracil, oxaliplatin, capecitabin, morphine, fentanyl, and oxycodone, with a correlation of > 0.9956 for all compounds. The precision and accuracy of all analytes were < 7.21% and 5.62%, respectively. Our study provides empirical support for a simple, reliable, specific, and suitable technique for clinical TDM and pharmacokinetics.

项与甲苯磺酸多纳非尼相关的新闻（医药）

2024-05-07

·药研网

2024 ASCO|泽璟制药将公布多纳非尼&吉卡昔替尼多项研究结果

5月7日，泽璟制药宣布，公司自主研发的甲苯磺酸多纳非尼片、盐酸吉卡昔替尼片（曾用名：杰克替尼）在内的合计18项临床研究结果将于2024年美国临床肿瘤学（ASCO）上公布。多纳非尼是一种口服多靶点、多激酶抑制剂类小分子抗肿瘤药物。目前，多纳非尼已经国内获批两项适应症，分别用于一线治疗晚期肝细胞癌，以及治疗局部晚期/转移性放射性碘难治性分化型甲状腺癌（RAIR-DTC）。2021年6月首次获批上市，适应症为一线治疗晚期肝细胞癌，其对标产品为德国拜耳的索拉非尼，后者也是目前肝细胞癌一线治疗的标准疗法之一。临床前药理学研究证实，多纳非尼片既可抑制VEGFR、PDGFR等多种受体酪氨酸激酶的活性，也可抑制肿瘤细胞增殖和肿瘤血管的形成，发挥多重抑制、多靶点阻断的抗肿瘤作用。盐酸吉卡昔替尼（曾用名：盐酸杰克替尼）是公司自主研发的一种新型JAK和ACVR1双抑制剂类药物，属于1类新药。吉卡昔替尼对Janus激酶包括JAK1、JAK2、JAK3和TYK2具有显著的抑制作用，且对JAK2和TYK2的抑制作用最强。目前正在开展多个免疫炎症性疾病和纤维化疾病的临床研究。此次大会多纳非尼&吉卡昔替尼的主要临床研究结果摘要信息如下：多纳非尼标题：使用综合多组学分析来确定多纳非尼与FADS2抑制剂联合治疗在肝细胞癌中的抗肿瘤效果Title:Use of integrated multi-omics analysis to determine antitumor efficacy of donafenib in combination with FADS2 inhibition in hepatocellular carcinoma摘要编号：e15083展示形式：在线发表主要研究者：朱旭教授标题：多纳非尼用于高复发风险的肝细胞癌患者根治性切除术后辅助治疗的一项多中心、回顾性研究Title: Adjuvant donafenib for patients with hepatocellular carcinoma at high risk of recurrence following radical resection: A multi-center, retrospective study in China摘要编号：e15129展示形式：在线发表主要研究者：刘连新王继洲教授标题：多纳非尼联合抗PD-1抗体治疗不可切除的肝细胞癌患者的有效性与安全性：一项回顾性真实世界研究Title: Efficacy and safety of Donafenib combined with anti-PD-1 antibodies for initially unresectable hepatocellular carcinoma（HCC）: A retrospective real-world study摘要编号：e16131展示形式：在线发表主要研究者：刘苏来/彭创教授标题：TACE/HAIC联合多纳非尼及免疫检查点抑制剂治疗不可切除肝细胞癌的疗效和安全性：一项多中心回顾性研究Title: Efficacy and safety of transarterial therapy combined with donafenib plus immune checkpoint inhibitors for unresectable hepatocellular carcinoma: a multicenter retrospective study摘要编号：e16133展示形式：在线发表主要研究者：商昌珍教授标题：多纳非尼联合TACE治疗不可切除肝细胞癌的疗效和安全性分析：一项前瞻性、单臂、单中心、II期临床研究Title: Efficacy and safety analysis of donafenib combined with transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma a prospective，single-arm，single center，phase Ⅱ clinical study摘要编号：e16134展示形式：在线发表主要研究者：李金鹏/宋金龙教授标题：比较TACE联合多纳非尼或仑伐替尼用于治疗不可切除肝细胞癌的疗效和安全性：一项回顾性真实世界研究Title: Comparing the efficacy and safety of TACE combined with donafenib VS lenvatinib in the treatment of unresectable hepatocellular carcinoma：A retrospectine real-world study摘要编号：e16137展示形式：在线发表主要研究者：黄明声/刘欢教授标题：TACE联合多纳非尼用于不可切除肝细胞癌一线治疗：一项真实世界临床研究Title: Transarterial chemoembolization (TACE) combined with Donafenib as first-line therapy for unresectable hepatocellular carcinoma (uHCC): A real-world clinical study摘要编号：e16145展示形式：在线发表主要研究者：范文哲教授标题：比较TACE联合多纳非尼或仑伐替尼治疗不可切除肝细胞癌的疗效和安全性Title: Comparing the efficacy and safety of TACE combined with donafenib or lenvatinib in the treatment of unresectable hepatocellular carcinoma摘要编号：e16153展示形式：在线发表主要研究者：吕维富/魏宁教授标题：多纳非尼联合TACE伴或不伴免疫疗法在中晚期肝细胞癌（HCC）中的疗效和安全性Title: A retrospective study on the efficacy and safety of Donafenib combined with Transarterial chemoembolization (TACE) and with/without immunotherapy in intermediate-advanced hepatocellular carcinoma (HCC).摘要编号：e16171展示形式：在线发表主要研究者：赵辉教授标题：TACE-HAIC联合多纳非尼及免疫疗法治疗伴有门静脉肿瘤血栓的肝细胞癌的有效性及安全性Title: TACE-HAIC combined with Donafenib and immunotherapy for hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT): A retrospective analysis.摘要编号：e16174展示形式：在线发表主要研究者：刘瑞宝尹立楠教授标题：多纳非尼联合TACE及抗PD-1抗体作为肝细胞癌一线治疗的疗效与安全性Title: The Efficacy and Safety of Donafenib Combined with Transcatheter Arterial Chemoembolization and Anti PD-1 Antibodies as First-line Therapy for Hepatocellular Carcinoma: A Retrospective Study摘要编号：e16178展示形式：在线发表主要研究者：郑家平教授标题：不同一线肝癌治疗药物（多纳非尼、索拉非尼或仑伐替尼）联合TACE治疗失败后序贯瑞戈非尼的疗效比较Title: Comparative effificacy of systemic sequential regorafenib after TACE combined with First-line targeted drugs(donafenib, sorafenib or lenvatinib) treatment failure for advanced hepatocellular carcinoma: A retrospective, single-center, real world study.摘要编号：e16190展示形式：在线发表主要研究者：吕维富/魏宁教授标题：术后辅助性肝动脉灌注化疗联合多纳非尼治疗单发大肿瘤伴微血管侵犯的肝细胞癌Title: Postoperative adjuvant hepatic arterial infusion chemotherapy combined with donafenib in hepatocellular carcinoma with solitary large tumor and microvascular invasion: a multicenter, prospective, single-arm, phase II trial摘要编号：e16227展示形式：在线发表主要研究者：张磊教授标题：多纳非尼联合抗PD-1抗体用于有高复发风险肝细胞癌患者切除后的辅助治疗（PATH研究）Title: Adjuvant theraPy with DonAfenib plus anTi-PD-1 antibody for patients (pts) at high risk of Hepatocellular carcinoma (HCC) recurrence after resection (PATH study)摘要编号：e16228展示形式：在线发表主要研究者：梁廷波/白雪莉教授标题：多纳非尼作为肝切除后肝细胞癌（HCC）患者的辅助治疗的疗效和安全性Title: Efficacy and safety of donafenib as adjuvant therapy for patients with hepatocellular carcinoma (HCC) after hepatectomy: A Retrospective, Multicenter Cohort Study摘要编号：e16234展示形式：在线发表主要研究者：杨欣荣教授标题：以多纳非尼为基础的系统性治疗方案用于肝细胞癌一线治疗的疗效和安全性Title: The efficacy and safety of donafenib-containing regimens as first-line therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study.摘要编号：e16243展示形式：在线发表主要研究者：尹国文/张庆桥教授泛TKI标题：立体定向放疗（SBRT）联合TACE及酪氨酸激酶抑制剂（TKIs）与单独TACE联用TKIs治疗伴有门静脉肿瘤血栓（PVTT）的不可切除肝细胞癌（uHCC）的一项随机对照试验Title: Stereotactic body radiotherapy (SBRT) combined with transcatheter arterialchemoembolization (TACE) and tyrosine kinase inhibitors (TKIs) versus TACE and TKISalone for unresectable hepatocellular carcinoma (uHCC) with portal vein tumor thrombus(PVTT):A randomized controlled trial摘要编号：4102展现形式：壁报展示分会场标题：Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary展示时间：2024.06.01 1:30 PM-4:30 PM主要研究者：王辛教授吉卡昔替尼标题：接受吉卡昔替尼治疗的骨髓纤维化患者中铁蛋白、血红蛋白与贫血反应之间的关联：ZGJAK006研究的事后分析Title: Association between ferritin, hemoglobin and anemia response in jaktinib-treated myelofibrosis (MF) patients (pts): A post-hoc analysis of the ZGJAK006 study摘要编号：e18527展示形式：在线发表主要研究者：金洁教授往期推荐视角 | 纸面之外的药明康德2023年报Claudin18.2ADC赛道群雄逐鹿：3家率先进入III期临床下一个10亿美元重磅炸弹选手"裁员潮”仍在加剧：2月多家药企裁员点击下方“药研网”，关注更多精彩内容

临床结果ASCO会议上市批准临床研究

2024-05-07

·泽璟制药

ASCO 2024 I 多纳非尼&吉卡昔替尼研究硕果绽放国际舞台

NEWS2024年5月7日，泽璟制药（股票代码：688266.SH）宣布，公司自主研发的甲苯磺酸多纳非尼片、盐酸吉卡昔替尼片（曾用名：杰克替尼）在内的合计18项临床研究结果将于2024年美国临床肿瘤学（ASCO）上公布。美国临床肿瘤学会年会（ASCO年会）是迄今为止最大规模、学术水平及权威等级均首屈一指的临床肿瘤学国际会议，汇集了世界各地的肿瘤学专家、医生、研究人员和制药业代表，每年ASCO年会对业界研究者而言可谓一场学术盛宴，许多重要的研究发现与成果都会在大会上首次披露，分享最新的肿瘤学研究成果、讨论最新的治疗方法和技术，以及推动肿瘤学领域的科学进步。本届ASCO年会将于2024年5月31日至6月4日在美国芝加哥McCormick Place Convention Center举行，今年的主题是The Art and Science of Cancer Care: From Comfort to Cure。此次大会多纳非尼&吉卡昔替尼（Jaktinib，曾用名：杰克替尼）的主要临床研究结果摘要信息如下：多纳非尼标题：使用综合多组学分析来确定多纳非尼与FADS2抑制剂联合治疗在肝细胞癌中的抗肿瘤效果Title:Use of integrated multi-omics analysis to determine antitumor efficacy of donafenib in combination with FADS2 inhibition in hepatocellular carcinoma摘要编号：e15083展示形式：在线发表主要研究者：朱旭教授标题：多纳非尼用于高复发风险的肝细胞癌患者根治性切除术后辅助治疗的一项多中心、回顾性研究Title: Adjuvant donafenib for patients with hepatocellular carcinoma at high risk of recurrence following radical resection: A multi-center, retrospective study in China摘要编号：e15129展示形式：在线发表主要研究者：刘连新王继洲教授标题：多纳非尼联合抗PD-1抗体治疗不可切除的肝细胞癌患者的有效性与安全性：一项回顾性真实世界研究Title: Efficacy and safety of Donafenib combined with anti-PD-1 antibodies for initially unresectable hepatocellular carcinoma（HCC）: A retrospective real-world study摘要编号：e16131展示形式：在线发表主要研究者：刘苏来/彭创教授标题：TACE/HAIC联合多纳非尼及免疫检查点抑制剂治疗不可切除肝细胞癌的疗效和安全性：一项多中心回顾性研究Title: Efficacy and safety of transarterial therapy combined with donafenib plus immune checkpoint inhibitors for unresectable hepatocellular carcinoma: a multicenter retrospective study摘要编号：e16133展示形式：在线发表主要研究者：商昌珍教授标题：多纳非尼联合TACE治疗不可切除肝细胞癌的疗效和安全性分析：一项前瞻性、单臂、单中心、II期临床研究Title: Efficacy and safety analysis of donafenib combined with transarterial chemoembolization in the treatment of unresectable hepatocellular carcinoma a prospective，single-arm，single center，phase Ⅱ clinical study摘要编号：e16134展示形式：在线发表主要研究者：李金鹏/宋金龙教授标题：比较TACE联合多纳非尼或仑伐替尼用于治疗不可切除肝细胞癌的疗效和安全性：一项回顾性真实世界研究Title: Comparing the efficacy and safety of TACE combined with donafenib VS lenvatinib in the treatment of unresectable hepatocellular carcinoma：A retrospectine real-world study摘要编号：e16137展示形式：在线发表主要研究者：黄明声/刘欢教授标题：TACE联合多纳非尼用于不可切除肝细胞癌一线治疗：一项真实世界临床研究Title: Transarterial chemoembolization (TACE) combined with Donafenib as first-line therapy for unresectable hepatocellular carcinoma (uHCC): A real-world clinical study摘要编号：e16145展示形式：在线发表主要研究者：范文哲教授标题：比较TACE联合多纳非尼或仑伐替尼治疗不可切除肝细胞癌的疗效和安全性Title: Comparing the efficacy and safety of TACE combined with donafenib or lenvatinib in the treatment of unresectable hepatocellular carcinoma摘要编号：e16153展示形式：在线发表主要研究者：吕维富/魏宁教授标题：多纳非尼联合TACE伴或不伴免疫疗法在中晚期肝细胞癌（HCC）中的疗效和安全性Title: A retrospective study on the efficacy and safety of Donafenib combined with Transarterial chemoembolization (TACE) and with/without immunotherapy in intermediate-advanced hepatocellular carcinoma (HCC).摘要编号：e16171展示形式：在线发表主要研究者：赵辉教授标题：TACE-HAIC联合多纳非尼及免疫疗法治疗伴有门静脉肿瘤血栓的肝细胞癌的有效性及安全性Title: TACE-HAIC combined with Donafenib and immunotherapy for hepatocellular carcinoma (HCC) with portal vein tumour thrombus (PVTT): A retrospective analysis.摘要编号：e16174展示形式：在线发表主要研究者：刘瑞宝尹立楠教授标题：多纳非尼联合TACE及抗PD-1抗体作为肝细胞癌一线治疗的疗效与安全性Title: The Efficacy and Safety of Donafenib Combined with Transcatheter Arterial Chemoembolization and Anti PD-1 Antibodies as First-line Therapy for Hepatocellular Carcinoma: A Retrospective Study摘要编号：e16178展示形式：在线发表主要研究者：郑家平教授标题：不同一线肝癌治疗药物（多纳非尼、索拉非尼或仑伐替尼）联合TACE治疗失败后序贯瑞戈非尼的疗效比较Title: Comparative effificacy of systemic sequential regorafenib after TACE combined with First-line targeted drugs(donafenib, sorafenib or lenvatinib) treatment failure for advanced hepatocellular carcinoma: A retrospective, single-center, real world study.摘要编号：e16190展示形式：在线发表主要研究者：吕维富/魏宁教授标题：术后辅助性肝动脉灌注化疗联合多纳非尼治疗单发大肿瘤伴微血管侵犯的肝细胞癌Title: Postoperative adjuvant hepatic arterial infusion chemotherapy combined with donafenib in hepatocellular carcinoma with solitary large tumor and microvascular invasion: a multicenter, prospective, single-arm, phase II trial摘要编号：e16227展示形式：在线发表主要研究者：张磊教授标题：多纳非尼联合抗PD-1抗体用于有高复发风险肝细胞癌患者切除后的辅助治疗（PATH研究）Title: Adjuvant theraPy with DonAfenib plus anTi-PD-1 antibody for patients (pts) at high risk of Hepatocellular carcinoma (HCC) recurrence after resection (PATH study)摘要编号：e16228展示形式：在线发表主要研究者：梁廷波/白雪莉教授标题：多纳非尼作为肝切除后肝细胞癌（HCC）患者的辅助治疗的疗效和安全性Title: Efficacy and safety of donafenib as adjuvant therapy for patients with hepatocellular carcinoma (HCC) after hepatectomy: A Retrospective, Multicenter Cohort Study摘要编号：e16234展示形式：在线发表主要研究者：杨欣荣教授标题：以多纳非尼为基础的系统性治疗方案用于肝细胞癌一线治疗的疗效和安全性Title: The efficacy and safety of donafenib-containing regimens as first-line therapy for hepatocellular carcinoma (HCC): A multicenter retrospective study.摘要编号：e16243展示形式：在线发表主要研究者：尹国文/张庆桥教授泛TKI标题：立体定向放疗（SBRT）联合TACE及酪氨酸激酶抑制剂（TKIs）与单独TACE联用TKIs治疗伴有门静脉肿瘤血栓（PVTT）的不可切除肝细胞癌（uHCC）的一项随机对照试验Title: Stereotactic body radiotherapy (SBRT) combined with transcatheter arterialchemoembolization (TACE) and tyrosine kinase inhibitors (TKIs) versus TACE and TKISalone for unresectable hepatocellular carcinoma (uHCC) with portal vein tumor thrombus(PVTT):A randomized controlled trial摘要编号：4102展现形式：壁报展示分会场标题：Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary展示时间：2024.06.01 1:30 PM-4:30 PM主要研究者：王辛教授吉卡昔替尼标题：接受吉卡昔替尼治疗的骨髓纤维化患者中铁蛋白、血红蛋白与贫血反应之间的关联：ZGJAK006研究的事后分析Title: Association between ferritin, hemoglobin and anemia response in jaktinib-treated myelofibrosis (MF) patients (pts): A post-hoc analysis of the ZGJAK006 study摘要编号：e18527展示形式：在线发表主要研究者：金洁教授关于甲苯磺酸多纳非尼片多纳非尼上市后，已被纳入国家卫健委《原发性肝癌诊疗指南（2024年版）》（证据等级1，推荐A）、《中国临床肿瘤学会（CSCO）原发性肝癌诊疗指南（2022）》（I级专家推荐和1A类证据）、《中国肝细胞癌经动脉化疗栓塞（TACE）治疗临床实践指南（2023年版）》、《中国肿瘤整合诊治指南（CACA指南）》、《肝癌术后辅助治疗中国专家共识（2023版）》、《肝癌新辅助治疗中国专家共识（2023版）》、《靶向免疫联合局部治疗中晚期肝细胞癌中国专家共识》、《原发性肝癌转化及围手术期治疗中国专家共识（2024版）》、《局部进展期甲状腺癌新辅助治疗中国专家共识（2023版）》、《晚期甲状腺癌靶向药物不良反应管理专家共识（2023年版）》等多个肝癌和甲状腺癌治疗领域的指南/共识。2022年9月，中国临床肿瘤学会肝癌专家委员会和中国临床肿瘤学会抗肿瘤药物安全管理专家委员会发布了《多纳非尼治疗肝细胞癌临床应用专家共识》。关于盐酸吉卡昔替尼盐酸吉卡昔替尼（曾用名：盐酸杰克替尼）是公司自主研发的一种新型JAK和ACVR1双抑制剂类药物，属于1类新药，公司拥有该产品的自主知识产权。吉卡昔替尼对Janus激酶包括JAK1、JAK2、JAK3和TYK2具有显著的抑制作用，且对JAK2和TYK2的抑制作用最强。吉卡昔替尼的作用机制为阻断JAK-STAT信号传导通路，直接或间接阻断多种相关细胞因子信号转导，抑制免疫过度或异常。另外，杰克替尼还可以通过抑制激活素受体1（ACVR1）活性，降低铁调素转录，改善铁代谢失衡，增加血红蛋白，降低骨髓纤维化患者贫血发生率和减少输血依赖。盐酸吉卡昔替尼片目前正在开展多个免疫炎症性疾病和纤维化疾病的临床研究。2022年10月，公司提交的吉卡昔替尼片治疗中、高危骨髓纤维化适应症的NDA申请获得国家药监局受理，目前正在审评审批过程中；同时，吉卡昔替尼片用于芦可替尼不耐受患者的安全性和有效性的IIB期临床试验已经完成、吉卡昔替尼片用于芦可替尼复发/难治的骨髓纤维化患者的安全性和有效性的IIB期临床试验已经完成。此外，公司正在开展吉卡昔替尼片用于重症斑秃（III期）、中重度特应性皮炎（III期）、强直性脊柱炎（III期）、特发性肺纤维化（II期）、中重度斑块状银屑病（II期）等自身免疫性疾病的临床试验。吉卡昔替尼片用于治疗骨髓纤维化的研究获得国家“重大新药创制”科技重大专项立项支持。关于泽璟制药（688266.SH）泽璟制药是一家专注于肿瘤、出血及血液疾病、免疫炎症性疾病和肝胆疾病等多个治疗领域的创新驱动型化学及生物新药研发和生产企业，致力于研发和生产具有全球自主知识产权、安全、有效、患者可负担的创新药物，以满足国内外巨大的临床需求。公司自成立以来，坚持独立自主的原始创新和改良再创新并重的发展策略。在研药品注重肿瘤、出血及血液疾病、免疫炎症性疾病和肝胆疾病等领域，填补国内空白，为尚未满足的临床需求提供治疗选择。公司注重同时布局大病种疾病和罕见病，注重在研药品的领先性、可及性、广谱性或特效性，从而形成产品管线的差异化综合竞争优势。公司建立了三个研发中心、三条GMP生产线，形成了泽璟在江苏昆山、上海张江、美国加州的拥有技术和资源优势的全球发展框架，最大限度地发挥泽璟在小分子新药和生物大分子新药的研发和产业化潜能。

ASCO会议临床结果临床2期

2024-04-25

·泽璟制药

ASCO 2024 I 泽璟制药多个新药研究成果入选ASCO 2024年会

NEWS2024年4月25日，泽璟制药（股票代码：688266.SH）宣布，公司自主研发的新药包括ZG005、ZGGS18、ZG0895、ZGGS15及多纳非尼、杰克替尼在内的合计19项临床研究结果将于2024年美国临床肿瘤学会（ASCO）上公布。美国临床肿瘤学会年会（ASCO年会）是迄今为止最大规模、学术水平及权威等级均首屈一指的临床肿瘤学国际会议，汇集了世界各地的肿瘤学专家、医生、研究人员和制药业代表，每年ASCO年会对业界研究者而言可谓一场学术盛宴，许多重要的研究发现与成果都会在大会上首次披露，分享最新的肿瘤学研究成果、讨论最新的治疗方法和技术，以及推动肿瘤学领域的科学进步。本届ASCO年会将于2024年5月31日至6月4日在美国芝加哥McCormick Place Convention Center举行。本次泽璟制药的主要临床研究结果摘要信息如下：ZG005ZG005 在晚期实体瘤患者中的剂量递增、耐受性、安全性、药代动力学和多队列扩展的 I/II 期临床研究摘要编号：2611展示形式：壁报展示分会场标题：Developmental Therapeutics-Immunotherapy时间：2024.06.01 9:00 AM-12:00 PM主要研究者：秦叔逵教授、程颖教授ZGGS18ZGGS18在晚期实体瘤患者中的剂量递增、耐受性、安全性、药代动力学和多队列扩展的I/II期临床研究摘要编号：2523展示形式：壁报展示分会场标题：Developmental Therapeutics-Immunotherapy时间：2024.06.01 9:00 AM-12:00 PM主要研究者：徐建明教授ZG0895盐酸ZG0895治疗晚期实体瘤患者的耐受性、安全性、药代动力学/药效学和初步疗效的开放、多中心、I期剂量递增和扩展试验摘要编号：e15103展示形式：在线发表主要研究者：朱骥教授ZGGS15注射用ZGGS15在晚期实体瘤患者中的剂量递增、耐受性、安全性、药代动力学的I期临床研究摘要编号：e14678展示形式：在线发表主要研究者：朱骥教授此外，杰克替尼的1项临床相关研究、多纳非尼相关的14项上市后临床研究数据，分别以壁报或在线发表的形式入选本次ASCO年会。关于ZG005 ZG005是公司自主研发的一种重组人源化抗 PD-1/TIGIT 双特异性抗体，拥有双靶向阻断PD-1和TIGIT的作用，既可以通过有效阻断PD-1与其配体PD-L1的信号通路，进而促进T细胞的活化和增殖；又可以有效阻断TIGIT与其配体PVR等的信号通路，促使PVR结合CD226产生共刺激激活信号，进而促进T细胞和NK细胞的活化和增殖，并产生两个靶点被同时阻断后的协同增强免疫系统杀伤肿瘤细胞的能力。ZG005是全球率先进入临床研究的同靶点药物之一，用于治疗实体瘤患者的临床试验已获NMPA和FDA批准，其在中国的I期剂量爬坡已经完成，I/II临床试验正在开展中。公司正在积极推进ZG005单药治疗复发难治肿瘤、联合化疗和/或其它靶向治疗药物治疗多种实体瘤的临床适应症的探索研究。关于ZGGS18 ZGGS18是一种重组人源化抗VEGF/TGF-β的双功能抗体融合蛋白，可以特异性地结合血管内皮生长因子（VEGF）和“捕获”转化生长因子-β（TGF-β），起到抑制肿瘤新生血管形成和降低肿瘤转移发生等协同抑制肿瘤生长的多重作用。另外，ZGGS18也可以改善和调节肿瘤微环境，从而可以和抗PD-1/L1抗体、公司正在开展临床研究的抗PD-1/TIGIT双特异性抗体ZG005等肿瘤免疫治疗药物联合增强肿瘤杀伤作用。根据公开查询，目前暂无相同作用机制的药品在国内外获批上市。ZGGS18用于治疗实体瘤患者的临床试验已获 NMPA 和FDA 批准，其在中国的 I 期剂量爬坡已经完成，I/II 期临床试验正在开展中。关于ZGGS15 ZGGS15是一个人源化抗淋巴细胞激活基因-3（LAG-3）和抗具有Ig和ITIM结构域的T细胞免疫受体（TIGIT）的双特异性抗体，有望用于治疗多种晚期实体瘤。ZGGS15拥有双靶向阻断LAG-3和TIGIT的作用，既可以通过有效阻断LAG-3与其配体MHC-II等的信号通路，激活TCR信号通路，又可以有效阻断TIGIT与其配体PVR等的信号通路，促使PVR结合CD226产生共刺激激活信号，进而促进T细胞和NK细胞的活化和增殖，并产生细胞因子，从而具有协同增强免疫系统杀伤肿瘤细胞的能力。根据公开查询，目前暂无相同作用机制的药品在国内外获批上市。ZGGS15用于治疗晚期实体瘤的临床试验申请已获NMPA和FDA批准，其在中国的I期剂量爬坡已经完成，I/II期临床试验正在开展中。关于ZG0895 ZG0895是公司自主研发的一种新型的高活性、高选择性的Toll样受体8（TLR8）激动剂，适应症为晚期实体瘤。另外，基于TLR8激动剂可激活机体的先天性免疫系统，由此TLR8激动剂也有望用于抗乙肝病毒感染等抗病毒治疗。根据公开查询，目前全球范围内尚未有高选择性TLR8激动剂类药物获批上市。ZG0895用于治疗实体瘤患者的临床试验已获NMPA和FDA批准，其在中国的I/II期临床试验正在开展中。关于泽璟制药（688266.SH）泽璟制药是一家专注于肿瘤、出血及血液疾病、免疫炎症性疾病和肝胆疾病等多个治疗领域的创新驱动型化学及生物新药研发和生产企业，致力于研发和生产具有全球自主知识产权、安全、有效、患者可负担的创新药物，以满足国内外巨大的临床需求。公司自成立以来，坚持独立自主的原始创新和改良再创新并重的发展策略。在研药品注重肿瘤、出血及血液疾病、免疫炎症性疾病和肝胆疾病等领域，填补国内空白，为尚未满足的临床需求提供治疗选择。公司注重同时布局大病种疾病和罕见病，注重在研药品的领先性、可及性、广谱性或特效性，从而形成产品管线的差异化综合竞争优势。公司建立了三个研发中心、三条GMP生产线，形成了泽璟在江苏昆山、上海张江、美国加州的拥有技术和资源优势的全球发展框架，最大限度地发挥泽璟在小分子新药和生物大分子新药的研发和产业化潜能。

ASCO会议临床1期临床结果

100 项与甲苯磺酸多纳非尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01X	DB15414

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
甲状腺癌	中国	苏州泽璟生物制药股份有限公司	2022-08-10
肝细胞癌	中国	苏州泽璟生物制药股份有限公司	2021-06-08

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
难治性甲状腺癌	临床3期	中国	苏州泽璟生物制药股份有限公司	2018-08-29
难治性分化型甲状腺癌	临床3期	中国	苏州泽璟生物制药股份有限公司	2018-07-26
转移性结直肠癌	临床3期	中国	苏州泽璟生物制药股份有限公司	2016-12-28
晚期肝细胞癌	临床3期	中国	苏州泽璟生物制药股份有限公司	2016-03-01
晚期恶性实体瘤	临床2期	中国	苏州泽璟生物制药股份有限公司	2024-05-10
晚期胆管癌	临床2期	中国	复旦大学	2022-10-18
胰腺继发性恶性肿瘤	临床2期	中国	复旦大学	2021-12-01
胆道肿瘤	临床2期	中国	苏州泽璟生物制药股份有限公司	2020-12-01
鼻咽癌	临床2期	中国	苏州泽璟生物制药股份有限公司	2017-02-08
转移性胃腺癌	临床2期	中国	苏州泽璟生物制药股份有限公司	2016-05-16

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临床结果

适应症

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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


ASCO2024	N/A	肝细胞癌一线 HBV infection	102	D+TACE/HAIC	齋鑰範網簾醖衊壓遞糧(憲憲鹽獵鑰繭襯顧範鹽) = 遞願廠積膚蓋構範衊鹽廠構簾遞糧簾窪艱顧齋 (鹽糧鏇積糧鏇膚鏇壓選 ) 更多	积极	2024-05-24
				D+TACE/HAIC+ICI	齋鑰範網簾醖衊壓遞糧(憲憲鹽獵鑰繭襯顧範鹽) = 憲壓網積夢顧膚鹹襯遞廠構簾遞糧簾窪艱顧齋 (鹽糧鏇積糧鏇膚鏇壓選 ) 更多
ASCO2024	N/A	肝细胞癌	-	Donafenib 100mg bid	鑰衊鏇襯選蓋積獵齋廠(選壓壓積製遞鹹鹽憲繭) = AEs occurred in 44 patients, including 39 with grade 1 or 2 AEs and 5 with grade 3 AEs. The most common AEs included hand-foot skin reaction, decreased platelet count, and diarrhea 繭範鹽淵築鹹鬱襯醖齋 (鑰簾顧鬱糧鹹膚遞選繭 )	-	2024-05-24
NCT04418401 (PATH study, ASCO2024)	临床1期	肝细胞癌辅助	30	Donafenib plus anti-PD-1 antibody	醖鬱遞壓選範鹹夢壓鏇(簾積膚築顧鹹窪鬱選廠) = 願膚餘艱繭廠壓網鹽艱壓鹽齋齋鏇製鏇餘獵壓 (艱衊鏇壓網構顧鏇範顧, 70.6% ~ 96.7)	积极	2024-05-24
ASCO2024	N/A	肝细胞癌辅助 AFP \| PIVKA-II	82	Donafenib	鏇構膚積膚構壓鬱齋獵(網築範遞觸繭憲鏇鹽網) = 壓窪鏇獵鏇餘網衊選築鏇選衊窪淵憲願鹹壓構 (觸製觸鬱獵範糧選簾顧 ) 更多	积极	2024-05-24
ZGDH3 (ASCO2024)	临床3期	不可切除的肝细胞癌一线	48	Donafenib combined with anti-PD-1 antibodies	膚夢網鏇衊遞鏇襯膚網(獵夢範選鹹襯齋顧艱製) = 齋簾壓艱膚網遞壓糧築構蓋廠願窪網製鏇淵積 (廠繭窪鹹壓齋餘範遞鑰, 8.9 ~ NA) 更多	积极	2024-05-24
ASCO2024	N/A	晚期肝细胞癌	87	Dona-TACE + Regorafenib	鹽網餘築網築餘獵襯鹽(遞鬱積艱廠網遞願衊糧) = The Dona-TACE group received regorafenib sequentially had a lowest incidence of grade 3-4 AEs (39.1%, P<0.05) 齋鏇廠襯鑰鹽繭淵鹽壓 (壓選築鏇鹽蓋鹹遞廠構 ) 更多	积极	2024-05-24
				Sora-TACE + Regorafenib
ChiCTR2100054041 (ESMO_TAT2024) 人工标引	临床4期	晚期肝细胞癌一线	27	donafenib	遞窪壓餘糧鹽齋顧簾蓋(築鹽範壓鬱艱範醖蓋積) = not reached 鬱選製網襯艱齋淵壓廠 (觸築繭鑰齋築糧廠獵艱 ) 更多	积极	2024-02-26
NCT05166772 (DoHAICs, ESMO2023) 人工标引	临床2期	不可切除的肝细胞癌	30	donafenib + sintilimab +oxaliplatin + leucovorin +fluorouracil	醖構願夢淵壓繭膚淵範(襯鹽遞齋膚遞齋窪窪鏇) = 獵繭壓淵網餘網顧夢獵廠鬱廠糧鏇鹽遞觸憲築 (膚衊鏇構遞遞遞鬱獵餘 ) 更多	积极	2023-10-23
				donafenib + sintilimab +oxaliplatin + leucovorin +fluorouracil (received hepatectomy)	壓醖廠鬱憲糧淵築鹹構(醖憲鹹齋積鬱糧衊窪窪) = 憲簾醖淵積範鑰膚簾憲築糧壓窪憲醖繭願範壓 (艱膚選襯觸艱壓餘積鏇 ) 更多
ESMO2023	N/A	不可切除的肝细胞癌一线	-	TACE+DP	憲顧網艱襯壓鹹醖選夢(窪餘鬱憲襯選鏇齋構鏇) = There was no significant difference in the incidence and severity of adverse events in the TACE+DP and TACE+D groups (any grade, 92.9% vs. 94.6%, P=0.270; grade 3 or 4, 33.8% vs. 37.3%, P=0.253) 構夢憲鬱淵鏇簾齋範醖 (簾壓襯艱遞糧艱齋鬱獵 )	积极	2023-10-23
				TACE+D
NCT02645981 (ZGDH3, ASCO2023) 人工标引	临床2/3期	晚期肝细胞癌一线	668	Donafenib	鬱積淵願積憲醖積艱鬱(壓願窪鏇衊餘襯網艱構) = 齋襯餘廠膚範艱夢顧觸遞窪壓衊築糧鑰廠製製 (憲觸淵齋衊獵簾齋築鏇 ) 更多	积极	2023-05-31
				Sorafenib	鬱積淵願積憲醖積艱鬱(壓願窪鏇衊餘襯網艱構) = 願觸艱願齋築選糧築膚遞窪壓衊築糧鑰廠製製 (憲觸淵齋衊獵簾齋築鏇 ) 更多