TACE With Dicycloplatin（TP21） in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial

To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma:
Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Secondary efficacy endpoints: PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), time to progression (TTP), 1-year progression-free survival, 1-year survival and 2-year survival assessed by the investigator.

开始日期2022-06-09

申办/合作机构

Zhongda Hospital Affiliated to Southeast University

100 项与双环铂相关的临床结果

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100 项与双环铂相关的转化医学

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100 项与双环铂相关的专利（医药）

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851

项与双环铂相关的文献（医药）

2025-01-01·Food Chemistry

Targeted/untargeted metabolomics and antioxidant properties distinguish Citrus reticulata ‘Chachi’ from Citrus reticulata Blanco

Article

作者: Li, Xiang ; Wang, Xue ; Fu, Fuhua ; Su, Zhipeng ; Shan, Yang ; Chen, Jiaxu ; Pan, Zhaoping ; Li, Gaoyang

Dried citrus peel (DCP), also called "Chen Pi", has edible and medicinal value. However, the specific differences among various sources remain unknown. Herein, we collected six DCP species, namely, one Citrus reticulata 'Chachi' (CZG) and five Citrus reticulata Blanco (CRB). Targeted high-performance liquid chromatography and untargeted ultra-high-performance liquid chromatography-tandem mass spectrometry were employed to comprehensively compare the phenolic compounds and metabolites in DCP. Interestingly, 13 different phenolic compounds were noted in DCP. The total phenolic compound content in all CRB samples (58.86-127.65 mg/g) was higher than that of CZG (39.47 mg/g). Untargeted metabolomic revealed 1495 compounds, with 115 differentially expressed metabolites for CRBs and CZG, particularly flavonoids (38), terpenoids (15), and phenolic acids and derivatives (9). Lastly, antioxidant assays revealed that all CRB samples exhibited higher antioxidant activities compared with CZG. Therefore, our study results provide a theoretical basis for the high-value utilization of citrus peels and their metabolites.

2024-12-01·Cytokine

Diphencyprone reduces the CD8+ lymphocytes and IL-4 and enhences IgG2a/IgG1 ratio in pathogenicity of acute leishmania major infection in BALB/c mice

Article

作者: Mousavian, Pourandokht ; Mashayekhi Goyonlo, Vahid ; Javanbakht, Mohammad ; Moosavian, Hamidreza ; Afzal Aghaei, Monovar ; Malekzadeh, Mohammadreza ; Reza Jafari, Mahmoud

BACKGROUNDThe exact role of different immune cells and cytokines in control or promotion of intracellular growth of leishmania has still remained a controversial topic. The aim of the present study was to study effects of cellular changes and relevant cytokines in cell mediated immunity by diphencyprone (DCP) in pathogenicity of acute L.major infection in BALB/c mice.METHODS45 healthy female BALB/c mice were injected with L. major promastigotes under the base of tail. The mice were randomly divided to three groups of 15 mice: (1) control group without any treatment. (2) acetone group: Acetone was applied topically on the cutaneous lesions weekly and (3) DCP group: DCP was applied topically on the cutaneous lesions with increasing concentrations to induce local allergy. The mice were followed by the end of eighth week, and then macroscopic changes, histopathology, immunology studies, and organ parasite burden were determined.RESULTSIn DCP group, in comparison to other groups the ulcer size and parasite burden in ulcer site and spleen increased, significantly. There was a deep lymphohistiocytic infiltration in the ulcer site. Total IgG, IgG1, and IgG2a levels as well as IgG2a/IgG1 ratio and intracellular IFN-gamma in CD8⁺ lymphocytes were significantly higher. IL4 and T CD8⁺ lymphocytes were significantly lower in DCP group. The IgG2a/IgG1 ratio was more than 1 in all groups.CONCLUSIONOur findings demonstrated that DCP reduced the CD8⁺ lymphocytes and IL-4 production. In spite of increased IgG2a/IgG1 ratio, the parasite burden and inflammation severity increased in infected mice. The results can show the pivotal role of CD8⁺ lymphocytes in conjunction with Th1 lymphocytes in the control of acute leishmania infection in mice.

2024-10-01·Environment International

Dermal exposure assessment of formal e-waste dismantlers to flame retardants and plasticizers using passive sampling methodologies

Article

作者: Balasch, A ; Eljarrat, E. ; Balasch, A. ; Eljarrat, E ; Moreno, T ; Peris, A ; Peris, A. ; Reche, C ; Reche, C. ; Moreno, T.

The recycling of e-waste can lead to the release of organic chemicals when materials containing additives are subjected to dismantling and grinding. In this context, the exposure of workers from a Catalonian e-waste facility to flame retardants and plasticizers (including organophosphate esters (OPEs), polybrominated diphenyl ethers (PBDEs), novel brominated flame retardants (NBFRs) and dechloranes) was assessed using T-shirts and wristbands as passive samplers. The study area includes an area exclusively dedicated to cathodic ray-tube (CRT) TVs dismantling, and a grinding area where the rest of e-waste is ground. All the families of compounds were detected in both T-shirts and wristbands, with the highest concentration levels corresponding to OPEs, followed by PBDEs, NBFRs, and dechloranes. The CRT area presented higher concentration levels than the grinding area. The compounds with higher concentrations in T-shirts were 2-ethylhexyl diphenyl phosphate (EHDPP), diphenyl cresyl phosphate (DCP) and triphenyl phosphate (TPHP), and the total concentration of all groups ranged between 293 and 8324 ng/dm²-h (hour). In the case of the wristbands, the most abundant compounds were DCP, TPHP, and BDE-209, with total concentrations between 188 and 2248 ng/dm²-h. The two sampling methods appear to be complementary, as T-shirts collect coarser particles, while wristbands also capture volatile compounds. Based on normalized surface and time concentrations, the estimated daily intake (EDI) through dermal contact was calculated and carcinogenic and non-carcinogenic risks (CR and non-CR) associated with this activity assessed. The results show median CR 29 and 16 times below the threshold in CRT and grinding areas respectively. The non-CR medians were 2 and 3 times below the threshold, although in the CRT area one exceptional value surpassed the threshold, suggesting that risk can exist for some workers in the facility.

项与双环铂相关的新闻（医药）

2024-11-15

·adalvo.com

Adalvo Secures DCP Approval for Apixaban Tablets

Adalvo announces the successful DCP approval for Apixaban Tablets. Based on the reference brand Eliquis, Apixaban is indicated for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). As per IQVIA, total global Apixaban sales for 2023 was $27.7Bn with a 3Y CAGR of 9%. With this approval, Adalvo is well-positioned to bring Apixaban Tablets to market as a crucial treatment option for patients suffering from DVT and PE. The DCP approval of Apixaban Tablets reflects Adalvo's commitment to delivering high-quality, differentiated treatments to our partners. Our rigorous development process ensures that we meet the highest standards of safety and efficacy, providing a reliable alternative for patients in need. There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. Partner Up Now!

上市批准

2024-11-15

·adalvo.com

Adalvo Announces Successful EU Approval for Mirabegron 50mg Prolonged-Release Tablets

Adalvo secures successful DCP approval for Mirabegron 50mg prolonged-release tablets. Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency, and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. According to IQVIA, Mirabegron achieved approximately $3.3Bn in global sales in 2023, with a 3-year CAGR of 2%. Additionally, registrations for Mirabegron 25mg are currently ongoing, demonstrating Adalvo's commitment to providing a wide range of treatment options. Adalvo’s success in securing this approval reflects our capabilities to develop complex, differentiated products. Building on the success of Mirabegron, Adalvo is also progressing well with the development of Mirabegron+Solifenacin, further expanding our portfolio and enhancing treatment options for patients. There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. Partner Up Now! Click Here To Get In Touch! © 2022-2024 Adalvo Limited. All right reserved

上市批准

2024-10-17

·医药魔方

通盈集团与中国生物推进多方面的医药合作

10月11日，通盈集团与中国生物制药有限公司宣布共同签署多方面战略谅解备忘录。中国医药行业未来发展前景广阔，预计将持续创新和增长。通盈集团在过去20年在医药创新不断投入，强调通过科技创新来解决重大未满足临床需求，为健康中国的宏大目标做贡献。通盈集团将加大在医药板块的布局和持续投资，通过投资和合作更好地推动我们关注的医疗方向。跟中国生物的合作是通盈集团近期的一个关键布局。通盈集团期待双方将依托各自的优势和资源，共同探索双环铂在多种癌症中的联合用药和开发抗感染、抗菌新产品。通盈集团索普兴大副总经理曹静婷表示：医药板块是集团核心板块之一。我们高度看好内部的技术平台，随着公司双环铂TP21在关键注册临床试验上的加速进展，我们也希望能够和最优秀的合作伙伴来推进TP21和新一代产品的全生命周期管理。备忘录表示，双方的合作包括双环铂TP21和中国生物旗下的免疫肿瘤产品在多癌症联合用药的探索以及依托各自研究团队和通盈集团双环铂技术平台开发抗感染、抗菌新产品。中国生物的贝莫苏拜单抗、派安普利单抗+盐酸安替罗尼胶囊等多款产品都是癌症治疗中关键的创新药物，未来市场预期巨大。【通盈集团】通盈集团积极布局医药健康产业，现拥有北京索普兴大医药研究有限公司、博晖生物制药（河北）有限公司、博晖生物制药股份有限公司、云南通盈药业有限公司、昆明贵研药业有限公司、云南通灏生物科技股份有限公司、云南汉创生物科技有限公司、通盈药业（青岛）有限公司等多家公司，已成功构建了集药物研发、临床试验、新药注册、生产制造及高端技术研发于一体的完整医药产业体系，形成了从研发前端到生产后端的全链条布局。【双环铂】双环铂是通盈集团全资子公司北京索普兴大医药研究有限公司自主研发的新一代铂类抗肿瘤药物，目前已完成晚期恶性肿瘤I期、前列腺癌II期和肝癌II期临床试验，肝癌III期临床试验正在进行中。已有临床数据表明，双环铂具有较好的临床疗效和安全性。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期引进/卖出临床2期

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适应症	国家/地区	公司	日期
小细胞肺癌	中国	北京索普兴大医药研究有限公司	2012-05-28

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适应症	最高研发状态	国家/地区	公司	日期
前列腺癌	临床2期	中国	北京市兴大科学系统公司	2017-08-18
前列腺癌	临床2期	中国	北京索普兴大医药研究有限公司	2017-08-18

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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


ASCO_GU2024	N/A	膀胱尿路上皮癌新辅助	-	Dicycloplatin	鹹餘憲構淵鹽製糧餘餘(衊膚蓋遞鏇築鏇餘築鏇) = 遞鏇鬱窪糧夢獵醖簾簾範願構繭構憲窪範構艱 (鏇願醖鏇築鬱願夢糧窪 )	-	2024-01-25