ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D（Refered Phase II dose） of ATG-031.

开始日期2023-12-08

申办/合作机构

德琪医药有限公司

NCT05698147

/ Recruiting临床1/2期IIT

Selinexor in Combination With Methotrexate and Rituximab for Relapsed /Refractory Central Nervous System (CNS) Lymphoma

This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.

开始日期2023-08-03

申办/合作机构

复旦大学附属华山医院

[+1]

NCT05718895

/ Recruiting临床1期

An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

开始日期2023-03-27

申办/合作机构

德琪医药有限公司

100 项与德琪医药有限公司相关的临床结果

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0 项与德琪医药有限公司相关的专利（医药）

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项与德琪医药有限公司相关的文献（医药）

2025-04-21·Cancer Research

Abstract 7326: ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases

作者: Hou, Bing ; Liu, Huiling ; Hu, Zaoshun ; Chen, Peng ; Mei, Jay ; Bian, Gang ; Li, Tengteng

AbstractBackground:CD19-targeted therapies, such as chimeric antigen receptor (CAR)-T or T-cell engagers (TCE), have been approved for the treatment of B cell malignancies. By depleting autoreactive B cells, CD19-targeted CAR-T have shown early yet promising efficacy in treating patients with B cell-driven autoimmune diseases. However, the clinical application of TCE continues to be greatly hindered by the unfavorable pharmacokinetics and toxicity associated with cytokine release syndrome. Here we developed a "2+1" CD19 x CD3 TCE, ATG-201, which effectively depletes B cells with minimal risk of CRS and IgG-like PK profile. It demonstrates potent anti-disease in vivo efficacy in mouse models for lymphoma and autoimmune diseases.Methods:ATG-201 was constructed by introducing a high affinity, novel conformational epitope-targeted anti-CD3 single chain fragment variable (scFv) to the hinge region of one of the heavy chains of a CD19 monoclonal antibody. It was evaluated in a series of in vitro studies for binding affinity, T cell dependent cytotoxicity (TDCC) cytokine release, and drug developability. The in vivo anti-lymphoma efficacy and pharmacodynamic effect were evaluated in Raji xenograft model. The tissue reside B cell depletion was assessed in CD34+ hematopoietic stem cells humanized NDG-hIL-15 mice. Pharmacokinetic parameters of ATG-201 was evaluated in normal Balb/c mice.Results:ATG-201 showed limited CD3+ T cell binding before CD19-crosslinking. It activated T cells and only in the presence of CD19+ cells. It induced potent TDCC against CD19 positive cells with pM range IC50. ATG-201 demonstrated stronger naïve B cell depletion activity with much lower cytokine release compared to benchmark TCEs in vitro. ATG-201 showed potent anti-lymphoma activity in PBMC-humanized subcutaneous Raji xenograft model with significant augment of infiltrated CD8+ T cells in tumor microenvironment and limited proinflammatory cytokines detected in plasma. Single dose ATG-201 completely and deeply depleted B cells in blood, bone marrow and spleen of CD34+ cells humanized NDG-hIL-15 mice. ATG-201 exhibited a mAb-like pharmacokinetic profile in Balb/c mice with a T1/2 of ∼300h. ATG-201 was stable at high concentration (125mg/ml) and under stress conditions. The surrogate CD19xCD3 TCE demonstrated potent efficacy in mouse systemic lupus erythematosus model, inhibiting the lymph node swelling and auto-antibody producing.Conclusion:ATG-201 demonstrates CD19-dependent CD3 binding and activation, inducing effective B cell depletion in vitro and in vivo with low cytokine release, which provides potential for the treatment of B cell malignancies and B cell related autoimmune diseases.Citation Format:Gang Bian, Huiling Liu, Tengteng Li, Zaoshun Hu, Peng Chen, Jay Mei, Bing Hou. ATG-201, a novel T-cell engager (TCE) effectively depletes B cells with reduced risk of CRS for the treatment of B cell malignancies and B cell related autoimmune diseases [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 7326.

2025-04-21·Cancer Research

Abstract 3509: ATG-110, a novel “2+1” LY6G6D-targeted T-cell engager (TCE) for the treatment of MSS colorectal cancer

作者: Chen, Peng ; Mei, Jay ; Hou, Bing ; Hua, Jiahui ; Lin, Ge ; Liu, Huiling ; Chen, Xueli ; Bian, Gang

AbstractBackground:Colorectal cancer (CRC) is one of the most common cancers worldwide and requires more effective and safer therapies to improve its poor survival outcome. LY6G6D is a GPI-anchored cell surface protein with expression that is particularly specific to colorectal cancer (CRC). LY6G6D exhibits significantly elevated expression levels in colorectal cancer (CRC) tissue comparing to normal tissue, particularly in pMMR/MSS CRC, which demonstrates primary resistance to immune checkpoint inhibitor (ICI) therapy. T cell engagers have shown encouraging efficacy in treating hematological malignancies, while exhibiting suboptimal performance in solid tumors. The potential of cytokine release syndrome (CRS) remains significant issues. We present a novel 2+1 LY6G6DxCD3 T cell engager, ATG-110, which demonstrated LY6G6D-dependent CD3 binding and significant anti-tumor activity with reduced cytokine release.Methods:ATG-110 was constructed by introducing a novel conformational epitope-targeted anti-CD3 single chain fragment variable (scFv) to the hinge region of one of the heavy chains of a LY6G6D monoclonal antibody. It was evaluated in a series of preclinical in vitro studies for binding affinity, T cell activation and cytokine release, T cell dependent cytotoxicity (TDCC), and drug developability. The in vivo anti-tumor efficacy was evaluated in PBMC-humanized immunodeficient NDG mice engrafted with LY6G6Dmedium-expression HT55 or LY6G6Dvery low-expression SW480 MSS CRC cells.Results:ATG-110 bound to LY6G6D-positive cell lines, LY6G6D-overexpression 293T, HT55, LS1034, with the nanomolar grade EC50. The CD3 binding site of ATG-110 is concealed by the LY6G6D Fab arm before binding to LY6G6D, due to the steric hindrance. Therefore, ATG-110 demonstrated limited binding capability to CD3+ cells before LY6G6D crosslinking. It activated T cells and induces cytokine release only in the presence of LY6G6D+ cells. In vitro, ATG-110 resulted in potent T cell dependent cytotoxicity with single-digit pM IC50 values on HT55 and SW480 cells. ATG-110 also showed potent anti-tumor activity in PBMC-humanized SW480 xenograft model and exhibited complete response (CR) in PBMC-humanized HT55 xenograft model. ATG-110 demonstrated good drug developability.Conclusion:ATG-110 demonstrated LY6G6D-dependent CD3 binding and activation with low risk of CRS. It showed powerful in vitro and in vivo anti-tumor efficacy against colorectal cancer, which warrants further clinical evaluation.Citation Format:Gang Bian, Jiahui Hua, Ge Lin, Xueli Chen, Huiling Liu, Peng Chen, Jay Mei, Bing Hou. ATG-110, a novel “2+1” LY6G6D-targeted T-cell engager (TCE) for the treatment of MSS colorectal cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3509.

2025-04-21·Cancer Research

Abstract 4230: Preclinical characterization of ATG-042, a novel MTAP null-selective PRMT5 inhibitor

作者: Mei, Jay ; Chen, Peng ; Hou, Bing ; Kong, Ya ; Lin, Ge ; Zhang, Ming

Background:Targeting the PRMT5-MTA complex has become a promising strategy for treating MTAPnull cancer in a synthetically lethal manner, avoiding on-target-off-tumor hematological toxicity when using first-generation, non-selective PRMT5 inhibitors. The MTAP gene is deleted in around 10-15% of all human malignancies and the top3 human cancers with the highest frequency of MTAP deletion are GBM, pleural mesothelioma and bladder cancer with high unmet medical need (TCGA data). Herein, we report the preclinical feature of ATG-042, a novel MTAPnull-selective PRMT5 small molecule inhibitor with good brain penetration.Methods:The in vitro activity and MTAP selectivity of ATG-042 on cell proliferation were profiled using HCT116 MTAP wild type (wt) cells, HCT116 MTAP knock out (ko) cells and multiple endogenous MTAPnull cell lines. The in vivo efficacy was tested in cell derived xenograft (CDX) mouse models with HCT116 MTAP wt cells, HCT116 MTAP ko cells, LU99 cells (MTAPnull) and U87MG-luc (MTAPnull). The pharmacokinetic and toxicological properties were assessed with corresponding assay methods.Results:ATG-042 demonstrated potent and selectively inhibitory effect on HCT116 MTAP ko cells’ proliferation (IC50=52nM) and SDMA expression (IC50=0.06nM), but very weak effect on HCT116 MTAP wt cells. Consistently, ATG-042 showed excellent anti-proliferative activities on multiple endogenous MTAPnull cell lines with IC50 values between 10nM and 100nM. ATG-042 demonstrated high permeability (Caco2 assay, A to B, Papp =12.2 x10-6cm/s;ER=0.9), good metabolic stability, and low risk of drug-drug interaction. In vivo PK study shows that ATG-042 is well absorbed, with a dose-dependent increase in plasma distribution and high oral bioavailability in mice, SD rats and beagle dogs. Furthermore, ATG-042 is brain-penetrable (B/P ratio=51% in mice; KPuubrain=0.73 in rats). ATG-042 showed robust in vivo efficacy in both subcutaneous CDX models (HCT116 -MTAP ko, LU99) and orthotopic CDX model (U87MG-luc) as a single agent. In addition, ATG-042 also exhibited the potential in combination with other drugs for antitumor therapy. ATG-042 was well tolerated in both SD rats and beagle dogs after four weeks of continuous administration.Conclusions:In summary, ATG-042 is an oral MTAP null-selective PRMT5 inhibitor with potent efficacy against MTAPnull tumor. It also demonstrated good tolerability and brain penetrability.Citation Format:Ya Kong, Ge Lin, Ming Zhang, Peng Chen, Jay Mei, Bing Hou. Preclinical characterization of ATG-042, a novel MTAP null-selective PRMT5 inhibitor [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4230.

1,985

项与德琪医药有限公司相关的新闻（医药）

2025-05-02

·医药笔记

礼来2025Q1：替尔泊肽大卖62亿美元

▎Armstrong2025年5月1日，礼来发布一季度财报，营业收入127亿美元，同比增长45%，核心产品销售额75亿美元，同比增长119%。礼来2025年580-610亿美元的收入指引不变，强调小分子GLP-1的成功具有重要意义。不过诺和诺德在减重药物市场上积极应对，允许多家远程医疗服务商大幅降价。同时，市场对于特朗普政府可能实施的药品关税影响业绩也存在担忧。礼来在公布亮眼的一季报数据后，股价却大跌12%，目前市值为7500亿美元。美国市场上，礼来GLP-1市场份额已经超过诺和诺德，并保持增长趋势。替尔泊肽降糖版一季度销售额38.42亿美元，同比增长113%。替尔泊肽减重版一季度销售额23.12亿美元，为去年一季度的4倍多，替尔泊肽两者合计61.54亿美元。信达生物信迪利单抗一季度销售额1.375亿美元，合10亿元人民币，同比增长19%。总结礼来核心产品销售额一路高涨，尤其是替尔泊肽在降糖市场快速替代司美格鲁肽，减重市场快速放量，预计今年将达到300亿美元销售额，占总营收的一半左右。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报抗体药物偶联物医药出海

2025-05-01

·医药笔记

Madrigal：首款MASH新药，上市首年大卖3.17亿美元

▎Armstrong2025年5月1日，Madrigal Pharmaceuticals发布一季度财报，MASH新药Rezdiffra销售额1.373亿美元。Rezdiffra从去年上市以来，季度销售额一路高涨，上市满一年实现3.174亿美元销售额。使用Rezdiffra的患者人数不断攀升，2025年一季度超过17000例，相比于31.5万例适用人群仅有5%的渗透率，意味着仍有很大的上涨空间。Rezdiffra对于处方医生的渗透率一路高升，体现了临床上巨大的未满足临床需求。Rezdiffra目前获批的是F2-F3阶段的MASH，对于F4阶段的临床试验正在进行中。目前的数据显示，Rezdiffra对于F4阶段的MASH同样有治疗潜力。总结昨天，司美格鲁肽治疗MASH的三期临床数据发表在新英格兰医学期刊上。FGF21在F4阶段也获得突破性的疗效数据，THR-β激动剂、GLP-1受体激动剂、FGF21的临床进展，未来将为广大MASH患者带来更多治疗选择。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报临床3期抗体药物偶联物

2025-04-30

·宜联生物

宜联生物医药全球首创VEGF ADC进入临床阶段

▎Armstrong2025年4月30日，宜联生物全球首创VEGF ADC新药YL242的临床试验申请获得NMPA受理。根据AACR年会上的公开信息，YL242采用宜联生物TMALIN技术平台构建，靶向游离VEGF，采用蛋白酶裂解三肽linker，毒素采用拓扑异构酶I抑制剂C24。YL242在血液中高度稳定，在肿瘤微环境中被特异性酶切割释放毒素，作用机制上同时结合了Payload的细胞毒性和VEGF抗体的血管抑制效应。TMALIN®利用肿瘤微环境和溶酶体在胞外胞内实现双重裂解机制，具有高水溶性、高均一性、高体内外稳定性以及肿瘤组织富集特性。总结宜联生物围绕TMALIN技术平台已经建立起丰富且具差异化特色的研发管线，多款ADC完成授权合作，自主推进的B7H3 ADC已经处于三期临床阶段，NaPi2b ADC处于一期临床阶段，CDH17 ADC、VEGF ADC已经申报临床试验。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

抗体药物偶联物AACR会议临床3期临床2期

100 项与德琪医药有限公司相关的药物交易

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100 项与德琪医药有限公司相关的转化医学

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管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

塞利尼索 ( ACADS x XPO1 )	难治性弥漫性大 B 细胞淋巴瘤更多	批准上市
替雷利珠单抗 ( PD-1 )	外周T细胞淋巴瘤更多	临床2期
Eltanexor ( XPO1 )	前列腺癌更多	临床2期
Padnarsertib ( NAMPT x PAK4 )	实体瘤更多	临床2期
ATG-022 ( CLDN18.2 x Tubulin )	转移性胃癌更多	临床2期