A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.

开始日期2025-02-21

申办/合作机构-

NCT06855823

/ Recruiting临床1/2期IIT

A Phase I/II, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib As Monotherapy or in Combination with Pomalidomide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.

开始日期2025-01-14

申办/合作机构

中山大学

NCT06716658

/ Recruiting临床2期IIT

Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.

开始日期2024-12-15

申办/合作机构

中国医学科学院血液病医院

[+6]

100 项与戈利昔替尼相关的临床结果

登录后查看更多信息

100 项与戈利昔替尼相关的转化医学

登录后查看更多信息

100 项与戈利昔替尼相关的专利（医药）

登录后查看更多信息

104

项与戈利昔替尼相关的文献（医药）

2025-05-01·CLINICAL IMMUNOLOGY

JAK inhibitor ameliorates inflammatory bowel disease in a patient with IKZF1 haploinsufficiency

Article

作者: Hoshino, Yuki ; Tagami, Yuji ; Nambu, Ryusuke ; Moriya, Kunihiko ; Nakazawa, Atsuko ; Inoue, Shota ; Kyushiki, Masashi ; Kojima, Ryo ; Kanegane, Hirokazu ; Imai, Kohsuke ; Isoda, Takeshi ; Ikai, Masaatsu ; Hoshino, Akihiro ; Ichimura, Kayoko

IKAROS, encoded by IKZF1, is a crucial transcription factor regulating hematopoiesis and B cell development. While IKZF1 haploinsufficiency variants are associated with various immunological disorders, inflammatory bowel disease (IBD) has been rarely reported. We report a case of IKZF1 haploinsufficiency presenting with an atypical IBD phenotype and its response to filgotinib. The patient was previously diagnosed with IKZF1 haploinsufficiency and presented with chronic diarrhea, fatigue and anemia. Laboratory findings indicated folate deficiency-induced megaloblastic anemia and malabsorption syndrome. Endoscopic examination showed inflammation with erythema in the colon and extensive villous blunting of the small intestine. Immunohistochemical analysis revealed increased pSTAT3/5 in the colon. Considering the clinical features and increased JAK-STAT cascade, treatment with filgotinib was initiated. At 10 weeks post-treatment, we observed improvement in endoscopic findings and suppression of pSTAT3/5. This case extends the clinical spectrum of IKZF1 haploinsufficiency. A JAK1 inhibitor is considered to be useful for IKZF1 haploinsufficiency-associated IBD.

2025-04-01·BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Filgotinib Improves Experimental Pulmonary Fibrosis by Modulating JAK1/STAT3/SOCS3/IL‐17A Signalling

Article

作者: Kong, Dexin ; Zhang, Guanghua ; Lv, Yunying ; Jiang, Wanglin

ABSTRACT:

Background:

Regulatory agencies in Europe and Japan have approved filgotinib, a selective JAK1 inhibitor, for use in treating rheumatoid arthritis, but its effect and mechanism of action in treating pulmonary fibrosis remain unclear.

Methods:

We performed an in vivo investigation in rats on filgotinib's effect on pulmonary fibrosis resulting from the intratracheal infusion of bleomycin (BLM). Then, we focused on the mechanisms by which filgotinib inhibits experimentally induced pulmonary fibrosis in vitro by determining its effect on TGF‐β1‐induced proliferation of mouse lung fibroblasts.

Results:

Continuous gavage of filgotinib at 20 mg/kg for 14 days elicited protective effects in the BLM‐induced rat experimental pulmonary fibrosis model, as reflected in changes in Hounsfield units as an indicator of overall pulmonary function and in the lung coefficient and lung microscopic pathology scores as indicators of gross pulmonary pathology. Protein expression levels of IL‐17A, phosphorylated tyrosine kinase (p‐JAK1), p‐STAT3 and cytokine signal transduction inhibitor 3 (SOCS3) were also changed. In in vitro studies, filgotinib at 1 μM reduced TGF‐β1‐induced fibroblast proliferation and produced lower levels of IL‐17A, p‐JAK1 and p‐STAT3, but higher SOCS3.

Conclusions:

Filgotinib appeared to alleviate experimental pulmonary fibrosis by reducing fibroblast proliferation via inhibition of the JAK1/STAT3/SOCS3/IL‐17A pathway.

2025-03-01·JOURNAL OF BIOTECHNOLOGY

Interferon inhibitors increase rAAV production in HEK293 cells

Article

作者: Wang, Yongdan ; Sha, Sha ; Fu, Qiang ; Yoon, Seongkyu

Recombinant adeno-associated viruses (rAAVs) comprise a promising viral vector for therapeutic gene delivery to treat disease. However, the current manufacturing capability of rAAVs must be improved to meet commercial demand. Previously published omics studies indicate that rAAV production through transient transfection triggers antiviral responses and endoplasmic reticulum stress responses in the host cell. Both responses negatively regulate viral production. We demonstrate that the modulation of the antiviral immune response (by blocking interferon signaling pathways) can effectively lower the production of interferon and enhance viral genome production. The use of interferon inhibitors before transfection can significantly increase rAAV production in HEK293 cells, with up to a 2-fold increase in productivity and up to a 6-fold increase in specific productivity. Compared to the untreated groups, the addition of these small molecules generally reduced viable cell density but increased vector productivity. The positive candidates were BX795 (a TBK inhibitor), TPCA-1 (an IKK2 inhibitor), Cyt387 (a JAK1 inhibitor), and ruxolitinib (another JAK1 inhibitor). These candidates were identified using deep well screening, and reproducible titer improvement was achieved in a 30 mL shake flask scale. Additionally, genome titer improvement is feasible and scalable in two different media, but the extent of improvement may vary.

214

项与戈利昔替尼相关的新闻（医药）

2025-04-01

·CPHI制药在线

恒瑞JAK1抑制剂再下一城！

关注并星标CPHI制药在线3月31日，恒瑞医药自免领域再传捷报！JAK1抑制剂艾玛昔替尼类风湿关节炎适应症获批，这是继强直性脊柱炎后，该药斩获的第二项重磅适应症。III期临床数据显示，其ACR20缓解率超70%，且疗效持续52周，显著优于安慰剂。临床数据：疗效与安全双优在类风湿关节炎的治疗领域，恒瑞 JAK1 抑制剂艾玛昔替尼展现出了卓越的临床数据，为患者带来了新的希望。其疗效与安全性优势显著，在多个关键指标上表现出色，为临床治疗提供了有力的支持。● 疗效显著：高缓解率彰显实力根据发表于《Annals of the Rheumatic Diseases》的研究结果，恒瑞 JAK1 抑制剂在治疗类风湿关节炎时，展现出了令人瞩目的疗效。在给药24周后，接受艾玛昔替尼 4mg QD 或 8mg QD 治疗的两个实验组，均达到主要终点。其中 4mg 组达到 ACR20 患者比例为 70.4%，8mg 组达到 ACR20 患者比例更是高达 75.1%，而安慰剂组仅为 40.4%。这一数据表明，艾玛昔替尼能够显著提高患者的缓解率，使更多患者的病情得到有效控制。52周时，ACR20 应答率分别为 73.3% 和 84.2%，ACR50 应答率分别为 56.7% 和 77.2%，ACR70 应答率分别为 36.9% 和 57.3%。较高的 ACR70 应答率，意味着有相当比例的患者在接受治疗后，不仅关节疼痛、肿胀等症状得到了明显改善，而且身体功能也得到了较大程度的恢复，能够更好地进行日常活动，提高了生活质量。与乌帕替尼、巴瑞替尼等已上市的JAK抑制剂相比，恒瑞艾玛昔替尼在ACR20和 ACR70 缓解率上具有一定的竞争力。虽然目前缺乏直接头对头的临床试验数据，但从已公布的各自临床试验数据来看，艾玛昔替尼的高缓解率使其在类风湿关节炎治疗市场中占据了一席之地。在针对中重度活动性类风湿关节炎患者的治疗中，艾玛昔替尼有望为患者提供更优的治疗选择，帮助他们获得更好的治疗效果。●安全可靠：低风险保障治疗艾玛昔替尼是恒瑞自主研发的高选择性的口服JAK1抑制剂，其高选择性是保障安全性的关键因素。JAK 激酶家族包括 JAK1、JAK2、JAK3 和 TYK2，它们在细胞因子信号传导中发挥着重要作用。然而，非选择性的 JAK 抑制剂在抑制相关信号通路的同时，也可能对其他正常的生理信号通路产生干扰，从而导致副作用的发生。恒瑞艾玛昔替尼通过高度选择性地抑制 JAK1 信号传导，能够精准地发挥抗炎和抑制免疫的生物学效应，同时减少对其他 JAK 激酶的影响，降低了副作用的风险。在临床试验中，艾玛昔替尼未报告重大心血管事件，这一结果与一些其他 JAK 抑制剂形成了鲜明对比。一些非选择性或选择性较低的 JAK 抑制剂在临床应用中，曾被报道与心血管事件的发生风险增加相关，这在一定程度上限制了它们的临床使用。艾玛昔替尼在安全性方面的优势，还体现在其整体不良反应发生率与安慰剂相当，且严重不良事件和导致停用研究药物的不良事件的发生率均未增加。这使得患者在接受治疗时，能够在获得良好疗效的同时，不必过于担心药物的安全性问题，提高了治疗的耐受性和依从性。对于类风湿关节炎患者来说，长期的治疗是必要的，而药物的安全性是保证患者能够坚持治疗的重要因素之一。恒瑞艾玛昔替尼的安全性优势，为患者提供了更可靠的治疗选择，有助于改善患者的长期治疗效果和生活质量。一药多适应症：恒瑞的精耕策略恒瑞 JAK1 抑制剂艾玛昔替尼在适应症拓展方面展现出了强大的战略布局，通过 “一药多适应症” 策略，不断挖掘药物的潜力，为更多患者带来希望，也为恒瑞在自免药物市场赢得了更广阔的发展空间。●已获批适应症：覆盖广泛患者群体目前，艾玛昔替尼已获批用于治疗强直性脊柱炎和类风湿关节炎。这两种疾病均为常见的自身免疫性疾病，患者群体庞大。强直性脊柱炎主要侵犯骶髂关节、脊柱骨突、脊柱旁软组织及外周关节，严重者可发生脊柱畸形和强直，我国强直性脊柱炎的患病率约 0.3%，发病高峰年龄在 18 岁 - 35 岁，患者总数约为 400 万。类风湿关节炎则是以侵袭性、对称性多关节炎为主要临床表现的慢性、全身性自身免疫性疾病，我国 RA 患病率约为 0.42%，患者总数约为 500 万，男女比约为 1:4。随着病程的延长，残疾率升高，给患者家庭和社会带来巨大的经济负担。艾玛昔替尼的获批，为这两类患者提供了新的治疗选择，能够有效改善患者的病情，提高生活质量。●在研管线：拓展适应症，挖掘单品价值除了已获批的适应症，艾玛昔替尼还在多个领域开展临床试验，包括斑秃、特应性皮炎、溃疡性结肠炎等。这些在研适应症具有广阔的市场潜力。斑秃是一种自身免疫性脱发疾病，全球大约有 1.47 亿斑秃患者，我国斑秃患者约 400 万人。目前临床上对于斑秃的治疗需求尚未得到充分满足，艾玛昔替尼若能成功获批斑秃适应症，将为广大斑秃患者带来福音。特应性皮炎是一种慢性炎症性皮肤病，病变复杂，临床表现和症状多样，严重影响患者的生活质量。全球范围内，针对特应性皮炎的治疗药物市场需求巨大，艾玛昔替尼在特应性皮炎的临床试验中已取得积极结果，有望在该领域占据一席之地。溃疡性结肠炎是一种病因尚不十分清楚的结肠和直肠慢性非特异性炎症性疾病，我国患者数量也相当可观。艾玛昔替尼在溃疡性结肠炎的临床推进，为该疾病的治疗提供了新的可能。通过不断拓展适应症，艾玛昔替尼能够最大化单品价值，满足不同患者群体的需求，提升恒瑞在自免药物市场的竞争力。剂型创新：满足多元治疗需求恒瑞对于艾玛昔替尼的规划，涵盖了多种剂型，包括口服片剂、皮肤制剂和外用混悬剂。不同剂型适用于不同的治疗场景，能够满足患者的多元化治疗需求。口服片剂是最常见的剂型，方便患者服用，适用于全身性疾病的治疗，如类风湿关节炎、强直性脊柱炎、溃疡性结肠炎等。皮肤制剂如艾玛昔替尼软膏，主要用于治疗皮肤相关疾病，如特应性皮炎、白癜风等。外用制剂能够直接作用于病变部位，提高药物的局部浓度，增强治疗效果，同时减少全身不良反应。对于轻中度特应性皮炎患者，外用制剂是一种更为安全有效的治疗选择。外用混悬剂则为一些特殊患者群体或特定疾病提供了更多的治疗方案，进一步丰富了艾玛昔替尼的剂型种类。这种剂型创新策略，使恒瑞能够更好地满足不同患者的治疗需求，提高药物的适用性和市场竞争力。国产 VS 外资：自免战场的博弈在自身免疫疾病治疗领域，JAK 抑制剂市场竞争激烈，外资巨头凭借其先发优势和丰富的产品线占据了一定的市场份额，而国产 JAK 抑制剂则在差异化竞争和性价比方面寻求突破，恒瑞作为国产药企的代表之一，其 JAK1 抑制剂艾玛昔替尼在这场博弈中展现出了独特的竞争力。●外资巨头垄断：“全能王”的市场压制艾伯维的乌帕替尼和辉瑞的阿布昔替尼在 JAK 抑制剂市场中表现强劲，堪称 “全能王”。乌帕替尼已获批 8 项适应症，涵盖类风湿关节炎、银屑病关节炎、特应性皮炎、强直性脊柱炎、中重度溃疡性结肠炎、活动性非放射学中轴型脊柱关节炎等多个领域，广泛的适应症覆盖使其能够满足不同患者群体的需求，在市场中占据了重要地位。其上市以来销售额急速上升，2019 - 2021 年销售额分别为 0.47 亿、7.31 亿、16.51 亿美元，艾伯维预计 2025 年乌帕替尼的销售额将超过 75 亿美元，市场潜力巨大。辉瑞的阿布昔替尼主要用于治疗特应性皮炎，通过阻断三磷酸腺苷（ATP）结合位点可逆性和选择性地抑制 JAK1，调节多种与特应性皮炎相关细胞因子发挥作用。2021 年 9 月在英国首次获批上市，随后陆续在日本、韩国、欧盟和美国获批，也已在我国获批上市，用于对其他系统治疗应答不佳或不适宜上述治疗的难治性、中重度特应性皮炎成人患者，为特应性皮炎患者提供了新的治疗选择，进一步巩固了辉瑞在 JAK 抑制剂市场的地位。●国产突围：差异化竞争与性价比优势面对外资巨头的市场压制，国产JAK抑制剂积极寻求突围，采取差异化竞争策略。迪哲医药的戈利昔替尼是全球首个且唯一针对外周 T 细胞淋巴瘤（PTCL）的高选择性 JAK1 抑制剂，其首个申报上市的适应症为复发 / 难治性（r/r）外周 T 细胞淋巴瘤（PTCL），并获 FDA “快速通道认定”。在 PTCL 治疗领域，戈利昔替尼展现出了独特的优势，相较现有疗法呈现出高缓解率和持久的临床获益，客观缓解率（ORR）达 44.3%，完全缓解（CR）率达 23.9%，两者均高于现有治疗方案近 2 倍，且在多种 PTCL 常见亚型中均观察到肿瘤缓解，中位缓解持续时间（DoR）长达 20.7 个月，超越现有疗法。这种差异化的适应症布局，使戈利昔替尼在竞争激烈的 JAK 抑制剂市场中脱颖而出，找到了自己的生存空间。恒瑞的艾玛昔替尼则走 “广谱抗炎” 路线，通过不断拓展适应症，覆盖多种自身免疫性疾病。已获批的强直性脊柱炎和类风湿关节炎适应症，针对这两种常见且患者群体庞大的疾病，为患者提供了新的治疗选择。在研的斑秃、特应性皮炎、溃疡性结肠炎等适应症，也有望在未来满足更多患者的需求。同时，艾玛昔替尼在剂型创新上也有所突破，涵盖口服片剂、皮肤制剂和外用混悬剂，满足全身性与局部治疗需求，进一步提升了产品的竞争力。与外资产品相比，恒瑞艾玛昔替尼在价格方面可能具有一定优势，且随着医保准入的推进，有望提高药物的可及性，以性价比撕开市场缺口。定价博弈：医保与市场的平衡医保准入对于国产 JAK 抑制剂的市场推广和价格策略具有重要影响。进入医保目录后，药品的销量有望大幅提升，但同时也需要面临价格下降的压力。以艾伯维的乌帕替尼为例，进入医保后价格降低，患者自付费用减少，这使得更多患者能够负担得起药物，从而扩大了市场份额。对于国产 JAK 抑制剂来说，医保准入是一把双刃剑。一方面，通过医保谈判降低价格，可以提高产品的可及性，增加患者的使用量，从而实现以量换价；另一方面，过低的价格可能会影响企业的利润空间，对研发投入和产品后续发展产生一定的制约。恒瑞艾玛昔替尼在定价博弈中，需要综合考虑成本、市场需求、竞争产品价格以及医保政策等因素。在保证产品质量和企业合理利润的前提下，制定合理的价格策略，以提高产品的市场竞争力。通过与医保部门的积极沟通和谈判，争取更有利的医保政策，同时加强市场推广，提高产品的知名度和认可度，扩大市场份额。只有在医保与市场之间找到平衡，国产 JAK 抑制剂才能在激烈的市场竞争中取得更好的发展。总结和展望艾玛昔替尼的类风湿关节炎适应症获批，不仅是恒瑞在自免领域的又一里程碑，更折射出国产创新药“深度开发单品价值”的战略升级。从快速起效到长效维持，从口服到外用，恒瑞正以“技术迭代+适应症拓展”重新定义JAK抑制剂的竞争规则。然而，面对外资巨头的专利护城河、国内扎堆研发的内卷压力，艾玛昔替尼若想真正成为“国产自免王牌”，仍需在临床优势、医保谈判、患者可及性上持续突破。这场自免赛道的马拉松，恒瑞能否率先撞线？答案或许藏在未来三年的市场与数据中。参考来源：恒瑞官网END2025金笔奖征文活动开启，来投稿吧！领取CPHI & PMEC China 2025展会门票智药研习社直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

临床结果

2025-03-20

·PRNewswire

Dizal's Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer

Golidocitinib is a JAK1 only inhibitor approved for the treatment of relapsed or refractory PTCL The combination of golidocitinib and PD-1 antibody showed synergistic anti-tumor effects in anti-PD-1-resistant NSCLC SHANGHAI, March 20, 2025 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced new findings on golidocitinib, a first-in-class Janus kinase 1 (JAK1) only inhibitor, in combination with PD-1 antibodies for patients who have progressed on anti-PD-1 therapy. The details of the trial design and clinical results will be presented at the 2025 European Lung Cancer Congress (ELCC 2025) in Paris, March 26-29. Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and NSCLC. Golidocitinib has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China. Preclinical studies also show that the combination of Golidocitinib and PD-1 antibody has synergistic potentials for anti-tumor effects. Building on these findings, an exploratory phase Ib clinical study combining golidocitinib with PD-1 antibodies was designed to explore the synergistic effects of this combined regimen in NSCLC patients who have failed from anti-PD-1 containing regimens. This study will enroll 30 locally advanced or metastatic NSCLC patients who have previously received anti-PD-1 monotherapy or anti-PD-1 therapy with platinum-containing chemotherapy regimens. "Immunotherapy alone or with chemotherapy is commonly used as front line treatment for NSCLC patients without driver mutations. Unfortunately, resistance is inevitable and once the disease progresses, the prognosis is poor and treatment option is limited." said Xiaolin Zhang, PhD, CEO of Dizal. "The findings we are presenting at ELCC 2025 highlight the potential for Golidocitinib-based combination regimen to delay or overcome the resistance. The preliminary results are very promising and justify further clinical validation." In addition to the golidocitinib-based combination therapy, positive results from a Phase II study of sunvozertinib in combination with Anlotinib will also be presented. Sunvozertinib combined with anlotinib was well tolerated and demonstrated encouraging antitumor activity in NSCLC patients with EGFR mutations who had failed prior EGFR-TKI therapies. As of December 25, 2024, the objective response rate (ORR) and the disease control rate (DCR) were 33.3% and 100%, respectively, in this heavily pre-treated patient population. Enrollment is ongoing and detailed results will be updated at the congress. Dizal presentation details during ELCC 2025 About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4). About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development, and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two approved drugs and multiple assets in global pivotal studies. To learn more about Dizal, please visit , or follow us on Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法临床1期快速通道上市批准

2025-03-20

·美通社

2025 ELCC | 迪哲医药舒沃哲、高瑞哲两项克服非小细胞肺癌耐药的研究进展首次亮相

破局非小细胞肺癌（ NSCLC ）靶向和免疫治疗耐药困境，舒沃哲 ® 和高瑞哲 ® 初步彰显临床潜力上海 2025年3月20日 /美通社/ -- 2025年3月20日，迪哲医药（股票代码：688192.SH）宣布，公司将于当地时间3月26日-29日在法国巴黎举行的2025年欧洲肺癌大会（ELCC）上，以壁报形式首次展示其自主研发的两款源头创新药物舒沃哲 ® （通用名：舒沃替尼片）和高瑞哲 ® （通用名：戈利昔替尼胶囊）分别针对晚期非小细胞肺癌（NSCLC）靶向和免疫治疗耐药的最新研究进展。舒沃哲 ® 联合 VEGF 抑制剂治疗 EGFR-TKI 耐药晚期 NSCLC 舒沃哲 ® 是一款针对多种表皮生长因子受体（EGFR）突变亚型的高选择性EGFR酪氨酸激酶抑制剂（TKI），既往研究表明，其单药治疗EGFR-TKI耐药的NSCLC患者展现出良好的抗肿瘤活性。临床前研究显示，EGFR-TKI与VEGF抑制剂联合可产生协同效应。安罗替尼是一款具有抗肿瘤血管生成和抑制肿瘤生长作用的TKI。舒沃哲 ® 与安罗替尼联合治疗EGFR-TKI耐药NSCLC的II期临床数据将在本次大会亮相。该研究计划招募45例经标准EGFR-TKI治疗失败的EGFR敏感突变患者。截至2024年12月25日，舒沃哲 ® 联合安罗替尼治疗EGFR-TKI耐药晚期NSCLC，展现出良好的抗肿瘤疗效和安全性：在12例完成首次评估的患者中，客观缓解率（ORR）为33.3%，疾病控制率（DCR）达100% 耐受性良好，安全性导入期未发生剂量限制性毒性（DLT）事件，临床易管理高瑞哲 ® 联合 PD-1 抑制剂治疗 PD-1 耐药晚期 NSCLC 另一项入选大会壁报展示的是一项关于高瑞哲 ® 与PD-1抑制剂联合治疗晚期NSCLC患者的Ib期探索性临床研究设计。该研究计划入组30例既往接受过PD-1单抗或PD-1单抗联合含铂化疗方案治疗的局部晚期或转移性NSCLC患者，旨在探索高瑞哲 ® 与PD-1单抗联合治疗方案针对PD-1耐药NSCLC的协同作用，主要研究终点为ORR。 JAK/STAT通路的过度激活导致肿瘤细胞表面PD-L1表达升高产生免疫逃逸，是癌症免疫治疗中对免疫检查点抑制剂产生耐药性的重要因素。既往研究表明，JAK抑制剂联合PD-1免疫疗法，可通过调节霍奇金淋巴瘤（HL）和NSCLC中的JAK/STAT通路，逆转或延缓免疫治疗耐药的发生。高瑞哲 ® 作为一款高选择性的JAK1抑制剂，能够有效抑制JAK/STAT通路，已通过优先审评在中国获批，用于治疗复发/难治外周T细胞淋巴瘤（r/r PTCL）。迪哲医药创始人、董事长兼首席执行官张小林博士表示："无论是EGFR敏感突变还是驱动基因阴性非小细胞肺癌（NSCLC）患者，在接受标准一线治疗后，耐药问题几乎不可避免，且目前的临床治疗选择仍然非常有限。舒沃哲 ® 和高瑞哲 ® 这两项联合治疗的最新研究，初步彰显了两款产品破局NSCLC靶向和免疫治疗耐药困境的潜力，为未来治疗策略的探索提供了新的方向。" 壁报展示摘要标题： 67P - 舒沃替尼联合安罗替尼治疗EGFR-TKI耐药晚期NSCLC患者的II期研究（WU-KONG9） 67P - A Phase II Study of Sunvozertinib Combined with Anlotinib in EGFR-TKIs resistant EGFRm Advanced NSCLC Patients（WU-KONG9）汇报人：胡洁（复旦大学附属中山医院）摘要编号：613 分会场：晚期NSCLC 展示时间：2025/3/28，13:00 - 13:45（欧洲中部时间）摘要标题： 126TiP - 一项开放标签、单臂、Ib期探索性研究，评估戈利昔替尼联合抗PD-1抑制剂在既往接受过含PD-1方案治疗的局部晚期或转移性NSCLC患者中的安全性和疗效 126TiP - An Open-Label, Single-Arm, Phase Ib Exploratory Study to Evaluate the Safety and Efficacy of Golidocitinib in Combination with Anti-PD-1 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Anti-PD-1 Containing Regimens 汇报人：钟华（上海交通大学医学院附属胸科医院）摘要编号：538 分会场：晚期NSCLC 展示时间：2025/3/28，13:00 - 13:45（欧洲中部时间）关于舒沃哲 ® （舒沃替尼片）舒沃哲 ® 是一款口服、不可逆、针对多种EGFR突变亚型的高选择性EGFR酪氨酸激酶抑制剂（TKI），首个适应症于2023年8月获国家药品监督管理局通过优先审评在中国批准上市，用于既往经含铂化疗出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR）20号外显子插入突变（exon20ins）的局部晚期或转移性非小细胞肺癌（NSCLC）患者。2024年4月，舒沃哲 ® 作为EGFR exon20ins NSCLC二/后线治疗的唯一Ⅰ级推荐方案，被列入《中国临床肿瘤学会（CSCO）非小细胞肺癌诊疗指南（2024版）》，随后，陆续被列入其他中国各大非小细胞肺癌权威指南并获得最高等级推荐。舒沃哲 ® 获批适应症已纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》。关于高瑞哲 ® （戈利昔替尼胶囊）高瑞哲 ® 是一款迪哲自主研发的高选择性Janus激酶1（JAK1）抑制剂，是全球首个且唯一作用于JAK/STAT通路的PTCL新机制治疗药物，于2024年6月获国家药监局批准在中国首发上市，适用于既往至少接受过一线系统性治疗的复发或难治的外周T细胞淋巴瘤（r/r PTCL）成人患者。高瑞哲 ® 获批适应症已纳入《国家基本医疗保险、工伤保险和生育保险药品目录（2024年）》。关于迪哲医药迪哲医药（股票代码：688192.SH）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了六款具备全球竞争力的产品管线，其中两大处于全球关键性临床试验阶段的领先产品，均已在中国获批上市。欲了解更多信息，请关注微信公众号：迪哲Dizal，或访问 www.dizalpharma.com 。前瞻性声明本新闻所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用"预期"、"相信"、"预测"、"期望"、"打算"、"有望"及其他类似词语进行表述时，凡与本公司有关的，目的均是要指明其属前瞻性表述。前瞻性表述乃基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些乃超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员概不承担（a）更正或更新本网站所载前瞻性表述的任何义务；及（b）若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。更多信息，敬请联系投资者关系： ir@dizalpharma.com 商务合作： bd@dizalpharma.com 媒体联络： pr@dizalpharma.com

优先审批申请上市免疫疗法引进/卖出临床结果

100 项与戈利昔替尼相关的药物交易

登录后查看更多信息

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
外周T细胞淋巴瘤	中国	迪哲（江苏）医药股份有限公司	2024-06-18

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
PD-L1阳性非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2024-01-01
复发性T细胞淋巴瘤	临床2期	中国	迪哲（江苏）医药股份有限公司	2022-05-31
蕈样真菌病	临床2期	中国	迪哲（江苏）医药股份有限公司	2021-12-23
塞扎里综合征	临床2期	中国	迪哲（江苏）医药股份有限公司	2021-12-23
EGFR突变的非小细胞肺癌	临床2期	澳大利亚	迪哲（江苏）医药股份有限公司	2018-04-16
克罗恩病	临床前	中国	迪哲（江苏）医药股份有限公司	-
非小细胞肺癌	临床前	英国	AstraZeneca PLC	-

登录后查看更多信息

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


NCT04105010 (JACKPOT8 Part B \| JACKPOT8, CTgov)	临床1/2期	外周T细胞淋巴瘤	171	AZD4205 (AZD4205 Group D)	衊鹽醖糧製網積齋鏇築 = 蓋鏇製壓壓鬱襯獵淵繭築選鑰鏇遞簾願艱構願 (壓廠觸淵積積遞願糧衊, 築鏇鹹選獵衊選獵獵憲 ~ 顧壓鹽願醖襯餘獵衊顧) 更多	-	2025-04-04
NCT04105010 (JACKPOT8 Part B \| JACKPOT8, CTgov)	临床1/2期	外周T细胞淋巴瘤	171	AZD4205 (AZD4205 Group A)	鏇餘壓齋淵築淵積觸廠 = 顧蓋夢艱憲獵觸夢遞糧積顧衊遞網窪壓衊網鬱 (憲簾醖獵淵築築衊鏇艱, 獵廠網壓鹹獵鹽遞構艱 ~ 餘範鬱艱廠簾範選醖餘) 更多	-	2025-04-04
NCT04105010 (JACKPOT8 Part B, Pubmed) 人工标引	临床2期	外周T细胞淋巴瘤二线	104	Golidocitinib 150 mg	鬱艱鏇選夢鏇餘選鏇觸(壓淵積觸選膚構醖積夢) = neutrophil count decreased (30 [29%]), white blood cell count decreased (27 [26%]), lymphocyte count decreased (22 [21%]), and platelet count decreased (21 [20%]), which were clinically manageable and reversible. Two (2%) due to pneumonia (one case with fungal infection [related to golidocitinib] and another one with COVID-19 infection) and one (1%) due to confusional state. 網製鬱襯憲積鑰夢蓋淵 (鏇壓夢襯醖壓鬱簾艱顧 )	积极	2024-01-01
CTR20213318 (JACKPOT26, ASH2023)	临床2期	外周T细胞淋巴瘤维持	48	Golidocitinib 150 mg	壓網膚齋鏇壓範齋憲餘(獵構簾顧積襯顧築窪鬱) = 餘壓選網獵淵鹹鹹蓋壓構遞鹽壓艱蓋鏇鏇範蓋 (鏇鏇衊觸淵壓夢夢構範 ) 更多	-	2023-12-11
NCT04105010 (JACKPOT8, ASH2023) 人工标引	临床2期	外周T细胞淋巴瘤二线	112	Golidocitinib 150 mg	糧簾鏇衊餘壓顧網範繭(遞繭齋淵憲顧壓簾簾壓) = 壓選壓餘構鬱遞襯蓋簾觸獵構艱窪蓋築窪膚鹹 (範鹹壓簾願壓夢鏇願簾, 33.7 ~ 55.3) 更多	积极	2023-12-09
NCT04105010 (JACKPOT8, ICML2023)	临床1/2期	外周T细胞淋巴瘤	104	Golidocitinib 150 mg	構窪襯膚網襯願淵築鏇(願窪範觸壓鑰夢構鑰積) = 憲構壓築淵遞鬱繭鏇膚簾鬱積衊網獵積衊憲築 (餘齋遞艱製衊憲鏇繭選 ) 更多	积极	2023-06-09
NCT04105010 (JACKPOT8, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	外周T细胞淋巴瘤	104	Golidocitinib	獵壓齋簾壓遞壓衊鑰製(餘夢膚廠廠廠鑰餘壓鬱) = 鹹顧範餘積廠艱廠繭壓鹹簾鹽鬱齋襯選獵蓋範 (網鹽齋憲觸構簾齋鑰蓋 ) 更多	积极	2023-05-26
NCT04105010 (ASCO2022) 人工标引	临床1/2期	外周T细胞淋巴瘤	51	GolidocitinibGolidocitinib 150 or 250 mg QD	顧糧夢窪製鹹醖範夢簾(選顧製衊築構構構壓餘) = 願糧顧窪膚願齋齋窪醖網壓構壓醖遞鹹簾鑰製 (壓窪膚繭鏇壓範鏇鹹淵 ) 更多	积极	2022-06-02
NCT04105010 (EHA2022)	临床1/2期	外周T细胞淋巴瘤	51	Golidocitinib	觸顧鹹獵鏇範鏇鏇糧蓋(糧襯繭築願範積鑰糧選) = 鏇齋鑰顧壓窪壓範鹹願廠願遞製蓋製齋膚製鑰 (構選觸範鹹鬱壓壓窪廠 ) 更多	-	2022-05-12
NCT04105010 (JACKPOT8, ICML2021)	临床1/2期	外周T细胞淋巴瘤	47	DZD4205 150 mg	積齋淵鹹選鑰選願遞鹽(壓獵膚繭顧餘憲獵構壓) = 糧衊鹽夢製鏇餘憲醖餘遞醖醖鏇構襯築鹹糧衊 (鹽壓鏇齋鏇窪遞廠選顧 ) 更多	积极	2021-06-17
NCT04105010 (JACKPOT8, ICML2021)	临床1/2期	外周T细胞淋巴瘤	47	DZD4205 250 mg	積齋淵鹹選鑰選願遞鹽(壓獵膚繭顧餘憲獵構壓) = 艱蓋鏇蓋鏇壓窪選簾夢遞醖醖鏇構襯築鹹糧衊 (鹽壓鏇齋鏇窪遞廠選顧 ) 更多	积极	2021-06-17