A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Anti-Tumor Efficacy and Safety of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (WU-KONG16)

To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.

开始日期2025-10-01

申办/合作机构

迪哲（江苏）医药股份有限公司

NCT07079475

/ Not yet recruiting临床1/2期

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment

开始日期2025-08-01

申办/合作机构

迪哲（江苏）医药股份有限公司

NCT06864624

/ Recruiting临床2期IIT

Sunvozertinib as Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)

This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.

开始日期2025-02-18

申办/合作机构

Tangdu Hospital

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100 项与舒沃替尼相关的临床结果

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100 项与舒沃替尼相关的转化医学

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100 项与舒沃替尼相关的专利（医药）

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项与舒沃替尼相关的文献（医药）

2025-10-01·CANCER LETTERS

Efficacy and safety of sunvozertinib monotherapy as first-line treatment in NSCLC patients with EGFR exon 20 insertion mutations: A phase 2, single-center trial

Article

作者: Lang, Hongli ; Gao, Xiaoxing ; Zhao, Jing ; Zhong, Wei ; Chen, Minjiang ; Yip, Chingwan ; Wang, Mengzhao ; Xu, Yan ; Wang, Mei ; Liu, Xiaoyan

Currently, no chemotherapy-free therapy is approved for the first-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins). Sunvozertinib is an oral EGFR tyrosine kinase inhibitor, which has been approved in China for ≥ second-line EGFR exon20ins NSCLC. We conducted a multi-group phase 2 study of sunvozertinib, WU-KONG15 (NCT05559645), to explore its antitumor efficacy in treatment-naïve EGFR exon20ins NSCLC (Group 4). Sunvozertinib was administered at 200 mg once daily (QD). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), duration of response (DoR), overall survival (OS), and safety. Exploratory endpoints included circulating tumor DNA (ctDNA) biomarkers. As of January 15, 2025, 26 treatment-naïve patients with EGFR exon20ins NSCLC were enrolled and included in the efficacy analysis set. The median PFS was 10.1 months (95 % CI: 6.2, 13.9), with confirmed ORR of 73.1 % (95 % CI: 52.2, 88.4) and median DoR of 10.5 months (95 % CI: 7.2, 21.2). The estimated median OS was 23.1 months (95 % CI: 13.1, NE). A total of 99 patients were included in the safety analysis set. The median relative dose intensity was 98.2 %. The incidence of Grade ≥3 treatment-related adverse events was 35.4 %, including blood creatine phosphokinase increased (10.1 %), diarrhoea (8.1 %) and anaemia (8.1 %). Negativity of plasma EGFR exon20ins ctDNA correlated with better tumor response. In conclusion, sunvozertinib monotherapy demonstrated significant and durable antitumor efficacy and was well-tolerated in treatment-naïve patients with EGFR exon20ins NSCLC, suggesting its potential as a favorable first-line treatment option.

2025-09-12·Med

Current paradigm of EGFR^ins20 in non-small cell lung cancer: A long way forward.

Review

作者: Salgia, Ravi ; Shrestha, Sagun ; Reyes, Amanda ; Pisick, Evan ; Nguyen, Danny ; Arias-Romero, Javier ; Cadman, Karla ; Malhotra, Jyoti ; Miyamura, Beatriz Viesser ; Fricke, Jeremy ; Mambetsariev, Isa

EGFR^ins20 alterations are detected in 5% to 12% of the EGFR mutated subgroup in advanced non-small cell lung cancer. Historically, these alterations have been correlated with worse prognosis among the common EGFR mutation subtypes, which largely respond only to chemotherapy. The availability of new targeted therapies with EGFR^ins20 activity has transformed the precision medicine landscape for patients, with improved outcomes and survival. Previous clinical trials evaluating EGFR holistic targeted therapies, such as erlotinib, gefitinib, and osimertinib, in EGFR^ins20 patients have all failed, requiring a realignment of EGFR^ins20 therapeutic drug development. New clinical trial data on EGFR^ins20-specific targeted therapies have led to US Food and Drug Administration (FDA) approval of amivantamab-vmjw and accelerated FDA approval of sunvozertinib, with more clinical trial drugs currently under investigation. Next-generation sequencing (NGS) testing, including liquid biopsy, should be prioritized to differentiate patients with this subtype and consider the individual EGFR^ins20 variants that may respond differently to available therapeutics.

2025-09-09·JOURNAL OF CLINICAL ONCOLOGY

Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B).

Article

作者: Felip, Enriqueta ; Di Noia, Vincenzo ; Shim, Byoung-Yong ; Yang, James Chih-Hsin ; Bosch-Barrera, Joaquim ; Joaquin, Andres Barba ; Carcereny, Enric ; Parra, Hector Soto ; Tiseo, Marcello ; Hinojal, Gonzalo Fernández ; Lee, Dae Ho ; Le, Xiuning ; Bazhenova, Lyudmila ; Mazieres, Julien ; Cobo Dols, Manuel Angel ; Memmott, Regan M ; Streich, Guillermo ; Fan, Yun ; Yang, Tsung-Ying ; D'Arcangelo, Manolo ; Sun, Meili ; Brungs, Daniel ; Pellini, Bruna ; Jaime, Jesus Corral ; Liu, Geoffrey ; Antonuzzo, Lorenzo ; de Castro Carpeno, Javier ; Luo, Yung-Hung ; Li, Xingya ; Greillier, Laurent ; Jänne, Pasi A ; Hu, Ying ; Hong, Qunying ; Doucet, Ludovic ; Wang, Mengzhao ; Lv, Dongqing ; Huang, Dingzhi ; Rodriguez, Luis Paz-Ares ; Fang, Jian ; Planchard, David ; John, Thomas ; Ghiringhelli, François ; Zalcman, Gerard ; Kim, Yu Jung ; Bearz, Alessandra ; Han, Ji-Youn ; Shum, Elaine ; Zheng, Li

PURPOSE:

WU-KONG1B (ClinicalTrials.gov identifier: NCT03974022) is a multinational phase II, dose-randomized study to assess the antitumor efficacy of sunvozertinib in pretreated patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).

METHODS:

Eligible patients with advanced-stage EGFR exon20ins NSCLC were randomly assigned by 1:1 ratio to receive sunvozertinib 200 mg or 300 mg once daily (200 and 300 mg-rand cohorts). After predefined interim analysis, additional patients were enrolled and treated with the 300 mg dose once daily. The primary end point was blinded independent review committee (IRC)-assessed confirmed objective response rate (cORR), and the key secondary end point was duration of response (DoR).

RESULTS:

Among 85, 89, and 107 efficacy-evaluable patients in 200 mg-rand, 300 mg-rand, and 300 mg-all (including randomly assigned and nonrandomized patients) cohorts, the cORRs were 45.9% (97.5% CI, 33.6% to 58.5%), 47.2% (97.5% CI, 35.1% to 59.5%), and 45.8% (97.5% CI, 34.8% to 57.0%), respectively, per IRC assessment. The predefined null hypothesis was rejected with statistical significance (P < .0001). Comparing 300 and 200 mg-rand cohorts, higher cORRs were observed in patients with baseline brain metastasis (52.4% v 28.6%) and previous amivantamab treatment (41.7% v 25%), as well as longer DoR (13.8 v 11.1 months). At 200 and 300 mg once daily, the most common treatment-related adverse events with grade ≥3 included diarrhea (2.2% v 18%), blood creatine phosphokinase increased (6.6% v 12.6%), and anemia (4.4% v 6.3%).

CONCLUSION:

Sunvozertinib is efficacious at both 200 and 300 mg once daily in treating platinum-pretreated patients with advanced EGFR exon20ins NSCLC. The treatment-related adverse events of sunvozertinib were consistent with an EGFR tyrosine kinase inhibitor, with a more favorable safety profile at 200 mg than 300 mg once daily.

396

项与舒沃替尼相关的新闻（医药）

2025-09-15

·迪哲Dizal

世界淋巴瘤日｜哲伴同行，愈见希望

关于高瑞哲®（戈利昔替尼胶囊）滑动阅览高瑞哲®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）》。 2025年4月，高瑞哲®治疗r/r PTCL被列入《中国临床肿瘤学会（CSCO）淋巴瘤诊疗指南（2025版）》Ⅰ级推荐方案。高瑞哲®针对JAK1的选择性高于对JAK家族其他成员200-400倍，从而可以在大幅提升PTCL 治疗效果的同时确保更好的临床治疗安全性。国际多中心关键性注册临床研究JACKPOT8 Part B数据显示：截至2023年8月31日，高瑞哲®单药显示出强效持久的抗肿瘤活性，客观缓解率（ORR）达44.3%，且其中一半以上肿瘤缓解的受试者达到了完全缓解（CR），CR率达23.9%。全亚型均获益良好，常见亚型 ORR 均超过40%。中位缓解持续时间（mDoR）达20.7个月，随访至2024年2月，中位总生存期（OS）达24.3个月。高瑞哲®用于治疗r/r PTCL，于2022年2月获美国食品药品监督管理局（FDA）“快速通道认定”（Fast Track Designation）。2023年9月，高瑞哲®新药上市申请获药品监督管理局（NMPA）新药审评中心（CDE）受理并纳入优先审评。2023年，高瑞哲®研究成果相继在国际顶刊发表：全球I期临床试验（JACKPOT8 Part A）刊于《肿瘤学年鉴》（Annals of Oncology，影响因子：51.8），JACKPOT8B研究刊于《柳叶刀·肿瘤学》（Lancet Oncology，影响因子：54.4）。关于迪哲医药滑动阅览迪哲医药（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，公司已建立了七款具备全球竞争力的产品管线，其中全球关键性临床试验已达到主要研究终点的两大领先产品——舒沃哲®已在中、美两国获批上市，高瑞哲®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。前瞻性声明滑动阅览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

CSCO会议优先审批上市批准申请上市临床1期

2025-09-10

·医药观澜

速递丨迪哲医药11项肺癌最新研究成果亮相2025WCLC

9月9日，迪哲医药宣布，该公司自主研发的新型肺癌靶向药舒沃替尼片和高选择性JAK1抑制剂戈利昔替尼胶囊在非小细胞肺癌（NSCLC）中的11项最新研究，亮相于2025年9月6日至9日在西班牙巴塞罗那举行的2025年世界肺癌大会（WCLC）。其中，舒沃替尼国际多中心注册临床研究"悟空1B"（WU-KONG1B）的最新数据在大会进行口头报告，并同步发表于国际期刊《临床肿瘤学期刊》（Journal of Clinical Oncology）。该研究最新数据显示，舒沃替尼片二/后线治疗表皮生长因子受体（EGFR）20号外显子插入突变（exon20ins）NSCLC具有良好的获益/风险比：抗肿瘤疗效显著且持久，安全性可控可管理。今年7月，舒沃替尼片基于"悟空1B"（WU-KONG1B）研究在美国通过优先审评获批上市，治疗EGFR exon20ins NSCLC。本次WCLC大会上还公布了舒沃替尼片多项研究，覆盖EGFR exon20ins NSCLC全线治疗、EGFR罕见及其他罕见突变（HER2 exon20ins）NSCLC、EGFR敏感突变合并共突变NSCLC，以及EGFR TKI耐药的EGFR突变晚期NSCLC等多个领域，并包含单药及多种联合治疗策略。研究显示，舒沃替尼片在EGFR exon20ins NSCLC不同治疗阶段（包括一线、二线、围手术期）均展现出良好的抗肿瘤疗效和安全性：舒沃替尼片联合安罗替尼一线治疗EGFR exon20ins NSCLC客观缓解率（ORR）超过80%，疾病控制率（DCR）达100%，展现出了积极的临床获益。舒沃替尼片联合贝伐珠单抗治疗经治EGFR exon20ins NSCLC也显示出持久的抗肿瘤疗效与良好的安全性：入组患者中85.7%观察到肿瘤靶病灶缩小，DCR达100%，中位随访时间15.2个月，中位缓解持续时间（DoR）达19.1个月，且3例（3/14）仍在持续缓解中。此外，真实世界病例显示，舒沃替尼片：用于EGFR exon20ins NSCLC早期患者新辅助治疗，表现出令人鼓舞的临床获益，3例患者术前均获得部分缓解（PR）；用于EGFR exon20ins NSCLC早期患者辅助治疗也显示出持续的疗效，且耐受性良好，患者顺利度过术后一年复发高峰期；用于一线维持治疗免疫治疗和化疗不耐受的EGFR exon20ins肺腺癌，显示出良好的抗肿瘤疗效和安全性。舒沃替尼针对EGFR罕见及其他罕见突变也表现出积极的临床疗效。舒沃替尼联合安罗替尼治疗其他EGFR罕见突变NSCLC研究中，一例EGFR罕见突变患者达到了颅内病灶完全缓解（iCR）。在一项真实世界病例系列报告中，舒沃替尼单药针对既往治疗失败的HER2 exon20ins晚期NSCLC展现出良好的抗肿瘤疗效和安全性。在EGFR敏感突变合并共突变NSCLC患者中，舒沃替尼联合安罗替尼一线治疗的ORR为77.8%，DCR达100%，有望为临床带来极具前景的治疗选择。同时，舒沃替尼单药或联合化疗治疗EGFR TKI耐药的EGFR突变晚期 NSCLC均表现出令人鼓舞的临床获益，凸显作为后续治疗策略的潜力。此外，迪哲还公布了戈利昔替尼胶囊在NSCLC治疗领域的最新探索。研究显示，戈利昔替尼胶囊联合抗PD-1单抗治疗经PD-1治疗的晚期NSCLC在剂量递增阶段未观察到剂量限制性毒性（DLT），目前研究仍在持续入组和数据收集中，将为戈利昔替尼胶囊在NSCLC的临床应用提供重要依据。舒沃替尼是一款口服、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月获中国国家药品监督管理局（NMPA）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。2025年7月，该产品二/后线治疗EGFR exon20ins NSCLC通过优先审评程序获美国FDA批准在美国上市，并被纳入美国国立综合癌症网络（NCCN）指南推荐。戈利昔替尼胶囊是一款迪哲医药自主研发的高选择性Janus激酶1（JAK1）抑制剂，是一款作用于JAK/STAT通路的PTCL新机制治疗药物，于2024年6月获NMPA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。参考资料：[1]聚焦肺癌前沿进展，迪哲医药11项最新研究成果亮相2025WCLC. From https://www.prnasia.com/story/502722-1.shtml免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

优先审批申请上市临床结果免疫疗法

2025-09-09

·PRNewswire

Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC

SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer (WCLC), held September 6–9 in Barcelona, Spain. ZEGFROVY: Targeting EGFR exon20ins and a wide spectrum of EGFR mutations The latest data from the multinational pivotal WU-KONG1 Part B (WU-KONG1B) study for ZEGFROVY were presented in an oral session at the conference and simultaneously published in the Journal of Clinical Oncology. Based on results from WU-KONG1B, ZEGFROVY received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2025 as the only targeted oral therapy for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The study showed robust and durable antitumor activity with a manageable safety profile. (#MA08.01). In addition to the oral presentation, multiple studies of ZEGFROVY were presented at the WCLC, highlighting its potential across a broad range of NSCLC patients, including those with EGFR exon20ins across all lines of therapy, uncommon EGFR and HER2 mutations, EGFR-sensitive mutation and co-mutations, and EGFR mutations resistant to EGFR TKIs. Both monotherapy and combination regimens were evaluated. In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings. ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43). In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13). Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins. As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49). In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55). In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47). In NSCLC patients harboring uncommon EGFR mutations, ZEGFROVY combined with anlotinib demonstrated promising efficacy, including one patient who achieved complete remission of intracranial lesions (#P3.12.43). In a separate real-world case series, ZEGFROVY exhibited clinical efficacy in advanced NSCLC with HER2 exon20ins, with tumor shrinkage obviously observed post-prior treatment failures (#EP.12.46). In treatment-naïve NSCLC patients with EGFR-sensitive mutation and co-mutations, ZEGFROVY in combination with anlotinib achieved an ORR of 77.8% and a DCR of 100% (#P3.12.22). In NSCLC patients with EGFR mutations who failed prior EGFR-TKI therapies, ZEGFROVY, both as monotherapy (#EP.12.43) and in combination with chemotherapy (#P3.12.47), was well tolerated and demonstrated encouraging antitumor activity. Golidocitinib: Janus kinase 1 (JAK1) only inhibitor Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC Resistance to first-line immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC) leads to limited treatment options and poor prognosis. Preclinical and early clinical data have shown synergistic effects between JAK inhibitors and anti-PD-1, suggesting a promising therapeutic strategy in this population. Golidocitinib in combination with anti-PD-1 was being evaluated in immune-resistant NSCLC patients. The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. Ongoing enrollment and data collection will provide deeper insights into clinical utility of golidocitinib (#P1.11.74). Dr. Xiaolin Zhang, CEO of Dizal, remarked, "Dizal is advancing therapies for patients with NSCLC across EGFR exon 20 insertion, uncommon and EGFR-sensitizing mutations to address significant unmet medical needs. Through scientific innovation, we aim to deliver safe, effective and transformative treatments to patients worldwide." - End - About ZEGFROVY®(sunvozertinib) ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The China approval is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. In addition, ZEGFROVY 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. ZEGFROVY 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. WU-KONG28, a phase III, multinational, randomized study assessing ZEGFROVY as a first-line treatment for patients with EGFR exon20ins NSCLC, has completed enrollment across 16 countries and regions. Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology. 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%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 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) were 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) were published in The Lancet Oncology (Impact Factor: 54.4). 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 multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit , or follow us on Linkedin or X. 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

临床结果临床3期免疫疗法上市批准优先审批

100 项与舒沃替尼相关的药物交易

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适应症	国家/地区	公司	日期
EGFR 20号外显子插入突变非小细胞肺癌	中国	迪哲（江苏）医药股份有限公司	2023-08-22

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌Ⅰ期	临床3期	中国	迪哲（江苏）医药股份有限公司	2025-10-01
非小细胞肺癌IIIA期	临床3期	中国	迪哲（江苏）医药股份有限公司	2025-10-01
非小细胞肺癌IIIB期	临床2期	中国	迪哲（江苏）医药股份有限公司	2025-02-18
非鳞状非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2023-02-15
HER2突变型非小细胞肺癌	临床2期	美国	迪哲（江苏）医药股份有限公司	2023-01-10
HER2突变型非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2023-01-10
HER2突变型非小细胞肺癌	临床2期	中国台湾	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	美国	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	中国台湾	迪哲（江苏）医药股份有限公司	2023-01-10

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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


NCT03974022 (WU-KONG1 Part B, WCLC2025)	临床2期	非小细胞肺癌二线 EGFR exon 20 insertion mutations	184	Sunvozertinib 200 mg	衊鹹窪鑰鹹製餘鏇顧衊(齋簾膚糧醖艱壓遞鏇餘) = 範廠壓膚膚鹹網齋鹹製鏇鬱餘衊遞艱築醖範鬱 (範顧網糧鑰範願鹽蓋製, 33.6 ~ 58.5) 更多	积极	2025-09-09
NCT03974022 (WU-KONG1 Part B, WCLC2025)	临床2期	非小细胞肺癌二线 EGFR exon 20 insertion mutations	184	Sunvozertinib 300 mg	衊鹹窪鑰鹹製餘鏇顧衊(齋簾膚糧醖艱壓遞鏇餘) = 鏇願網鑰顧淵鹹廠遞觸鏇鬱餘衊遞艱築醖範鬱 (範顧網糧鑰範願鹽蓋製, 35.1 ~ 59.5) 更多	积极	2025-09-09
NCT06348927 (WUKONG32, WCLC2025)	临床2期	晚期非小细胞肺癌一线 EGFR sensitive mutation (Ex19del, L858R)	16	Sunvozertinib+Anlotinib	積獵顧鬱壓築蓋餘願觸(顧觸醖廠齋範積蓋積膚) = 選鹽憲鑰淵膚鬱鏇構淵鬱獵艱鏇鏇襯艱顧鬱鑰 (窪鏇願網願壓簾齋鹹夢 ) 更多	积极	2025-09-09
NCT06195189 (WUKONG36, WCLC2025)	临床2期	晚期非小细胞肺癌三线 \| 二线 EGFR sensitive mutation (Ex19del, L858R)	9	Sunvozertinib+Platinum containing dual drug chemotherapy	鹹醖顧壓鑰築蓋獵憲觸(範膚廠餘鬱糧獵獵鹹糧) = 築觸簾遞顧夢齋膚顧顧淵簾選艱網積顧醖範鑰 (顧鹽蓋鏇膚遞網範蓋鏇 ) 更多	积极	2025-09-09
NCT06276283 (WU-KONG29, WCLC2025)	临床2期	晚期非小细胞肺癌二线 EGFR ex20ins mutation	19	bevacizumab+Sunvozertinib (previously treated patients with EGFRm NSCLC)	製獵廠醖壓築願糧觸鹽(醖鬱鹽鬱糧繭築艱鑰選) = 夢鏇衊鏇衊糧鹹鹹顧製襯遞範衊鏇襯鹽鹽糧壓 (夢獵願夢膚襯範網壓願 ) 更多	积极	2025-09-08
NCT06276283 (WU-KONG29, WCLC2025)	临床2期	晚期非小细胞肺癌二线 EGFR ex20ins mutation	19	bevacizumab+Sunvozertinib (patients with baseline brain metastasis)	廠願網壓簾齋壓繭簾齋(艱鏇鏇鏇艱淵廠築廠夢) = 艱繭蓋觸夢獵蓋膚憲築獵壓鑰鏇獵齋繭遞觸醖 (願網憲鑰顧壓鏇醖淵窪 ) 更多	积极	2025-09-08
NCT03974022 (WU-KONG1B, FDA \| FDA_CDER) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	85	Sunvozertinib 200 mg	鹽構窪築廠構衊觸艱夢(餘襯窪窪築醖鹹窪窪憲) = 艱壓艱鏇繭選餘構糧遞壓淵製蓋製觸鹽選繭膚 (襯艱鏇窪窪顧衊糧蓋襯, 35 ~ 57) 更多	积极	2025-07-02
NCT06182761 (WUKONG9, ESMO_ELCC2025)	临床2期	EGFR突变的非小细胞肺癌 EGFR sensitizing mutations	45	Sunvozertinib 300 mg + Anlotinib 12 mg	鏇壓網膚廠糧願獵淵築(窪衊築襯鹹鏇觸構鹽襯) = 夢憲糧簾艱齋簾獵鏇簾廠顧膚醖糧蓋醖簾鬱築 (鑰鬱築遞獵鏇鏇積廠壓 ) 更多	积极	2025-03-26
NCT05559645 \| NCT03974022 \| CTR20192097 (WU-KONG15, Pubmed) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	40	Sunvozertinib	鹹鹹醖繭蓋遞簾鹽憲餘(淵願醖廠襯獵窪廠窪襯) = 衊廠齋壓夢夢繭淵顧蓋廠廠範遞觸顧遞觸簾衊 (獵鬱鬱廠遞糧餘齋鏇窪 ) 更多	积极	2024-12-02
NCT03974022 (WU-KONG1B, ESMO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Mutation	107	Sunvozertinib 300 mg	顧觸鹽構構衊遞構衊簾(製繭壓獵窪膚膚壓淵膚) = 簾窪範鹽襯築遞顧繭鏇壓獵鑰夢顧願齋淵憲窪 (餘積選積衊衊廠鏇範蓋 )	积极	2024-09-14
NCT03974022 (WU-KONG1B, PRNewswire) 人工标引	临床2期	非小细胞肺癌 EGFR Exon 20 Insertion	111	舒沃哲 300mg	糧範膚築築網鬱膚齋艱(廠窪鏇蓋壓醖觸網鏇鹹) = 膚蓋構鏇鏇淵鬱範壓鹹鏇獵衊衊壓鹽艱獵觸窪 (艱範艱憲鹹醖醖齋衊蓋 ) 更多	积极	2024-06-02
NCT03974022 (WU-KONG1, ASCO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	184	Sunvozertinib 200 mg	餘艱餘糧範築齋鹽築鹹(憲鹽鬱膚醖觸夢憲齋窪) = 淵鏇鬱築窪顧醖憲範範齋蓋鑰餘獵醖願蓋鑰顧 (襯膚淵製餘鑰範觸顧鹽 ) 达到更多	积极	2024-05-24