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...
The U.S. FDA Granted Fast Track Designation to Dizal's Birelentinib for Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
* Birelentinib (DZD8586) received Fast Track Designation from the U.S. FDA for relapsed/refractory CLL/SLL * Supporting data from a pooled analysis of phase I/II studies of birelentinib showed an objective response rate of 84.2% in heavily pretreated CLL/SLL patients SHANGHAI, Aug. 6, 2025 /P...
Dizal's ZEGFROVY® (sunvozertinib) Receives FDA Accelerated Approval as the Only Targeted Oral Treatment for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
* ZEGFROVY is the only approved targeted oral treatment for NSCLC with EGFR exon20ins * Approval follows the U.S. FDA's Priority Review and is supported by the pivotal WU-KONG1 Part B study, in which ZEGFROVY demonstrated statistically significant and clinically meaningfulbenefits to patien...
Dizal Completes Enrollment for its Phase III Pivotal Study of Sunvozertinib vs. Platinum Doublet in Treatment Naïve NSCLC Patients with EGFR Exon20 Insertional Mutations
SHANGHAI, June 19, 2025 /PRNewswire/ -- Dizal announced the completion of patient enrollment for its WU-KONG28 clinical trial: a multinational, randomized phase III study evaluating the efficacy and safety of sunvozertinib versus platinum-based doublet chemotherapies as a first-line treatment for...
Dizal Showcases Two First-in-Class Therapies in Hematologic Malignancies at EHA and ICML 2025
* Golidocitinib demonstrated promising efficacy in maintaining and enhancing tumor response in peripheral T-cell lymphoma (PTCL) post first-line therapy with a 24-month disease-free survival (DFS) rate of 74.2% * DZD8586 exhibited significant antitumor activity in heavily pretreated chronic l...
Dizal to Highlight its Portfolio Advances in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2% * DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safet...
Dizal to Present Promising Clinical Data on Golidocitinib and DZD8586 for the Treatment of Lymphoma at the Coming International Hematology Conferences
* The latest 2-year follow-up data on golidocitinib as a maintenance therapy for peripheral T-cell lymphoma (PTCL) patients who achieved tumor response after first-line systemic therapy will be presented orally at the 2025 ICML * A pooled safety and efficacy analysis of two Phase I/II studies ...
Dizal to Showcase Data in Hematologic Malignancies and Lung Cancer at ASCO 2025
* DZD8586 study results in B-cell non-Hodgkin lymphomas (B-NHLs) were selected for oral and poster presentations. The analysis in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after covalent or non-covalent BTK inhibitors and BTK degraders was selected for oral presentation ...
Dizal Announces DZD8586 and DZD6008 Presentations at 2025 ASCO Annual Meeting
SHANGHAI, April 1, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that results of its investigational drug candidatesDZD8586 and DZD6008, have been selected for pr...
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 biopharmac...
U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application
* If approved, Sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins * Sunvozertinib's NDA was submitted based on the multinational pivotal WU-KONG1 Part B study, the results of which were presented...
Dizal Announces Positive Pooled Data of Sunvozertinib in EGFR Tyrosine Kinase Inhibitor-Resistant Non-Small Cell Lung Cancer Published in Lung Cancer
Sunvozertinib, as a single agent, demonstrated promising antitumor activity and favorable safety profile in heavily pretreated patients with EGFR-mutated NSCLC who had developed resistance to EGFR TKI treatment SHANGHAI, Dec. 11, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical compa...
Dizal Presents Latest Data of DZD8586, a LYN/BTK Dual Inhibitor, in B-cell Non-Hodgkin Lymphoma at the 2024 ASH Annual Meeting
DZD8586 demonstrated encouraging anti-tumor activity with manageable safety and favorable pharmacokinetic (PK) characteristics in patients with B-NHL SHANGHAI, Dec. 9, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment o...
Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an oral session at the 2024 ASCO Annual Meeting Sunvozertinib is the world's first and only oral drug approved for NSCLC patients with EGFR exon20ins SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- Dizal (SSE:68...
Sunvozertinib Granted Breakthrough Therapy Designation by China CDE for the First-Line Treatment of Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Fourth Breakthrough Therapy Designation for sunvozertinib in NSCLC with EGFR exon20ins SHANGHAI, Oct. 13, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the Center...
Subgroup Analysis from Pivotal WU-KONG1B Study Exhibits Robust Efficacy of Sunvozertinib in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations Across Different Baseline Characteristics
Results of subgroup analysis from the pivotal WU-KONG1B study in relapsed or refractory NSCLC with EGFR exon20ins presented at ESMO 2024 * Sunvozertinib demonstrated promising anti-tumor efficacy, regardless of EGFR exon20ins region classification, race, region, baseline brain metastasis, prio...
Golidocitinib Approved in China as First-in-class JAK1 Only Inhibitor for the Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma
* Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for the treatment of r/r PTCL based on results from the multinational pivotal JACKPOT8B study. * Golidocitinib monotherapy demonstrated superior and durable clinical benefits and a favorable safety profile in r/...
Dizal Reveals New Findings from Biomarker Analysis, Highlighting Sunvozertinib as an Effective Treatment for Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
* Anittumor efficacy of sunvozertinib was observed in patients regardless of baseline EGFR exon20ins status in plasma ctDNA. * Sunvozertinib could effectively clear EGFR exon20ins in plasma ctDNA, confirming its direct effect on EGFR pathway. * The resistance to sunvozertinib could be thro...
Breakthrough in Lung Cancer Treatment: Dizal to Unveil Groundbreaking Results of Sunvozertinib for Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations at 2024 ASCO Annual Meeting
Topline results from Dizal's global pivotal phase II WU-KONG1 Part B study of sunvozertinib will be showcased in a featured oral presentation at the conference. SHANGHAI, April 24, 2024 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing groundbreaking new med...
FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung can...
