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...
Dizal's Sunvozertinib Pivotal Study Results Published in The Lancet Respiratory Medicine
SHANGHAI, Dec. 13, 2023 /PRNewswire/ -- Dizal today announced that the results of a phase 2 pivotal study of sunvozertinib for the treatment of platinum-pretreated non-small-cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins) (WU-KONG6) were published in the peer-...
Dizal Impresses with Its Differentiated Hematological Oncology Portfolio at 2023 ASH
SHANGHAI, Dec. 12, 2023 /PRNewswire/ -- Dizal presented compelling data from its robust portfolio of hematological oncology at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition held inSan Diego, California from December 9-12. The data showcased updated results of Dizal's ...
Dizal's Golidocitinib Pivotal Trial Demonstrates Superior and Durable Clinical Benefits for Patients with r/r PTCL in Oral Presentation at 2023 ASH
* Full analysis of multinational pivotal study results of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (JACKPOT8 PART B) simultaneously published inThe Lancet Oncology and presented in oral session at the 65th American Society of Hematology Annual Meeting and Ex...
Golidocitinib Granted Priority Review by China NMPA for the Treatment of r/r PTCL
SHANGHAI, Sept. 21, 2023 /PRNewswire/ -- Dizal announced today that the China National Medical Products Administration (NMPA) has granted priority review status to golidocitinib, Dizal's investigational JAK1-only inhibitor, for the treatment of relapsed or refractory peripheral T-cell lymphoma (r...
Dizal Announces China CDE Acceptance of New Drug Application for Golidocitinib for Relapsed or Refractory PTCL
SHANGHAI, Sept. 14, 2023 /PRNewswire/ -- Dizal today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for golidocitinib for the treatment of relapsed or refractory peripheral T-cell lymphom...
Dizal Announces Clinical Results of Golidocitinib Published in Annals of Oncology
SHANGHAI, Sept. 10, 2023 /PRNewswire/ -- Dizal today announced the publication of the Phase I clinical data of golidocitinib for the treatment of relapsed or refractory (r/r) peripheral T cell lymphomas (PTCL) (JACKPOT8 PARTA) in Annals of Oncology(2022-2023 Impact Factor: 51.8). PTCL is an ...
Dizal's Sunvozertinib Approved by China NMPA with Potential for Best-in-class Therapy in NSCLC with EGFR Exon20ins Mutations
* Sunvozertinib, a selective EGFR TKI targeting a wide spectrum of EGFR mutations, is the first Chinese Innovative drug approved for NSCLC Patients with EGFR Exon20ins * Approval based on the results of primary endpoint from WU-KONG6 study, which demonstrated a superior confirmed objective re...
2023WCLC Oral Presentation | Molecular Analysis Validates the Effectiveness of Tumor Tissue-Based and Plasma ctDNA Testing in Identifying NSCLC Patients with EGFR Exon20ins Eligible for Treatment with Sunvozertinib
* A high concordance was observed between tumor tissue-based and plasma circulating tumor DNA (ctDNA) testing in detecting EGFR exon 20 insertion (Exon20ins) mutations. * Both tumor tissue-based and plasma ctDNA testing can be used to identify patients who may benefit from treatment with su...
Dizal's Oncology Pipeline Continues to Impress with Two Oral Presentations at 2023 ASCO Annual Meeting
SHANGHAI, May 25, 2023 /PRNewswire/ -- Dizal (688192.SH) today announced that data from its oncology portfolio will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting,June 2-6, 2023 in Chicago. The data which include updated analyses of Dizal's two leading assets...
Dizal's Rapidly Evolving Oncology Pipeline to Make Waves at 2023 ASCO Meeting
Topline Results from Pivotal Studies of Sunvozertinib and Golidocitinib Selected for Oral Presentations SHANGHAI, April 26, 2023 /PRNewswire/ -- Dizal today announced that multiple clinical data of its two leading assets – sunvozertinib and golidocitinib have been selected for presentations...
Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations
SHANGHAI, Jan. 10, 2023 /PRNewswire/ -- Dizal (SHEX: 688192) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR exon20ins...
Dizal Announces Sunvozertinib Meets Primary Endpoint in its First Pivotal Study in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 ESMO
* The confirmed objective response (cORR), as assessed by blinded independent central review (BICR), was 59.8% in advanced NSCLC with EGFR exon20ins mutations after at least one line of platinum-based chemotherapies * The response rate for patients with baseline brain metastasis was 48.4% * ...
Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO
PARIS, Sept. 5, 2022 /PRNewswire/ -- Dizal reported the promising safety and pharmacokinetic data from the global Phase I study ofDZD1516 in patients with HER2 positive metastatic breast cancer (HER2+ MBC) who relapsed from multiple prior treatments at the 2022 European Society for Medical Oncolo...
