[{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical's DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Pharmaceutical Receives U.S. FDA Fast Track Designation for DZD4205 (Golidocitinib) for the Treatment of Refractory or Relapsed Peripheral T-Cell Lymphoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces Pre-clinical and Clinical Results of Sunvozertinib (DZD9008) Published in Cancer Discovery","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces New Data from the Phase I\/II Study of Golidocitnib in Refractory or Relapsed Peripheral T Cell Lymphoma Selected for Oral Presentation at 2022 EHA Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal to Demonstrate the Strength and Rapid Acceleration of its Clinical Portfolio at ASCO 2022","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Demonstrates Clinical Update for Sunvozertinib (DZD9008) in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 WCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces Positive Phase I Clinical Trial Results for DZD1516 in Treating HER2 Breast Cancer at 2022 ESMO","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces Sunvozertinib Meets Primary Endpoint in its First Pivotal Study in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 ESMO","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Anova Enterprises","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Anova Partners with Dizal (Jiangsu) Pharmaceuticals to Accelerate Development of DZD9008 for Patients with Advanced or Metastatic NSCLC with EGFR Exon20 Insertion Mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dizal Announces China CDE Acceptance of New Drug Application for Golidocitinib for Relapsed or Refractory PTCL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Golidocitinib Granted Priority Review by China NMPA for the Treatment of r\/r PTCL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Dizal Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Dizal Pharmaceutical
DZD9008 (sunvozertinib) was designed as an oral, potent, irreversible, and selective EGFR tyrosine kinase inhibitor. It is being evaluated for the treatment of Exon20ins-mutated locally advanced or metastatic non-small cell lung cancer.
DZD4205 (golidocitinib) is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL.
DZD4205 (golidocitinib) is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL.
The partnership aims to accelerate the development of DZD9008 (sunvozertinib), an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity, for patients with EGFR Exon20ins mutant NSCLC.
DZD9008 (sunvozertinib) is an investigational, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations for the treatment of advanced NSCLC.
DZD1516 was well tolerated at doses ≤ 250 mg, and in consistent with its high selectivity, no wild-type EGFR-related AEs have been reported. Thus, 250 mg was defined as MTD.
DZD9008 (sunvozertinib) also demonstrated a favorable safety profile, Of all 277 patients in the safety set, the most common treatment-related adverse events were diarrhea and rash, the majority of which were Grade 1/2 and clinically manageable.
Updated findings from the studies, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%. In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%.
Sunvozertinib (DZD9008) shows superior efficacy in NSCLC patients harboring EGFR exon 20 insertion mutations after platinum and anti-PD(L)1 treatment failures. It also demonstrates superior efficacy in patients after platinum and anti-PD(L)1 treatment failures.
The clinical data from ongoing phase I/II study of DZD4205/AZD4205 (golidocitnib) shows good safety and promising anti-tumor efficacy in patients with r/r PTCL, providing an exciting potential treatment option for these patients.
Market Place
Upload your Marketing & Sales content on your company Virtual Booth, click HERE
