Drugs / Sunvozertinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | China (NMPA) | ZEGFROVY | non-small cell lung carcinoma | 2026-05-29 | “the New Drug Application (NDA) for ZEGFROVY as a first-line treatment for EGFR exon20ins NSCLC has been accepted” dizalpharma.com ↗ |
| Filed | US (FDA) | — | non-small cell lung carcinoma | 2024-11-08 | “announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” dizalpharma.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | ZEGFROVY | — | 2025-07-02 | fda.gov ↗ |
| Filed | China (NMPA) | — | advanced non-small cell lung cancer with EGFR exon20ins mutations after platinum-based chemotherapy | 2023-01-10 | “The China NMPA has accepted new drug application (NDA) and granted priority review for sunvozertinib” dizalpharma.com ↗ “The NMPA has accepted new drug application (NDA) and granted priority review for sunvozertinib” dizalpharma.com ↗ “has accepted the New Drug Application (NDA) for sunvozertinib” dizalpharma.com ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06905197 | May 2025 → Sep 2027 expected | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06084104 | Oct 2023 → Jun 2024 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05926180 | Jul 2023 → May 2024 | non-small cell lung carcinoma | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05418582 | Jan → Jun 2022 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05159895 | Sep 2021 → Mar 2022 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04909242 | Apr 2021 → Feb 2022 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/24 trials · 1 met primary | ||||||
| Phase 1/2 | NCT07079475 | Jul 2025 → Jun 2028 expected | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06195189 | Feb 2024 → Dec 2027 expected | non-small cell lung carcinoma | Sichuan University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04148742 | Aug 2021 → Jul 2023 | B-cell non-Hodgkin lymphoma | Dizal Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03974022 | Jul 2019 → Jul 2024 overdue | non-small cell lung carcinoma | Dizal Pharmaceuticals | Active not recruiting | Met primary |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT06864624 | Feb 2025 → Dec 2026 expected | non-small cell lung carcinoma | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07117890 | Feb 2025 → Feb 2027 expected | non-small cell lung carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07274761 | Oct 2024 → May 2030 expected | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06348927 | Jul 2024 → Oct 2025 overdue | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06355609 | Jul 2024 → Dec 2025 overdue | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06182761 | Jan 2024 → Jan 2026 overdue | non-small cell lung carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06295432 | Jun 2023 → Dec 2026 expected | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06276283 | Feb 2023 → Dec 2025 overdue | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05712902 | Jul 2021 → Oct 2022 overdue | non-small cell lung carcinoma | Dizal Pharmaceuticals | Active not recruiting | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT07182682 | Dec 2025 → Sep 2029 expected | non-small cell lung carcinoma | Dizal Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05668988 | Dec 2022 → Jan 2026 overdue | non-small cell lung carcinoma | Dizal Pharmaceuticals | Active not recruiting | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT05559645 | Nov 2021 → Dec 2026 expected | non-small cell lung carcinoma | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 34
| Date | Issuer | Release |
|---|---|---|
| 2026-08-21 | Dizal Pharmaceuticals | Results Dizal to Present Emerging Data on ZEGFROVY® in Non-Small Cell Lung Cancer at WCLC 2026 dizalpharma.com ↗
Promising efficacy results strengthen its potential as an earlier treatment option. |
| 2026-05-29 | Dizal Pharmaceuticals | Results Dizal Announces Phase 3 WU-KONG28 Results: ZEGFROVY® (Sunvozertinib) Outperforms Platinum-Doublet Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer dizalpharma.com ↗
ZEGFROVY, administered at 300 mg once daily, demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS), the primary endpoint of the study, as assessed by blinded independent central review (BICR). |
| 2026-05-27 | Dizal Pharmaceuticals | Regulatory Dizal’s ZEGFROVY® (Sunvozertinib) New Drug Application Accepted and Granted Priority Review by China National Medical Products Administration for First-Line Treatment of EGFR Exon 20 Insertion-Mutated Non-Small Cell Lung Cancer dizalpharma.com ↗ |
| 2026-03-27 | Dizal Pharmaceuticals | Results Dizal’s ZEGFROVY® (Sunvozertinib) Shows Profound Antitumor Activity as First-Line Treatment in Advanced NSCLC Patients with PACC or Other Uncommon Mutations at ELCC 2026 dizalpharma.com ↗
Per investigator assessment, tumor lesion shrinkage was observed in 100% of patients, with an overall response rate (ORR) of 81.3%, and a disease control rate (DCR) of 100%. |
| 2026-03-21 | Dizal Pharmaceuticals | Results Dizal Announces Positive Topline Phase 3 Results from WU-KONG28 Study: Evaluating Oral, Once-Daily ZEGFROVY® (Sunvozertinib) vs. Platinum-Containing Chemo Doublet in First-Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation (exon20ins) dizalpharma.com ↗
Topline results demonstrated that ZEGFROVY significantly improved PFS compared to platinum-based doublet chemotherapy, with meaningful clinical benefit. |
| 2025-09-09 | Dizal Pharmaceuticals | Results Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC dizalpharma.com ↗
ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. |
| 2025-07-03 | Dizal Pharmaceuticals | Regulatory 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 dizalpharma.com ↗
This indication is approved under Accelerated Approval based on overall response rate and duration of response. |
| 2025-03-20 | Dizal Pharmaceuticals | Results Dizal’s Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer dizalpharma.com ↗
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. |
| 2025-01-07 | Dizal Pharmaceuticals | Regulatory U.S. FDA Granted Priority Review to Dizal’s Sunvozertinib New Drug Application dizalpharma.com ↗ |
| 2024-12-11 | Dizal Pharmaceuticals | Results Dizal Announces Positive Pooled Data of Sunvozertinib in EGFR Tyrosine Kinase Inhibitor-Resistant Non-Small Cell Lung Cancer Published in Lung Cancer dizalpharma.com ↗
The results of the analysis demonstrated that sunvozertinib exhibited promising antitumor activity and favorable safety profile, warranting future investigations into its potential in patients with EGFR mutated NSCLC who have developed resistance to EGFR TKIs. |
| 2024-11-08 | Dizal Pharmaceuticals | Regulatory 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 dizalpharma.com ↗ |
| 2024-10-13 | Dizal Pharmaceuticals | Regulatory 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 dizalpharma.com ↗
This designation is the fourth BTD that Dizal has received for sunvozertinib in EGFR exon20ins NSCLC. |
| 2024-10-11 | Dizal Pharmaceuticals | Regulatory NMPA Grants Marketing Approval to the First Co-Developed NGS-Based Companion Diagnostic for Lung Cancer in China dizalpharma.com ↗
the companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) for sunvozertinib, developed through their collaboration, has been approved by the National Medical Products Administration (NMPA) of China. |
| 2024-09-17 | Dizal Pharmaceuticals | Results 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 dizalpharma.com ↗
Per independent review committee (IRC) assessment, target lesions shrinkage was observed in 92.4% (98/106) of patients. |
| 2024-06-02 | Dizal Pharmaceuticals | Results Sunvozertinib’s Global Pivotal WU-KONG1B Study Meets Primary Endpoint in Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations dizalpharma.com ↗
The study demonstrated statistically significant outcomes on the primary endpoint for sunvozertinib and highlighted its significant clinical value to patients around the globe. |
| 2024-05-24 | Dizal Pharmaceuticals | Results 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 dizalpharma.com ↗
Decrease of EGFR exon20ins mutant allele was observed in 85.7% of patients with sunvozertinib treatment. |
| 2024-04-07 | Dizal Pharmaceuticals | Regulatory 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 dizalpharma.com ↗
This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1). |
| 2023-12-13 | Dizal Pharmaceuticals | Results Dizal’s Sunvozertinib Pivotal Study Results Published in The Lancet Respiratory Medicine dizalpharma.com ↗
The study’s primary endpoint, the independent review committee (IRC) -assessed ORR reached 61%, indicating a significant improvement over existing treatment options. |
| 2023-10-23 | Dizal Pharmaceuticals | Results Sunvozertinib Demonstrates Best-in-Class Potential as a First-Line Treatment for EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer Patients dizalpharma.com ↗
The confirmed objective response rate (cORR) by investigator assessment reached an impressive 78.6%. |
| 2023-08-23 | Dizal Pharmaceuticals | Regulatory Dizal's Sunvozertinib Approved by China NMPA with Potential for Best-in-class Therapy in NSCLC with EGFR Exon20ins Mutations dizalpharma.com ↗
In August 2023, sunvozertinib received approval from NMPA for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies. |
| 2023-08-17 | Dizal Pharmaceuticals | Results 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 dizalpharma.com ↗
The objective response rates (ORRs) in subjects with EGFR Exon20ins mutations in tumor tissue and plasma ctDNA were 59.8% and 63.0% respectively, which were comparable to the ORR of 60.8% in the whole efficacy population. |
| 2023-06-07 | Dizal Pharmaceuticals | Results Dizal Leads China’s Biotech Innovation by Showcasing Strength of its Oncology Pipeline dizalpharma.com ↗
With longer follow-up, patients treated with sunvozertinib achieved a confirmed objective response rate (cORR) of 60.8% assessed by independent review committee (IRC). |
| 2023-05-26 | Dizal Pharmaceuticals | Results Dizal’s Oncology Pipeline Continues to Impress with Two Oral Presentations at 2023 Oncology Meeting In Chicago dizalpharma.com ↗
Patients treated with sunvozertinib (n = 97) achieved a confirmed objective response rate (cORR) of 60.8% assessed by independent review committee (IRC). |
| 2023-01-17 | Dizal Pharmaceuticals | Regulatory Sunvozertinib Granted Priority Review by China NMPA for the Treatment of EGFR Exon20ins Mutation Positive Lung Cancer dizalpharma.com ↗
The Priority Review designation for this application was supported by clinical results from the WU-KONG6 study, a multicenter, single-arm, Phase II pivotal study conducted in China to evaluate the efficacy and safety of sunvozertinib in platinum-pretreated NSCLC patients with EGFR exon20ins mutations. |
| 2023-01-10 | Dizal Pharmaceuticals | Regulatory Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations dizalpharma.com ↗
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 sunvozertinib for the treatment of advanced NSCLC with EGFR exon20ins mutations after platinum-based chemotherapies. |
| 2023-01-10 | Dizal Pharmaceuticals | Regulatory Dizal Announces China CDE Approval of IND application for Phase 2 Study of Sunvozertinib in Combination with Golidocitinib for Non-Small Cell Lung Cancer dizalpharma.com ↗ |
| 2022-11-02 | Dizal Pharmaceuticals | Results Dizal to Present Latest Scientific Advancements across its Fast-growing Innovative Pipeline at 2022 CSCO dizalpharma.com ↗
Confirmed ORR per BICR 59.8% (58/97) |
| 2022-09-05 | Dizal Pharmaceuticals | Results Dizal Announces Sunvozertinib Meets Primary Endpoint in its First Pivotal Study in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 ESMO dizalpharma.com ↗
Dizal today announced positive topline results from the first pivotal study of sunvozertinib (DZD9008) in platinum-pretreated NSCLC Patients with EGFR exon20ins mutations at the European Society for Medical Oncology (ESMO) Annual Meeting. |
| 2022-08-05 | Dizal Pharmaceuticals | Results Dizal Demonstrates Clinical Update for Sunvozertinib (DZD9008) in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 WCLC dizalpharma.com ↗
As of April 30, 2022, 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%. |
| 2022-05-27 | Dizal Pharmaceuticals | Results Dizal to Demonstrate the Strength and Rapid Acceleration of its Clinical Portfolio at ASCO 2022 dizalpharma.com ↗
Results from the Phase 1/2 trial of sunvozertinib, which is evaluating the efficacy and safety of sunvozertinib in previously treated NSCLC patients with EGFR Ex20ins, showed sunvozertinib yielded a best ORR of 48.4% and DCR of 90.3%. |
| 2022-05-05 | Dizal Pharmaceuticals | Results Dizal Announces Pre-clinical and Clinical Results of Sunvozertinib (DZD9008) Published in Cancer Discovery dizalpharma.com ↗
Antitumor efficacy was observed at the doses of 100 mg and above in patients with EGFR exon20ins NSCLC across different subtypes, with prior amivantamab treatment as well as with baseline brain metastasis. |
| 2022-01-28 | Dizal Pharmaceuticals | Regulatory 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 dizalpharma.com ↗
Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. |
| 2019-04-28 | Dizal Pharmaceuticals | Regulatory Dizal Announces NMPA Acceptance of IND Application for DZD9008 dizalpharma.com ↗
China National Medical Products Administration (NMPA) accepted IND application for DZD9008. |
| 2019-04-09 | Dizal Pharmaceuticals | Regulatory Dizal Announces Successful Completion of IND Filing with US FDA for DZD9008 dizalpharma.com ↗
US FDA completed the review of DZD9008 IND (Investigational New Drug) application and concluded that Dizal may proceed with their proposed clinical investigation. |
All press releases naming this drug 37 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sunvozertinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07079475 ↗ |
| Known as | 122507 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314564 ↗ |
| Known as | A-1801 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314564 ↗ |
| Known as | ASYM-122507 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314564 ↗ |
| Known as | DZ'0586 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314564 ↗ |
| Known as | DZ00000586 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314564 ↗ |
| Known as | DZD9008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05926180 ↗ |
| Action | Inhibit | “Oral EGFR Inhibitor, Sunvozertinib” NCT03974022 ↗ |
| Modality | Small molecule | — CHEMBL5314564 ↗ |
| Route | Oral | “Assessing an Oral EGFR Inhibitor, Sunvozertinib” NCT03974022 ↗ |
| Target | EGFR | “Oral EGFR Inhibitor, Sunvozertinib” NCT03974022 ↗ |