Dizal Submits New Drug Software to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Most cancers with EGFR Exon 20 Insertion Mutations

The submission is supported by information from the pivotal WU-KONG1 Half B examine, which featured in an oral session on the 2024 ASCO Annual Assembly

Sunvozertinib is the world’s first and solely oral drug permitted for NSCLC sufferers with EGFR exon20ins

SHANGHAI, Nov. 8, 2024 /PRNewswire/ — Dizal (SSE (LON:):688192), a biopharmaceutical firm dedicated to growing novel medicines for the remedy of most cancers and immunological ailments, introduced as we speak the submission of a New Drug Software (NDA) to the U.S. Meals and Drug Administration (FDA) in search of approval of sunvozertinib for the remedy of regionally superior or metastatic non-small cell lung most cancers (NSCLC) sufferers with epidermal development issue receptor (EGFR) exon 20 insertion mutations (exon20ins), as detected by an FDA-approved check, whose illness has progressed on or after platinum-based chemotherapy.

Beforehand, sunvozertinib obtained accelerated approval in China, making it the world’s first and solely oral drug for NSCLC sufferers with EGFR exon20ins. It has additionally been granted Breakthrough Remedy Designations (BTDs) by each the U.S. FDA and the China Middle for Drug Analysis (CDE) for treating EGFR exon20ins NSCLC.

The submission is supported by outcomes from the WU-KONG1 Half B examine, a multinational pivotal examine investigating the efficacy and security of sunvozertinib in relapsed or refractory EGFR exon20ins NSCLC sufferers from Asia, Europe, North America, and South America. Sunvozertinib met the first endpoint by demonstrating statistically vital and clinically significant goal response price (ORR), as assessed by an impartial assessment committee (IRC), whereas sustaining a manageable security profile. Knowledge from the examine have been introduced in an oral session on the 2024 American Society of Medical Oncology (ASCO) Annual Assembly.

“We are encouraged by the potential of sunvozertinib as a single oral agent to improve outcomes for patients with EGFR exon20ins NSCLC.” stated Xiaolin Zhang, PhD, CEO of Dizal. “The filing for approval of sunvozertinib marks Dizal’s first NDA submission to the FDA, which represents an important step forward as we continue our efforts to address unmet medical needs globally. We look forward to working closely with the FDA on their review of our application.”

Lung most cancers is the main explanation for most cancers incidence and mortality worldwide. NSCLC accounts for about 80%-85% of all lung cancers. Sufferers with NSCLC harboring EGFR exon20ins are reported to have poorer prognosis than these with different EGFR sensitizing mutations. Sunvozertinib, with its innovatively designed molecular construction, supplies enhanced efficacy, security, and ease of administration.

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About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor found by Dizal scientists concentrating on a large spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib obtained approval from NMPA to deal with superior NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is predicated on the outcomes of WU-KONG6 examine, the pivotal examine of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The first endpoint of the examine was the confirmed general response price (cORR) as assessed by the Unbiased (LON:) Overview Committee (IRC) reached 60.8%. Anti-tumor efficacy was noticed throughout a broad vary of EGFR exon20ins subtypes, and in sufferers with pretreated and secure mind metastasis. As well as, sunvozertinib additionally demonstrated encouraging anti-tumor exercise in NSCLC sufferers with EGFR sensitizing, T790M, and unusual mutations (resembling G719X, L861Q, and many others.), in addition to HER2 exon20ins.

Sunvozertinib confirmed a well-tolerated and manageable security profile within the clinic. The most typical drug-related TEAEs (treatment-emergent hostile occasion) have been Grade 1/2 in nature and clinically manageable.

Two international pivotal research are ongoing in ‰¥ 2nd line (WU-KONG1 Half B) and 1st line setting (WU-KONG28), respectively, in NSCLC sufferers with EGFR exon20ins.

Pre-clinical and scientific outcomes of sunvozertinib have been printed in peer-reviewed journals Most cancers Discovery (NASDAQ:) and The Lancet Respiratory Medication .

About Dizal

Dizal is a biopharmaceutical firm, devoted to the invention, growth and commercialization of differentiated therapeutics for the remedy of most cancers and immunological ailments. The corporate goals to develop first-in-class and groundbreaking new medicines, and additional tackle unmet medical wants worldwide. Deep-rooted in translational science and molecular design, it has established an internationally aggressive portfolio with two main property in international pivotal research, each of which have already been launched in China.

To study extra about Dizal, please go to www.dizalpharma.com, or comply with us on Linkedin or Twitter.

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