Dizal Announces China CDE Acceptance of New Drug Application for Sunvozertinib for Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations

2023-01-10

临床2期申请上市临床结果突破性疗法优先审批

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 mutations after platinum-based chemotherapies.

Sunvozertinib (DZD9008) is an investigational, best-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon20 insertion (exon20ins) mutations. Sunvozertinib has been granted Breakthrough Therapy Designation by both the US FDA and China CDE.

"This is our first NDA submission, a significant milestone for Dizal. All available data indicates that sunvozertinib is a best-in-class drug with superior efficacy and safety profile. It will provide a much-needed treatment option for Chinese patients. We are doing everything we can to accelerate our global clinical development programs to make it available to cancer patients outside of China as soon as possible." said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal. "At Dizal, we are committed to discovering and developing innovative medicines for the benefit of cancer patients globally."

The NDA submission for sunvozertinib is based on data 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. The primary objective of the study was Objective Response Rate according to RECIST v1.1, with Duration of Response (DOR) as the key secondary objective. As of July 31, 2022, the confirmed objective response (cORR), as assessed by blinded independent central review (BICR), was 59.8% . The objective response rate for patients with baseline brain metastasis was 48.4%. Sunvozertinib showed superior safety profile. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable. Global pivotal studies of sunvozertinib in patients with advanced NSCLC with EGFR exon20ins in the 1st line and ≥ 2nd line setting are ongoing.

About Dizal

Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies.

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Dizal Pharmaceutical Co.