Dizal announced that sunvozertinib has been approved by thNational Medicical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations, whose disease has progressed on or after platinum-based chemotherapy. Sunvozertinib, with its superior efficacy and safety profile, is the first and only Category-I Innovative Drug in China for the treatment of lung cancer that has been granted breakthrough therapy designations from both the NMPA and the FDA. Sunvozert inib cemented "best-in-class" position due to its superior efficacy and safety profile.

Non-small cell lung cancer (NSCLC) is the most common type of cancer in China, with the highest incidence and mortality rates. EGFR is the most common driver gene mutation in NSCLC, and the EGFR Exon20ins mutation is the most prevalent rare type, accounting for approximately 12% of all EGFR mutations. However, due to its unique spatial configuration and high heterogeneity, there has been a persistent lack of safe and effective targeted treatment options for this mutation.

Consequently, patients with EGFR Exon20ins mutations have experienced limited survival benefits, highlighting the urgent clinical need to address this challenge. The NMPA approval is based on the results from WU-KONG6, the pivotal study of sunvozertinib in platinum-pretreated NSCLC patients with EGFR Exon 20 mutations conducted in China. Topline readouts were presented in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Among 97 patients treated with the recommended phase II dose (RP2D) of 300mg QD: The studydy's primary endpoint, cORR achieved 60.8%, indicating a significant improvement compared to current treatment options. The overall safety is similar to other EGFR TKIs and clinically manage, demonstrating a benign safety profile. About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity.

In August 2023, sunvozertinib received approval from NMPA for the treatment of advanced NSCLC with EGFR Exon20in mutations after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunVozertinib in platinum -based chemotherapy pretreated NSCLC with EGFRExon20ins mutations. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD reached 60.8%.

Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis. The most common drug related TEAEs (treatment emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in = 2nd line (WU-KONG1 PART B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EG FR Exon20ins mutations.

Pre-clinical and Phase I clinical results of sunvozertinIB were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022.