Sunvozertinib Tablets Approved in China for NSCLC by China NMPA

Aug, 2023. China NMPA approved the Category 1 innovative drug Sunvozertinib Tablets (Chinese trade name:SHUWUZHE) of Dizal (Jiangsu) Pharmaceutical Co., Ltd for use in adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed on or following platinum-based chemotherapy.

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 mutation have experienced limited survival benefits, highlighting the urgent clinical need to address this challenge.


Sunvozertinib is an EGFR tyrosine kinase inhibitor. The marketing of this drug provides a new treatment option for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR 20 exon insertion mutations.

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. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. 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 EGFR 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.

About Dizal

Dizal is a 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 and one already approved.

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