The State Food and Drug Administration accepted the marketing application of Ditze Pharma suvortinib

January 10, 2023 – Ditze Pharma (688192. SH) announced that its new drug application for suvortinib tablets (DZD9008), an innovative drug in the field of lung cancer, has been accepted by the National Medical Products Administration and included in the proposed priority review for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received platinum-based chemotherapy and carry an EGFR exon 20 transposition (EGFR exon20ins) mutation.

Suvortinib is an orally available, highly selective tyrosine kinase inhibitor (TKI) for multiple EGFR mutant subtypes, which is the first and only national innovative drug in the field of lung cancer that has been recognized as a breakthrough therapy by China and the United States, and the first Chinese original innovative drug for EGFR exon20ins mutant advanced NSCLC that has been accepted for marketing.

The application is based on the first Chinese registered clinical study of suvortinib (Wukong 6, WU-KONG6), the results of which were announced at the 2022 European Society for Medical Oncology (ESMO) Congress: as of July 31, 2022, the tumor response rate (cORR) confirmed by the Evaluation Committee of Blinded Independent Centers (BICR) was 59.8%, and the cORR was 48.4% for patients with EGFR exon20ins mutation with stable and asymptomatic brain metastases at baseline. Demonstrated best-in-class efficacy worldwide with an overall good safety profile.

Lung cancer is the second largest malignant tumor in the world, non-small cell lung cancer accounts for about 85%, and the most common mutation is EGFR mutation. EGFR exon20ins mutation is a refractory subtype of EGFR mutation, and the objective response rate (ORR) of traditional EGFR-TKI, immunotherapy and chemotherapy for EGFR exon20ins mutant advanced NSCLC is less than 20%1. Last year a new drug conditionally marketed in the United States, the ORR was 28-40% 2-3.

Suvortinib is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) against multiple EGFR mutant subtypes, which was recognized as a breakthrough therapy (BTD) in China and the United States in 2020 and 2022 respectively with excellent efficacy and safety, becoming the first and only class I new drug in the field of lung cancer to obtain dual BTD in China and the United States, and is now in the global registration clinical stage. The preferred indication of suvortinib is for the treatment of EGFR exon 20 insertion mutation non-small cell lung cancer, which is undergoing registered clinical trials in China, the United States, Europe, South Korea, Australia and other countries and regions, and the primary endpoint is the objective response rate (ORR) assessed by the Blinded Independent Center Evaluation Committee (BICR) according to RECIST 1.1. As of July 31, 2022, data from registered clinical trials in China showed that suvortinib in the treatment of EGFR exon 20 exon insertion mutant (EGFR exon20ins) advanced non-small cell lung cancer (NSCLC) that had failed previous platinum-containing chemotherapy had an ORR of 59.8% at the recommended dose of phase II (RP2D) of 300 mg; The ORR for patients with brain metastases at baseline was 48.4%. In addition, initial efficacy has been observed with suvortinib in patients with EGFR-sensitive mutations, T790M mutations, and HER2 exon 20 insertion mutations in non-small cell lung cancer. The translational scientific research results of suvortinib were listed in the top international journal Cancer Discovery in April 2022 (impact factor: 39.397).