On 23 August 2023, Dizal Pharmaceutical Co., Ltd (SHA: 688192), a TIBS-invested company, announced that Sunvozertinib has been approved by the National Medical 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.
The NMPA approval is based on the results from the pivotal study of Sunvozertinib in platinum-pretreated NSCLC patients with EGFR Exon20ins mutations conducted in China. In pre-treated advanced NSCLC patients with EGFR Exon20ins mutations, monotherapy with Sunvozertinib achieved a remarkable ORR (objective response rate) of 60.8%, indicating a significant improvement compared to current treatment options. The overall safety is similar to other EGFR TKIs and clinically manageable, demonstrating a benign safety profile.
Dizal is thrilled to bring Sunvozertinib, the potentially best-in-class targeted therapy, to patients in China. Furthermore, the commercial launch of Sunvozertinib represents a significant milestone for Dizal, underscoring the company’s capabilities from research and development to commercialization. The company will accelerate their efforts to achieve profitability and ensure the rapid accessibility of Dizal's innovative therapies to patients in China and worldwide.
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. Dizal was IPO listed on the Shanghai Stock Exchange STAR Market in December 2021 and TIBS invested in Dizal in July 2020.
More details, please find at http://www.dizalpharma.com/news/
