Dizal Pharmaceutical Announced Successful NDA with Priority Review for Sunvozertinib in China
2023-01-10 18:21

On 10th January 2023, Dizal Pharmaceutical Co., Ltd (SHA:688192), a TIBS invested company, announced the successful submission of New Drug Application (NDA) with priority review for Sunvozertinib (DZD9008) in China for the treatment of advanced non small cell lung cancer (NSCLC) with EGFR exon20ins mutations after platinum-based chemotherapies. Its NDA submission in USA is expected within 2023.

Sunvozertinib is the first NDA submission for Dizal, and the ONLY innovative drug in the lung cancer field that has been granted “Breakthrough Therapy Designation” by both the U.S. FDA and China NMPA. The clinical data indicated that Sunvozertinib is a best-in-class drug with superior efficacy and safety profile. It will provide a much-needed treatment option for lung cancer patients globally.

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 the two leading drug candidates in global pivotal studies. Dizal (SHA:688192) was listed in the Shanghai Stock Exchange STAR Market in December 2021. TIBS invested in Dizal in July 2020.

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