“RZ-001″, an anti-cancer drug developed by Rznomics Inc. (CEO Lee Seong-wook), has been designated by the U.S. Food and Drug Administration as a fast track for the development of treatment for brain cancer (glioblastoma).
Fast Track is a system established by the FDA to actively support new drug developers. It was created to expedite the process of developing treatments for potentially life-threatening or serious diseases.
Once Fast Track designation is obtained and the standards set by the FDA are met, RZ-001 can move quickly through the review process and receive certification, allowing for freer communication with the FDA throughout the process. In addition, Rznomics will have an advantage in obtaining approval because it can undergo a “rolling review” for each of its data areas during the New Drug Application review process.
RZ-001, an anti-cancer drug, is a new drug utilizing Rznomics’ proprietary ribonucleic acid substitution enzyme platform technology. This drug has received Investigational New Drug (IND) approval, a clinical trial plan approval from the Ministry of Food and Drug Safety of the Republic of Korea and the U.S. FDA for the treatment of liver cancer (hepatocellular carcinoma) and brain cancer (glioblastoma).
Lee Seong-wook, CEO of Rznomics, said, “With this approval, RZ-001 has been recognized for its innovation and potential as an anti-cancer drug. We hope to quickly complete clinical trials and provide effective treatment options for patients suffering from refractory cancers.”
Rznomics’ affiliated research center is located in the Pangyo Techno Valley bio-cluster. In October 2023, the Ministry of SMEs and Startups selected it as one of the “50 outstanding achievements in technology development of small and medium-sized enterprises”.
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