Zencurix Applies for Liquid Biopsy Liver Cancer Early Diagnosis IND... "Targeting 30 Trillion Won Market"

[Asia Economy Reporter Hyunseok Yoo] GenCurix announced on the 6th that it has completed the submission of the Investigational New Drug (IND) application for the clinical trial to obtain approval from the Ministry of Food and Drug Safety for HEPA eDX, a liquid biopsy early diagnosis test for liver cancer developed in-house.

This product diagnoses liver cancer at an early stage by examining the methylation of biomarkers using a small amount of blood. It is expected to be used not only for early diagnosis but also for recurrence monitoring.

The company stated, “The approval clinical trial for HEPA eDX will be conducted at multiple centers,” adding, “As this is a pioneering technology with no products yet successfully commercialized overseas, we have discussed clinical research methods for a long time with the top domestic experts to accurately prove its performance.”

In particular, this clinical trial will be led by Professor Wang Hee-jung of Inje University Haeundae Paik Hospital as the principal investigator. Professor Wang is a leading authority in liver transplantation and hepatobiliary surgery, having served as president of the Korean Liver Cancer Association, the Korean Association of Hepato-Biliary-Pancreatic Surgery, and the Korean Surgical Society.

Moon Young-ho, Vice President of Research and Development, said, “Starting with the liver cancer early diagnosis market, which is expected to grow beyond 30 trillion KRW, we will dominate the early diagnosis market with liquid biopsy products for various cancer types,” and added, “We will do our best to ensure the success of this clinical trial and rapidly commercialize the product.”

Since February, GenCurix has been conducting research to validate HEPA eDX in collaboration with the Ajou University Hospital Innovative Medical Device Demonstration Support Center. Through this demonstration support project, the product format for approval by the Ministry of Food and Drug Safety was finalized, and clinical and analytical performance verification was carried out.