VIVOZON PHARMACEUTICAL CO., LTD Selected as Multi-Year Performer for Global Regulatory Response Cost Support Program

[Financial News] VIVOZON PHARMACEUTICAL CO., LTD, an affiliate of VIVOZON PHARMACEUTICAL CO., LTD., has been selected as a multi-year implementing company for the '2026 Global Regulatory Response Cost Support Project' promoted by the Korea Health Industry Development Institute. Through this project, the company plans to accelerate its response to U.S. Food and Drug Administration (FDA) regulations and preparation for a New Drug Application (NDA) for its non-narcotic analgesic, JOURNAVX.
VIVOZON PHARMACEUTICAL CO., LTD announced on the 11th that, following its selection for this project, it will receive support for costs necessary for official preliminary consultations with overseas regulatory agencies, as well as for the preparation and organization of permit data, and responses to inquiries and supplementary requests from regulatory agencies.
The Global Regulatory Response Cost Support Program was established to assist domestic pharmaceutical and biotech companies with overseas licensing and country-specific regulatory responses, thereby helping them enter global markets and commercialize their businesses.
VIVOZON PHARMACEUTICAL CO., LTD plans to utilize this support to pursue an official meeting with the FDA. The company intends to engage in phased consultations with the FDA to identify key regulatory requirements for late-stage clinical development and NDA submission in the U.S., and incorporate them into its future development and regulatory strategies.
In particular, the plan is to continue preparing for the U.S. confirmatory Phase 3 clinical trial and NDA by integrating clinical and non-clinical data and manufacturing and quality control (CMC) data secured domestically and abroad to meet U.S. approval standards and by reviewing key regulatory issues in advance.
JOURNAVX is a non-narcotic analgesic used for moderate to severe acute pain after surgery. It was approved by the Ministry of Food and Drug Safety in December 2024 as the 38th new drug in Korea. Based on domestic approval and clinical data, as well as clinical development data accumulated in the United States, VIVOZON PHARMACEUTICAL CO., LTD is preparing for late-stage clinical development in the U.S.
"Through the selection for this support program, we are now able to proceed with official communication with U.S. regulatory agencies and preparations for approval more systematically," said a VIVOZON PHARMACEUTICAL CO., LTD official. "We will thoroughly prepare for regulatory issues expected at the FDA meeting to ensure that this leads to Phase 3 clinical trials and an NDA in the U.S."

[email protected] Jeong Sang-hee Reporter