[E-Daily Reporter Shin Ha-yeon ] GENEMATRIX INC.(109820)announced on the 14th that it has been selected for the “Support Program for Self-Sufficiency in Essential Vaccinations,” led by the Ministry of Health and Welfare’s Vaccine Commercialization Technology Development Project Team, and has signed a support agreement. The total project cost for the hepatitis A vaccine clinical trial under this agreement is 3.112 billion won.

This project supports the clinical development of domestically produced vaccine candidates to establish a stable supply chain for essential preventive vaccines. Although the hepatitis A vaccine has been included in the National Immunization Program (NIP) since 2015, the country currently imports all of its vaccine bulk and finished products, resulting in a high level of dependence on foreign sources.

Based on this funding, GENEMATRIX INC. will begin full-scale clinical development of “GMAI-02,” a next-generation hepatitis A vaccine it is developing in-house.

The company has compiled data on the immunogenicity and efficacy of GMAI-02, as well as preclinical safety data, and received approval for its Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety in the first half of last year.

It has now finalized the clinical trial site and plans to begin the Phase 1 trial in the second half of this year. The company plans to evaluate safety and immune responses during Phase 1 and, based on the results, seek approval for a Phase 2 Investigational New Drug (IND) application.

Through the development of GMAI-02, GENEMATRIX INC. aims to localize the production of the hepatitis A vaccine, for which Korea currently relies on imports. The company plans to secure a domestic supply base through subsequent clinical trials while also exploring opportunities to enter the global market.

Kim Soo-ok, CEO of GENEMATRIX INC., stated, “Securing the necessary funding for clinical trials through this support agreement with the Ministry of Health and Welfare is highly significant, as it lays the groundwork for more stable clinical development moving forward.” She added, “This marks an important milestone, as GMAI-02 has moved beyond the research and development phase and entered full-scale clinical development.”

She added, “We will thoroughly evaluate safety and immune responses through the Phase 1 clinical trial and proceed with subsequent trials without delay to develop a vaccine that is competitive in the global market.”