LG Chem Expands Clinical Data for Polio Vaccine "Eupolio"

Strengthening Its Position as a Leading Company in the Global Polio Vaccine Market

LG Chem announced on the 17th that, as a result of the Phase 3b (additional clinical trial) of its independently developed polio vaccine Eupolio, it has confirmed long-term safety, sustained immunogenicity, boosting effects, and the appropriateness of cross-administration with live vaccines.

Since 2021, LG Chem has been supplying Eupolio to more than 50 countries through UNICEF, which is the largest global vaccine procurement market. Eupolio holds a market share of approximately 35% in the UNICEF procurement market, with cumulative sales reaching 300 billion KRW.

LG Chem conducted this additional clinical trial after product commercialization in order to secure a broader range of advantages for Eupolio in the increasingly competitive procurement market, aiming to become an irreplaceable supplier.

To this end, LG Chem began the Phase 3b trial in earnest by registering the first participant in January 2023, evaluating long-term safety and efficacy in about 2,000 participants at 11 institutions in the Philippines and Thailand.

According to the primary endpoint of this clinical trial, which was the long-term (6 months) safety evaluation, most adverse events following immunization (AEFI) observed after vaccination were mild to moderate, and no serious adverse drug reactions (SADR) related to the drug were reported.

LG Chem assessed the initial (4 weeks after the basic three-dose regimen) immune response as an efficacy indicator, confirming that both the seroprotection rate and the neutralizing antibody conversion rate, which are representative indicators of the degree of virus infection prevention, were above 98%.

In the long-term (one year after the basic three-dose regimen) immune response evaluation, effective immunogenicity was found to be sustained. In the evaluation of the boosting effect following an additional (fourth) dose at the one-year mark, both the seroprotection rate and the neutralizing antibody conversion rate reached 100%, providing evidence for the usefulness of a fourth dose.

In addition, to analyze the appropriateness of cross-administration between the oral polio vaccine (OPV) and Eupolio, Eupolio was administered following the oral vaccine, resulting in both the seroprotection rate and the neutralizing antibody conversion rate reaching 100%. Countries that receive vaccines through UNICEF and similar channels adopt a cross-administration approach using both oral live vaccines and injectable inactivated vaccines. Through this clinical trial, LG Chem has now obtained data optimized for such market environments.

Kim Sungho, Head of Specialty Care Business Division at LG Chem, stated, "We will actively pursue the expansion of our vaccine business to new regions so that more infants and young children worldwide can receive high-quality vaccines," adding, "We will faithfully fulfill our social responsibilities as a pharmaceutical company by achieving timely localization of essential basic vaccines such as the hexavalent combination vaccine and by continuously developing new vaccines."