InscoBio "ApimezUS, First Korean Company in FDA Phase 3 to Expect US Listing"

Insukobi announced on the 4th that its subsidiary Apimeds' US branch (hereinafter Apimeds US, Apimeds Pharmaceuticals US Inc.) is the first company among domestic bio industry firms conducting Phase 3 clinical trials with the U.S. Food and Drug Administration (FDA) to be imminently listed on the New York Stock Exchange (NYSE).

Apimeds US pursued the listing to secure funding for the Phase 3 clinical trial of 'Apitox,' a candidate drug for multiple sclerosis (MS) treatment, with the U.S. FDA. Last month, the registration statement (S-1) for the listing was converted to public status on the Securities and Exchange Commission (SEC)'s electronic disclosure system Edgar, completing all procedures for approval.

Apitox is Apimeds US's main pipeline, and upon completion of the listing, it plans to enter Phase 3 clinical trials with the FDA. Apitox is already marketed domestically under the name 'Apitoxin' as a treatment for osteoarthritis.

Since early this year, sales have been on the rise, and the business is expanding with a goal of achieving annual sales of 10 billion KRW. Additionally, Apimeds US plans to expand its business into new drugs based on additional natural substances alongside existing bee venom. Preclinical studies for rheumatoid arthritis, lupus, and psoriasis have also been completed, and the company stated that after listing, Phase 3 trials will proceed rapidly, facilitating easy expansion of indications.

Apimeds US is expected to be the first domestic bio company conducting FDA Phase 3 trials to be listed on the NYSE. While the number of domestic bio companies entering FDA clinical trials is increasing, Apimeds US is the first to pursue listing ahead of Phase 3 after completing Phases 1 and 2. Yuhan Corporation’s lung cancer drug 'Leclaza,' SK Biopharm’s epilepsy drug 'Cenobamate,' and Dong-A ST’s subsidiary Neurobo Pharmaceuticals’ obesity drug (semaglutide) are currently undergoing Phase 1 or 2 trials with the U.S. FDA.

An Insukobi representative said, “Apimeds US has completed FDA Phases 1 and 2 for the multiple sclerosis treatment and has been preparing for U.S. listing to secure competitiveness ahead of the final Phase 3. Through the listing, we will strategically and rapidly advance clinical trials to leap forward as a global bio company.”