HLB Pharmaceutical Receives Domestic Phase 1 Approval for Long-Acting Thrombosis Injection

Oral Treatment 'Eliquis' Formulation Change
Enhancing Convenience and Reducing Side Effects

[Asia Economy Reporter Chunhee Lee] HLB Pharmaceutical announced on the 3rd that it has received approval from the Ministry of Food and Drug Safety for the domestic Phase 1 clinical trial plan (IND) to develop the oral thrombosis treatment drug 'Eliquis (active ingredient Apixaban)' as a long-acting injectable formulation (HLBP-024).

'HLBP-024' is a therapeutic agent developed based on HLB Pharmaceutical's long-acting injectable platform 'SMEBR'. HLB Pharmaceutical previously succeeded in transferring the long-acting injectable technology for obesity treatment to Humedix based on SMEBR. With this IND approval, the company plans to develop various pipelines applying uniform microparticle manufacturing technology in the future.

This clinical trial is the first domestic trial applying HLB Pharmaceutical's SMEBR technology. HLB Pharmaceutical plans to conduct a clinical study comparing the safety, tolerability, and pharmacokinetic characteristics by administering HLBP-024 and Eliquis respectively to healthy subjects. Through this trial, they aim to verify the blood coagulation inhibition effect and safety of HLBP-024.

BMS's oral thrombosis treatment 'Eliquis (active ingredient Apixaban)' (Photo by Korea BMS)

Eliquis, developed by Bristol-Myers Squibb (BMS), is a blockbuster drug with global sales reaching 20 trillion KRW in 2021. However, it requires twice-daily dosing, which is inconvenient, and there have been unmet needs for long-acting injectables due to side effects such as gastrointestinal bleeding and thrombosis issues caused by short-term discontinuation. HLBP-024 is being developed as an injectable formulation that can maintain efficacy for several weeks with a single administration, potentially improving these inconveniences and risks of side effects.

Lee Sang-hwi, head of research at HLB Pharmaceutical, said, "HLBP-024 is not a long-acting injectable that merely imitates overseas products but is directly developed by HLB Pharmaceutical, holding original patents. It holds great significance across the domestic pharmaceutical industry, and we will do our best to commercialize it."

HLB Pharmaceutical plans to expand global clinical trials based on the domestic clinical trial results of HLBP-024. Additionally, they intend to continue expanding their pipeline targeting various intractable diseases such as obesity, diabetes, and dementia using the long-acting injectable platform.