Alteogen, Early Supply of Samples for Global Phase 3 Clinical Trial

[Asia Economy Reporter Hyungsoo Park] Alteogen, a biobetter development company, announced on the 26th that it has supplied clinical phase 3 samples (IMP III) of its recombinant human hyaluronidase ‘ALT-B4’ upon request from overseas clients.

Alteogen’s ALT-B4 is a platform technology that can convert existing intravenous (IV) formulation drugs into subcutaneous (SC) formulations by adding an extremely small amount. From 2019 to 2021, the company signed license-out agreements with global pharmaceutical companies every year, recognizing its world-class technological competitiveness.

Demand is increasing as commercialization of SC formulation antibody therapeutics progresses. One of the world’s top 10 pharmaceutical companies, a client, is about to complete clinical phase 1. Accordingly, the supply of ALT-B4 for global clinical phase 3 was advanced ahead of the original plan.

An Alteogen official explained, "Early supply of clinical samples signifies the next step toward the first commercialization of SC formulations using ALT-B4," adding, "Interest from potential clients is growing as global clinical trials proceed." He also said, "We expect to lead favorable situations in contracts with companies currently discussing additional technology exports."

SC formulations are emerging as a major trend in the overseas pharmaceutical industry due to their convenience and safety in administration. Unlike competitors who grant exclusive rights by target, Alteogen’s license agreements are concluded by granting non-exclusive rights.

Recently, commercialization of SC formulation antibody therapeutics using competitors’ hyaluronidase is underway. The company explained that interest and demand from pharmaceutical companies competing with these drugs are increasing.

This content was produced with the assistance of AI translation services.