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Biobetter

HL143 (Engineered Interferon alpha-2b)


HanAll has developed a single amino acid variant of native IFN-alpha-2a which is a biobetter product. By utilizing Resistein™ technology, Hanferon™ is protease resistant therefore has longer half-life and improved AUC compared to native IFN-alpha.

Hanferon™ project is partly supported by the Korean government and HanAll has finished the open-label, randomized, safety, tolerability, dose finding, PK/PD, and preliminary efficacy study of subcutaneous (SC) Hanferon™ in combination with ribavirin

(RBV) in treatment-naive subjects with genotype 1 hepatitis C which enrolled 30 patients at sites in the United States. This study actively compared between the two different doses of HanferonTM plus RBV and Pegasys® plus RBV. The primary endpoint was HCV RNA level at Week 4, and the secondary endpoint was the proportion of patients who reached rapid virological response (RVR) at Week 4 (using HCV RNA level). Moreover, HanAll received molecular patents in US and Europe.

Vitatropin™ (oral, human growth hormone)


HanAll is developing orally available human growth hormone (Vitatropin™ / HL032) which would be the first. By using Resistein™ technology, HL032 is protease resistant therefore has significantly higher bioavailability compared to the native human growth hormone after oral administration. After its absorption, Vitatropin™ is less prone to first pass effect, thus its excretion rate is reduced in body. Moreover, due to its protease resistant characteristics, once distributed it will not be degraded easily by the proteases.

Preclinical data have shown that Vitatropin™ had significantly high bioavailability and PD parameters were comparable to the native human growth hormone (i.e. injection) when administered orally in rats and monkeys.

Molecular patent of Vitatropin™ was issued in Korea, US, and Europe. HanAll has received supports from the Korean government with this project and recently completed phase I trial in Korea comparing against Genotropin® to observe bioavailability. Also, molecular patent of Vitatropin™ was issued in Korea and US.