earticle

영어

The protein therapeutics are mostly parenteral formulations due to the characteristics of protein with a low stability or fragility. It results the frequent injection of medication to treat the patients for long period. To satisfy the unmet medical need of patients such as reducing the number of injection or changing the route of administration, the new formulations of products are developed such as a long-acting form of product utilizing DDS(Drug Delivery System) technique. The recent achievement of DDS techniques derives the products available to satisfy the unmet medical needs of less frequent injection, emerging as a new technologyf protein therapeutics development by adding a higher value on the patent-off biopharmaceuticals. There are few cases of microparticle formulations used as long-acting or slow releasing protein or peptide therapeutics developed using biodegradable and biocompatible polymers as matrix material. Depending on the action mechanisms of targeted therapeutic proteins, the products are to be designed by control of biodegradation rate with selection of polymers in terms of molecular weight, the ratio of mixing ingredients, and hydrophilic property. The achievable technique of long-acting or slow releasing microparticle formulation for development of protein or peptide therapeutics is limited so far. The desire and expectation for a better hGH(human growth hormone) product has driven a number of pharmaceutical companies to develop SR-hGH (sustained-release hGH) products. LB03002 is the biocompatible hyaluronic acid-based formulation with promising features such as, complete release of hGH, structural integrity/activity of hGH, easy administration with 26 gauge needle, and no significant injection site reaction. Moreover, the clinical data obtained at present demonstrate the bioavailability, efficacy and safety of LB03002 comparable to those of daily injection products. The efficacy and safety of LB03002 administered once-aweek in adults with GHD(growth hormone deficiency) were evaluated in a phase III clinical study, completed recently. The clinical study results will be presented to discuss how well be designed based on its action mechanism.