On 23rd, Hanall Bio Pharma (CEO Kim Seong-uk and CEO Park Seung-guk) has announced that the company has submitted the application for the approval of clinical trial phase 1 test plan of investigational new drug (IND) on new medicine “HL036” of dry eye disease to the Ministry of Food and Drug Safety.
Dry eye disease is a disease from damaged surface of eyeball by excessive evaporation of tear or insufficient formation of tear, and the disease occurs from high osmosis and accumulation of infective material within tear. From aging society, excessive use of computer, and environmental change due to use of air conditioning and heating equipment, the number of dry eye disease patients are increasing.
A new medicine under development by Hanall Bio Pharma for dry eye disease, “HL036” is Bio Better medicine of eye drop for eye wash made of advanced anti-TNF antibody. By restricting the combination with acceptor of TNF to cause various inflammatory diseases, this medicine has outstanding therapeutic mechanism of anti-inflammation.
The anti-TNF antibody is the largest antibody medicine with the market size of 26 trillion KRW over the world, and the representative product is Enbrel Inj for treatment of rheumatoid arthritis. “HL036” is Bio Better with molecular reorganization that has been improved to indicate more stability and vitality and high tissue-distribution rate compare to conventional anti-TNF antibody. This advanced “HL036” may be applied to arthritis, chronic respiratory infection, neurological infection, inflammatory bowel disease, and other severe inflammation besides a dry eye disease.
One of the staffs of Hanall Bio Pharma has clarified, “As a result of pre-clinical trial (animal test), “HL036” has outstanding effects and stability. The clinical trial phase 1 will begin in the second quarter and will be done by the end of this year.
Bio Better is a field to enhance medicinal effect and convenience of conventional original bio medicines through advanced technology, and it takes 47.7% of the protein bio medicine market over the world (20 trillion KRW). While prices of biosimilar products, generic drugs of biomedicines, are about 70% of prices of original products, prices of Bio Better are 2~3 times prices of original products, and thus it is regarded as the prospective field, and Hanall Bio Pharma is very strong in Bio Better.