Green Cross Co. has invested up to 10 percent of its annual turnover in research and development (R&D). This year, the company is planning to increase R&D spending by more than 30 percent from last year.
By treatment, Green Cross is currently focusing on developing vaccines, recombinant proteins, plasma-derived proteins and monoclonal antibodies. By disease, Green Cross is concentrating its R&D resources on infectious diseases, cancer and rare incurable diseases.
For intravenous administrative therapies, Green Cross applied to the United States Food and Drug Administration (FDA) for a Biologics License Application (BLA) for human normal immunoglobulin G for intravenous administration (IVIG-SN) in January this year. IVIG-SN is intended for the treatment of primary immunodeficiency diseases (PID), a class of inherited genetic disorders that cause a deficient or absent immune system. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete the review is scheduled for the fourth quarter of 2016. IVIG-SN has demonstrated positive results in a Phase III study in patients with PID.
After developing Hunterase in 2012 for Hunter Syndrome, for which only one treatment option was available in the past, Green Cross is quickly emerging as a potent player in the international market for Hunter Syndrome drugs. Hunter Syndrome is a rare disorder that primarily affects males. It interferes with the body’s ability to break down and recycle specific mucopolyssacaridoses. Its symptoms include developmental delays, skeletal deformities, airway obstruction and eventually death before reaching the age of 20. A company spokesperson said Green Cross Corp. will step up its efforts to increase its global market share for the drug to 50 percent, as Hunterase is competitive in both efficacy and price.
Moreover, Green Cross has developed an antibody, GC1102, which is intended to neutralize the hepatitis B virus. GC 1102 has undergone Phase 2 clinical trials with liver transplant patients for the first time in the world, and has started Phase 1 clinical trial with chronic hepatitis B patients.
Currently, Phase 1 clinical trial for GC1118, an antibody that targets colorectal cancer, is underway. Featuring a different mechanism from existing therapeutics, GC118 is intended to block a broad spectrum of epidermal growth factor receptors' (EGFR) activation and binding, which results in cancer. Moreover, non-clinical trials for next-generation hemophilia therapies and a variety of innovative biopharmaceuticals are underway.
Green Cross is actively engaged in a variety of studies for developing influenza vaccines. The company’s getting the sales approval for an H5N1 avian influenza vaccine from the Ministry of Food and Drug Safety in Korea in December 2015 represents the fruits of decades of development of vaccine manufacturing expertise and R&D prowess. H5N1 is the first development of its kind in Korea by a domestic manufacturer and the second avian influenza vaccine that has been granted approval in Korea following a flu vaccine (H1N1) which had obtained the marketing approval in 2009. H5N1 is expected to better prepare the nation for a highly pathogenic avian influenza-caused pandemic.
Green Cross is also engaged in developing a variety of formulations and packaging methods like multi-dose and single vials and prefilled syringe cartridges to better serve patient needs.