InJennie Therapeutics (Reg.S) (hereinafter InJennie)'s flagship drug pipeline, 'IGT-427' (MK-8748), has entered four large-scale Phase 3 clinical trials. As recent studies of competing drugs with the same mechanism for ophthalmic diseases have been halted, global market interest is expected to grow further. Analysts note that it is being treated as a core pipeline asset, with U.S.-based research and development partner Merck (MSD) set to invest approximately 1 trillion won in Phase 3 studies.
According to industry sources on the 21st, MSD began two Phase 3 clinical trials for MK-8748 in neovascular age-related macular degeneration (NVAMD) in the first half of this year and has recently effectively entered two Phase 3 trials for diabetic macular edema (DME). This structure involves conducting a total of four Phase 3 clinical trials simultaneously with MK-8748.
MK-8748 is a bispecific antibody that activates the vascular endothelial cell receptor 'TIE2' while simultaneously inhibiting vascular endothelial growth factor (VEGF). In October 2022, InJennie licensed out MK-8748 (then known as IGT-427) at the preclinical stage to EyeBio, a U.K.-based biotechnology company specializing in eye diseases. The total contract value of this technology transfer exceeds 1 trillion won. In July 2024, global big pharma MSD acquired EyeBio. MSD is leading clinical trials under the name MK-8748.
MK-8748 is a retinal disease drug candidate with a mechanism that directly activates TIE2, and it is drawing global market attention by entering four large-scale Phase 3 clinical trials simultaneously. Among retinal disease drug candidates with the same mechanism, Roche's 'RG6351' was known to have halted development in July after progressing through Phase 2. Another competing drug with the same mechanism is Astellas' 'ASP4021,' which is understood to have effectively ceased development. Consequently, MK-8748 is now the only retinal disease drug pipeline that has entered large-scale Phase 3 clinical trials via direct TIE2 activation.
In particular, MSD tends to employ a strategy of concentrating resources on large-scale late-stage trials when it has confidence in early clinical data. The fact that MSD is investing approximately 1 trillion won in four Phase 3 trials for MK-8748 can be interpreted as indicating that the company sees a high probability of success.
Praise for MK-8748 continues among domestic securities firms. Lee Ho-cheol and Lim Jae-hyun, researchers at Shinhan Investment Corp, stated, "MSD has set an aggressive target of over 5 billion dollars (approximately 691.85 billion won) in annual ophthalmology revenue by the mid-2030s with just MK-8748 and MK-3000, continuing its aggressive investment," and valued the new drug potential of MK-8748 at approximately 115.65 billion won. They forecast that MSD will complete Phase 3 trials for wet age-related macular degeneration and diabetic macular edema in parallel by 2028 and file for U.S. approval in 2029.
Following IGT-427, InJennie is preparing for global research and commercialization of its subsequent pipeline. The kidney disease treatment 'IGT-303' began Phase 1/2a clinical trials in Australia last November after completing preclinical studies. The company plans to pursue a technology transfer next year. The triple antibody anticancer drug 'IGT-532,' which targets both the immune system and tumor blood vessels, is currently at the preclinical stage.
An official from InJennie said, "Given that InJennie's drug candidate has entered four large-scale global Phase 3 trials led by MSD, we believe InJennie's technological competitiveness has been proven." The official added, "We will secure meaningful data for IGT-303, which is currently undergoing a self-conducted Phase 2a trial in South Korea, Australia, and New Zealand, to accelerate technology transfer negotiations with global big pharma next year." The official further stated, "We will also accelerate the research and development of subsequent pipelines for cardiovascular diseases and solid tumors to establish a unique position in the global market."
in THEBIO
