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GX-G6 for Type 2 Diabetes, Receives Phase I IND Approval in Europe
Genexine Inc. (KOSDAQ: 095700), a clinical stage biotechnology company developing innovative biologics focused on immuno-oncology and metabolic diseases, today announced that GX-G6, long-acting glucagon-like peptide-1 (GLP-1), received Phase I IND approval from The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Germany.
GX-G6 is long-acting GLP-1 based on Genexine’s proprietary hyFc Platform technology for type 2 diabetes (T2D) targeting both weekly and twice-monthly regimen compared to conventional daily therapeutics. Phase I clinical trial is scheduled to begin in the first half of 2017 with plans to enroll up to 48 healthy volunteers in Germany. GX-G6 was designated as the government project supported by Ministry of Health and Welfare and Ministry of Trade, Industry, and Energy.
According to the GlobalData report, the global T2D pharmaceutical market in 2015 was $31.2B, including both branded and generic drugs. The sales of GLP-1 receptor agonists (GLP-1 RAs) therapeutics was $3.8B taking 9% of the overall T2D market in 2016. According to the forecast, GLP-1 RAs market will almost triple, reaching $11.1B at a Compound Annual Growth Rate (CAGR) of 12.2%, accounted for 18% of the total market in 2025.
▶ About Genexine:
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and metabolic diseases. Genexine has robust pipelines in clinical and pre-clinical stages based on long-acting Fc fusion technology and therapeutic DNA technology. In the clinical stage, Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both adult and pediatric GHD, currently in multinational phase II trials. GX-188E therapeutic DNA vaccine for HPV-associated diseases is in Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia II/III and plans to enter into Phase 1b/2a trial in cervical cancer with GX-188E in combination Keytruda (anti- PD-1 therapy) of Merck (also known as MSD) 1H of 2017. Founded in 1999, Genexine has over 150 employees and half of them are scientists with MSc or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.