The Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for Biolaxy’s oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first Phase I clinical study.
Nodlin is developed with NOD technology, a patented bio-adhesive nano-particle oral delivery technology, to overcome the barriers of oral insulin. Nodlin is an oral insulin formulation to replace insulin injections many diabetic patients have to endure during their life time.
The company claims that Nodlin is the first candidate developed with NOD technology and is positioned as basal insulin formulation, based on the pre-clinical data.
William Lee, CEO of Biolaxy, said: “IND approval is a significant milestone achievement for Biolaxy. We have experienced long delay in the approval process due to regulatory uncertainties, but we are very happy now Biolaxy is back on track in full speed to develop urgently needed drugs for the patients.”