Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

Diabetes is a disorder characteristic of high blood glucose and poor metabolism. The complications of diabetes often result in severe micro- and macro-vascular diseases, loss of vision, kidney failure, and amputation. Insulin, as an effective diabetic treatment, can slow down diabetic disease progression. However, insulin is given by multiple daily injections at present, which significantly hinders its use.

Oral drug administration is a preferred route. However, the gastrointestinal (GI) tract is designed to digest nutrients like proteins and presents significant challenges for oral insulin including enzyme degradation and poor absorption. Currently, there is no approved oral insulin product despite intensive research in this field.

Nodlin is developed with NOD technology, a patented bio-adhesive nano-particle oral delivery technology, to overcome the barriers of oral insulin.

"IND approval is a significant milestone achievement for Biolaxy," quoted from William Lee, CEO. "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."