China's National Medical Products Administration (NMPA) has issued a notification document rejecting the marketing application for Tianmai Biotechnology's recombinant human insulin enteric-coated capsule, ORMD-0801. The application, submitted in April 2023, sought approval for treating type 2 diabetes (T2D) patients inadequately controlled by oral hypoglycaemic agents. The failed drug is an oral insulin capsule developed by Israel's Oramed Pharmaceuticals, which intended to protect the insulin through the gastrointestinal tract using just an enteric coating supplemented with protease inhibitors and absorption enhancers.

This questionable design already led to a previous Phase III trial failure for ORMD-0801. In January 2023, Oramed announced that its global Phase III study (ORA-D-013-1) for the candidate did not meet its primary or secondary endpoints, showing no significant improvement in glycaemic control compared to a placebo. Following that result, Oramed terminated its clinical development program for T2D. In 2015, the Israeli company sold China rights for an undisclosed amount to Tianmai Bio, which is yet to release the results from a separate Phase III trial in China.

According to PharmCube's NextBiopharm® database, other developers burdened with ORMD-0801 deals include South Korea's Medicox as well as OraTech, a joint venture formed with China-based Tianhui Incubator. Click here to request a free trial for NextBiopharm®.