Hefei Tianhui Biotechnology Co Ltd, a strategic partner of Oramed, is moving toward regulatory approval and has submitted the data to the National Medical Products Administration.

Oramed has recently completed an analysis of the data from its U.S.-based, Phase 3 trial ORA-D-013-1, for type 2 diabetes. 

This analysis found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. 

These subsets exhibited an over 1% placebo-adjusted, statistically significant reduction in HbA1c. 

In January, the company announced the topline data from the ORA-D-013-1 study that did not meet its primary endpoint, which compared the efficacy of ORMD-0801 to placebo in improving glycemic control.

The significant impact of baseline BMI on the responder group within the U.S. Phase 3 trial aligns with the positive data from the HTIT trial in China. 

ORMP Price Action: ORMP shares are up 20.32% at $3.40 on the last check Monday.