The Chinese partner of Oramed Pharmaceuticals Inc., Hefei Tianhui Incubator of Technologies Co., Ltd, has reached the significant regulatory milestone of approval of an investigational new drug application (“IND”) for two doses of its oral insulin (ORMD-0801). The approval of the IND by the Center For Drug Evaluation of the China National Medical Products Administration (“NMPA”, formerly the CFDA) of the oral insulin paves the way for the start of clinical trials in China.
“We are pleased that the Chinese regulatory authorities have approved the IND, as it sets a clear path forward for approval of oral insulin in China, bringing oral insulin closer to becoming a reality in the Chinese market,” stated Oramed CEO Nadav Kidron.
Oramed Pharmaceuticals Inc., also announced that its U.S. patent for the technology “Protease Inhibitor-Containing Compositions, Compositions Comprising Same, and Methods for Producing and Using Same” has been allowed by the United States Patent and Trademark Office.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed‘s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).