Oramed Pharmaceuticals Inc., a company developing of oral drug delivery systems, announced today that its Chinese partner, 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 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 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).
Oramed Pharmaceuticals Inc.
- Chinese Regulatory Authority [NMPA] Approves IND Application of Oramed’s Oral Insulin Capsules. (2019, March 26). PR Newswire. Retrieved: https://prnmedia.prnewswire.com/news-releases/chinese-regulatory-authority-nmpa-approves-ind-application-of-orameds-oral-insulin-capsules-300818458.html