China Poised to Lead with Oral Insulin Availability, Phase III Trials Successful
New Delhi, May 26: China is on the verge of becoming the first country to offer oral insulin to the world, as reported on Friday.
Hefei Tianhui Biotechnology (HTIT) in China has completed Phase III trials for oral insulin and has submitted a marketing authorization application (MAA) to the National Medical Products Administration.
The Phase III trial conducted by US-based Oramed Pharmaceuticals, known as ORA-D-013-1, showcased significant reduction in A1C levels—a measure of average blood sugar over two to three months—for the treatment of Type 2 diabetes. HTIT is a strategic partner of Oramed Pharmaceuticals.
Prashant Khadayate, a Pharma Analyst at GlobalData, stated, “Oral insulin is a paradigm shift from the traditional injectable insulin market. Therefore, there would be a lot of opportunities and challenges in the commercialization of oral insulins.”
He added, “Even though insulin delivery through injections has improved significantly for patients, compliance is always an issue for injectable forms of insulin. Hence, oral insulin will always be preferred, potentially reducing the discomfort associated with injections and thereby improving overall compliance, provided it is equally effective in terms of efficacy and safety. Notably, it is difficult to comment on its efficacy and safety with injectable insulins as Phase III trials included only placebo.”
HTIT obtained exclusive rights to Oramed’s oral insulin ORMD-0801 in China, Hong Kong, and Macau in November 2015.
However, Oramed terminated its oral insulin clinical trial activities in the US for Type 2 diabetes in January 2023 due to disappointing results from the Phase III ORA-D-013-1 trial.
In 2006, Pfizer launched Exubera, the world’s first inhaled insulin. However, it was withdrawn from the market just a year later due to commercial failure.
“A new mode of insulin delivery is always appreciated, but it should also be commercially successful. Since oral insulin is a new form of insulin delivery, HTIT and Oramed should develop an effective commercial strategy to ensure its success in the market,” commented Khadayate.
Currently, there are only two oral insulin products in Phase III trials worldwide. With an estimated growth rate of 2.21 percent in diagnosed cases of Type 2 diabetes in China, from 57.4 million in 2022 to 63.3 million in 2028 according to GlobalData, the introduction of a new oral insulin treatment option will enhance market accessibility.
