Hefei Tianhui Biotechnology (HTIT) has recently submitted a marketing authorisation application (MAA) in China for the world’s first oral insulin for type 2 diabetes (T2D). If approved, China will become the world’s first country with oral insulin availability, says GlobalData.
According to GlobalData’s Pharma Intelligence Center, there are only two oral insulins in Phase III globally. Moreover, small players dominate the entire pipeline in development around oral insulins.
The number of diagnosed prevalent cases of type 2 diabetes in China is estimated to grow at a CAGR of 2.21 per cent from 57.4 million in 2022 to 63.3 million in 2028, as per GlobalData. Considering the huge T2D patient population in China, a new oral insulin treatment option will further improve market access.
Prashant Khadayate, Pharma Analyst at GlobalData, comments, “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.”
In November 2015, HTIT in-licensed exclusive rights to Oramed’s oral insulin ORMD-0801 in China, Hong Kong, and Macau. HTIT successfully completed Phase III trials of oral insulin in China, prior to the submission of MAA in China. On the contrary, its partner Oramed terminated its oral insulin clinical trial activities in the US in T2D following disappointing results of the Phase III ORA-D-013-1 trial in January 2023.
Khadayate concludes, “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. Back in July 2006, Pfizer launched the world’s first inhaled insulin, Exubera, but barely a year later, it withdrew Exubera from the market as it was not commercially successful. A new mode of insulin delivery is always appreciated, but it should be commercially successful as well. Since, oral insulin is a new form of insulin delivery, HTIT and Oramed should develop an effective commercial strategy to make it successful in the market.”