CHINA —China is on the verge of a groundbreaking achievement in the field of diabetes treatment, as Hefei Tianhui Biotechnology Co. Ltd. (HTIT) has submitted a marketing authorization application (MAA) for the world’s first oral insulin designed specifically for type 2 diabetes (T2D).
This significant milestone positions China to become the first country worldwide to offer oral insulin to T2D patients, according to insights from GlobalData, a prominent data and analytics company.
Within the global landscape of oral insulin development, only two candidates have advanced to Phase III trials, reflecting the nascent stage of this transformative treatment modality.
Interestingly, smaller players dominate the pipeline, indicating the potential for disruptive innovation in the field.
The prevalence of diagnosed cases of type 2 diabetes in China is projected to grow at a compound annual growth rate (CAGR) of 2.21% from 57.4 million in 2022 to an estimated 63.3 million by 2028, as outlined by GlobalData’s Pharma Intelligence Center.
With such a substantial T2D patient population in China, the introduction of a new oral insulin therapy would greatly enhance access to effective treatment options.
Prashant Khadayate, a Pharma Analyst at GlobalData, highlights the advantages of oral insulin: “While the delivery of insulin through injections has significantly improved for patients, compliance remains an issue with injectable forms.
“Therefore, oral insulin is preferred as it has the potential to reduce the discomfort associated with injections, ultimately improving overall patient compliance, provided its efficacy and safety are comparable.”
Notably, assessing efficacy and safety through injectable insulins alone is challenging, as Phase III trials typically involve placebo controls.
HTIT secured exclusive licensing rights to Oramed’s oral insulin ORMD-0801 in China, Hong Kong, and Macau back in November 2015.
Prior to the submission of the MAA in China, HTIT successfully completed Phase III trials for oral insulin within the country.
However, HTIT’s partner, Oramed, faced setbacks in the United States, leading to the discontinuation of their oral insulin clinical trial activities in T2D following disappointing results from the Phase III ORA-D-013-1 trial in January 2023.
Khadayate emphasizes that oral insulin represents a paradigm shift in the traditional market dominated by injectable insulin.
Consequently, the commercialization of oral insulins presents both significant opportunities and challenges.
The history of diabetes treatment has seen attempts at innovative delivery methods. In July 2006, Pfizer launched the world’s first inhaled insulin, Exubera.
Unfortunately, commercial success eluded Exubera, leading to its withdrawal from the market barely a year later.
“While a new mode of insulin delivery is always welcomed, its success in the market is equally crucial. Given that oral insulin represents a novel form of insulin delivery, HTIT and Oramed should develop an effective commercial strategy to ensure its triumph,” Khadayate remarks.
Presently, only two oral insulins are progressing through Phase III trials globally.
Considering the significant population of T2D patients in China, the introduction of a new oral insulin treatment option will undoubtedly improve market access and transform the lives of those affected by this chronic condition.
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