Samchundang Pharmaceutical Signs Clinical Trial Agreement for Oral GLP-1
Samchundang Pharmaceutical announced on the 17th that it has signed a clinical contract with a CRO (Contract Research Organization) following the confirmation of the Institutional Review Board (IRB) schedule for the oral GLP-1 (semaglutide) clinical trial (BE Study) on the 15th of this month.
The clinical (BE Study) product is the oral formulation among ‘Ozempic and Wegovy (both injectable)’ and ‘Rybelsus (oral),’ which are widely known as obesity and diabetes treatments to the general public.
A company representative explained, “Samchundang Pharmaceutical has been developing an original formulation patent-avoiding product incorporating innovative delivery materials developed through the S-PASS platform technology in order to enter the market as a global first. Recently, we also completed the pharmacokinetic study (PK Study) confirming bioequivalence.”
Although the original product’s substance patent will expire in 2026, many formulation patents are expected to expire between 2031 and 2039. Therefore, the company expects that if Samchundang Pharmaceutical begins product sales from 2026, it is highly likely to become the only company in the world to hold a long-term generic oral semaglutide product for at least five years.
The company representative added, “The substance secured through the S-PASS platform technology is fundamentally different from SNAC, which is the core of the original company’s formulation patent, thus fundamentally avoiding the formulation patent. This has been confirmed through technology verification (Due Diligence) conducted by global partners as well as non-clinical studies and PK Study results.”
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He continued, “Samchundang Pharmaceutical is accelerating registration work to obtain product approvals by region (country), starting with the clinical (BE Study). Following the recent signing of the Term Sheet in the United States, we are also speeding up negotiations for supply contracts in other regions.”
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