Sam Chun Dang Pharm begins bioequivalence study for oral semaglutide

Sam Chun Dang Pharm said Wednesday that it has initiated a bioequivalence study for its oral semaglutide, a generic version of Novo Nordisk’s Rybelsus tablets. 

The product is developed using the company’s proprietary S-PASS platform, which converts injectable drugs into pill form.

Unlike Rybelsus, which utilizes Jersey-based Emisphere Technologies' Eligen SNAC drug delivery system, Sam Chun Dang’s version employs a SNAC-free formulation enabled by its S-PASS technology. This innovation allows the company to bypass multiple formulation patents.

“Our generic oral semaglutide is expected to enter the market as early as 2026 due to its avoidance of formulation patents, allowing it to compete in the $56 billion global semaglutide market, which is growing at double-digit annual rates,” a company official said. “This early market entry is anticipated to maximize economic benefits, including revenue growth.”

The official also noted that the bioequivalence study results are expected to accelerate regulatory submissions and contract negotiations. 

Sam Chun Dang has already signed term sheets with key markets such as the United States and Japan and plans to provide updates on development timelines and country-specific agreements through non-deal roadshows.

In addition, the company aims to expedite contracts and regulatory filings in regions including Europe, India, the Middle East, and China.