Sam Chun Dang Pharm (SCD) saw its stock hit the daily upper limit in early trading on Monday. The surge came after the company announced receiving a Pre-ANDA response from the U.S. Food and Drug Administration (FDA) regarding its generic oral semaglutide application.
As of 9:34 a.m. (Korean time) on Monday, SCD’s shares were trading at 239,000 KRW (about 161 USD), up 29.82% from the previous day’s close, reaching the maximum allowed daily increase.
The company hailed this response as a significant milestone, confirming that its oral semaglutide is now under official review following the FDA’s generic (ANDA) development process.
Pre-ANDA is an official FDA procedure where the agency consults on development strategies, reference listed drugs (RLD), and bioequivalence (BE) testing plans before a formal generic application. The FDA’s response included an ANDA meeting tracking number and designated the original drug, Rybelsus, as the reference listed drug (RLD).
Samchundang Pharmaceutical’s oral semaglutide in development uses a proprietary S-PASS platform, creating an SNAC-Free formulation that doesn’t rely on the absorption enhancer SNAC used in the original product.
Rybelsus currently holds a formulation patent for SNAC until 2039, which is believed to limit market entry for competitors using similar technology.
SCD reports that it has already obtained bioequivalence (BE) data meeting FDA guidelines, which it used in this Pre-ANDA consultation. The company emphasized that this development further solidifies its foundation for pursuing a competitive strategy to enter the U.S. market.