[Edaily Reporter Hyera Lee ] SAM CHUN DANG PHARM CO. LTD(000250)The stock hit its daily price limit following news that the company had received a “Pre-ANDA (Product Development Meeting) Response” from the U.S. Food and Drug Administration (FDA) ahead of its Abbreviated New Drug Application (ANDA) for the oral semaglutide. Analysts attribute the surge in buying interest to the perception that regulatory uncertainties regarding the development path—which had been a source of concern in the market—have been largely resolved.

According to MP Doctor on the 20th, as of 9:20 a.m. that day, SAM CHUN DANG PHARM CO. LTD was trading at 239,000 won, up 29.82% from the previous day.
A Pre-ANDA is an official procedure for consulting with the FDA in advance—prior to submitting a generic drug application—regarding development strategies, reference drugs, and bioequivalence test plans. SAM CHUN DANG PHARM CO. LTD explained that this response confirmed its development strategy is being officially reviewed in accordance with the FDA’s ANDA process.
The response included the ANDA meeting tracking number assigned by the FDA, and the original drug, Rybelsus, was specified as the reference drug (RLD). Accordingly, SAM CHUN DANG PHARM CO. LTD assessed that the regulatory uncertainty regarding the development path, which had been raised in the market, has been largely resolved.
SAM CHUN DANG PHARM CO. LTD is pursuing the development of differentiated products based on its proprietary platform technology. The oral semaglutide the company is developing is an “S-PASS”-based, SNAC-free formulation that does not use SNAC, the absorption enhancer employed by the existing originator product. Since the formulation patent for the originator drug Rybelsus is protected until 2039, there are restrictions on the market entry of competing products utilizing the same technology. SAM CHUN DANG PHARM CO. LTD aims to commercialize the world’s first SNAC-free oral semaglutide generic using its proprietary technology.