[Edaily Reporter Kwon Oh Seok ] SAM CHUN DANG PHARM CO. LTD ( SAM CHUN DANG PHARM CO. LTD(000250)) announced on the 20th that it has received a response from the U.S. Food and Drug Administration (FDA) regarding its Pre-ANDA (Product Development Meeting) submission, which was conducted prior to filing an Abbreviated New Drug Application (ANDA) for oral semaglutide.

A Pre-ANDA is an official procedure conducted prior to filing a generic drug application, during which the company consults with the FDA on its development strategy, reference listing drug (RLD), and bioequivalence (BE) study plans. The company explained that this response confirms its development strategy is being formally reviewed in accordance with the FDA’s ANDA process.
This response included the ANDA meeting tracking number assigned by the FDA, and the original drug, Rybelsus, was specified as the reference drug (RLD). Consequently, it is 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 existing originator products.
Currently, Rivelsus is protected by formulation patents related to SNAC until 2039, which is understood to restrict the market entry of competing products utilizing the same technology. The company aims to circumvent these restrictions through its proprietary technology and commercialize the world’s first SNAC-free oral semaglutide generic.
In the U.S. market, an ANDA is a regulatory pathway that allows for automatic substitution with the originator drug at the pharmacy level upon recognition of therapeutic equivalence, providing a structure that is advantageous for market entry through insurance companies and pharmacy benefit managers (PBMs). In contrast, improved new drugs are sold as separate branded products, resulting in additional sales and marketing burdens.
SAM CHUN DANG PHARM CO. LTD emphasized that it has already secured bioequivalence data compliant with FDA guidelines, which it utilized in these Pre-ANDA consultations, thereby reaffirming the feasibility of its U.S. market entry strategy.
SAM CHUN DANG PHARM CO. LTD official stated, “Based on our proprietary platform technology, we will secure a differentiated competitive edge in the global oral GLP-1 market and do our utmost to ensure that commercialization efforts with our global partners proceed smoothly and lead to tangible results.”