Sam Chun Dang Pharm(000250) said on the 20th that it received a response from the U.S. Food and Drug Administration (FDA) regarding procedures for developing an oral semaglutide generic. However, this does not mean Sam Chun Dang Pharm's generic has cleared the FDA approval threshold.
That day, Sam Chun Dang Pharm was in transaction at 239,000 won, up 29.82% from the previous close. Sam Chun Dang Pharm recently said it received a Pre-ANDA response letter from the FDA regarding development of an oral semaglutide generic. Investors expecting the company's U.S. entry appear to have flocked to the stock.
Pre-ANDA is only a procedure to consult with the FDA in advance on development strategy. This response letter does not finally confirm the possibility of approval for the generic or the approval pathway. Actual approval will be decided in the subsequent ANDA review process.
Sam Chun Dang Pharm has not yet submitted an ANDA or entered a formal review. The FDA examines drug equivalence, quality, and manufacturing facilities during the ANDA review. If there are deficiencies in this process, the agency requests supplementation. Whether the generic can be approved without additional clinical trials is also determined in the ANDA review. Only after clearing these multiple thresholds is final approval possible.
Semaglutide is a glucagon-like peptide-1 (GLP-1) class compound. It lowers blood sugar and suppresses appetite, and is used to treat diabetes and obesity. Sam Chun Dang Pharm is developing an oral semaglutide generic using its proprietary platform. The company said it has signed supply contracts in the United States and Europe. A Sam Chun Dang Pharm official said, "Regulatory uncertainty has eased with receipt of the FDA response letter."
Sam Chun Dang Pharm promoted that it is developing an oral obesity drug generic and insulin, and its share price rose from the 230,000-won range at the end of last year to the 1.1 million-won range at the end of March this year. After various controversies erupted and the stock plunged, it was designated in April as an issuer with inadequate disclosures by the Korea Exchange (KRX). The reason for the sanction was that it distributed, as a press release rather than a disclosure, materials containing the company's Canadian market results for its Eylea biosimilar.