Samchundang Pharmaceutical is experiencing a surge in its stock price after receiving an official response from the U.S. Food and Drug Administration (FDA) regarding the development of an oral semaglutide generic. As of 9:39 a.m. on July 20, the company’s shares rose by 54,900 won (29.82%) to 239,000 won, according to the Korea Exchange.
The receipt of the Pre-ANDA response from the FDA has been interpreted as a positive signal for investor sentiment. The Pre-ANDA process involves formal discussions with the FDA about the development strategy for generic drugs, reference listed drugs (RLD), and plans for bioequivalence (BE) testing prior to submitting a generic drug application.
Samchundang Pharmaceutical stated that it has secured BE data in line with FDA guidelines, which was utilized in the Pre-ANDA discussions, reaffirming its strategy for entering the U.S. market.
A company representative noted, "This official response from the FDA represents significant progress, demonstrating that the oral semaglutide development program is proceeding as planned in consultation with regulatory authorities. It lays a solid foundation for more stable advancement in approval development and global commercialization in the future."
Additionally, Samchundang Pharmaceutical recently signed an exclusive supply agreement with a U.S. partner that includes milestone payments of approximately $100 million and revenue sharing. The company has also secured exclusive licensing and commercialization agreements in 11 European countries and is in discussions for business opportunities in Canada, Japan, and the Middle East.
* This article has been translated by AI.
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