Jeon In-seok, CEO of Samchundang Pharma, said the company’s oral semaglutide has been recognized by the U.S. Food and Drug Administration as a generic version of Wegovy, while also announcing the withdrawal of a planned stock block sale worth about $1.7 billion.
Speaking at a press conference held April 6 at the company’s headquarters in Asia, Jeon addressed controversy surrounding the drug’s generic status, stating that it had been accepted under the FDA’s Abbreviated New Drug Application (ANDA) pathway and that relevant documents had been submitted.
Samchundang Pharma also disclosed some documents submitted to the FDA and the European Medicines Agency related to its S-PASS platform and oral semaglutide. The company said the technology has secured patents and avoids existing ones by using a formulation that does not rely on SNAC.
S-PASS is a platform technology that converts injectable protein-based drugs into oral formulations. The company is expanding its pipeline to include oral insulin and obesity treatments based on this platform.
However, the disclosed materials indicate only that the submission met formal administrative requirements and was accepted for review, and do not confirm the drug’s technical validity or final generic status.
Addressing concerns that ANDA acceptance alone does not establish generic recognition, Jeon said the submission and review process itself demonstrates the substance of the technology and marks entry into an official validation stage.
Regarding partnerships with global companies, Jeon said Samchundang Pharma operates on a model of directly producing and supplying products rather than focusing solely on technology transfers, with milestone payments functioning as partial upfront funding for development costs rather than compensation for technology value.
Jeon also addressed the withdrawal of the previously announced block deal, saying his intent as a major shareholder to fulfill tax obligations had been misinterpreted and that he could no longer overlook damage to the company’s value.
He said taxes totaling about $1.5 billion, including gift and capital gains taxes, will be paid through stock-backed loans. He added that any remaining difference from the initially planned $1.7 billion would have been used to repurchase company shares, describing the approach as the most straightforward and transparent option he could choose.