Its shares surged 29.82 percent to close at the daily trading limit of 239,000 won after the drugmaker said it had received a written response from the U.S. Food and Drug Administration (FDA) regarding its oral semaglutide generic, a pill for Type 2 diabetes, although the approval process remains far from complete.
The FDA feedback came before the filing of an abbreviated new drug application (ANDA), which is required to market generic medicines in the U.S.
However, it is only part of the early process and does not involve an assessment of the drug itself.
Samchundang has yet to file its ANDA, meaning regulators have not begun reviewing the application for approval and could still request additional studies or documentation, or reject the submission.
The FDA identified Danish drugmaker Novo Nordisk's Rybelsus, an oral semaglutide treatment for Type 2 diabetes, as the reference listed drug (RLD) for Samchundang's generic version.
Samchundang said the FDA's response itself marked an important step in the development of its drug and its future commercialization efforts.
Investors seem overly excited, as the drug is still a long way from approval as Samchundang has yet to file its ANDA, and the FDA has not begun a formal review of the application.
Another key question is whether Samchundang's existing bioequivalence (BE) data will be sufficient. BE studies determine whether a generic drug is absorbed by the body at a similar rate and to a similar extent as the reference medicine.
Even after a formal review begins, regulators can still require additional clinical studies, potentially delaying approval. Jordan-based drugmaker Hikma Pharmaceuticals, for example, received an FDA Complete Response Letter (CRL) for its generic version of Advair Diskus, a widely used asthma medication, and had to conduct another clinical trial before resubmitting its application.
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