Recently, our company received the “Notice of Approval for Clinical Trials” for oxcarbazepine sustained-release tablets, issued and approved by the National Medical Products Administration. This approval allows our company to commence clinical trials for this product, making us the first domestic company to obtain such a notice of approval for this particular formulation.
The oxcarbazepine extended-release tablets are classified as a Class 3 chemical drug, belonging to the category of central nervous system medications. They are indicated for the treatment of partial-onset seizures and generalized tonic-clonic seizures. The indication submitted in this application is “for the treatment of partial-onset seizures in patients aged 6 years and older.” In China, similar products—oxcarbazepine tablets and oxcarbazepine oral suspension—have been available on the market for many years, with well-established efficacy and safety profiles. As an improved extended-release formulation, oxcarbazepine extended-release tablets have already been marketed in the U.S. for several years, presenting lower safety risks compared to conventional tablets and requiring only once-daily administration, thereby enhancing patient compliance, especially among pediatric patients. Our company’s oxcarbazepine extended-release tablets are a China-U.S. concurrent-line product. On September 11, 2024, our company submitted its first Abbreviated New Drug Application (ANDA) for oxcarbazepine extended-release tablets to the U.S. FDA.
The oxcarbazepine extended-release tablets were jointly initiated by the Pharmaceutical Research Institute of Renfu Pharmaceutical Group and our company. The Pharmaceutical Research Institute of the Group is responsible for pharmaceutical studies, bioequivalence studies, clinical trial design, and regulatory submissions. In December 2024, the company submitted a clinical trial application to the Drug Review Center of the National Medical Products Administration and received acceptance.
