China Resources Double Crane subsidiary secures Oxcarbazepine tablets approval

China Resources Double Crane Pharmaceutical announced its controlled subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., has obtained a drug registration certificate for Oxcarbazepine Tablets. The drug, classified as a Chemical Drug Category 4, has a specification of 0.3g. It is approved for treating primary generalized tonic-clonic seizures and partial seizures, with or without secondary generalized seizures, in adults and children aged five years and older. The approval was granted on November 12, 2025, and is considered to have passed bioequivalence evaluation.

Hunan Xiangzhong Pharmaceutical initiated the generic drug's research and development in August 2021, submitting the marketing application on July 26, 2024. As of the announcement date, the company's cumulative R&D investment for Oxcarbazepine Tablets totaled RMB14,216,400 (unaudited). This approval is expected to enrich the company's product line and enhance its market competitiveness.

Oxcarbazepine Tablets were originally developed by Novartis Pharmaceuticals Corp. and first approved in the US in January 2000, with market entry in China in June 2003 under the brand name "Trileptal®". The domestic market for Oxcarbazepine Tablets in 2024 reached RMB738m in total sales (terminal price). According to the National Medical Products Administration, ten manufacturers in mainland China, including Hunan Xiangzhong Pharmaceutical, have received approval for Oxcarbazepine Tablets. Nine of these have passed or are deemed to have passed bioequivalence evaluation.