China-based Hainan Huluwa Pharmaceutical Group Co., Ltd (SHA: 605199) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of UCB Pharma’s Briviact (brivaracetam). The Category III injectable is in development for use as an adjuvant treatment for partial seizures in adults, adolescents, and children over two years old, with or without secondary systemic seizures, and as an alternative when oral preparation is not feasible.
Brivaracetam’s Global Approval and Market Potential in China
Brivaracetam was approved as an adjuvant therapeutic drug for treating partial seizure type epilepsy patients aged 16 years and above, with or without secondary systemic seizures, in Europe in January 2016 and in the US in February 2016. However, it is not yet available in China, and no generic versions are present on the market. Hainan Huluwa Pharmaceutical’s development of a generic version of Briviact aims to address this gap, potentially providing a new treatment option for epilepsy patients in China.-Fineline Info & Tech
