Jiangsu Kangyuan Pharmaceutical's Perampanel Tablets, China's First Approved Generic, Receives Market Authorization

On November 13, the National Medical Products Administration (NMPA) of China announced the delivery of the drug approval certificate for Perampanel Tablets, manufactured by Jiangsu Kangyuan Pharmaceutical Co., Ltd. This marks the approval and market launch of China's first generic version of Perampanel Tablets.

Perampanel, originally developed by Japanese company Eisai Co., Ltd., is a highly selective, non-competitive AMPA receptor antagonist. It targets the activity of postsynaptic AMPA receptors and glutamate to reduce excessive neuronal excitation associated with seizures. Glutamate is a major neurotransmitter involved in the initiation of epileptic seizures.

Currently, Perampanel has been approved for multiple indications in the United States, including:

- Adjunctive treatment of partial-onset seizures (with or without secondary generalized seizures) and primary generalized tonic-clonic seizures in patients aged 12 years and older.

- Monotherapy for the treatment of partial-onset seizures (with or without secondary generalized seizures) in patients aged 12 years and older.

- Monotherapy and adjunctive therapy for the treatment of partial-onset seizures (with or without secondary generalized seizures) in pediatric patients aged 4 years and older.

In March 2023, China's "Clinical Diagnosis and Treatment Guidelines for Epilepsy" (revised edition) were officially released, recommending Perampanel as a first-line treatment for newly diagnosed focal-onset seizures and as a treatment option for various seizure types and epilepsy syndromes. Perampanel tablets were included in the priority review process in 2018 and received market approval in China in 2019. By the end of 2020, Perampanel was successfully included in the national medical insurance system and experienced rapid growth.

According to Eisai's financial report, global sales of Perampanel have steadily increased since its launch in 2012, reaching 31.9 billion yen (approximately 160 million RMB) in 2021 and continuing to rise to 37.1 billion yen (approximately 186 million RMB) in 2022, representing a year-on-year growth of 17%. In 2021, Perampanel tablets' sales in China were approximately 60 million RMB (1.2 billion yen), which surpassed 100 million RMB (2.4 billion yen) in 2022, reflecting a growth rate of over 100%.

According to Frost & Sullivan analysis, the number of patients with epilepsy in China increased from 544,000 in 2016 to 753,000 in 2020, and it is projected to exceed one million by 2024. With the growing population of epilepsy patients, the anti-epileptic drug market in China is expected to reach 4.8 billion RMB by 2025.

As the first approved generic version of Perampanel, Kangyuan Pharmaceutical's Perampanel Tablets has successfully captured a share of the 5 billion RMB anti-epileptic drug market.

Additionally, in April of this year, the NMPA included Perampanel in the second category of psychotropic drugs, with implementation starting on July 1. Generally, second-category psychotropic drugs are prescribed for a maximum of 7 days.