Fusen Pharma (01652) has announced that the market application for "Piracetam Injection," developed by its wholly-owned subsidiary, Jiaheng (Zhuhai Hengqin) Medical Technology Co., Ltd., has been approved by China's National Medical Products Administration.
The injection is approved for treating memory decline and mild-to-moderate brain dysfunction caused by various conditions, including acute and chronic cerebrovascular diseases, brain trauma, and various toxic encephalopathies. It is also indicated for children with intellectual developmental delay.
Piracetam Injection is a cerebral metabolic enhancer. It is the first drug in the "cetam" class developed based on the structure of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It works by activating adenylate kinase, increasing the brain's ATP/ADP ratio, and enhancing the absorption and utilization of amino acids, proteins, and glucose. This promotes brain cell metabolism and improves the cerebral cortex's resistance to hypoxia.
Furthermore, in vitro experiments have found that piracetam can protect mitochondria from influences like oxidative stress, exerting a protective effect on these cellular structures. As a brain metabolism-improving drug, piracetam is widely used in clinical practice due to its significant efficacy and minimal side effects.
For the treatment of Alzheimer's disease, it is recommended by the "Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment" and the "Expert Consensus on the Diagnostic and Treatment Process for Cognitive Impairment in the Elderly in China." Its neuroprotective effects are also included in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke," and it is a recommended medication in the "Expert Consensus on the Clinical Management of Post-Stroke Aphasia."
This product is classified as a Category B drug in China's National Reimbursement Drug List. According to data from Menet, the sales of Piracetam Injection across China's three major terminals and six key markets are projected to exceed 250 million yuan in 2025.
The group's Piracetam Injection in the 20ml:8mg specification has been sold in the domestic Chinese market for many years and has gained significant market recognition. The newly approved specifications, which also include 5ml:1mg and 15ml:3mg, will meet the diverse treatment needs of different patients.
Piracetam Injection represents another important product for the group, further enriching its product pipeline in the neurological field. The launch of this product will provide more treatment options for patients with cerebrovascular diseases and cognitive disorders.