FUSEN PHARM (01652): "Agomelatine tablets" approved for market launch.

Fusen Pharm (01652) announced that its wholly-owned subsidiary, Henan Fusen Pharm Co., Ltd., has developed the "Agomelatine Tablets" (brand: Yueshule), and the application for market approval has been approved by the Chinese National Medical Products Administration for the treatment of adult depression. Depression is a common mental disorder with over 300 million patients globally. Traditional antidepressant drugs mainly work by regulating monoamine neurotransmitters, but have limitations such as slow onset and significant side effects. "Agomelatine Tablets" is a new type of antidepressant drug with a unique mechanism that breaks through the traditional monoamine neurotransmitter system. It has a dual mechanism of stimulating melatonin (MT1 and MT2) receptors and blocking serotonin (5-HT) receptors, providing both sleep regulation and antidepressant effects. Agomelatine blocks the 5-HT2C receptor in the postsynaptic membrane, increasing the release of the prefrontal cortex, dopamine, and norepinephrine to exert its antidepressant effects. Agomelatine also activates melatonin receptors MT1 and MT2 to restore disrupted biological rhythms in patients, reduce sleep latency, increase sleep duration, and improve sleep quality. In addition, Agomelatine can regulate central emotional and cognitive neural circuits to effectively improve symptoms such as mood swings, decreased attention, and memory loss, helping patients achieve comprehensive social functioning recovery. "Agomelatine Tablets" is a second-class national medical insurance product recommended by authoritative guidelines such as the "Chinese Depression Prevention and Treatment Guidelines", "Chinese Adult Insomnia Diagnosis and Treatment Guidelines", and "Guidelines for the Treatment of Anxiety and Mood Disorders by the International Society of Bipolar Disorders". According to Minet data, sales of Agomelatine Tablets in the top three Chinese terminals and six major markets are expected to exceed 700 million yuan by 2025. "Agomelatine Tablets" is another important product of the group, further enriching the company's line of antidepressant products. The launch of this product will provide more treatment options for millions of patients with depression.