FUSEN PHARM (01652) has announced that its wholly-owned subsidiary, Henan FUSEN Pharmaceutical Co., Ltd., has received approval from China's National Medical Products Administration for the market launch of its "Agomelatine Tablets" (brand name: Yueshule). The drug is approved for treating adult depression.

Depression is a common mental disorder affecting over 300 million people globally. Traditional antidepressants primarily work by modulating monoamine neurotransmitters but often have limitations such as slow onset and noticeable side effects.

The "Agomelatine Tablets" represent a novel antidepressant with a distinct mechanism of action. It moves beyond the traditional monoaminergic system, featuring a dual mechanism of melatonin (MT1 and MT2) receptor agonism and 5-hydroxytryptamine (5-HT) receptor antagonism, combining both sleep regulation and antidepressant pharmacological effects.

Agomelatine exerts its antidepressant effect by antagonizing postsynaptic 5-HT2C receptors, which increases the release of dopamine and norepinephrine in the prefrontal cortex. Simultaneously, it activates melatonin receptors MT1 and MT2 to help restore the patient's disrupted biological rhythms, shortening sleep latency, increasing sleep duration, and improving sleep quality.

Furthermore, agomelatine can effectively alleviate associated symptoms like emotional fluctuations, reduced attention, and memory decline by modulating central neural circuits related to emotion and cognition, aiding in the comprehensive recovery of patients' social functioning.

The "Agomelatine Tablets" are listed as a Class B national medical insurance product in China. It is recommended as a first-line antidepressant in several authoritative domestic and international guidelines, including the Chinese Guidelines for Prevention and Treatment of Depressive Disorders and the Canadian Network for Mood and Anxiety Treatments/International Society for Bipolar Disorders Guidelines for the Management of Bipolar Disorder.

Data indicates that sales of Agomelatine Tablets across China's three major end markets are projected to exceed 700 million yuan by 2025.

This product represents another significant addition to the Group's portfolio, further enriching its antidepressant product line. Its market launch is expected to provide millions of depression patients with more treatment options.