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At present, two research centers, Beijing Anding Hospital affiliated with Capital Medical University and Wuhu Hospital affiliated with Capital Medical University, are recruiting suitable subjects.

 

 

 

It is reported that ZG-001 is a newly developed antidepressant class 1 drug with a completely new structure by Zhigen Medicine, intended for the treatment of adult depression disorders, including major depressive disorder (MDSI) or refractory depression (TRD).

 

 

 

Preclinical studies have shown that the antidepressant mechanism of ZG-001 is clear. Experimental data indicate that a single oral administration of ZG-001 can rapidly increase the expression of pTrkB in the brain, activate the BDNF TrkB signaling pathway, and thus exert a rapid and long-lasting antidepressant effect.

 

 

 

The results of the Phase I clinical study showed that ZG-001 has excellent safety and no adverse reactions exceeding Grade 1 were observed. ZG-001 has rapid oral absorption and excellent pharmacokinetic performance, with a linear increase in exposure with increasing dosage; There is no significant gender difference and no accumulation. Both non clinical studies and phase I clinical studies have shown that ZG-001 does not have any psychological side effects such as drug dependence or separation.

 

 

 

The above research results indicate that ZG-001 is expected to become a new generation of antidepressant drugs with higher safety and better efficacy.

 

 

 

Depression is a common mental disorder with a high incidence and high clinical cure rate, characterized by obvious and persistent low mood. The symptoms are diverse, including sustained emotional sadness, loss of interest, physical sleep disorders, changes in appetite, fatigue, cognitive inattention, memory loss, self blame, etc; Its causes involve genetic, neurobiological, and psychosocial factors; There are various treatment methods including medication, psychological therapy, and physical therapy.

 

 

 

In terms of medication treatment for depression, in recent years, with the continuous increase in the number of mental illness patients, as well as the deepening of patients' scientific understanding of depression and the improvement of treatment acceptance rate, the demand for antidepressants in the market has experienced rapid growth. Data shows that the market size of antidepressant drugs in China will reach 18.41 billion yuan in 2022, and is expected to reach 23.8 billion yuan by 2030.

 

 

 

Facing the vast blue ocean of the market, domestic pharmaceutical companies are actively expanding their presence, and domestic antidepressants are making progress one after another. Since 2025, there have been continuous updates on the progress of antidepressant products.

 

 

 

On February 10th, Renfu Pharmaceutical announced that its subsidiary, Yichang Renfu Pharmaceutical, has recently obtained the "Drug Clinical Trial Approval Notice" for Breprazole tablets issued by the National Medical Products Administration. The approved indication for this product is to be used in combination with other antidepressants for the treatment of depression. Currently, there are no other companies in China that have been approved.

 

 

 

On January 20th, Enhua Pharmaceutical announced that the company has recently obtained the "Drug Registration Certificate" for hydrobromic acid furosemide tablets approved and issued by the National Medical Products Administration, with a specification of 10mg and registration classification