The Phase I clinical trial of the ZG-001 capsule project under development by Warner Pharmaceuticals has been completed with the approval of the National Medical Products Administration. According to the data, ZG-001 is a Class 1 new drug intended for the treatment of adult depression disorders, including major depressive disorder (MDSI), refractory depression (TRD), or major depressive disorder (MDD).

 

 

 

This drug is a novel antidepressant with a completely new structure. 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 this Phase I clinical study indicate that ZG-001 has excellent safety and no adverse reactions exceeding Grade 1 have been observed. ZG-001 has excellent pharmacokinetic properties, rapid absorption, and a linear increase in exposure with increasing dosage; There is no significant gender difference and no accumulation.

 

 

 

Suoyuan Biotechnology recently announced that its innovative drug DB104 (liafensine) has obtained FDA fast track qualification for the treatment of refractory depression. This medicine is administered through DGM ™ The platform has discovered a new biomarker DGM4, and clinical trials have shown significant efficacy and high safety for DGM4 positive TRD patients. This breakthrough is expected to meet the long-term unmet clinical needs in this field.

 

 

 

In addition, according to the review, in July, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that two clinical applications for the Class 1 new drug HS-10380 submitted by Haosen Pharmaceutical and Hansen Pharmaceutical were approved, intended to treat manic episodes of bipolar I disorder. Bipolar I disorder manic episode is one of the manifestations of bipolar disorder (also known as manic depressive disorder). HS-10380 is a multi-target agonist currently undergoing clinical research for use in schizophrenia. The clinical trial approval of HS-10380 for bipolar disorder indicates that this new drug is about to initiate clinical research for this type of disease.

 

 

 

In May, Shanghai Pharmaceutical announced that the innovative drug "I040" for depression had been approved by the National Medical Products Administration to conduct clinical trials. I040 is a small molecule compound, and preclinical studies have shown that I040 can improve core symptoms in multiple animal models of depression, with good safety.

 

 

 

In April, Enhua Pharmaceutical announced that it had received the "Drug Clinical Trial Approval Notice" for the Class 1 chemical drug NH103 oxalate tablets approved and issued by the National Medical Products Administration, and agreed to conduct clinical research on this product for antidepressant treatment. NH103 has strong and balanced inhibitory activity against the commonly used antidepressant target serotonin transporter (SERT) and the antidepressant activity enhancing target 5HT2A/5HT2C receptor. Currently, there are no antidepressants with the same mechanism on the market.

 

 

 

On October 8th, Jingxin Pharmaceutical also stated on the investor interaction platform that the company's self-developed Class 1 new drug JX11502MA capsules for treating schizophrenia are currently progressing smoothly and will soon promote its research and development and market launch.

 

 

 

Data shows that there is a huge market space for antidepressants in China. It is predicted that the market size of antidepressants in China is expected to reach 23.8 billion yuan by 2030, with a compound annual growth rate of 4.2% from 2022 to 2030. The vast market has also attracted pharmaceutical companies to keep up. According to statistics, in 2023, a total of 7 new Class 1 antidepressants were approved for clinical trials in China. Among them, KH607 tablets from Kanghong Pharmaceutical, HS-10506 tablets from Haosen Pharmaceutical, MI078 capsules from Minowei, ZG-001 capsules from Zhigen Pharmaceutical, and LV232 capsules from Nantong and Fenglianwang have all started Phase I clinical trials.

 

 

 

In addition, according to data statistics, as of June 9th, there are at least 22 new antidepressant class 1 chemical drugs under development in China, but the current research and development progress is mostly in clinical phase I and II. There are currently two drugs entering Phase III clinical trials, namely Dongyangguang Pharmaceutical, which launched the Phase III clinical trial of the antidepressant new drug phosphometizone tablets in July 2021; On May 11th of this year, Jibei Pharmaceutical launched the Phase III clinical trial of its new antidepressant drug JJH201501 tablets.