Hansoh Pharmaceutical's Class 1 New Drug HS-10380 Granted IND Approval for Manic Episodes Associated with Bipolar I Disorder

Intelligent Finance APP learned on July 23 that the official website of the Center for Drug Evaluation under China's National Medical Products Administration announced that two clinical trial applications for HS-10380, a Class 1 new drug submitted by Hansoh Pharma (03692), have been approved for the treatment of manic episodes in Bipolar I Disorder. Manic episodes in Bipolar I Disorder are one of the manifestations of bipolar disorder (also known as manic-depressive illness). The approval of the clinical trial for HS-10380 targeting bipolar disorder means this new drug is about to initiate clinical research for this type of disease.

Data shows that HS-10380 is one of the self-developed projects by Hansoh Pharma in the field of neurological disorders. According to publicly available information, HS-10380 is a multi-target agonist that partially acts on D2, D3, and 5-HT1A receptors, with significant antagonistic effects on the 5-HT2A receptor, showing potential to improve symptoms in patients with psychiatric disorders. Preclinical studies have found that HS-10380 demonstrates superior competitive binding ability to 5-HT1A and 5-HT2A receptors compared to similar control drugs, while also exhibiting high plasma exposure and demonstrating good efficacy in animal models.

In addition, the clinical research of HS-10380 for schizophrenia is already underway. In March 2022, the product received its first clinical approval from the NMPA for the treatment of schizophrenia. According to the China Drug Clinical Trial Registration and Information Disclosure Platform,HS-10380 is currently undergoing multiple clinical studies targeting schizophrenia.It is reported that as an oral preparation with a multi-target mechanism, HS-10380 demonstrated good overall safety and tolerability in healthy subjects after single and multiple dosing.