Hansoh Pharma's Class 1 Innovative Drug HS-10380 Receives IND Approval for Manic Episodes in Bipolar I Disorder

On July 23, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that the two clinical trial applications for HS-10380, a Class 1 new drug submitted by Hansoh Pharma/Hansoh Pharmaceutical Group Company Limited, have been approved for the proposed 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 depression). HS-10380 is a multi-target agonist currently under clinical investigation for schizophrenia.

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

Bipolar disorder, formerly known as manic depression, is a common mental health condition. This illness can cause extreme mood swings, including mania or hypomania characterized by elevated mood, and depression characterized by low mood. These mood fluctuations affect the patient’s sleep, energy, activity, judgment, behavior, and ability to think clearly. In certain cases, mania may lead to a disconnect from reality.

Bipolar disorder and related conditions come in various types, among which Bipolar I Disorder refers to having had at least one manic episode, with periods of hypomania or major depressive episodes before and after the manic episode. The main clinical treatments for this type of condition currently include mood stabilizers, antipsychotics, certain antidepressants, psychotherapy, education, and support, among others.

The approval of the clinical trial for HS-10380 targeting bipolar disorder means that this new drug is about to launch clinical research for this type of disease.

Meanwhile, 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 conducting multiple clinical studies targeting schizophrenia. As an oral formulation with a multi-target mechanism, HS-10380 has demonstrated good overall safety and tolerability in both single-dose and multiple-dose administrations in healthy subjects.

Public information shows that Hansoh Pharma is also developing another pipeline product, HS-10353, in the depression field. This is a GABA receptor positive allosteric modulator, and its Phase 2 clinical trial for depression is currently ongoing.