SK Biopharmaceuticals and Shanghai Medicilon have been conducting various preclinical experiments for SKL-PSY since 2011. When its preclinical development has been successfully completed through the efforts of Medicilon CRO services, they will start clinical development with the newly-joined partners, Southwest Synthetic Pharmaceuticals and PKUCare Pharmaceutical R&D Center, both of which are subsidiaries of PKU International HealthCare Group.
Unlike currently-marketed antidepressants that can require 2-4 weeks to become effective, SKL-PSY has a relatively quick onset of therapeutic effects in animal models of depressive and manic states. The molecule is expected to be effective for both mania and depression. Use in both indications can be problematic for currently-marketed antidepressants or other agents for the treatment of bipolar disorder.
The combined current market size for antidepressants and treatments for bipolar disorder is estimated to be $39 billion annually.
SK Biopharmaceuticals, PKU International HealthCare Group, and Medicilon have agreed to start clinical trials following an Investigational New Drug (IND) application later this year.
Dr. Christopher Gallen, CEO and President of SK Biopharmaceuticals, said, “Through this agreement, both SK Biopharmaceuticals and PKU International can achieve tremendous synergy through the combination of R&D competencies, know-how, and experiences that each company brings to the table. This agreement allows SK Biopharmaceuticals to further advance our efforts to become a global leader in drug development and to have an excellent partner in the emerging Chinese market while allowing PKU International to advance as an innovator CNS Pharma in China.”