December 9, 2025
Source: drugdu
44
On December 8, Grand Pharmaceutical (00512) issued an announcement stating that the Group's traditional Chinese medicine...Class 1 innovative drugsThe Phase II clinical trial of GPN01360 in China successfully met its clinical endpoint. This study enrolled 148 patients with depression, who received oral administration for 8 weeks. The primary assessment was the efficacy and safety of GPN01360 compared to placebo in treating depression. Results showed that the primary efficacy endpoint, the change from baseline on the Hamilton Depression Rating Scale (HAMD-17), was significantly different from placebo (P=0.0006<0.05). Secondary efficacy endpoints, such as the Montgomery-Asperger's Depression Rating Scale (MADRS), also showed significant differences (P<0.05). Furthermore, GPN01360 demonstrated good safety and tolerability, with no significant toxic side effects observed.
GPN01360 is a Class 1.1 innovative traditional Chinese medicine for the treatment of depression . Its main ingredients include 12 herbs such as Bupleurum, Curcuma longa, and Citrus medica , which have the effects of soothing the liver and spleen, relieving depression, and calming the mind. Depression is a significant public health problem worldwide, affecting patients' work and lives. According to the World Health Organization, approximately 332 million people globally suffer from depression. The development of GPN01360 aims to meet clinical needs for the treatment of depression and provide patients with new treatment options.
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