Grand Pharmaceutical (00512.HK): TCM Class 1.1 Innovative Drug GPN01360 Completes First Patient Enrollment in Phase III Depression Study
NewTimeSpace News: Grand Pharmaceutical Group Limited (stock code: 00512) issued a voluntary announcement on July 23 that its TCM innovative drug GPN01360 for the treatment of depression has completed the first patient enrollment and dosing in the Phase III clinical study conducted in China.
According to the announcement, this study is a randomized, double-blind, placebo parallel-controlled, multi-center Phase III clinical study, planned to enroll 480 patients with depression, with oral administration for 8 weeks, aiming to evaluate the efficacy, safety, and tolerability of GPN01360 compared to placebo in the treatment of depression (liver depression and spleen deficiency syndrome). The primary clinical endpoint is the change from baseline in total score of the Hamilton Depression Rating Scale ("HAMD-17") at Week 8. Secondary endpoints include the change from baseline in total score of the Montgomery-Åsberg Depression Rating Scale ("MADRS") at Week 8, HAMD-17 remission and response rates at Week 8, change from baseline in Pittsburgh Sleep Quality Index ("PSQI") score at Week 8, change from baseline in Clinical Global Impression-Severity of Illness (CGI-S) score, Clinical Global Impression-Global Improvement (CGI-I) score, and adverse event incidence rates, among other efficacy and safety indicators.
The announcement stated that GPN01360 is a Class 1.1 TCM innovative drug for the treatment of depression (liver depression and spleen deficiency syndrome), and is a TCM innovative achievement supported by the national "Major New Drug Innovation" special program. This product is based on the ancient classical formula "Xiaoyao San" and was developed through modern pharmacological and clinical research screening and optimization. The prescription consists of 12 TCM ingredients including Bupleurum, Curcuma, and Buddha's hand, with functions of soothing the liver and strengthening the spleen, and relieving depression and calming the spirit. Completed Phase II clinical studies have shown that GPN01360 has good safety and efficacy in the treatment of depression, with relatively significant improvement in symptoms of depression with anxiety and insomnia.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
- Zhongtai Futures (01461.HK): Positive Profit Alert, Interim Net Profit Attributable to Parent Expected to Rise 190% to 210%
- CITIC Resources (01205.HK): Interim Profit Attributable to Shareholders Expected at HK$238 Million to HK$322 Million
- Likin Resources (02245.HK): Estimated net profit attributable to parent company for H1 of approximately RMB 2.25 billion to RMB 2.5 billion, up 57% to 75% year-on-year
