GRAND PHARMA (00512) announced that its innovative Traditional Chinese Medicine (TCM) drug GPN01360 for treating depression has successfully achieved the clinical endpoint in its Phase II study conducted in China. This milestone marks significant progress in the group’s TCM development for the otolaryngology segment.
The study was a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial involving 148 depression patients who received oral treatment for eight weeks. It aimed to preliminarily evaluate the efficacy and safety of GPN01360 compared to a placebo in treating depression (liver stagnation and spleen deficiency syndrome).
The primary endpoint was the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) total score at week eight. Secondary endpoints included changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, HAMD-17 response and remission rates, Pittsburgh Sleep Quality Index (PSQI) score, Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I), and adverse event rates.
Results showed a statistically significant difference (P=0.0006 <0.05) in the primary efficacy endpoint (HAMD-17) between GPN01360 and the placebo. Secondary efficacy measures, including MADRS, TCM syndrome scores, HAMD-17 response and remission rates, and Hamilton Anxiety Scale (HAMA), also demonstrated significant improvements (P<0.05). PSQI exhibited a notable therapeutic trend. Additionally, GPN01360 exhibited good safety and tolerability, with no significant toxic side effects observed.
GPN01360 is a Class 1.1 innovative TCM drug derived from the ancient classical formula "Xiaoyao San," optimized through modern pharmacology and clinical research. Composed of 12 herbs, including Bupleurum, Curcuma, and Bergamot, it is designed to soothe the liver, strengthen the spleen, and relieve depression. The drug targets liver stagnation and spleen deficiency-type depression, characterized by symptoms such as low mood, slow thinking, reduced willpower, anxiety, insomnia, poor appetite, and fatigue.
Previous human experience studies involving nearly 100 participants demonstrated GPN01360’s efficacy and safety in alleviating depressive symptoms, anxiety, insomnia, and improving gastrointestinal function.
Depression, a prevalent mental disorder, affects work, learning, and social functioning, with severe cases leading to suicide. The relapse rate is 75%-90%, making it a lifelong condition and a leading cause of global disease burden. According to WHO, approximately 332 million people worldwide suffer from depression, with a prevalence of 4.0% (5.7% in adults). Depression is the second-largest contributor to years lived with disability (YLDs), ranking first among individuals aged 15-29. It causes an estimated 12 billion lost workdays annually, resulting in nearly $1 trillion in economic losses.
In China, the adult depression prevalence is 6.8%, exceeding the global average, with over 90 million affected individuals. Current clinical cure rates remain below 30%, and existing antidepressants face challenges such as delayed efficacy (increasing suicide risk) and adverse effects (impacting patient compliance). Thus, there remains a significant unmet clinical need, and GPN01360 may offer a novel treatment option.
As a leading otolaryngology drug R&D, production, and sales enterprise in China, GRAND PHARMA boasts a diverse product pipeline covering ophthalmology, ENT, and oral diseases, including chemical and TCM formulations, OTC drugs, medical devices, and consumer products. The company has established a nationwide marketing network and a specialized sales team.
TCM is a key strategic focus for GRAND PHARMA’s otolaryngology segment. Leveraging TCM’s advantages in chronic disease management, the group has expanded into cardiovascular, neurological, and other chronic disease areas with competitive products such as Maixuekang series, Danzhen Toutong Capsules, and Lishukang Capsules.
Through its "aircraft carrier cluster" product pipeline strategy, GRAND PHARMA continues to strengthen its leadership in otolaryngology while exploring new chronic disease treatment fields like cardiology and neurology. The group remains committed to innovation, investing in global R&D to address unmet clinical needs and accelerate the commercialization of advanced therapies for patients worldwide.