In a significant development for its traditional Chinese medicine (TCM) portfolio, Grand Pharma (SEHK: 00512) has announced the dosing of the first patient in the China-based Phase III clinical study for its novel TCM drug, GPN01360, intended for the treatment of depression.
This milestone represents a major advancement for the company's specialty in the otolaryngology and ophthalmology sectors. The Phase III trial is designed as a randomized, double-blind, placebo-controlled, multi-center study. It aims to enroll 480 patients with depression and involves an 8-week oral treatment period. The primary objective is to evaluate the efficacy, safety, and tolerability of GPN01360 compared to a placebo for treating depression specifically characterized by liver constraint and spleen deficiency.
The primary clinical endpoint is the change from baseline in the total score of the 17-item Hamilton Depression Rating Scale (HAMD-17) at the end of the 8-week period. Secondary endpoints include various other efficacy and safety measures, such as changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) score, HAMD-17 response and remission rates, changes in Pittsburgh Sleep Quality Index (PSQI) scores, and changes in Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores, along with the incidence of adverse events.
GPN01360 is a Class 1.1 innovative TCM drug for treating depression with the liver constraint and spleen deficiency pattern. It is a key research achievement supported by China's national "Major New Drug Innovation" program. The formulation is based on the ancient classical prescription "Xiaoyao San" and has been optimized through modern pharmacological and clinical research. Comprising 12 herbal ingredients, including Bupleurum, turmeric, and finger citron, it is designed to soothe the liver, fortify the spleen, relieve depression, and calm the mind.
This TCM product is primarily intended for depression presenting with symptoms such as low mood, slowed thinking, reduced volitional activity, anxiety, insomnia, forgetfulness, poor appetite, and fatigue. Completed Phase II clinical studies have indicated that GPN01360 possesses favorable safety and efficacy profiles in treating depression, showing notable improvement in symptoms like accompanying anxiety and insomnia.
Depression, also known as depressive disorder, is a common mental health condition that can severely impact a patient's work, studies, and social life, and in severe cases, may lead to suicide. With a relapse rate as high as 75-90%, it is considered a lifelong illness and is the leading cause of disease burden attributable to mental disorders globally, representing a major public health challenge.
According to the latest statistics from the World Health Organization (WHO), approximately 332 million people worldwide suffer from depressive disorders, with a total prevalence of about 4.0% and an adult prevalence of 5.7%. Depressive disorders are the second-largest contributor to years lived with disability (YLDs) globally and the top contributor among the 15-29 age group. Depression and anxiety are estimated to result in the loss of 120 billion working days annually, causing nearly US$1 trillion in economic losses.
In China, a national mental health survey indicates the prevalence of depressive disorders among adults is 6.8%, higher than the global average, with a total affected population exceeding 90 million. The current clinical cure rate for depression remains below 30%, and treatment faces bottlenecks such as the delayed onset of action of common antidepressants, which can prolong suicide risk, and side effects that affect patient adherence.
Consequently, there remains a significant unmet clinical need for depression treatment, and GPN01360 is expected to offer a novel therapeutic option.
As one of China's leading integrated enterprises in the research, production, and sales of otolaryngology and ophthalmology drugs, the company boasts a leading number of marketed products. Its therapeutic areas cover multiple specialties, including ophthalmology, otolaryngology, and stomatology, with product forms spanning chemical and traditional Chinese medicine preparations, health products, prescription drugs, over-the-counter medications, medical devices, and consumer goods. It has established a professional marketing team and a nationwide sales network.
TCM is a key strategic direction within its otolaryngology and ophthalmology business segment. Leveraging the core advantages of TCM in chronic disease management, the company is deepening its focus on the TCM sector. While consolidating its product matrix in otolaryngology and ophthalmology, it has strategically deployed several TCM products with distinct competitive advantages to expand into new therapeutic areas such as cardiovascular and neurological chronic diseases. This marks a strategic shift for its TCM business from a single specialty focus to a comprehensive chronic disease treatment approach.
Capitalizing on the strong synergistic effects of its "aircraft carrier cluster" style product pipeline, the company not only continues to expand its leading position in its original specialty areas but is also actively exploring new directions in chronic disease treatment, such as cardiology and neurology. This aims to systematically broaden the boundaries of chronic disease management and open up new avenues for growth.
The company remains highly committed to the research and development of innovative products and advanced technologies. Centered on patient needs and driven by technological innovation, it continues to increase investment in global innovative products and technologies to address unmet clinical demands, enrich its product pipeline, and enhance its industrial layout. Adopting a strategy of "global operational deployment and dual-circulation business development," it aims to foster a new pattern of integrated domestic and international development. By fully leveraging its industrial strengths and R&D capabilities, the company seeks to rapidly bring innovative technological products to market, providing more advanced and diverse treatment options for patients worldwide.