Yuanda Pharmaceutical (00512): The Phase III clinical study of GPN01360, a Class 1.1 innovative traditional Chinese medicine drug in China, completed the first patient enrollment

Zhitong Finance App News, Yuanda Pharmaceutical (00512) issued an announcement. Recently, the Phase III clinical study of GPN01360, an innovative traditional Chinese medicine drug used by the Group to treat depression, completed the first patient enrollment in China. This is a major milestone in the Group's proprietary Chinese medicine sector.

The study was a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. It was proposed to enroll 480 depressed patients and administered orally for 8 weeks. The aim was to evaluate the efficacy, safety, and tolerability of GPN01360 compared to placebo in treating depression (liver depression and spleen deficiency). The study's main clinical endpoint indicators were changes in the total score of the Hamilton Depression Scale (HAMD-17) over the weekend of 8 compared to baseline; secondary endpoints included changes in the total score of the 8-weekend Montgomery-Eisberg Depression Scale (MADRS) compared to the baseline, 8-weekend HAMD-17 response rate and efficiency, changes in the 8-weekend Pittsburgh Sleep Quality Index (PSQI) score compared to baseline, overall clinical impression scale-disease severity (CGI-S) score compared to baseline, clinical overall impression scale-overall improvement (CGI-I) score, adverse event score incidence Other efficacy and safety indicators.

GPN01360 is a Class 1.1 innovative traditional Chinese medicine drug for the treatment of depression (liver depression and spleen deficiency). It is an innovative result of traditional Chinese medicine research and development supported by the national “Major New Drug Creation” project. This product is based on the ancient classic formula “Xiaoyao San” and optimized through modern pharmacology and clinical research. The prescription consists of 12 flavors of traditional Chinese medicines such as chaihu, tulip, and Buddha's hand, which have the effects of relieving the liver and spleen, relieving depression and calming the mind. This traditional Chinese medicine is mainly used to treat liver depression and spleen deficiency. Typical symptoms include depression of mood, slow thinking, decreased mental activity, anxiety, insomnia and forgetfulness, poor eating, and fatigue. Completed phase II clinical studies have shown that GPN01360 has good safety and efficacy in treating depression, and has significant improvements in symptoms such as depression accompanied by anxiety and insomnia.

Depression, also known as depressive disorder, is a common mental disorder. It can affect patients' work, study, and social life. In severe cases, it can lead to suicide, and the recurrence rate is as high as 75%-90%. It is a lifelong disease. It is the primary cause of the global burden of diseases caused by mental disorders, and it is also a major global public health problem. According to the latest World Health Organization (WHO) statistics, there are approximately 332 million people with depressive disorder worldwide, with a total prevalence rate of about 4.0%, of which 5.7% are adults. Depressive disorder is the second largest cause of lost years of healthy life expectancy (“YLDs”) worldwide. Among them, in the 15-29 age group, it is the leading factor for YLDS, putting a huge burden on global social productivity. Depression and anxiety can cause 12 billion workdays lost every year, and economic losses of nearly 1 trillion US dollars. China's mental health survey shows that the prevalence of depressive disorder among adults in China is 6.8%, which is higher than the global average, and the total number of patients exceeds 90 million. Currently, the clinical cure rate for depressive disorder is less than 30%, and there are still some bottlenecks in clinical treatment. For example, the risk of suicide cannot be controlled as soon as possible due to delays in efficacy of commonly used antidepressants, and adverse drug reactions often affect patient compliance. Therefore, there is still a large unmet clinical need for treatment of depression, and the Group's GPN01360 is expected to provide a new clinical treatment option.

As one of the major comprehensive enterprises in the R&D, production and sales of facial medicine in China, the Group has the highest number of product pipelines in the industry. The treatment fields cover multi-disciplinary diseases including ophthalmology, otolaryngology, stomatology, etc., covering chemical preparations, traditional Chinese medicine preparations and health products, including prescription drugs, OTC, devices, consumer goods, etc., and has established a specialized marketing team to form a nationwide marketing network. Proprietary Chinese medicine is one of the important layout directions of the Group's facial medicine sector. Based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment, the Group continues to deeply cultivate the proprietary Chinese medicine circuit. On the basis of consolidating and improving the facial medicine product matrix, it has successfully expanded its business into treatment fields such as cardiovascular and cerebrovascular chronic diseases and neurology through the strategic layout of traditional Chinese medicine, and has achieved a strategic transformation of the proprietary Chinese medicine business from a single field of facial medicine to a comprehensive chronic disease treatment field. Based on the strong synergy of the “aircraft carrier cluster” product pipeline, the Group not only continues to expand its leading edge in the field of facial surgery, but is also actively expanding new chronic disease treatment directions such as cardiology and neurology, with the aim of systematically broadening the treatment boundaries of chronic disease management and opening up a new growth track.

The Group has always attached great importance to research and development of innovative products and advanced technology, with patient needs as the core, scientific and technological innovation, increasing investment in innovative global products and advanced technology, enriching and improving product pipelines and industrial layout in response to unmet clinical needs, adopting a “global operation layout, dual cycle business development” strategy to form a new pattern of domestic and international dual cycle linkage development and mutual promotion, giving full play to the Group's industrial advantages and R&D strength, and quickly launch innovative scientific and technological products to provide patients around the world with more advanced and diverse treatment plans.