Yuanda Pharmaceutical (00512): The Phase II clinical study of GPN01360, a Class 1 innovative traditional Chinese medicine drug in China, successfully reached the clinical end

Zhitong Finance App News, Yuanda Pharmaceutical (00512) issued an announcement. Recently, the Phase II clinical study of GPN01360, the Group's innovative traditional Chinese medicine drug for treating depression, successfully reached the clinical end in China. The success of this clinical study is a major milestone in the Group's proprietary Chinese medicine sector.

The study was a randomized, double-blind, placebo-controlled, multicenter phase II clinical study. 148 depressive patients were enrolled and administered orally for 8 weeks. The purpose was to initially evaluate the efficacy and safety 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; secondary endpoints included changes in the total score of the 8-weekend Montgomery-Eisberg Depression Scale (MADRS) compared to baseline, 8-weekend HAMD-17 response rate and efficiency, 8-weekend Pittsburgh Sleep Quality Index (PSQI) score change value compared to baseline, overall clinical impression scale-disease severity (CGI-S), overall clinical impression scale-overall improvement (CGI-I) score compared to baseline change in incidence of adverse events rate Other efficacy and safety indicators.

The results showed that the main efficacy index HAMD-17 after 8 weeks of treatment was significantly different from the baseline change value compared to placebo (P=0.0006<0.05); secondary efficacy indicators such as MADRS, TCM symptoms points, relief rate and efficiency of HAMD-17, and Hamilton Anxiety Scale (HAMA) all had significant differences (P<0.05) after 8 weeks of treatment (P<0.05); PSQI showed a clear treatment trend. Furthermore, GPN01360 was safe and well tolerated, and no significant toxic side effects were found throughout the trial period. The above research results show that GPN01360 has good safety and efficacy in treating depression, and also significantly improves symptoms such as depression accompanied by anxiety and insomnia.

GPN01360 is a Class 1.1 innovative traditional Chinese medicine for the treatment of depression (liver depression and spleen deficiency). It is based on the classic ancient prescription “Xiaoyao San” and optimized through modern pharmacology and clinical research. The prescription consists of 12 traditional Chinese medicines such as chaihu, tulip, and Buddha's hand, which have the effects of relieving the liver and spleen, relieving and calming the mind. This traditional Chinese medicine is mainly used to treat liver depression and spleen deficiency. Typical symptoms include low mood, slow thinking, decreased mental activity, anxiety, insomnia and forgetfulness, poor eating, and fatigue. Early human empirical studies of nearly 100 people showed that GPN01360 showed good efficacy and safety in improving symptoms of depression, relieving anxiety and insomnia, and regulating spleen and stomach function.

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 depression worldwide, with a total prevalence rate of about 4.0%, of which 5.7% are adults. Depression is the second largest cause of lost years of healthy life expectancy (“YLDs”) due to disability worldwide. Among them, it is the leading factor for YLDS in the 15-29 age group, putting a huge burden on global social productivity. Depression and anxiety can cause loss of 12 billion working days and nearly 1 trillion US dollars in economic losses every year. China's mental health survey shows that the prevalence of depression 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 depression 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 cultivate the proprietary Chinese medicine circuit. On the basis of consolidating and improving the facial features matrix, it has successfully expanded its business into the treatment fields of chronic cardiovascular disease and neurology through the strategic layout of various proprietary Chinese medicines with significant competitive advantages, such as Meixukang series products, Danzhen headache capsules, and reshukang capsules, etc., to achieve a strategic transformation of the traditional Chinese medicine business from a single field of facial medicine to the field of comprehensive chronic disease treatment. 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.