Depression treatment ushered in the “China Plan” Yuanda Pharmaceutical (00512) Class 1 innovative traditional Chinese medicine GPN01360 has remarkable clinical efficacy in domestic phase II

The Zhitong Finance App learned that significant progress has been made in the research and development of domestically produced antidepressants. Recently, Yuanda Pharmaceutical (00512) successfully reached a clinical end in the domestic phase II clinical study of GPN01360, a Class 1.1 innovative traditional Chinese medicine drug. The product showed remarkable efficacy and safety advantages. It is expected to become a new treatment option for patients with depression in China and contribute China's strength to global depression treatment.

This important achievement marks that Yuanda Pharmaceutical has taken an important step in the field of modernizing traditional Chinese medicine, and is also a major milestone in the company's proprietary Chinese medicine direction. If GPN01360 is successfully launched in the future, it will not only enrich the company's product pipeline, but also promote the further upgrading of the business pattern, help the company expand its advantages in the field of proprietary Chinese medicine to the fields of chronic cardiovascular and cerebrovascular diseases and neurology, covering a wider range of patient groups, thus creating a new performance growth engine for the company.

Classic prescriptions have been innovated and upgraded, pointing to the nearly 10 billion yuan depression treatment market

Depression is a common mental illness with a recurrence rate of 75%-90%. It often causes patients to feel depressed and lose interest. In severe cases, it can lead to suicide, greatly affecting patients' work and social life. It is also known as the “invisible killer” of human mental health.

Due to the large number of patients and high social impact, depression has become the fourth largest disease in the world, and the second leading cause of years of loss of healthy life expectancy (YLDs) due to disability (YLDs) worldwide. The disease already affects about 332 million people worldwide and can cause economic losses of nearly $1 trillion a year. Depression is also high in our country. According to the China Mental Health Survey, the prevalence of depression among adults in China is 6.8%, which is higher than the global average. Currently, there are about 95 million patients.

In recent years, along with the increase in public awareness of depression, patients' demand for medical treatment has also continued to rise, and the pharmaceutical market is also expanding more and more. According to Insight Consulting data, the market size of depression drugs in China has reached about 9.7 billion yuan in 2024, and is expected to grow at a compound annual growth rate of 8.1% to 14.3 billion yuan in 2029.

In stark contrast to the growing demand from patients, depression has a cure rate of less than 30%. This shows that the current treatment plan for depression, which is dominated by Western medicine, is actually not effective in meeting patients' treatment needs. Fundamentally, mainstream antidepressants on the market generally have disadvantages such as delayed efficacy, significant side effects, and easy recurrence after discontinuation. These factors seriously affect patients' compliance.

Therefore, developing a safe and effective novel antidepressant has always been a hot topic of research and urgent need in the pharmaceutical field. Traditional Chinese medicine, on the other hand, provides new ideas and directions for the current difficult development of drugs for depression. Take GPN01360, an innovative traditional Chinese medicine launched by Yuanda Pharmaceutical, as an example. This product is based on the ancient classic prescription “Xiaoyao San”, and its efficacy in relieving the liver, relieving depression, strengthening the spleen, and nourishing blood has been verified in rich clinical practice over the past 100 years. Furthermore, modern medical research has found that “Xiaoyao San” can achieve antidepressant effects by regulating intestinal microorganisms, liver and kidney metabolic disorders, etc.

GPN01360 has achieved better control of efficacy and safety through modern pharmacology and clinical research screening optimization on the basis of inheriting the essence of “Xiaoyao San”. According to the phase II clinical trial of 148 patients with depression enrolled in this phase II clinical trial, GPN01360 had significant differences (P<0.05) in the main clinical endpoint index, the total score of the 8-weekend Hamilton Depression Scale (HAMD-17), as well as multiple indicators of secondary clinical endpoints (P<0.05) compared to placebo, and the improvement of symptoms such as depression accompanied by anxiety and insomnia was also quite obvious. At the same time, GPN01360 also showed good safety and tolerability throughout the test period, and no obvious toxic side effects were found. These multi-dimensional indicators show the clinical value of the drug in improving core symptoms of depression.

These positive clinical research data have laid a solid foundation for the subsequent successful development of GPN01360, and are expected to solve the problem of poor patient adherence to existing Western medicines due to side effects, thereby improving the sustainability and effectiveness of long-term treatment and bringing new hope for improving the clinical cure rate of depression. At the same time, GPN01360 will also provide strong evidence-based medical evidence for traditional Chinese medicine to treat mental disorders such as depression, and verify the unique advantages and scientific value of proprietary Chinese medicine.

Collaborative empowerment of “aircraft carrier cluster” pipelines to continuously enhance the comprehensive advantages of the industry

In recent years, the market potential of traditional classic prescriptions has been fully unleashed, and the unique value of traditional Chinese medicine in chronic disease prevention and treatment has also been widely recognized. In this context, the country has introduced a number of policies to encourage the innovation and development of traditional Chinese medicine. The “Opinions on Comprehensively Deepening Pharmaceutical and Medical Device Supervision and Reform to Promote the High-Quality Development of the Pharmaceutical Industry” issued by the General Office of the State Council clearly states that it is necessary to increase support for research and innovation in traditional Chinese medicine research and development, and actively support the transformation of traditional Chinese medicine formulations from famous traditional Chinese medicine prescriptions and medical institutions into new traditional Chinese medicines. Strong policy support has injected a dose of strength into the innovation and development of traditional Chinese medicine. Since this year, China's efficiency in reviewing new traditional Chinese medicines has improved markedly. Compared with the same period last year, the approved new drugs have greatly improved, and innovative traditional Chinese medicine is ushering in a golden period of development.

As a Class 1.1 innovative traditional Chinese medicine, GPN01360 is a typical example of Yuanda Pharmaceutical's organic combination of traditional Chinese medicine and modern medicine. It is also a vivid practice of responding to national strategies and promoting the inheritance and innovation of traditional Chinese medicine. According to reports, the company has always taken proprietary Chinese medicines as one of the important layout directions in the facial medicine sector. Based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment, the company continues to deepen the traditional Chinese medicine circuit. On the basis of consolidating and improving the facial function product matrix, it has successfully expanded its business into the field of treatment of chronic cardiovascular diseases and neurology through the strategic layout of various proprietary Chinese medicines with significant competitive advantages such as cardiovascular and cerebrovascular chronic diseases and neurology.

At present, Yuanda Pharmaceutical is one of the major comprehensive enterprises in the R&D, production and sales of facial medicine in China. It has the highest number of product pipelines in the industry. The treatment field covers 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 cover the whole country.

With the continuous expansion of Yuanda Pharmaceutical's facial features business, based on the strong synergy of the “aircraft carrier cluster” product pipeline, the company not only continues to expand its leading edge in the original 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. Driven by both policy support and market drive, Yuanda Pharmaceutical relies on its strong industrial advantages to comprehensively enhance its comprehensive competitiveness in the field of chronic disease treatment with proprietary Chinese medicines, and is expected to continue to add strong growth impetus to the company in the future.