The Zhitong Finance App learned that domestically produced antidepressants have ushered in significant progress! Yuanda Pharmaceutical (00512) recently announced that GPN01360, a Class 1.1 innovative traditional Chinese medicine drug used by the company to treat depression, has completed the first domestic phase III clinical study to enroll patients.
As a modern drug optimized from ancient classic formulations, if subsequent clinical data from GPN01360 is positive, the product is expected to further restructure the current drug market for depression treatment with differentiated treatment advantages, provide new treatment options for patients with depression, or re-activate the traditional Chinese medicine research and development ecosystem, driving more high-quality varieties into the fast track of clinical development.
Modernize and upgrade classic ancient recipes to contribute China's solutions to 300 million people with depression around the world
According to the announcement, GPN01360 is a traditional Chinese medicine innovation achievement focused on supporting research and development in the national “Major New Drug Creation” project. The product is based on the ancient classic formula “Xiaoyao San”, and has achieved a breakthrough from “traditional prescriptions” to “modern innovative drugs” through modern pharmacology and clinical research. The prescription consists of 12 traditional Chinese medicines such as chaihu, tulip, and Buddha's hand. It has the effects of relieving liver and spleen, and is accurately suited to liver and spleen deficiency depression, and can be used to relieve typical symptoms of depression such as depression, decreased mental activity, anxiety, insomnia and amnesia, and fatigue. Phase II clinical studies that have been completed previously showed that GPN01360 is safe and has significant improvements in symptoms such as depression accompanied by anxiety and insomnia, which also lays a good foundation for the promotion of phase III clinical research.
The purpose of the phase III clinical study initiated by GPN01360 was to evaluate the efficacy, safety, and tolerability of this product compared to placebo treatment for depression (liver depression and spleen deficiency). The main end point was the change in the total score of the Hamilton Depression Scale (HAMD-17) compared to the baseline after 8 weeks of treatment, and included a comprehensive evaluation of sleep quality and other multi-dimensional indicators.
The launch of GPN01360's clinical research coincided with a huge unmet demand in the depression treatment market. According to reports, depressive disorder is already the second leading cause of loss of years of healthy life expectancy (“YLDs”) due to disability worldwide. It is also the leading factor for YLDS in the 15-29 age group. It can cause losses of 12 billion working days and economic losses of nearly 1 trillion US dollars every year, putting a huge burden on global social productivity. 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. Focusing at home, 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.
Behind the huge disease base is a huge drug market space. Frost & Sullivan data shows that in 2018-2022, China's antidepressant market continued to grow at a compound annual growth rate of 12.7%. By 2030, the domestic antidepressant market will reach 24 billion yuan, while the global market size is expected to reach 17.6 billion US dollars by 2030.
Although the market continues to grow rapidly, clinical treatment of depression in China still faces huge shortcomings such as low cure rates and poor drug compliance. Currently, the clinical cure rate for depression in China is less than 30%, and the overall recurrence rate is as high as 75%-90%. In terms of drug treatment, existing antidepressants, mainly Western medicine, generally have problems such as delayed efficacy and large side effects, and a large number of patients still face the dilemma of not being able to use high-quality compatible drugs. In this context, there is an urgent need for more safe, effective, and highly compliant treatment options. Innovative traditional Chinese medicine, represented by GPN01360, may provide new clinical treatment options. This will not only contribute solutions with Chinese characteristics to global depression treatment, but also help enhance the academic status of traditional Chinese medicine in the field of psychiatry.
Broaden new chronic disease treatment tracks and promote strategic upgrading of proprietary Chinese medicine business
In fact, in recent years, the proprietary Chinese medicine industry has ushered in structural development opportunities. On the one hand, national policies continue to increase the inheritance and innovation of traditional Chinese medicine. The “Opinions of the General Office of the State Council on Improving the Quality of Traditional Chinese Medicine and Promoting the High-Quality Development of the Traditional Chinese Medicine Industry” clearly proposes to promote the marketing of ancient classic traditional Chinese medicine compound formulations, providing institutional guarantees for relevant enterprises; on the other hand, with the full release of chronic disease management requirements, proprietary Chinese medicines are continuing to be released with advantages such as high safety and mild side effects.
As a leading innovative comprehensive pharmaceutical company, Yuanda Pharmaceutical is gradually building an advantage in the field of proprietary Chinese medicine in line with policy and industry trends. The current phase III clinical study of GPN01360 has made new progress, which is a major milestone in the direction of the company's proprietary Chinese medicine in facial medicine. In addition to GPN01360, an innovative proprietary Chinese medicine, the company also has GPN01020, an innovative traditional Chinese medicine drug that can be used to prevent migraine. The product was converted from in-hospital preparations in grade 3 A medical institutions. It has now been officially approved by the Drug Administration to carry out phase II clinical research, which is expected to provide a new treatment option for migraine, a common chronic disease.
As one of the major comprehensive enterprises in the R&D, production and sales of facial medicine in China, Yuanda Pharmaceutical has the highest number of product pipelines in the industry. The treatment fields cover various 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, forming a marketing network covering the whole country.
Relying on a variety of drugs with differentiated and innovative advantages, Yuanda Pharmaceutical is expected to achieve a systematic layout of innovative proprietary Chinese medicine business. Currently, based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment, the company continues to cultivate the proprietary Chinese medicine circuit. Through the strategic layout of various proprietary Chinese medicines with significant competitive advantages, the company has successfully expanded its business into treatment fields such as cardiovascular and cerebrovascular chronic diseases and neurological medicine, and has achieved a strategic transformation of the proprietary Chinese medicine business from a single field of facial medicine to the field of comprehensive chronic disease treatment.
This transformation not only reflects Yuanda Pharmaceutical's deep exploration of the clinical value of traditional Chinese medicine, but also reflects its diversified, systematic and integrated business layout strategy. Based on the strong synergy of the “aircraft carrier cluster” product pipeline, Yuanda Pharmaceutical not only continues to expand its leading edge in the original field of facial surgery, but also continues to expand new growth tracks in emerging chronic diseases such as cardiology and neurology. In the future, as various innovative proprietary Chinese medicine pipelines continue to be launched and commercialization capabilities continue to be released, the company is expected to form a healthy development pattern of deep collaboration and complementary empowerment among various business segments and product categories, further consolidating its leading position on various competitive circuits.