Grand Pharma (00512) is exploring the innovative track of traditional Chinese medicine treatment for depression with a goal of achieving billions in revenue. The first patient has been enrolled in the domestic Phase III clinical trial of GPN01360.

Domestic antidepressant drugs usher in a major breakthrough! GRAND PHARMA (00512) recently announced that the company's innovative traditional Chinese medicine GPN01360 for the treatment of depression has completed the first patient dosing in the domestic Phase III clinical trial. As a modern drug optimized from ancient classic prescriptions, if the subsequent clinical data of GPN01360 are positive, the product is expected to further reshape the current drug market for the treatment of depression with its differentiated therapeutic advantages, providing a new treatment option for depression patients, and may once again activate the development environment for traditional Chinese medicine, driving more high-quality varieties to enter the fast lane of clinical development. Modernizing classic ancient prescriptions, contributing Chinese solutions to 300 million global depression patients According to the announcement, GPN01360 is a key research and development achievement supported by the national "major new drug creation" special focus. The product is based on the ancient classic prescription "Xiao Yao San", and through modern pharmacology and clinical research optimization, it has achieved a breakthrough from "traditional prescription" to "modern innovative drug". The prescription consists of 12 Chinese herbs including Bupleurum, Gardenia, and Finger Citron, with the effects of soothing the liver, invigorating the spleen, relieving depression, and calming the spirit. It is accurately suitable for the liver depression and spleen deficiency type of depression, and can be used to relieve typical symptoms of depression such as emotional low, slow thinking, decreased will activity, restlessness, anxiety, insomnia, forgetfulness, decreased appetite, and fatigue. Previous Phase II clinical studies have shown that GPN01360 is safe, and has a significant improvement in symptoms such as depression accompanied by anxiety and insomnia, laying a good foundation for the progress of its Phase III clinical studies. The Phase III clinical study initiated by GPN01360 aims to evaluate the effectiveness, safety, and tolerability of the product compared to placebo in treating depression (liver depression and spleen deficiency syndrome). It plans to enroll 480 patients with depression, administer oral medication for 8 weeks, with the main endpoint being the change in the total score of the Hamilton Depression Rating Scale (HAMD-17) after 8 weeks of treatment compared to baseline, and simultaneously include multiple dimensions such as sleep quality for comprehensive evaluation. The clinical research of GPN01360 coincides with the huge unmet demand in the depression treatment market. It is reported that depression is the second leading cause of years lived with disability (YLDs) caused by all injuries worldwide, and is the primary factor of YLDs in the 15-29 age group. It can lead to a loss of 12 billion working days annually, with an economic loss of nearly 1 trillion US dollars, bringing a huge burden to global social productivity. According to the latest statistics from the World Health Organization (WHO), approximately 332 million people globally suffer from depression, with a total prevalence rate of about 4.0%. The adult prevalence rate is 5.7%. Focusing on China, the mental health survey in China shows that the prevalence rate of depression in the adult population is 6.8%, higher than the global average level, and the total number of patients exceeds 90 million. Behind the huge number of patients is a vast market space for medicines. Frost & Sullivan data shows that the market size of antidepressant drugs in China is expected to maintain a compound annual growth rate of 12.7% from 2018 to 2022, and the domestic market size of antidepressant drugs is expected to reach 24 billion RMB by 2030, while the global market size is estimated to reach 17.6 billion USD by 2030. Despite continuous high market growth, clinical treatment of depression in China still faces major shortcomings such as low cure rate and poor medication compliance. Currently, the 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, the existing main Western antidepressant drugs generally have problems such as delayed efficacy and significant side effects, leaving many patients in a dilemma of having no suitable medications available. In this context, there is an urgent need for more safe, effective, and highly compliant treatment options, and innovative traditional Chinese medicines such as GPN01360 may provide new treatment options for clinical practice. This will not only contribute a Chinese solution with unique characteristics to the global treatment of depression, but also help elevate the academic status of traditional Chinese medicine in the field of mental health. Expanding the new track of chronic disease treatment, promoting the strategic upgrade of traditional Chinese medicine business In fact, in recent years, the traditional Chinese medicine industry has been experiencing structural development opportunities. On the one hand, national policies continue to strengthen the inheritance and innovation of traditional Chinese medicine. The "Opinions of the State Council on Enhancing the Quality of Chinese Medicine and Promoting the High-Quality Development of Traditional Chinese Medicine Industry" clearly states the promotion of the listing of traditional Chinese medicine compound preparations based on ancient classic prescriptions, providing institutional guarantees for related enterprises; on the other hand, with the comprehensive release of the demand for chronic disease management, traditional Chinese medicine is continuously increasing production with advantages such as high safety and mild side effects. As a leading innovative comprehensive pharmaceutical company, GRAND PHARMA is adapting to policy and industry trends, gradually establishing advantages in the field of traditional Chinese medicine. The recent progress in the Phase III clinical research of GPN01360 is a significant milestone in the company's direction of traditional Chinese medicine for ophthalmology. In addition to the innovative traditional Chinese medicine GPN01360, the company also has the traditional Chinese medicine innovation drug GPN01020 for preventive treatment of migraine, which has been transformed from an in-hospital preparation of a Grade III Class A medical facility and has been clinically used for over thirty years. It has officially obtained approval from the Drug Administration to carry out Phase II clinical research, providing a new treatment option for migraine, a common chronic disease. As one of China's leading comprehensive enterprises in the research and development, production, and sales of ophthalmology medicines, GRAND PHARMA ranks among the industry leaders in the number of products in the pipeline, covering various medical disciplines including ophthalmology, otolaryngology, dentistry, etc. The company covers chemical preparations, traditional Chinese medicine preparations, and health products, including prescription drugs, OTC products, medical devices, consumer products, etc., and has established a professional marketing team with a nationwide marketing network. Leveraging a variety of drugs with differentiated innovative advantages, GRAND PHARMA is expected to achieve a systematic layout in the innovative traditional Chinese medicine business. Currently, based on the core advantages of traditional Chinese medicine in the treatment of chronic diseases, the company continues to focus on the path of traditional Chinese medicine, expanding new growth paths such as cardiovascular and cerebrovascular diseases, neurology, and other treatment fields, achieving a strategic transformation from the single field of ophthalmology to comprehensive treatment of chronic diseases. This transformation not only reflects GRAND PHARMA's in-depth exploration of the clinical value of traditional Chinese medicine, but also demonstrates its diversified, systematic, and integrated business layout strategy. With the strong synergistic effect of the "carrier-cluster" product pipeline, GRAND PHARMA continues to expand its leading advantages in the original field of ophthalmology and further focuses on emerging chronic disease tracks such as cardiovascular and cerebrovascular diseases, neurology, etc., expanding new growth paths. In the future, as multiple innovative traditional Chinese medicine pipelines continue to land and the commercialization capabilities continue to be released, the company is expected to form a benign development pattern with deep synergy and complementary empowerment in various business sectors and product categories, further solidifying its leading position in various advantageous tracks.