The Zhitong Finance App learned that recently, Yuanda Pharmaceutical (00512) completed the first domestic phase II clinical study of GPN01020, a Class 1.1 innovative traditional Chinese medicine drug for the preventative treatment of migraines. This is another important milestone in the direction of proprietary Chinese medicine by Yuanda Pharmaceutical in the facial medicine sector. It also marks that this innovative traditional Chinese medicine, converted from in-hospital formulations, is steadily moving from long-term clinical experience accumulation to a critical stage of evidence-based verification.
If clinical research progresses smoothly in the future, GPN01020 is expected to provide a localized treatment plan for the prevention of chronic migraine and contribute Chinese wisdom to the long-term management of chronic neurological diseases. At the same time, relying on the traditional Chinese medicine innovation path of “human experience+standardized clinical trials”, Yuanda Pharmaceutical will also provide replicable industrial samples for the standardized and industrialized development of traditional Chinese medicine.
From in-hospital preparations to Class 1.1 innovative traditional Chinese medicine drugs, mature solutions point to the 10 billion migraine market
According to the announcement, GPN01020 was converted from an in-hospital formulation from a grade 3 A medical institution. The hospital has more than 20 years of in-hospital clinical application experience. The functional treatment of this product is to activate blood circulation, relieve qi deficiency, and is suitable for vascular neurological headaches, traumatic headaches, hypertension, cerebral arteriosclerosis, etc.; previous clinical applications have mainly focused on primary headaches (such as tension headaches, migraines, etc.) and secondary headaches (such as vascular headache, neurovascular headache, etc.), with a wide range of indications and strong clinical adaptability.
Previous clinical studies have verified the efficacy and safety of GPN01020. According to the results of various IIT studies conducted earlier, GPN01020 has shown good efficacy and safety in reducing the number and frequency of migraine attacks and improving migraine related symptoms. This will also provide strong data support for the smooth progress of future clinical research on this product.
The current phase II clinical study is to enroll 180 patients with migraine (blood stasis block syndrome) to evaluate the efficacy, safety, and tolerability of GPN01020 compared to placebo in preventing migraine attacks. Relying on this clinical trial, GPN01020, an empirical formula that has been accumulated in hospitals for more than 20 years, will truly embark on a standardized verification path based on evidence-based evidence.
According to reports, migraine is a common chronic seizure brain dysfunction disease. Repeated episodes over a long period of time can lead to serious loss of health, decreased quality of life, and loss of productivity. According to the “2019 Global Burden of Disease Study” report published by “The Lancet” magazine, the loss of life expectancy due to disability due to migraine ranked second among all human diseases. According to statistics, about 1.04 billion people worldwide suffer from migraines, with a lifetime prevalence rate of about 10% for men and 22% for women; the annual prevalence of migraine in China is 9%, and the annual treatment cost for confirmed patients exceeds 299.4 billion yuan. Also, according to GBD data, the number of migraine patients in China reached 199 million in 2021.
What contrasts with the huge number of patients is the low rate of treatment and diagnosis. According to the “Chinese Migraine Diagnosis and Treatment Guidelines (2022 Edition)”, the migraine treatment rate in China is only 52.9%, and the correct diagnosis rate is only 13.8%. A large number of patients have long been in a state of patience or self-medication, and disease management is far from being in place. In addition to diagnosis, there are also significant unmet needs at the clinical treatment level. Clinically, migraine is currently not curable. Current medication is divided into two routes: treatment during an acute attack and preventive treatment. The former focuses on rapid and continuous pain relief, restoration of patient function, and reduction of adverse events; the latter focuses on reducing the frequency of headaches and precursor attacks, reducing the extent and duration of headaches, thereby improving the efficacy of acute treatment, reducing acute medication consumption, avoiding treatment upgrades, reducing disability, and improving quality of life. For patients with frequent seizures, preventative treatment is a key part of disease control. However, with regard to current mainstream treatments, some patients have problems such as poor compliance and inability to tolerate adverse drug reactions. Therefore, clinically, there is an urgent need for a drug with remarkable curative effect and good safety.
The huge clinical gap corresponds to a considerable market size. According to Nature data, the total value of the global migraine market has reached 9.6 billion US dollars in 2022, and is expected to reach 17.5 billion US dollars in 2027; of these, the preventive migraine market is expected to be 10.1 billion US dollars, with a compound annual growth rate of about 11.3%. Preventive treatments are the fastest-growing segment of the market where new products are most needed. However, the migraine preventive treatment scenario corresponding to GPN01020 is an area where current clinical needs have not been fully met.
If development goes well in the future, GPN01020 will not only become another strong driving force for Yuanda Pharmaceutical's performance growth, but the product will also provide new clinical medication options and contribute to the world's migraine prevention plan.
Relying on proprietary Chinese medicines to break the chronic disease circuit and create a gradient product matrix
In recent years, the country has continued to issue documents to support integrity and innovation in traditional Chinese medicine, and provide clear policy support for enterprises to lay out proprietary Chinese medicine pipelines. A series of documents such as the “Fifteenth Five-Year Plan” for the Revitalization and Development of Traditional Chinese Medicine and the “Implementation Plan for the High-Quality Development of the Traditional Chinese Medicine Industry (2026-2030)” clearly state that they support the discovery and transformation of specialty formulations such as classic recipes, famous and old traditional Chinese medicine experience recipes, and improve the “three combinations” of traditional Chinese medicine theory, human experience, and clinical trials. This further clarifies the development direction of the traditional Chinese medicine industry, and is expected to accelerate the launch of new traditional Chinese medicines with a characteristic review system.
At the same time, the treatment ideas of overall regulation and dynamic diagnosis of traditional Chinese medicine are naturally in line with the logic of prevention and treatment of chronic diseases. The shift from “disease treatment as the center” to “health as the center” promoted at the national level has also created realistic conditions for the promotion of proprietary Chinese medicines in the long-term management of chronic diseases. Industry experts said that traditional Chinese medicine has contributed more and more high-level evidence-based evidence, clinical guidelines and international standards, and contributed Chinese wisdom and Chinese solutions to the global prevention and treatment of chronic diseases.
Yuanda Pharmaceutical's layout, such as GPN01020, has accurately followed the policy and industry line of encouraging the transformation of traditional Chinese medicine empirical recipes and the use of traditional Chinese medicine to manage chronic diseases. 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 chronic cardiovascular disease and neurology, 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.
Among them, GPN01360, an innovative traditional Chinese medicine drug used to treat depression, is a national “major new drug creation” project focused on supporting the research and development of traditional Chinese medicine innovations. The phase III clinical study carried out in China completed the first patient group administration in July 2026.
GPN01360 has formed a good synergy with GPN01020, which has made progress in research and development, and proprietary Chinese medicines such as Danzhen headache capsules, Doptay® Magecan series, and rishukang capsules, etc., to cover different scenarios such as acute attacks, prevention and maintenance, and comorbidities, reaching patient groups at different stages of onset and symptoms, and constructing a graded product matrix from headache and circulatory disorders to neuropsychiatric comorbidities.
Based on this proprietary Chinese medicine product matrix with differentiated advantages, Yuanda Pharmaceutical is also continuing to broaden its disease coverage boundaries in the fields of neurology, cardiovascular chronic diseases, and strengthen the R&D and industrialization layout of traditional Chinese medicine in the field of chronic brain diseases. The company has built a comprehensive chronic disease treatment platform and continues to consolidate its competitive advantage in the field of traditional Chinese medicine for chronic neurological diseases.
Looking forward to the future, Yuanda Pharmaceutical said that the company will take patient needs as the core, be driven by scientific and technological innovation, increase investment in innovative global products and advanced technology, enrich and improve product pipelines and industrial layout in response to unmet clinical needs, adopt a “global operation layout, dual cycle management development” strategy to form a new pattern of domestic and international dual cycle linkage development and mutual promotion, give full play to the company'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.