Breaking into the chronic disease track: GRAND PHARMA (00512)'s innovative Chinese patent medicine enrolls the first patient in its domestic clinical trial, potentially filling the gap in preventive migraine treatment

Recently, the domestic Phase II clinical study of GPN01020, a Class 1.1 innovative Chinese patent medicine developed by GRAND PHARMA (00512) for the preventive treatment of migraine, completed enrollment of its first patient. This marks another important milestone for GRAND PHARMA in the direction of Chinese patent medicines within its otorhinolaryngology segment, and also signifies that this innovative Chinese medicine, transformed from a hospital preparation, is steadily moving from long-term accumulation of clinical experience into the key stage of evidence-based verification. If future clinical research progresses smoothly, GPN01020 is expected to provide a localized treatment regimen 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 innovative Chinese medicine pathway of "human use experience + standardized clinical trials," GRAND PHARMA will also provide a replicable industry model for the standardized and industrialized development of Chinese medicine. From hospital preparation to Class 1.1 innovative Chinese medicine, a mature regimen targets the RMB10 billion migraine market According to the announcement, GPN01020 was transformed from a hospital preparation of a Grade 3A hospital, where it has more than 20 years of in-hospital clinical application experience. The product's indications are to promote blood circulation and remove blood stasis, regulate qi and tonify deficiency, and it is suitable for vascular neurogenic headache, traumatic headache, hypertension, cerebral arteriosclerosis, etc. with qi deficiency and blood stasis syndrome; previous clinical applications mainly focused on primary headaches (such as tension-type headache, migraine, etc.) and secondary headaches (such as vascular headache, neurovascular headache, etc.), with broad indication coverage and strong clinical adaptability. Previously conducted clinical studies have verified the efficacy and safety of GPN01020. According to the results of multiple IIT studies carried out earlier, GPN01020 has shown good efficacy and safety in reducing the number of migraine attack days and attack frequency and improving migraine-related symptoms, which will also provide strong data support for the smooth advancement of future clinical research on the product. The Phase II clinical study being advanced this time plans to enroll 180 patients with migraine (blood stasis obstruction syndrome), aiming to evaluate the efficacy, safety, and tolerability of GPN01020 compared with placebo in the preventive treatment of migraine attacks. Relying on this clinical trial, GPN01020, an experienced formula that has been accumulated in hospitals for more than 20 years, will truly embark on a standardized verification path that speaks through evidence-based evidence. It is reported that migraine is a common chronic episodic brain dysfunction disease, and long-term recurrent attacks can lead to serious health loss, reduced quality of life, and loss of productivity. The Global Burden of Disease Study 2019 report published by The Lancet shows that years lived with disability caused by migraine rank second among all human diseases. According to statistics, about 1.04 billion people worldwide suffer from migraine, with a lifetime prevalence of about 10% in men and about 22% in women; the annual prevalence of migraine in China is 9%, and the annual treatment cost for diagnosed patients exceeds RMB299.4 billion. In addition, according to GBD data, the number of migraine patients in China reached 199 million in 2021. In contrast to the huge patient population, the consultation rate and diagnosis rate are relatively low. According to data from the Chinese Guidelines for the Diagnosis and Treatment of Migraine (2022 Edition), the consultation rate for migraine in China is only 52.9%, and the correct diagnosis rate is only 13.8%. A large number of patients remain in a state of endurance or self-medication for a long time, and disease management is far from adequate. Beyond diagnosis, there are also many unmet needs at the clinical treatment level. Clinically, migraine cannot yet be cured, and existing drug treatment is divided into two pathways: acute attack treatment and preventive treatment. The focus of the former is rapid and sustained pain relief, restoration of patient function, and reduction of adverse events; the focus of the latter is to reduce the frequency of headache and aura attacks, alleviate headache severity, shorten duration, and thereby improve the efficacy of acute-phase treatment, reduce acute-phase medication consumption, avoid treatment escalation, reduce disability, and improve quality of life. For patients with frequent attacks, preventive treatment is the key link in disease control. However, for current mainstream therapeutic drugs, some patients have problems such as poor compliance and inability to tolerate adverse drug reactions. Therefore, there is an urgent clinical need for a drug with significant efficacy and good safety. The huge clinical gap corresponds to a considerable market size. Nature data show that the total value of the global migraine market reached US$9.6 billion in 2022 and is expected to reach US$17.5 billion in 2027; among this, the market size for preventive migraine is expected to be US$10.1 billion, with a compound annual growth rate of about 11.3%. Preventive treatment is precisely the fastest-growing segment of this market and the one most in need of new products. The preventive migraine treatment scenario corresponding to GPN01020 is exactly an area where current clinical needs have not yet been fully met. If future development progresses smoothly, GPN01020 will not only become another strong driver of GRAND PHARMA's performance growth, but the product will also provide new medication options for clinical practice and contribute a Chinese solution for migraine prevention to the world. Breaking through the chronic disease track relying on Chinese patent medicines, building a gradient product matrix In recent years, the state has continued to issue documents to support the inheritance and innovation of traditional Chinese medicine, providing clear policy support for enterprises to build Chinese patent medicine pipelines. A series of documents such as the 15th 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 propose support for the discovery and transformation of characteristic formulas such as classic famous formulas and experienced formulas of famous veteran Chinese medicine practitioners, and improve the review and evidence system of "three combinations" of traditional Chinese medicine theory, human use 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 Chinese medicines through a characteristic review system. At the same time, the treatment approach of traditional Chinese medicine, which emphasizes overall regulation and dynamic syndrome differentiation, naturally fits the logic of chronic disease prevention and treatment. The national-level shift from "focusing on treating diseases" to "focusing on health" has also created realistic conditions for the promotion of Chinese patent medicines in long-term chronic disease management. Industry experts said that traditional Chinese medicine has contributed more and more high-level evidence-based evidence, clinical guidelines, and international standards, contributing Chinese wisdom and Chinese solutions to global chronic disease prevention and treatment. GRAND PHARMA's layout of Class 1.1 new Chinese medicines such as GPN01020 derived from in-hospital proven formulas precisely aligns with the policy and industry mainline of encouraging the transformation of experienced Chinese medicine formulas and using traditional Chinese medicine to achieve chronic disease management. The company is based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment, continues to deepen its presence in the Chinese patent medicine track, and through strategic layout of multiple Chinese patent medicines with significant competitive advantages, has successfully expanded its business into treatment areas such as chronic cardiovascular and cerebrovascular diseases and neurology, and has achieved a strategic transformation of its Chinese patent medicine business from a single field of otorhinolaryngology to the comprehensive chronic disease treatment field. Among them, GPN01360, an innovative Chinese medicine for the treatment of depression, is an innovative Chinese medicine achievement supported by the national "Major New Drug Creation" special project, and its Phase III clinical study in China completed first patient enrollment and dosing in July 2026. GPN01360, together with GPN01020, which achieved R&D progress this time, and the company's already marketed Chinese patent medicines such as Danzhen Headache Capsules, Duoputai Maixuekang series, and Lishukang Capsules, have formed a good synergistic effect, achieving coverage of different scenarios such as acute attacks, preventive maintenance, and comorbid accompanying conditions, reaching patient groups at different disease stages and with different syndromes, and building a gradient product matrix from headache and circulatory disorders to neuropsychiatric comorbidities. Based on this Chinese patent medicine product matrix with differentiated advantages, GRAND PHARMA is also continuously broadening the boundaries of disease coverage in neurology and chronic cardiovascular and cerebrovascular diseases, strengthening 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 advantages in the field of traditional Chinese medicine for chronic neurological diseases. Looking ahead, GRAND PHARMA stated that the company will take patient needs as the core and technological innovation as the driver, increase investment in globally innovative products and advanced technologies in response to unmet clinical needs, enrich and improve the product pipeline and industrial layout, adopt the strategy of "global operational layout, dual-circulation business development," form a new pattern of domestic and international dual-circulation linkage and mutual promotion, fully leverage the company's industrial advantages and R&D strength, quickly bring technological innovation products to market, and provide global patients with more advanced and diverse treatment options.