Grand Pharma (00512) announced that its innovative Traditional Chinese Medicine drug GPN01020, intended for the preventive treatment of migraines, has recently received approval from the National Medical Products Administration of China to proceed with Phase II clinical studies. The trial is designed as a randomized, double-blind, placebo-controlled, multicenter Phase II study, planning to enroll 180 migraine patients. It aims to evaluate the efficacy, safety, and tolerability of GPN01020 compared to a placebo in preventing migraine attacks in patients diagnosed with blood stasis syndrome.
This approval marks a significant milestone for the company's Traditional Chinese Medicine development efforts within its ophthalmology and otolaryngology segment. GPN01020 is classified as a Class 1.1 innovative Traditional Chinese Medicine drug and is intended for the preventive treatment of migraines associated with blood stasis syndrome. The product originated from a hospital preparation used in a top-tier tertiary medical institution and has been clinically applied there for over 20 years. Its functions include promoting blood circulation, removing blood stasis, regulating qi, and tonifying deficiency. It is indicated for vascular neurogenic headaches, post-traumatic headaches, hypertension, and cerebral arteriosclerosis related to qi deficiency and blood stasis.
Previous clinical applications have primarily focused on primary headaches, such as tension-type headaches and migraines, as well as secondary headaches, including vascular and neurovascular headaches. Results from earlier investigator-initiated clinical studies involving hundreds of patients have shown that GPN01020 exhibits favorable efficacy and safety in reducing the number of migraine days and frequency of attacks, as well as improving migraine-related symptoms.
According to the Chinese Guidelines for the Diagnosis and Treatment of Migraine, migraine is a common chronic episodic brain dysfunction disorder. Long-term recurrent attacks can lead to significant health loss, reduced quality of life, and productivity decline. A report from The Lancet's Global Burden of Disease Study 2019 indicated that migraine ranks second among all diseases globally in terms of years lived with disability. Statistics show that approximately 1.04 billion people worldwide suffer from migraines, with a lifetime prevalence of about 10% in men and 22% in women. In China, the annual prevalence of migraine is 9%, and the annual treatment cost for diagnosed migraine patients exceeds 299.4 billion yuan, posing substantial negative impacts on patients, families, and society. Migraine has thus become a major global public health issue.
Currently, there is no cure for migraine, and clinical management primarily relies on pharmacological treatments to control symptoms effectively. Migraine drug therapy is divided into acute treatment for发作期 and preventive treatment. The former focuses on rapid and sustained pain relief, restoring patient function, and reducing adverse events, while the latter aims to reduce the frequency and severity of headaches and auras, shorten duration, improve the efficacy of acute treatments, reduce medication overuse, and enhance quality of life by minimizing disability. However, some patients experience poor compliance or intolerance to adverse effects with current mainstream treatments, creating an urgent clinical need for drugs with significant efficacy and good safety profiles. Grand Pharma's GPN01020 is expected to offer a new therapeutic option.
As one of China's leading integrated companies in the research, development, production, and sale of ophthalmology and otolaryngology drugs, Grand Pharma maintains one of the industry's largest product pipelines. Its therapeutic areas cover multiple specialties, including ophthalmology, otolaryngology, and stomatology, with products spanning chemical drugs, Traditional Chinese Medicine preparations, and health products across categories such as prescription drugs, OTC medications, medical devices, and consumer goods. The company has established a professional marketing team and a nationwide sales network.
Traditional Chinese Medicine represents a key strategic direction within Grand Pharma's五官科 segment. Leveraging the core advantages of Traditional Chinese Medicine in chronic disease management, the company continues to deepen its presence in this area. By strategically expanding its portfolio with competitively advantaged products such as the Maixuekang series, Danzhen Toutong Capsules, and Lishukang Capsules, Grand Pharma has successfully extended its business into chronic disease areas like cardiovascular and cerebrovascular diseases and neurology. This has enabled a strategic transition from a focus solely on五官科 to a broader chronic disease treatment landscape.
Benefiting from the strong synergistic effects of its "aircraft carrier cluster" product pipeline, Grand Pharma is not only strengthening its position in its original五官科 domains but also actively exploring new chronic disease treatment directions such as cardiology and neurology. The aim is to systematically broaden the scope of chronic disease management and open up new growth avenues.
The company remains highly committed to the research and development of innovative products and advanced technologies. Centered on patient needs and driven by technological innovation, Grand Pharma continues to increase investment in global innovative products and advanced technologies to address unmet clinical demands. Through its strategy of "global operation layout and dual-circulation development," the company fosters a new pattern of domestic and international synergy, leveraging its industrial strengths and R&D capabilities to rapidly bring innovative technological products to market, providing more advanced and diverse treatment options for patients worldwide.
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