GRAND PHARMA (00512): First patient enrolled in Phase II clinical study in China of GPN01020, an innovative traditional Chinese medicine for preventive treatment of migraine

GRAND PHARMA (00512) announced that recently, the Group's innovative traditional Chinese medicine GPN01020 for the preventive treatment of migraine has completed the enrollment of the first patient in its Phase II clinical study conducted in China. The study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical study planning to enroll 180 migraine patients, aimed at evaluating the efficacy, safety, and tolerability of GPN01020 compared with placebo in the preventive treatment of migraine attacks (blood stasis obstruction syndrome). The completion of first patient enrollment in this clinical study is a major milestone for the Group in the direction of Chinese patent medicines within the otorhinolaryngology (ENT) segment. GPN01020 is a Class 1.1 innovative traditional Chinese medicine, intended for the preventive treatment of migraine (blood stasis obstruction syndrome). This product was transformed from a hospital preparation of a Grade 3A hospital and has been used clinically in that hospital for more than twenty years. Its indications are to promote blood circulation and remove blood stasis, regulate qi and tonify deficiency, and it is applicable to vascular neuropathic headache, traumatic headache, hypertension, cerebral arteriosclerosis, etc. of qi deficiency and blood stasis syndrome. The product's previous main clinical application areas mainly include primary headaches (such as tension-type headache, migraine, etc.) and secondary headaches (such as vascular headache, neurovascular headache, etc.). Results from multiple previously conducted IIT studies show that GPN01020 has demonstrated good efficacy and safety in reducing the number of migraine attack days and attack frequency, and improving migraine-related symptoms. In the direction of Chinese patent medicines, the Group, based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment, continues to deepen its efforts. On the basis of consolidating and improving the ENT product matrix, through strategic layout of multiple Chinese patent medicines with significant competitive advantages, it has successfully expanded its business into treatment areas such as cardio-cerebrovascular chronic diseases and neurology, achieving a strategic transformation of its Chinese patent medicine business from the single ENT field to the comprehensive chronic disease treatment field. Among them, GPN01360, an innovative traditional Chinese medicine for the treatment of depression, is an innovative traditional Chinese medicine achievement supported by the national "Major New Drug Creation" special program, and its Phase III clinical study conducted in China completed the enrollment and dosing of the first patient in July 2026. The two innovative traditional Chinese medicines under development form good synergy with marketed Chinese patent medicines such as Danzhen Toutong Capsules, Duoputai Maixuekang series, and Lishukang Capsules. The pipeline combination can achieve coverage of different scenarios such as acute attacks, preventive maintenance, and comorbid accompanying conditions, reaching patient groups at different stages of onset and with different syndromes, building a gradient product matrix from headache and circulatory disorders to neuropsychiatric comorbidities, further broadening the Group's disease coverage boundaries in neurology and cardio-cerebrovascular chronic disease fields, and strengthening the research and development and industrialization layout of traditional Chinese medicine in the brain chronic disease field. This is of important strategic significance for the Group to build a differentiated comprehensive chronic disease treatment platform, consolidate the achievements of the strategic transformation of the Chinese patent medicine segment, and continuously build competitive advantages in the field of traditional Chinese medicine for neurological chronic diseases.