Zhitong Finance App News, Yuanda Pharmaceutical (00512) announced that recently, the Group completed the first patient enrollment in the Phase II clinical study of GPN01020, an innovative traditional Chinese medicine drug for preventive treatment of migraines in China. The study was a randomized, double-blind, placebo-controlled, multicenter phase II clinical study involving 180 migraine patients to evaluate the efficacy, safety, and tolerability of GPN01020 compared to placebo in preventing migraine attacks. The completion of this clinical study to enroll the first patient is a major milestone in the Group's proprietary Chinese medicine sector.
GPN01020 is a Class 1.1 innovative traditional Chinese medicine, intended for the preventive treatment of migraine (hemorrhagic blockade). This product was converted from in-hospital formulations in grade 3 A medical institutions, and has been clinically used in this hospital for more than 20 years. Its functions are to activate blood circulation and relieve qi deficiency. It is suitable for vascular neurological headache, traumatic headache, hypertension, and cerebral arteriosclerosis with symptoms of gas ischemia and blood stasis. The main clinical application areas of this product have mainly included primary headache (such as tension headache, migraine, etc.) and secondary headache (such as vascular headache, neurovascular headache, etc.). The results of several IIT studies conducted earlier showed that GPN01020 showed good efficacy and safety in reducing the number and frequency of migraine attacks and improving migraine related symptoms.
In the direction of proprietary Chinese medicine, the group continues to cultivate based on the core advantages of traditional Chinese medicine in the field of chronic disease treatment. On the basis of consolidating and improving the facial medicine product matrix, the group successfully expanded its business into treatment fields such as cardiovascular and cerebrovascular chronic diseases and neurological medicine through a strategic layout of various proprietary Chinese medicines with significant competitive advantages, and realized the strategic transformation of the proprietary Chinese medicine business from a single field of facial medicine to the field of comprehensive chronic disease treatment. Among them, GPN01360, an innovative traditional Chinese medicine drug used to treat depression, is a traditional Chinese medicine innovation that the country's “Major New Drug Creation” project focuses on supporting research and development. The Phase III clinical study carried out in China completed the first patient enrollment in July 2026. The two innovative Chinese medicine drugs under development form a good synergy with existing proprietary Chinese medicines such as Danzhen headache capsules, Doptai® Maxukang series, and lishukang capsules. The pipeline combination can cover different scenarios such as acute attacks, prevention and maintenance, and comorbidities, reach patient groups with different stages of onset and symptoms, and construct a graded product matrix from headache and circulatory disorders to further broaden the Group's disease coverage boundaries in the fields of neurology and chronic cardiovascular diseases, and strengthen the Group's disease coverage boundaries in the field of neurology and chronic cardiovascular disease. Industrialized layout to build and consolidate a differentiated comprehensive chronic disease treatment platform for the Group The achievements of the strategic transformation of the proprietary Chinese medicine sector and continuing to build a competitive advantage in the field of traditional Chinese medicine for chronic neurological diseases are of great strategic significance.