Livzon Pharmaceutical Group Inc. (01513) has announced that its subsidiary, Sichuan Guangda Pharmaceutical Co., Ltd., has received a Drug Registration Certificate (Certificate No.: 2026S03950) from the National Medical Products Administration for Wandaitang Granules.
The formulation of this product originates from Fu Qingzhu's Obstetrics and Gynecology, written by Fu Shan during the Qing Dynasty, and has been included in the National Administration of Traditional Chinese Medicine's Catalogue of Ancient Classic Famous Formulas (First Batch).
According to the original classical texts, this formula is a classic prescription for treating leukorrheal diseases. Its functions and indications are described as: "Tonifying the spleen and soothing the liver, resolving dampness and stopping vaginal discharge. Used for leukorrheal diseases with liver depression and spleen deficiency, and damp-turbidity pouring downward syndrome. Symptoms include white or pale yellow vaginal discharge that is thin and odorless, pale complexion, fatigue and loose stools, pale tongue with white coating, and slow or weak-soft pulse." The core therapeutic approach of the formula is to tonify the spleen and soothe the liver, resolve dampness and stop vaginal discharge.
This formula has been recorded in numerous gynecological medical cases throughout successive dynasties, and multiple modern clinical and experimental studies have also been conducted. It has been included in the planned textbook of Formula Science. As a commonly used gynecological formula, it is widely applied for excessive thin and clear vaginal discharge as well as chronic pelvic inflammatory disease, vaginitis, cervicitis, and other conditions belonging to spleen deficiency with excessive dampness.
As of the disclosure date of this announcement, the cumulative direct R&D investment in Wandaitang Granules amounts to approximately RMB 4.4746 million. This product is the first in China to be approved for marketing and is also the second Class 3.1 new drug approved for the Company, further enriching the Company's product pipeline and helping to enhance the market competitiveness of the Company's products. Following its launch, this product can promote the widespread clinical application of classic famous formulas, help improve the capacity of traditional Chinese medicine clinical diagnosis and treatment services, and enhance medication convenience for patients.
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