江苏康缘药业股份有限公司关于获得参蒲颗粒药品注册证书的公告

Core Viewpoint - Jiangsu Kangyuan Pharmaceutical Co., Ltd. has received the drug registration certificate for "Shenpu Granules," which is expected to provide a new treatment option for patients suffering from chronic pelvic pain due to pelvic inflammatory disease [1][2]. Drug Basic Information - Drug Name: Shenpu Granules - Main Ingredients: Dangshen, Daxueteng, Dandelion, Banzhu, and Soapberry [1] - Dosage Form: Granule - Specification: 6g per bag (equivalent to 33.6g of medicinal slices) - Registration Category: Traditional Chinese Medicine Class 1.1 - Exclusivity: Yes - Indications: Benefits Qi and activates blood circulation, clears damp-heat, and alleviates pain, specifically for chronic pelvic pain due to pelvic inflammatory disease [1][2]. Drug Development and Market Situation - Shenpu Granules, previously known as "Shenpu Pelvic Granules" and "Shenpu Pelvic Comfort Granules," is an exclusive product developed based on clinical experience from Professor Tan Yong of Nanjing University of Chinese Medicine [2][3]. - Clinical studies indicate that Shenpu Granules significantly alleviate chronic pelvic pain and improve various symptoms associated with pelvic inflammatory disease, showing good safety and tolerability [2][3]. - Pelvic inflammatory disease is common among women in China, with approximately 41% of women of childbearing age experiencing varying degrees of gynecological inflammatory diseases, and the incidence rate for married women reaching 70% [2][3]. Impact on the Company - The approval of Shenpu Granules enhances the company's product lineup in the gynecology sector, improving its market competitiveness and brand influence [4]. - The cumulative R&D investment in the Shenpu Granules project amounts to approximately 62.16 million yuan [3].