Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its subsidiary, Guangdong Fangsheng R&D Pharmaceutical Co., Ltd., received approval for clinical trials of the innovative traditional Chinese medicine, Ziying Granules, aimed at treating chronic pelvic pain due to pelvic inflammatory disease [1][6]. Group 1: Drug Information - The drug Ziying Granules is classified as a Class 1.1 traditional Chinese medicine and is intended for clinical trials to treat chronic pelvic pain resulting from pelvic inflammatory disease [1][2]. - The cumulative R&D investment for this drug project is approximately 8.4717 million yuan (about 1.2 million USD) as of the announcement date [3]. Group 2: Market Situation - The market for traditional Chinese medicine in gynecological diseases has shown stability, with sales remaining around 5.7 billion yuan from 2020 to 2023, and a growth rate of 3.38% in the first three quarters of 2024 [4]. - The market share for gynecological regulation drugs is 47.38%, with a year-on-year sales growth of 6.61%, while gynecological inflammation drugs account for 35.02% of the market, with a slight decline in sales by 1.75% [4]. - The demand for drugs treating chronic pelvic pain is significant, with various existing products in the market, including Fuke Qianjin Tablets and Guizhi Fuling Capsules, which have notable sales figures [4][5]. Group 3: Approval Process - Following the receipt of the clinical trial approval, Fangsheng R&D will conduct the necessary clinical trials and compile the application materials for product registration and market launch [6].
湖南方盛制药股份有限公司关于控股子公司中药创新药研发项目获得药物临床试验批准通知书的公告