宫炎平片/胶囊

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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
Shang Hai Zheng Quan Bao· 2025-08-10 18:40
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].
方盛制药: 方盛制药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
Zheng Quan Zhi Xing· 2025-08-10 08:16
Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its subsidiary, GuangDong Fangsheng R&D Pharmaceutical Co., Ltd., received approval for clinical trials of its innovative traditional Chinese medicine, Ziying Granules, aimed at treating chronic pelvic pain due to pelvic inflammatory disease [2][3]. Drug Information - Drug Name: Ziying Granules - Dosage Form: Granule - Registration Category: Traditional Chinese Medicine Class 1.1 - Application Matter: Clinical Trials - Acceptance Number: CXZL2500030 - Approval Conclusion: The clinical trial application for Ziying Granules was accepted on May 22, 2025, and is approved to proceed with trials for chronic pelvic pain [2][3]. New Drug Details - Ziying Granules are based on clinical experience for treating pelvic inflammatory disease and are intended for chronic pelvic pain with symptoms including lower abdominal pain, lumbar discomfort, and abnormal discharge [3]. Market Situation for Similar Drugs - The market for traditional Chinese medicine in gynecological diseases has maintained sales around 5.7 billion yuan from 2020 to 2023, with a growth rate of 3.38% in the first three quarters of 2024. The market share for gynecological regulation drugs is 47.38%, with a year-on-year sales increase of 6.61% [3]. - The demand for drugs treating pelvic inflammatory disease is significant, with over 3.2 billion yuan in sales for traditional Chinese medicine gynecological drugs in urban pharmacies in the first three quarters of 2024, despite a 6.40% year-on-year decline [3]. Competitor Products - Current treatments for chronic pelvic pain include various products such as Fuke Qianjin Tablets/Capsules, Guizhi Fuling Capsules/Pills/Tabs, and others, with sales data indicating significant market presence [4][5].