Core Viewpoint - Fangsheng Pharmaceutical (603998) announced that its subsidiary, Guangdong Fangsheng Rongo Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its innovative traditional Chinese medicine, Ziying Granules, which is based on years of clinical experience in treating pelvic inflammatory disease [1] Company Summary - Fangsheng Pharmaceutical's subsidiary has developed Ziying Granules, which is aimed at treating pelvic inflammatory disease [1] - The approval for clinical trials marks a significant milestone in the company's drug development efforts [1]

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].

Core Viewpoint - The announcement highlights that Fangsheng Pharmaceutical's subsidiary, Guangdong Fangsheng R&D Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of its innovative traditional Chinese medicine, Ziying Granules, aimed at treating chronic pelvic pain due to pelvic inflammatory disease [1] Company Summary - Fangsheng Pharmaceutical's Ziying Granules is classified as a Class 1 innovative traditional Chinese medicine [1] - The product is specifically designed for the treatment of chronic pelvic pain associated with pelvic inflammatory disease, characterized by damp-heat and blood stasis syndrome [1] - As of the date of the announcement, Ziying Granules have not yet been launched in domestic or international markets [1]

湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 药物名称：紫英颗粒 剂型：颗粒剂 注册分类：中药 1.1 类 申请事项：临床试验 受理号：CXZL2500030 证券代码：603998 证券简称：方盛制药 公告编号：2025-067 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，湖南方盛制药股份有限公司（以下简称"公司"或"方 盛制药"）控股子公司广东方盛融科药业有限公司（以下简称"方 盛融科"）中药创新药研发项目紫英颗粒收到国家药品监督管理 局核准签发的《药物临床试验批准通知书》。现将相关情况公告 如下： 一、药物的基本情况 妇科疾病是女性的常见病、多发病，中成药在妇科疾病的治 疗中占据重要地位。米内网数据显示，在我国零售药店终端中成 药妇科用药的销售额 2020-2023 年保持在 57 亿元左右，2024 年 前三季度增长率为 3.38%，整体平稳向前。从亚类情况 ...

Group 1 - The core point of the article is that Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its subsidiary, Guangdong Fangsheng R&D Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its innovative traditional Chinese medicine project, Ziying Granules [2] Group 2 - The approval signifies a significant step in the development of innovative drugs within the traditional Chinese medicine sector [2] - This development may enhance the company's portfolio and potentially lead to new revenue streams in the pharmaceutical market [2] - The clinical trial approval reflects the growing recognition and regulatory support for traditional Chinese medicine in the broader pharmaceutical industry [2]

Group 1 - The core point of the article is that Fangsheng Pharmaceutical (603998.SH) announced that its subsidiary, Guangdong Fangsheng Runkang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its innovative traditional Chinese medicine, Ziying Granules [1] - The product is developed based on years of clinical experience in treating pelvic inflammatory disease and is aimed at alleviating chronic pelvic pain as a sequela of pelvic inflammatory disease [1] - The symptoms targeted by the treatment include lower abdominal pain, lumbar and sacral discomfort, increased vaginal discharge with yellow and thick characteristics, fluctuating low fever, aggravated abdominal pain during menstruation, chest tightness, poor appetite, dry mouth, loose stools or constipation, and yellowish urine [1]

Group 1 - The core point of the article is that Fangsheng Pharmaceutical (603998.SH) announced that its subsidiary, Guangdong Fangsheng R&D Pharmaceutical Co., Ltd. (referred to as "Fangsheng R&D"), has received the clinical trial approval notice from the National Medical Products Administration for its innovative traditional Chinese medicine project, Ziying Granules [1] - The Ziying Granules are developed based on years of clinical experience in treating pelvic inflammatory disease and are specifically aimed at addressing chronic pelvic pain as a sequela of pelvic inflammatory disease [1] - The symptoms targeted by the Ziying Granules include lower abdominal pain, lumbar and sacral discomfort, increased vaginal discharge with yellow and thick characteristics, fluctuating low fever, exacerbated abdominal pain during menstruation, chest tightness, poor appetite, dry mouth, loose stools or constipation, and yellowish urine [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its self-developed traditional Chinese medicine, Ziying Granules, aimed at treating chronic pelvic pain due to pelvic inflammatory disease [1] Group 1 - The approved clinical trial is specifically for Ziying Granules, which targets chronic pelvic pain associated with pelvic inflammatory disease sequelae [1] - Ziying Granules is classified as a Class 1 innovative traditional Chinese medicine and has not yet been launched in domestic or international markets [1] - The symptoms addressed by Ziying Granules include lower abdominal pain, lumbar discomfort, increased vaginal discharge, and other related symptoms [1]

剂型：颗粒剂 受理号：CXZL2500030 注册分类：中药1.1类 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年5月22日受理的紫英颗粒 临床试验申请符合药品注册的有关要求，在进一步完善临床试验方案的基础上，同意本品开展用于盆腔 炎性疾病后遗症-慢性盆腔痛的临床试验。 格隆汇8月10日丨方盛制药(603998.SH)近日，公司控股子公司广东方盛融科药业有限公司(以下简称"方 盛融科")中药创新药研发项目紫英颗粒收到国家药品监督管理局核准签发的《药物临床试验批准通知 书》。 申请事项：临床试验 药物名称：紫英颗粒 ...

Group 1 - The core point of the article is that Fangsheng Pharmaceutical's subsidiary, Fangsheng R&D, has received approval from the National Medical Products Administration for the clinical trial of its innovative traditional Chinese medicine, Ziying Granules [1] - Ziying Granules is classified as a Class 1 innovative traditional Chinese medicine and has not yet been launched in domestic or international markets as of the announcement date [1] - The product is developed based on years of clinical experience in treating pelvic inflammatory disease and is specifically aimed at alleviating chronic pelvic pain associated with pelvic inflammatory disease sequelae [1]