登录新浪财经APP 搜索【信披】查看更多考评等级 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 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。 二、新药的相关情况 本品系多年治疗盆腔炎的临床经验方审订而成。用于盆腔炎性疾病后遗症-慢性盆腔痛（湿热瘀结 证），症见下腹隐痛、腰骶胀痛、带下量多，色黄质稠、低热起伏、经期腹痛加重、胸闷纳呆、口干、 大便溏或便秘、小便黄赤者。 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 ...

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].