Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd. (referred to as "Fangsheng Jianmeng"), has received approval from the National Medical Products Administration for the clinical trial of its generic drug, RuLuGuoLi tablets, for the treatment of prostate cancer [1] Group 1 - The clinical trial approval indicates a significant step forward in the development of RuLuGuoLi tablets [1] - The project is part of the company's strategy to expand its product offerings in the oncology sector [1]

Group 1 - Company announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has received the clinical trial approval notice from the National Medical Products Administration for the development of the generic drug RuLuGuoLi tablets [1] - This approval marks a significant step in the company's efforts to expand its pharmaceutical product offerings and enhance its research and development capabilities [1]

证券代码：603998 证券简称：方盛制药 公告编号：2025-084 湖南方盛制药股份有限公司 关于子公司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"）全资子公司广东方盛健盟药业有限公司（以下简称"方 盛健盟"）化药仿制药研发项目瑞卢戈利片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： 湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 一、药物的基本情况 药物名称：瑞卢戈利片 剂型：片剂 注册分类：化药 3 类 申请事项：临床试验 受理号：CYHL2500136 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 8 月 1 日受理的瑞卢戈利片临床试验申请符合 药品注册的有关要求，同意本品开展前列腺癌的临床试验。 二、药品的相关情况 瑞卢戈利片为一种促性腺激素释放激素（GnRH）受体拮抗 剂，用于治疗成人 ...

湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 湖南方盛制药股份有限公司 关于控股股东部分股份质押的公告 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。 重要内容提示: ●湖南方盛制药股份有限公司（以下简称"公司"）控股股东暨实际控制人张庆华 先生办理完成了3,500万股（占公司总股本的7.97%）股份质押手续； ●截至本公告披露日，张庆华先生直接持有公司的股份总数为156,019,500股，占公 司股份总数（439,081,360股）的35.53%；张庆华先生质押的公司股份总数为100,905,200 股（含本次增加质押的股份），占其直接持有公司股份总数的64.67%，占公司股份总数 的22.98%；张庆华先生控股的湖南开舜投资咨询有限公司之控股子公司泰州共生咨询有 限公司（原"泰州共生创业投资管理有限公司"，以下简称"共生咨询"）持有公司股 份数为9,131,807股，共生咨询质押的公司股份总数为0股；张祖嵘女士持有公司股份数 423,300股，张祖嵘女士质押的公司 ...

Core Viewpoint - Fangsheng Pharmaceutical (603998) announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has received the Clinical Trial Approval Notice from the National Medical Products Administration for the development of the generic drug RuLuGoli Tablets, which is a GnRH receptor antagonist for the treatment of advanced prostate cancer in adults [1] Company Summary - The RuLuGoli Tablets have not yet been launched in China, and there are currently no original or generic products approved for sale in the country [1] - Other companies, such as Haibu Pharmaceutical and Lianhuan Pharmaceutical (600513), have also received clinical trial approvals and plan to conduct related clinical trials [1]

Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced that its wholly-owned subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd. (referred to as "Fangsheng Jianmeng"), has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its chemical generic drug research project, Relugolix tablets, which is a GnRH receptor antagonist used for the treatment of advanced prostate cancer [1]. Group 1 - Fangsheng Jianmeng has obtained regulatory approval for the clinical trial of Relugolix tablets [1]. - Relugolix is indicated for the treatment of adult patients with advanced prostate cancer [1].

Core Viewpoint - Fangsheng Pharmaceutical's subsidiary has received approval for a clinical trial of a new drug aimed at treating advanced prostate cancer, indicating progress in its drug development pipeline [1] Group 1: Company Developments - Fangsheng Pharmaceutical announced on October 15 that its wholly-owned subsidiary, Fangsheng Jianmeng, has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the drug RuLuGoli Tablets [1] - RuLuGoli Tablets are classified as gonadotropin-releasing hormone (GnRH) receptor antagonists, specifically designed for the treatment of adult advanced prostate cancer [1]

Core Viewpoint - Fangsheng Pharmaceutical's subsidiary has received approval for the clinical trial of a new drug, Relugolix, which is a GnRH receptor antagonist for treating advanced prostate cancer [1] Group 1: Drug Development and Approval - The clinical trial approval notification for Relugolix was issued by the National Medical Products Administration [1] - The total investment in the drug development project has reached approximately 3.89 million yuan (around 0.6 million USD) as of the announcement date [1] Group 2: Market Potential - The global sales of Relugolix in 2023 amounted to 300 million USD, reflecting a year-on-year growth rate of 58.6% [1] - The drug development process, from research to clinical trial approval and production, is lengthy and involves multiple stages, which can be affected by various uncertainties [1]

Core Viewpoint - Fangsheng Pharmaceutical's stock has shown a significant increase in price and trading activity, indicating positive market sentiment and potential investment interest [1][2]. Group 1: Stock Performance - Fangsheng Pharmaceutical's stock price increased by 21.18% year-to-date, with a 1.34% rise in the last five trading days, 7.44% in the last 20 days, and 18.57% in the last 60 days [2]. - As of October 14, the stock was trading at 12.13 CNY per share, with a market capitalization of 5.326 billion CNY [1]. Group 2: Financial Performance - For the first half of 2025, Fangsheng Pharmaceutical reported revenue of 834 million CNY, a year-on-year decrease of 8.35%, while net profit attributable to shareholders was 169 million CNY, reflecting a year-on-year increase of 23.67% [2]. Group 3: Shareholder Information - As of June 30, 2025, the number of shareholders increased to 33,100, with an average of 13,245 circulating shares per shareholder, a decrease of 0.36% from the previous period [2]. - The company has distributed a total of 689 million CNY in dividends since its A-share listing, with 444 million CNY distributed over the last three years [3]. Group 4: Institutional Holdings - As of June 30, 2025, major institutional shareholders include ICBC Medical Health Stock, holding 5.3997 million shares, and Rongtong Health Industry Flexible Allocation Mixed A/B, which increased its holdings by 500,000 shares to 5 million [3].

Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. has signed a contract with Liao Ning Yifan Pharmaceutical Co., Ltd. to acquire the marketing authorization for "Compound Dexamethasone Cream," which includes ownership of the drug formula, production process, technical secrets, and related patents and data [2][11]. Group 1: Transaction Overview - The company has entered into a technology transfer contract to acquire the marketing authorization for "Compound Dexamethasone Cream" [2]. - The transaction does not constitute a related party transaction or a major asset restructuring, and it is within the approval authority of the chairman, thus not requiring board or shareholder approval [2]. - The transfer fee is structured in three phases, with 30% payable within five working days of signing, another 30% upon completion of production site change, and 40% after receiving the approval notice from the drug review center [8]. Group 2: Market Situation - There are 103 companies in China that have obtained production licenses for "Compound Dexamethasone Cream" [3]. - The sales figures for the cream in physical pharmacies were 175 million yuan in the first half of 2025 and projected to reach 429 million yuan in 2024 [3]. - The global market sales for dexamethasone formulations were approximately $1.198 billion in 2022 and $1.203 billion in 2023 [3]. Group 3: Impact on the Company - The acquisition aligns with the company's strategy to become a health industry group focused on innovative traditional Chinese medicine, enhancing its product pipeline and potentially providing new profit growth points [11]. - The addition of this dermatological product category is expected to strengthen the company's market competitiveness and facilitate industry chain integration and expansion [11].