紧张型头痛易反复发作，目前临床常用止痛、镇静类药物对症治疗，但长期用药副作用显著，还可能引 发药物过度使用性头痛，加重病情。养血祛风止痛颗粒的研发自2014年启动，累计投入约2700万元，相 继完成II期（2014—2018年）、III期（2018—2022年）临床试验及长期毒性试验（2023—2024年）。研 究证实，该药能减少头痛发作频率、时长及强度，改善头痛伴随的昏沉、乏力、心悸等中医症状，同时 降低止痛药使用趋势。遵循中医"急则治标，缓则治本"的原则，养血祛风止痛颗粒既能快速缓解短期头 痛症状，又能有效降低头痛发作频率，实现了短期疗效与长期调理的兼顾，且成分中不含毒性药材，安 全性高，契合慢性病长期管理的需求。 新药研发能力是方盛制药成立以来确立并持续打造的核心竞争优势。近年来方盛制药持续聚焦主业，加 大研发投入，显著提升了中药创新药的研发速度与效率，并成功推动小儿荆杏止咳颗粒、玄七健骨片等 中药创新药的获批上市及商业化。养血祛风止痛颗粒获批进一步丰富了方盛制药中药创新药产品管线， 将强化其"以中药创新药为核心的多产品矩阵"的综合竞争力，有利于加速推进"打造成为以中药创新药 为核心的健康产业集团"的发 ...

Core Viewpoint - Fangsheng Pharmaceutical has launched a new traditional Chinese medicine (TCM) product, "Yangxue Qufeng Zhitong Granules," which is the first TCM innovation drug targeting frequent tension-type headaches in China, enhancing the company's competitive edge in TCM innovation [1][2] Group 1: Product Launch and Development - The "Yangxue Qufeng Zhitong Granules" was officially launched on December 21, 2025, and is a significant achievement after over ten years of research and clinical trials [1] - This new drug is based on the classic formula "Shengxian Decoction" by renowned physician Zhang Xichun and received its drug registration certificate from the National Medical Products Administration in June 2025 [1] - Fangsheng Pharmaceutical has successfully developed three TCM innovation drugs since 2016, showcasing its leading capabilities in TCM innovation [1] Group 2: Sales and Future Plans - The company aims for the new TCM innovation drug to achieve over 100 million yuan in sales within two years and plans to launch 1-2 new TCM innovation drugs every 2-3 years [2] - The goal is to create a product matrix with multiple products generating annual sales of 300-500 million yuan, targeting a compound growth in performance over the next 3-5 years [2] Group 3: Ongoing Research and Development - Fangsheng Pharmaceutical has several TCM innovation drugs under development, including "Yiqi Xiaoliu Granules," "Ziying Granules," and "Fuke Zhi Xue Xiaotong Granules," with clinical trial approvals received [2] - Other ongoing projects include "Zhulong Tongluo Tablets," "Jianwei Qutong Pills," and "Sanhua Jiegou Pills," with "Xiaoer Jingxing Zhitong Granules" expanding to adult indications and "Jianwei Qutong Pills" currently in phase III clinical trials [2] Group 4: Strategic Focus on Industrial Hemp - Industrial hemp is a key focus in the company's development strategy, with its subsidiary, Yunnan Fuya Biotechnology Co., achieving large-scale production of high-purity CBD and related products [2] - The subsidiary has begun overseas sales, with revenue nearing 20 million yuan in the first three quarters of 2025, showing significant growth and a reduction in operating losses [2] - The company anticipates that its annual revenue will exceed 30 million yuan for the first time [2]

强化中药创新药战略布局 新药研发能力是方盛制药成立以来确立并持续打造的核心竞争优势。近年来，公司持续聚焦主业，加大 研发投入，显著提升了中药创新药的研发速度与效率，并推动小儿荆杏止咳颗粒、玄七健骨片等中药创 新药的获批上市及商业化。 作为一款神经系统疾病的中药创新药，养血祛风止痛颗粒获批进一步丰富方盛制药中药创新药产品管 线，将强化其"以中药创新药为核心的多产品矩阵"的综合竞争力，有利于公司加速推进"打造成为以中 药创新药为核心的健康产业集团"的发展战略，有望持续提升公司的整体盈利水平。 中证报中证网讯（记者 吴科任）12月21日，方盛制药（603998）在长沙举办"养血祛风止痛颗粒"新品 上市发布会暨投资者接待日活动。方盛制药相关负责人表示，养血祛风止痛颗粒是我国首个用于频发性 紧张型头痛的1.1类中药创新药，于2025年6月获得国家药监局颁发的《药品注册证书》。该新药源于近 代名医张锡纯"升陷汤"经典方剂，历经十余年研发与临床试验，成为国内首个明确针对频发性紧张型头 痛（气血两虚证）的中药创新药。 新产品潜在市场需求大 根据中华医学会神经病学分会、中华医学会神经病学分会头痛协作组编制发布的《中国紧张型头痛 ...

公司全资子公司云南芙雅生物科技有限公司的工业大麻业务在2025年前三季度营业收入接近2000万元， 同比大幅增长，预计全年营收有望首次突破3000万元。 方盛制药主营业务为药品的研发、生产与销售。前三季度公司实现归母净利润2.68亿元，同比增长 17.60%。 核校：孙萍 中证智能财讯 方盛制药（603998）12月21日举办新品上市发布会暨投资者接待日活动，公司管理层就 近期经营、研发及新品规划与投资者进行了交流。活动重点提及，公司中药创新药"养血祛风止痛颗 粒"近期通过国家医保谈判，首次纳入2025年国家医保目录。 公司在交流中介绍了未来战略布局，表示将加大中药创新药投入，未来三年加速在研管线进程，并着力 打造多个年销售额达3至5亿元的产品矩阵。对于新纳入医保的养血祛风止痛颗粒，公司制定了2026年的 市场目标，计划覆盖公立医疗机构超过500家，并力争其销售收入超过公司上一款中药创新药"玄七健骨 片"的首年销售水平。 研发方面，公司目前拥有覆盖多科室的中药创新药研发管线，其中益气消瘤颗粒、紫英颗粒等多个项目 已获得药物临床试验批准通知书。此外，化药研发项目吲哚布芬片已取得药品注册证书。 ...

Core Points - The company has completed the change registration of its "Drug Production License" and obtained the new license from the Hunan Provincial Drug Administration [1][2] - The changes include the addition of new production ranges for tablets and raw materials, as well as the acceptance of commissioned production for specific products [1][3] - The new license will not significantly impact the company's existing production structure or current performance [3] Summary of Changes - The production address at 789 Lushong Road, Changsha, Hunan, has added a new production range for tablets, which will only be used for registration purposes [1] - The raw material production facility at 368 Huanglong Road, Tongguan Town, has added new raw materials for registration, including Remdesivir and others [1] - The company will produce Huangtengsu dispersible tablets and Jingangteng dispersible tablets under commission from Hunan Xiangya Pharmaceutical Co., Ltd. [1] - The company will also produce Yinhuang granules under commission from Hunan Ruixin Pharmaceutical Co., Ltd. [1] Impact on the Company - The changes in the "Drug Production License" will not affect the company's existing production capacity, which will remain stable [3] - The company does not expect any significant impact on its current performance due to the new license [3] Product Inclusion in National Medical Insurance - The company's product, Yinxue Qufeng Zhitong Granules, has been included in the 2025 National Medical Insurance Directory, which is expected to enhance its market promotion and sales potential [5][7] - This product is based on a traditional Chinese medicine formula and has not yet been officially launched for sale [6][7] - The company aims to strengthen its position in the market by increasing investment in the research and development of innovative Chinese medicine products [7]

Group 1: Core Views - Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its innovative traditional Chinese medicine, Yangxue Qufeng Zhitong Granules, has been included in the National Medical Insurance Directory for 2025, which is expected to enhance market promotion and sales scale [1][3] - The product is based on a modified formula of a well-known traditional Chinese medicine and aims to supplement qi and nourish blood while alleviating pain [1][2] Group 2: Drug Sales Situation - Yangxue Qufeng Zhitong Granules, classified as a Category 1 innovative traditional Chinese medicine, was approved for listing on June 9, 2025, but has not yet officially commenced sales [2] Group 3: Impact on the Company - The inclusion of Yangxue Qufeng Zhitong Granules in the medical insurance directory is anticipated to positively impact the company's future operating performance and market share, although it will not have a significant short-term effect [3] - The company has a strategic goal to become a health industry group centered on innovative traditional Chinese medicine, with plans to increase investment in research and market cultivation [3]

GPN01360 是一款用于治疗抑郁症(肝郁脾虚证)的1.1类中药创新药，基于古代经典方剂"逍遥散"，通过 现代药理学与临床研究筛选优化而成，处方由柴胡、郁金、佛手等12 味中药组成，具有疏肝健脾、解 郁安神的功效。该中药主要用于治疗肝郁脾虚型抑郁症，其典型症状包括情绪低落、思维迟缓、意志活 动减退、心烦焦虑、失眠健忘、食少纳呆及神疲乏力等。前期近百人的人用经验研究表明，GPN01360 在改善抑郁症状、缓解焦虑失眠及调理脾胃功能方面表现出良好疗效与安全性。 抑郁症也称抑郁障碍，是一种常见的精神障碍，可影响患者的工作、学习和社会生活，严重时可导致自 杀，且复发率高达75%-90%，是一种终生性疾病，是全球精神障碍所致疾病负担的首要原因，也是全球 重大的公共卫生问题。根据世界卫生组织(WHO)最新统计数据，全球大约有3.32亿人患有抑郁症，总患 病率约4.0%，其中成人患病率达5.7%。抑郁症是全球范围内全因伤残引起的健康寿命损失年(years lived with disability，"YLDs")的第二大因素，其中在15-29岁年龄组中，是YLDs的首要因素，为全球社会生 产力带来了巨大负担，抑郁与焦虑每 ...

该研究是一项随机、双盲、安慰剂平行对照、多中心的II期临床研究，入组148例抑郁症患者，口服给 药8周，旨在初步评价GPN01360相较于安慰剂治疗抑郁症(肝郁脾虚证)的有效性和安全性。该研究的主 要临床终点指标为8周末汉密尔顿抑郁量表(「HAMD-17」)总分较基线的变化值；次要终点包括8周末 蒙哥马利-艾斯伯格抑郁量表(「MADRS」)总分较基线的变化值、8周末HAMD-17缓解率和有效率、8周 末匹兹堡睡眠质量指数(「PSQI」)评分较基线的变化值、临床总体印象量表-疾病严重程度(CGI-S)、临 床总体印象量表-总体改善(CGI-I)评分较基线的变化值、不良事件发生率等有效性和安全性指标。 格隆汇12月8日丨远大医药(00512.HK)公告，近日，集团用于治疗抑郁症的中药创新药GPN01360在中国 开展的II期临床研究成功达到临床终点。这次临床研究的成功是集团在五官科板块中成药方向的重大里 程碑进展。 GPN01360是一款用于治疗抑郁症(肝郁脾虚证)的1.1类中药创新药，基于古代经典方剂「逍遥散」，通 过现代药理学与临床研究筛选优化而成，处方由柴胡、郁金、佛手等12味中药组成，具有疏肝健脾、解 郁 ...

Core Viewpoint - Yiling Pharmaceutical's innovative traditional Chinese medicine, Qifang Nizhong Pian, has been included in the National Medical Insurance Directory for 2025, marking a significant recognition of its innovation and clinical efficacy in treating allergic rhinitis [1] Group 1: Product Inclusion and Market Impact - Qifang Nizhong Pian is one of 12 exclusive products from Yiling Pharmaceutical included in the national medical insurance directory [1] - The recent adjustment added 114 new drugs, with 50 being innovative drugs, indicating a strong policy support for "true innovation" in the pharmaceutical industry [1] Group 2: Clinical Efficacy and Research Support - Qifang Nizhong Pian has demonstrated significant efficacy in treating persistent allergic rhinitis, with a total clinical symptom improvement rate of 74.71% and a patient satisfaction improvement rate of 89% [3] - The drug's safety and efficacy were validated through randomized, double-blind, placebo-controlled, multi-center Phase II and III clinical trials, published in the international journal "Ethnopharmacology" [3] Group 3: Mechanism of Action and Advantages - The pharmacological mechanisms of Qifang Nizhong Pian include anti-allergic, anti-inflammatory, immune regulation, and improvement of nasal mucosal tissue damage, supporting its "holistic treatment" approach [4] - Compared to other treatments for allergic rhinitis, Qifang Nizhong Pian offers comprehensive regulation, improving both local and systemic symptoms, thus aiding patients in quickly resuming their daily activities [4] Group 4: Additional Products - In addition to Qifang Nizhong Pian, Yiling Pharmaceutical has 11 other exclusive products, including Tongxinluo, Ginseng Pine Heart Capsules, and Lianhua Qingwen, that have also entered the new medical insurance directory [4]

Core Viewpoint - Fangsheng Pharmaceutical's subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has successfully negotiated to include its exclusive product, Yao Xue Qu Feng Zhi Tong Granules, in the 2025 Medical Insurance Directory, which is expected to positively impact the company's future performance and market share, although the short-term effects will be limited [1] Summary by Categories Product Information - Yao Xue Qu Feng Zhi Tong Granules is classified as a Category 1.1 innovative traditional Chinese medicine and was approved for market launch on June 9, 2025 [1] - The payment standard for the product is set at 7 yuan per bag (8g), with an effective period until December 31, 2027 [1] Market Impact - The inclusion in the medical insurance directory is anticipated to have a positive effect on the company's future performance and market share [1] - There are no changes in the status of other major products, with no exits or additions reported [1]