Core Viewpoint - The market perceives a saturated space for anti-epileptic drugs, but there exists a significant treatment gap in epilepsy, with 51.7 million people affected globally as of 2021, and current medications having limited efficacy and notable side effects. New drugs with promising clinical data may address this unmet need [1][3]. Group 1: Treatment Gap in Epilepsy - Approximately 9 million epilepsy patients in China face a treatment gap, with around 30% of patients unable to achieve effective seizure control despite monotherapy or polytherapy [1][3]. Group 2: New Drug Development - The pipeline for anti-epileptic drugs is expanding due to the discovery of new targets and technologies, with breakthroughs expected to fill the unmet market needs. Current anti-seizure medications (ASMs) have limited efficacy and significant side effects [3]. - Notable advancements in overseas clinical trials include Xenon's XEN1101, Longboard's Bexicaserin, and Stoke's Zorevunersen, while domestic progress includes Hainan Haiyao's new generation KCNQ potassium channel activator [3].

Investment Rating - The report suggests a positive outlook for the epilepsy drug industry, highlighting potential breakthroughs in new drug targets and a rich pipeline of anti-seizure medications (ASMs) under development [3][59]. Core Insights - Epilepsy is a common neurological disorder with a significant patient population, estimated at 51.7 million globally and approximately 9 million in China, with 500,000 to 600,000 active cases annually [3][59]. - The mechanisms of epilepsy are complex, leading to a substantial treatment gap, as about 30% of patients do not achieve effective seizure control with current therapies [3][59]. - The research and development pipeline for ASMs is active, focusing on precision medicine and multi-target mechanisms, with promising candidates like XEN1101, Bexicaserin, and Zorevunersen showing advanced clinical progress [3][59]. Summary by Sections Section 1: Epilepsy as a Common Neurological Disorder - Epilepsy affects a large number of individuals, with a global prevalence rate of 658 per 100,000 people and a 10.8% increase in prevalence from 1990 to 2021 [8]. - In China, the estimated prevalence is about 7.0 per 1,000, with 40,000 new cases each year, making it the second most common neurological condition after headaches [8][29]. Section 2: ASMs as the Current Treatment of Choice - ASMs are the primary treatment for epilepsy, but they have limited efficacy and significant side effects, which continue to impact patient outcomes [20][29]. - The market for epilepsy treatment is projected to grow from approximately $8.6 billion in 2024 to $13.9 billion by 2034, with a CAGR of 5.1% [24][29]. Section 3: Active R&D Pipeline for ASMs - The focus of ASM development is on precision treatment and individualized medication, with over 200 projects currently disclosed, many in advanced clinical stages [33][36]. - Notable candidates include XEN1101, a potassium channel opener, which has shown promising results in reducing seizure frequency in clinical trials [39][44]. Section 4: Valuation of Key Companies - The report includes a valuation table for key companies in the epilepsy drug market, highlighting their market capitalization and projected revenues [61]. - Companies such as Hainan Haiyao and Lizhu Group are noted for their active pipelines and potential for growth in the epilepsy treatment sector [61].

证券代码：000566 证券简称：海南海药 海南海药股份有限公司 口服 2.5-25 mg 派恩加滨片后，药物迅速吸收，并 迅速生成代谢产物，两者均在达峰后快速分布，随后缓慢 消除。派恩加滨极少以原型形式从尿液中排泄，少量以代 谢产物形式从尿液排泄。食物影响研究显示食物会延长派 恩加滨及其代谢产物的 Tmax，但对于派恩加滨及其代谢 物的 PK 暴露量影响较小。 安全性情况：研究中无受试者发生 DLT、不良事件通 用术语标准(CTCAE)≥3 级的 TEAE、导致死亡的 TEAE、 严重给药期间不良事件(STEAE)和导致退出研究的 TEAE 或特别关注的不良事件(AESI)。 3、派恩加滨 Ib 期临床研究药代动力学结果和安全性 结果？ 回复：健康成年受试者口服派恩加滨后，可以迅速生 成代谢产物，多次剂量递增试验日总剂量 10mg~15mg 剂量 范围内派恩加滨以及代谢产物在连续用药 8-9 天后，其血 药浓度均已处于稳态，血药浓度及暴露量均随着剂量的增 加而逐渐提高。 所有受试者均未发生 SAE、SADR、>3 级的 TEAE 及 ADR、 导致退出试验的 TEAE 及 ADR。 4、派恩加滨Ⅱa 期疗效 ...

Core Viewpoint - Hainan Haiyao Co., Ltd. is accelerating its transformation into an innovative R&D pharmaceutical manufacturer, focusing on the development of new drugs and leveraging the Hainan Free Trade Port policies to enhance its product pipeline and contribute to public health [2][3][4]. Group 1: Innovation and R&D - The company has made significant progress with two new drugs, Fluorofenidone and Paenangin, marking a shift towards innovative drug development [2]. - Hainan Haiyao is committed to developing strategic emerging industries, establishing platforms for large molecule CDMO and national-level testing, and expanding its pipeline for rare and prevalent diseases [2][4]. - The company has increased its R&D investment and has achieved notable success in the generic drug sector, with 34 specifications of 16 products passing consistency evaluations since 2021 [4]. Group 2: International Collaboration and Product Introduction - Hainan Haiyao is actively introducing high-quality foreign products to enrich its product pipeline and enhance medical service levels, establishing partnerships with international biopharmaceutical companies [3]. - The company is negotiating with several global pharmaceutical giants to select products with advanced technology and significant market potential for introduction into China [3]. Group 3: Talent Development and Research Infrastructure - Hainan Haiyao has recruited over 90 high-level R&D talents from prestigious universities both domestically and internationally, establishing a new drug R&D system that integrates production, learning, and research [3]. - The company has set up specialized teams for overseas product introduction and technical analysis to accelerate the integration of advanced biopharmaceutical products [3].

投资者关系活动类 别 □特定对象调研 □分析师会议 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 √其他（电话会议） 活动参与人员 华夏基金管理有限公司 长盛基金管理有限公司 景顺长城基金管理有限公司 上市公司接待人员 姓名 董事会秘书、副总经理 石磊 证券事务代表 王小素 资深证券事务经理 曾文燕 时间 2025 年 5 月 14 日 地点 电话线上交流 交流内容及具体问 答记录 1、公司与中国药科大学联合实验室开展情况？ 回复：联合实验室主要从事创新药物与仿制药的研 发工作。其目标是对标国内外的先进水平，不断提高新 药研发的科学性、可靠性和权威性。公司与中国药科大 学开展临床候选化合物的发现研究、仿制药合成工艺方 面研究及体外生物活性评价平台建设等项目，目前还处 于比较早期的药物筛选与优化阶段。 2、派恩加滨目前的临床试验情况？入组病例情 况？目前同类型创新药研发情况？ 回复：公司正在开展派恩加滨Ⅱa 期临床研究，已 完成低剂量队列入组，正在进行中剂量队列入组，相关 临床入组正在进行，数据尚未揭盲。靶向 KCNQ 通道抗癫 痫创新药全球进展最快的为加拿大 Xenon 公司的 XEN110 ...

Group 1: Drug Development and Clinical Trials - Pinegabine is being developed using a stepwise approach, first assessing its efficacy in combination therapy before evaluating its effectiveness as a monotherapy [2] - The company is currently conducting Phase IIa clinical trials for Pinegabine, with low-dose cohort enrollment completed and mid-dose cohort enrollment ongoing [2] - Pinegabine is positioned as a me-better drug compared to Retigabine, which was withdrawn from the market due to safety concerns [3] Group 2: Market Analysis and Product Characteristics - Epilepsy is the second most common neurological disorder after stroke, with a significant portion of patients experiencing treatment-resistant epilepsy [4] - There is a lack of innovative antiepileptic drugs in recent years, particularly for special types of epilepsy and acute seizures [4] - Pinegabine demonstrates superior chemical stability and higher brain distribution compared to Retigabine, enhancing its efficacy and safety profile [4] Group 3: Patent and Market Strategy - The patent for Pinegabine is held by the Shanghai Institute of Materia Medica, with exclusive rights for clinical development and commercialization in mainland China [5] - The company plans to explore international rights transfer and partnerships based on the outcomes of Phase II clinical trials [5] Group 4: Future Prospects and Expansion - Pinegabine may expand its indications based on Phase II clinical results and market needs, potentially targeting conditions like severe depression due to KCNQ mutations [4] - Fluorofenone, another drug in development, is expected to enter Phase III clinical trials in the second half of 2025, having been included in the breakthrough therapy list by the National Medical Products Administration [6] - The company aims to focus on anti-fibrosis indications initially, with potential future expansions depending on clinical trial outcomes [6]

证券研究报告 医药生物 行业定期报告 hyzqdatemark 2025 年 04 月 28 日 证券分析师 刘闯 SAC：S1350524030002 liuchuang@huayuanstock.com 李强 SAC：S1350524040001 liqiang01@huayuanstock.com 板块表现： 抑郁/癫痫新药需求突出，建议关注华纳药厂/海南海药 投资评级： 看好（维持） ——医药行业周报（25/4/21-25/4/25） 投资要点： 投资观点及建议关注标的：展望 2025 年，我们认为医药板块已经具备多方面的积极发展因素， 请务必仔细阅读正文之后的评级说明和重要声明 联系人 本周医药市场表现分析：4 月 21 日至 4 月 25 日，医药指数上涨 1.16%，相对沪深 300 指数 超额收益为 0.77%。本周创新药板块依旧活跃，舒泰神、迪哲医药、荣昌生物等表现较好， 一季报陆续来临，Q1 业绩关注度逐步提升，甘李药业、何氏眼科、海泰新光等 Q1 业绩较好， 股价表现亮眼。建议关注：1）创新药出海不受关税影响，继续重点推荐 A 股信立泰、科伦药 业、热景生物、一品红、科兴制药、恒瑞医药； ...