Group 1 - The company conducted an investor relations activity focusing on the progress of innovative drug research and development, overseas rights cooperation, resolution of industry competition, and layout in the health sector [2] - The company is currently conducting Phase IIa clinical trials for the innovative drug Painegabine, with 100% enrollment of the target 36 participants, and expects to unblind and read results by the end of 2025 [2] - The company has completed the Phase II clinical trial for Fluofenone and is preparing for Phase III clinical trials, with data expected to be read out by the end of this year [2] Group 2 - The company is actively seeking suitable partners for overseas rights cooperation for Painegabine [2] - The company is addressing industry competition commitments with a focus on resolution [2] - The company has partnered with AFT Pharmaceuticals from New Zealand to become the exclusive sales agent for five products and signed a strategic cooperation agreement with Malaysia's Aikang International Group to leverage the Hainan Free Trade Port policy [2] Group 3 - The company plans to focus on the neuropsychiatric field, introducing a long-acting injection of Paliperidone for schizophrenia treatment, and aims to develop a product cluster [2] - The company is enhancing its product pipeline in traditional Chinese medicine, focusing on gastrointestinal health products, and aims to expand overseas registration and sales [2] - The company is deepening collaborations with universities and research institutions to explore high-end formulations and international partnerships [2]

Clinical Trials and Drug Development - The company is conducting Phase IIa clinical trials for the drug Paenagabin, with a target enrollment of 36 cases, which has been fully achieved at a 100% completion rate. Preliminary data shows promising therapeutic effects [2][3] - The Phase II data for Paenagabin is expected to be unblinded and results read out by the end of 2025 [2][3] - The Phase II clinical research for another drug, Fluorofenone, has completed subject enrollment and data cleaning, with results expected to be revealed by the end of this year [3][4] - Preparations for the Phase III clinical trials of Fluorofenone are underway, anticipated to start between the end of this year and early next year [3][4] Market Expansion and Partnerships - The company is actively seeking international partners for the commercialization of innovative drugs, with future expansion dependent on the Phase II clinical results of Paenagabin [3][4] - A strategic cooperation agreement has been signed with Malaysia's Aikang International Group to introduce high-quality health products and promote traditional Chinese medicine products in the Malaysian market [3][4] Product Development and Focus Areas - The company plans to focus on the neuropsychiatric field, introducing a long-acting injection for the treatment of schizophrenia, thereby forming a product cluster in this area [4] - The company aims to expand its gastrointestinal product line, particularly the Gut Health series, targeting grassroots medical institutions and increasing user base [4] - There is a commitment to deepen collaborations with universities and research institutions to enhance competitiveness in high-end formulations [4] Risk Management - There are uncertainties regarding the success of subsequent clinical trials for innovative drugs and the potential for obtaining approval from the National Medical Products Administration [4] - The company emphasizes the importance of timely information disclosure regarding the progress of innovative drugs and encourages investors to make cautious decisions [4]

Core Viewpoint - Hainan Haiyao's new anti-epileptic drug, Paiengabin, is progressing rapidly in clinical trials, with its development being second only to Xenon's XEN1101 globally, indicating a significant opportunity in the anti-epileptic market due to unmet clinical needs and potential overseas value [1][3]. Group 1: Market Potential - The global epilepsy patient population is approximately 51.7 million, with around 9 million in China, highlighting a substantial market for anti-epileptic treatments [1]. - The Chinese anti-epileptic drug market has seen a compound annual growth rate of 2% over the past five years, with a market size of 5.3 billion RMB in 2023, and is expected to reach a scale in the hundred billion range [2]. Group 2: Drug Development and Advantages - Paiengabin, a new generation KCNQ2 channel agonist, shows significant improvements over the first-generation drug Retigabine, including better chemical stability, activity, and safety profile [3][4]. - Non-clinical and early clinical trials indicate that Paiengabin has superior efficacy, distribution, and safety compared to Retigabine, making it a promising option for patients with epilepsy [4]. Group 3: Clinical Progress and Competitive Landscape - Paiengabin is currently the fastest progressing KCNQ channel agonist in clinical trials in China, having successfully completed Phase IIa studies, while the global landscape shows limited competition with only a few candidates in development [5][6]. - The focus on developing effective and safer KCNQ2-targeted anti-epileptic drugs positions Hainan Haiyao favorably in a market with significant unmet needs [5]. Group 4: Strategic Transformation - Hainan Haiyao has adopted a strategy of combining generics with innovation, enhancing its R&D capabilities, and focusing on high-value innovative drugs to drive growth [7]. - The company's commitment to innovation and its robust pipeline are expected to facilitate its entry into the international pharmaceutical market, benefiting a larger patient population [7].

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].

Core Viewpoint - The 37th Academic Exchange Conference on Spleen and Stomach Diseases organized by the Chinese Association of Traditional Chinese Medicine was successfully held, showcasing the latest clinical research and developments in the treatment of gastrointestinal diseases, particularly highlighting the unique product "Fengliao Stomach and Intestine Kang Granules" from Hainan Haiyao Co., Ltd [1][2]. Group 1: Company Developments - Hainan Haiyao presented its unique traditional Chinese medicine product, Fengliao Stomach and Intestine Kang Granules, at the conference, which has shown promising results in clinical evaluations [1][2]. - The clinical study of Fengliao Stomach and Intestine Kang Granules demonstrated its effectiveness in treating adult acute diarrhea, showing a trend of better efficacy compared to the control group [2]. - The product has received multiple registrations and certifications, including five registration approvals and two invention patents, and has been recognized in twelve treatment guidelines [2]. Group 2: Market Trends - The sales of digestive system medications in China's urban retail pharmacies have shown steady growth, with a rebound in the first quarter of 2025 reaching nearly 15 billion yuan, a year-on-year increase of 2.29% [3]. - The market for traditional Chinese medicine in digestive diseases has remained stable, with significant growth in specific categories, such as stomach medications, which accounted for 24.09% of the market share [3]. - The increasing willingness of consumers to use natural and low-side-effect traditional Chinese medicine products is expected to enhance the market prospects for Hainan Haiyao's flagship products [3]. Group 3: Research and Development - Hainan Haiyao has established a robust R&D system, focusing on innovative drugs, formulations, and traditional Chinese medicine, with significant investments in major disease areas [5][6]. - The company has invested 397 million yuan in R&D over the past three years, with 124 million yuan allocated in 2024, representing 12.48% of its revenue [5]. - Two key innovative drugs, Fluorofenone and Painegabin, are currently in Phase II clinical trials, indicating the company's commitment to advancing its drug development pipeline [6].

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].

Core Viewpoint - Hainan Haiyao (000566.SZ) announced uncertainty regarding the success of clinical trials for its innovative drugs, Paiengabin and Fluorofenidone, and their potential approval by the National Medical Products Administration [1] Group 1 - The company held an investor communication event on May 24, 2025, to discuss the clinical status and characteristics of its innovative drugs [1] - The future success of the clinical trials for Paiengabin and Fluorofenidone is uncertain, as is the likelihood of receiving market approval [1] - The company commits to timely information disclosure regarding the progress of its innovative drugs [1]

Group 1: Clinical Trials and Results - The company is conducting Phase IIa clinical trials for the drug Paiengabin, with 12 subjects enrolled in the first dose group, showing a 25.47% reduction in seizure frequency over 28 days compared to baseline [5] - In Phase I clinical studies, Paiengabin demonstrated linear pharmacokinetics across doses of 2.5-25 mg, with no serious adverse events reported [3][4] - The Phase IIa trial results are still blinded, and final efficacy data will be available post-unblinding [5] Group 2: Drug Characteristics and Comparison - Paiengabin is a KCNQ potassium channel agonist, designed to overcome the limitations of the previously marketed drug Retigabine, which was withdrawn due to safety concerns [6] - Non-clinical studies indicate that Paiengabin has superior chemical stability and better distribution in the brain compared to Retigabine, enhancing its efficacy against epilepsy [7] Group 3: Future Development and Market Strategy - The company plans to explore expanding Paiengabin's indications based on Phase II clinical outcomes and market demand, potentially including severe depression caused by KCNQ mutations [9] - The patent for Paiengabin is held by the Shanghai Institute of Materia Medica, with exclusive rights for clinical development and commercialization in mainland China [9] - The company is considering international rights transfer for Paiengabin, depending on the outcomes of the Phase II trials [9] Group 4: Fluorofenone Clinical Trials - Fluorofenone's Phase I clinical trials have shown good safety and tolerability in healthy subjects, with adverse events primarily mild to moderate [10] - The Phase II mid-analysis for Fluorofenone included 156 subjects, with a 55.6% reduction in Ishak fibrosis scores after 48 weeks [11] - The company anticipates entering Phase III clinical trials for Fluorofenone in the second half of 2025, with the drug included in the list of breakthrough therapies by the National Medical Products Administration [11]

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].

Group 1: Collaboration and Research Development - The company collaborates with China Pharmaceutical University to establish a joint laboratory focused on innovative and generic drug development, aiming to enhance the scientific reliability and authority of new drug research [2] - The joint laboratory is currently in the early stages of drug screening and optimization, working on clinical candidate discovery and the establishment of an in vitro bioactivity evaluation platform [2] Group 2: Clinical Trials and Drug Development - The company is conducting Phase IIa clinical trials for the drug Paenagabin, with 70 cases enrolled in Phase Ia and 20 cases in Phase Ib [4] - Paenagabin is positioned as a me-better drug compared to Retigabine, which was withdrawn from the market due to stability and safety issues; Paenagabin shows higher activity and better distribution in the brain [3] - The company plans to expand the indications for Paenagabin based on Phase II clinical results and market demand, potentially including severe depression caused by KCNQ mutations [3][4] Group 3: Future Prospects and Market Strategy - The company anticipates entering Phase III clinical trials for the drug Fluorofenidone in the second half of 2025, which has been included in the list of breakthrough therapies by the National Medical Products Administration [5] - Fluorofenidone is expected to expand its indications to include patients with liver fibrosis caused by metabolic liver diseases, depending on clinical trial outcomes [5][6] Group 4: Shareholder Information - The reduction of shares by Yunnan International Trust is a passive action based on prior agreements and will not affect the company's long-term operations and development [6]