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].

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]

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]