HAINAN HAIYAO(SZ:000566)2025-05-25 08:30Group 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potassium channel agonist, designed to overcome the limitations of the previously marketed drug Retigabine, which was withdrawn due to safety concerns [6] - Non-clinical studies indicate that Paiengabin has superior chemical stability and better distribution in the brain compared to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]