吉贝尔(688566) - 江苏吉贝尔药业股份有限公司投资者关系活动记录表（2024年12月26日）

Group 1: Drug Overview - JJH201501 is a new multi-receptor acting antidepressant with significant efficacy and safety advantages over control drugs [3][4] - The drug has a longer half-life and higher blood concentration, leading to improved therapeutic effects [3][4] Group 2: Mechanism of Action - JJH201501 is a deuterated compound that stabilizes the pharmacologically active form, resulting in prolonged exposure in the body [3] - It acts as a selective serotonin reuptake inhibitor (SSRI) and partial agonist at 5-HT1A and 5-HT1B receptors, while antagonizing 5-HT1D, 5-HT3, and 5-HT7 receptors [3] Group 3: Clinical Trials and Results - Phase II clinical trials have shown that the 10mg and 15mg doses of JJH201501 are statistically superior to placebo and comparable to Vortioxetine 20mg [4] - The incidence of adverse events (AEs) is lower than that of Vortioxetine 20mg, indicating good safety [4] Group 4: Future Development Plans - Currently, JJH201501 is undergoing Phase III clinical trials with an enrollment completion rate of approximately 86% [4] - The company plans to submit a market application by the end of March 2025 [4] Group 5: Market Potential - The global prevalence of depression is estimated at 350 million, with a prevalence rate of 3%-5% in China, affecting over 54 million people [5] - The antidepressant market is substantial, with Vortioxetine's global annual sales around $1 billion and over 150 million yuan in China [5] - The company has a positive outlook on the market potential for JJH201501 due to increasing public awareness and government support for mental health services [5]