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江苏吉贝尔药业股份有限公司 2025年第三季度报告
Zheng Quan Ri Bao· 2025-10-30 22:59
Core Viewpoint - The company, Jiangsu Jibeier Pharmaceutical Co., Ltd., has completed the Phase III clinical trial of its new antidepressant drug JJH201501, which shows significant efficacy and safety compared to existing treatments [8][9]. Financial Data - The financial report for the third quarter indicates that the financial data has not been audited, and the company assures the accuracy and completeness of the information provided [3][5]. Clinical Trial Details - The Phase III clinical trial of JJH201501 involved a randomized, double-blind, placebo-controlled design with a total of 525 participants across four groups [8][9]. - The trial demonstrated that both the 10mg and 15mg doses of JJH201501 significantly outperformed the placebo group in treating depression, with results comparable to the standard treatment, venlafaxine [9]. Safety and Tolerability - The safety profile of JJH201501 is favorable, with lower incidences of common adverse reactions in the 10mg group compared to venlafaxine, and similar rates in the 15mg group [9]. - The recommended initial dose for JJH201501 is 10mg once daily, with the possibility of increasing to 15mg based on individual patient response [9].
吉贝尔:前三季度营收利润稳健增长 抗抑郁新药完成三期临床
Core Insights - Jibeier (688566.SH) reported a steady growth in revenue and profit for the first three quarters of 2025, with revenue reaching 704 million yuan, a year-on-year increase of 9.52%, and net profit attributable to shareholders reaching 197 million yuan, up 12.80% [1] Group 1: Company Performance - The company has completed the Phase III clinical trial for its new antidepressant drug JJH201501 and plans to submit a New Drug Application (NDA) [1] - JJH201501 is developed using a deuterated drug research platform and is designed to have a multi-receptor action mechanism, potentially offering improved pharmacokinetics [1] Group 2: Market Context - There are approximately 95 million depression patients in China, with 30.28% being under 18 years old, indicating a significant market for antidepressant drugs [2] - The global antidepressant market was valued at approximately $14.5 billion in 2022 and is expected to reach $17.6 billion by 2030 [2] Group 3: Clinical Trial Results - JJH201501 demonstrated good safety and tolerability in clinical trials, with lower incidence rates of common adverse reactions compared to the existing drug vortioxetine [3] - The trial results showed that the dropout and permanent discontinuation rates due to adverse reactions in the 10mg and 15mg groups were comparable to the placebo group and lower than the 20mg group of vortioxetine [3] Group 4: Commercialization Strategy - The company is actively promoting the commercialization of JJH201501, leveraging its existing product channels to accelerate market entry [3] - JJH201501's Phase III clinical trials were conducted across over twenty hospitals nationwide, providing a strong foundation for future commercialization efforts [3]