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].

格隆汇10月30日丨吉贝尔(688566.SH)发布三季报，2025年前三季度实现营业总收入7.04亿元，同比增长 9.52%；归属母公司股东净利润1.97亿元，同比增长12.8%；基本每股收益为0.99元。 ...

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]

Core Insights - The core viewpoint of the articles is that the new antidepressant drug JJH201501 developed by Jibeier has successfully completed Phase III clinical trials, demonstrating significant efficacy and safety advantages over existing treatments, particularly in the context of the large unmet need among China's 95 million depression patients [2][5]. Group 1: Clinical Trial Results - JJH201501's Phase III trial involved 525 patients and showed statistically significant efficacy compared to the placebo group, with results comparable to the positive control drug, vortioxetine [3]. - The trial's design was rigorous, featuring a randomized, double-blind, placebo-controlled approach, which reflects the confidence of the sponsor in the drug's potential [3]. - The safety profile of JJH201501 was favorable, with the 10mg dose group showing a lower incidence of adverse reactions compared to the vortioxetine 20mg group [3][4]. Group 2: Drug Mechanism and Design - JJH201501 is a first-class chemical drug designed based on a multi-receptor mechanism, optimized for pharmacokinetics through deuteration, which enhances its antidepressant effects and promotes neurogenesis [4]. - Preclinical studies indicated that JJH201501 has a longer half-life and higher blood concentration compared to vortioxetine, suggesting it may be a new standard in antidepressant therapy [4]. Group 3: Market Potential and Industry Context - The antidepressant market in China is projected to reach approximately 24 billion yuan by 2030, with a significant unmet demand due to low treatment rates among the 95 million depression patients [5][6]. - The success of JJH201501 could disrupt the current market dominated by imported and generic drugs, as there has been a scarcity of domestic innovative drugs in this field [6]. - Following the successful Phase III trial, Jibeier plans to submit a New Drug Application (NDA) to the National Medical Products Administration (NMPA), with expectations for approval by late 2025 to early 2026 [6].

Core Viewpoint - The announcement by Jibeier regarding the completion of Phase III clinical trials for its antidepressant drug JJH201501 highlights its significant efficacy and safety advantages over existing treatments, indicating a potential breakthrough in the antidepressant market, which serves a large unmet need among 95 million depression patients in China [1][4]. Group 1: Clinical Trial Results - JJH201501's Phase III trial involved 525 depression patients and demonstrated statistically significant efficacy compared to the placebo group, with results comparable to the positive control, vortioxetine [2][5]. - The trial's design, which included a rigorous random, double-blind, placebo-controlled approach, reflects the company's confidence in the drug's "best-in-class" potential [2][3]. - The safety profile of JJH201501 is promising, with the 10mg dose showing a lower incidence of adverse reactions compared to vortioxetine, while the 15mg dose was comparable or lower [2][3]. Group 2: Market Potential and Industry Context - The antidepressant market in China is projected to reach approximately 24 billion yuan by 2030, with a significant unmet demand due to less than 50% treatment rates among the 95 million depression patients [4]. - The current market is dominated by imported original drugs and domestic generics, with a notable lack of innovative domestic products, making JJH201501 a potential game-changer [4]. - The successful launch of JJH201501 could provide a substantial market opportunity, with sales peak estimates reaching 2 billion yuan, positioning it as a significant player in the antidepressant sector [5].

抗抑郁一类新药 JJH201501 III 期临床试验（以下简称"试验"）采用随机、 双盲、安慰剂及阳性对照多中心设计，共设置试验药物 10mg 组、试验药物 15mg 组、安慰剂组和阳性对照组 4 个组别，试验药物 10mg 组、试验药物 15mg 组和 安慰剂组各 150 例受试者，阳性对照组 75 例受试者，共 525 例受试者，接受为 期 8 周的双盲试验。 证券代码：688566 证券简称：吉贝尔 公告编号：2025-048 江苏吉贝尔药业股份有限公司 自愿披露在研抗抑郁一类新药 JJH201501 III 期临床试验结果的公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或 者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、产品的基本情况 江苏吉贝尔药业股份有限公司（以下简称"公司"）依托于氘代药物研发技 术平台正在研发的抗抑郁新药 JJH201501 是一款新型的多受体作用机制的抗抑 郁一类新药，具有明显的抗抑郁作用。前期研究表明，JJH201501 可明显延长药 物在人体内的半衰期，延长药物在体内滞留时间，提高药物在体内的血药浓度以 及 AUC（评价药物 ...

Core Viewpoint - The clinical trial results for the antidepressant drug JJH201501 developed by the company show significant efficacy at 10mg and 15mg dosage groups compared to the placebo group, and are comparable to the 20mg group of hydrobromide venlafaxine tablets, with good safety and tolerability [2] Summary by Categories - **Clinical Trial Results** - The III phase clinical trial results indicate that the 10mg and 15mg dosage groups of JJH201501 have significantly better efficacy than the placebo group [2] - The efficacy of JJH201501 at these dosages is comparable to that of the 20mg group of hydrobromide venlafaxine tablets [2] - The safety and tolerability of JJH201501 are reported to be good [2] - **Future Plans** - The company plans to submit a New Drug Application (NDA) after completing the III phase clinical trial [2]

江苏吉贝尔药业股份有限公司 2025 年第三季度报告 证券代码：688566 证券简称：吉贝尔 江苏吉贝尔药业股份有限公司 2025 年第三季度报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者 重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 公司董事会及董事、高级管理人员保证季度报告内容的真实、准确、完整，不存在虚假记载、误 导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 第三季度财务报表是否经审计 □是 √否 江苏吉贝尔药业股份有限公司 2025 年第三季度报告 | 稀释每股收益（元/股） | 0.24 | -11.11 | 0.99 | 8.79 | | | --- | --- | --- | --- | --- | --- | | 加权平均净资产收益率 | 减少 2.01 | 个百分 0.38 | 8.46 | 减少 0.09 | 个百 | | （%） | | 点 | | 分点 | | | 研发投入合计 | 17,459,813.64 ...

Group 1 - The company has received approval from the National Medical Products Administration for the marketing application of Gatifloxacin, a chemical raw material drug [1][2] - Gatifloxacin is a broad-spectrum antibacterial agent effective against various bacteria, including Gram-positive and Gram-negative bacteria, and is the main raw material for the company's Gatifloxacin eye drops [2] - The approval is valid until October 21, 2030, and the company is required to continue accumulating research data on nitrosamine impurities and improve control strategies as necessary [2] Group 2 - The approved Gatifloxacin raw material is primarily intended to meet the production needs of the company's Gatifloxacin eye drops, and it is not expected to have a significant impact on the company's recent operations [3]

Policy Developments - Liaoning Province will implement direct payment of maternity allowances to employees starting November 1, 2025, enhancing convenience and satisfaction for the public [1] Drug and Device Approvals - Hengrui Medicine's subsidiary received clinical trial approval for injection of Rukang Qutuzumab, aimed at treating advanced non-small cell lung cancer [2] - Jibeier received approval for the market application of the chemical raw material drug, Gatifloxacin, which is expected to support its production needs [3] Financial Reports - Ping An Good Doctor reported a 13.6% increase in revenue to 3.725 billion, with a net profit of 216 million, up 45.7% year-on-year [4] - Te Yi Pharmaceutical achieved a 985% increase in net profit, reporting 65.22 million in the first three quarters, with significant growth in traditional Chinese medicine sales [5] - Lijun Pharmaceutical reported a revenue of 9.116 billion, a slight increase of 0.38%, with a net profit of 1.754 billion, up 4.86% [6] Capital Market - In Shanghai's Baoshan District, 17 key biopharmaceutical projects were signed, with total investments exceeding 2 billion, aimed at enhancing the local biopharmaceutical industry [7][8] Industry Developments - Baiyang Pharmaceutical signed a cooperation agreement with Peking University International Hospital to establish a radiosurgery treatment center, enhancing access to high-quality medical resources [10] - Qiang Brain Technology established a new company in Chengdu focusing on AI-related businesses, including medical devices and internet data services [11] Regulatory Actions - The Shanghai Stock Exchange issued a regulatory warning to Zhejiang Dongya Pharmaceutical for discrepancies in the use of raised funds, highlighting the responsibility of the company's former board secretary [12]