CNS系列报告-抗抑郁药 单胺深化与新机制探索并行， 抗抑郁药市场与新药研发进展几何？ www.swsc.com.cn 西南证券研究院 2025年11月 分析师：杜向阳 执业证号：S1250520030002 电话：021-68416017 邮箱：duxy@swsc.com.cn 分析师：伍云逍 执业证号：S1250525100003 电话： 021-68416017 邮箱：wyxiao@swsc.com.cn CNS药品一页图之——抑郁、失眠、焦虑 苯二氮䓬类（BZRAs，BZDs）:艾司唑仑、阿普唑仑、劳拉西泮、奥沙西泮、氯硝西泮、地西泮、地达西尼、短效（咪 达唑仑、三唑仑）等 非苯二氮䓬类（BZRAs，non-BZDs） ：唑吡坦（商品名思诺思）、佐匹克隆、右佐匹克隆、扎来普隆 食欲素受体拮抗剂（ORAs，双DORAs）：苏沃雷生、莱博雷生、达利雷生等 褪黑素受体激动剂：雷美尔通、阿戈美拉汀 巴比妥类：苯巴比妥、司可巴比妥、异戊巴比妥、硫喷妥钠 安眠药物 其它镇静安 眠药药 具有抗焦虑作用的药物：SSRIs、SNRIs、NaSSAs、TCAs、MAOIs、RIMAs等 苯二氮䓬类（BZDs）:艾司唑仑、 ...

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].

Core Viewpoint - AstraZeneca has announced a complete withdrawal from the CNS (Central Nervous System) field, terminating multiple pipeline projects, marking a significant strategic decision following its $80 billion revenue target announcement [1][2]. Group 1: AstraZeneca's Strategic Decision - The decision to exit the CNS field reflects the high difficulty of product development in this area and the pressure to achieve short-term KPIs, leading the company to focus on more certain high-revenue products like weight loss drugs and ADCs [2][4]. - The withdrawal indicates a significant loss of research investment and time, as the CNS field has seen mixed results in recent years, with other major companies like Amgen, Pfizer, and Sanofi also abandoning CNS projects [2][8]. Group 2: CNS Market Overview - The CNS market is considered the third-largest disease market, with a strong necessity for drug control and long medication cycles for conditions such as depression, schizophrenia, Parkinson's, and Alzheimer's [2][3]. - Despite recent setbacks, there have been notable breakthroughs in the CNS field, including advancements in Alzheimer's treatments and new mechanisms for schizophrenia drugs, indicating potential for future growth [7][12]. Group 3: Challenges in CNS Drug Development - CNS drug development faces significant challenges, including limited understanding of brain mechanisms, the blood-brain barrier, and subjective symptom assessment, leading to lower approval rates compared to non-CNS drugs [4][5]. - The slow iteration of drugs in the CNS field means that any successful product can enjoy a longer lifecycle with less competition, which has allowed smaller companies to establish themselves [5][12]. Group 4: Domestic CNS Players - The domestic CNS drug market in China is projected to grow from approximately $16.9 billion in 2022 to $31.1 billion by 2030, with a compound annual growth rate (CAGR) of nearly 8%, outpacing global growth [12][13]. - Local companies are increasingly focusing on innovative CNS drugs, with several firms transitioning from generics to original drug development, leveraging improved research infrastructure and market demand [13][14].