新京报讯（记者张秀兰）12月25日，国家药监局官方网站显示，再鼎医药旗下药品呫诺美林曲司氯铵 （商品名为凯捷乐）已获国家药监局批准上市，用于治疗成人精神分裂症。该药也成为70余年来首个获 批的具有全新作用机制的精神分裂症疗法。 今年9月，中华医学会发布的《中国精神分裂症防治指南（2025年版）》已将呫诺美林曲司氯铵胶囊作 为创新疗法纳入，这是该款药物全球首次被收录于国家级指南。 精神分裂症是一种慢性且常导致残疾的精神疾病，会影响患者的思考、感受和行为方式。精神分裂症的 核心症状包括阳性症状（如幻觉和妄想）、阴性症状（如动机和愉悦感缺失以及社交退缩）和认知症状 （如记忆、注意力和决策方面的缺陷）。与一般人群相比，精神分裂症患者的预期寿命缩短了10-20 年。当前尽管已有抗精神病疗法，但许多精神分裂症患者在接受现有抗精神病药物治疗期间，仍然会面 临阴性症状和认知症状疗效有限，或出现体重增加、高泌乳素血症以及被称为锥体外系综合征的运动障 碍等副作用问题。由于这些问题，大约75%的患者在18个月内停止服药。治疗中止后，可能会导致包括 复发、住院和更长的缓解时间等健康影响。 与目前主要靶向多巴胺或5-羟色胺受体的抗精神 ...

周三，再鼎医药(ZLAB.US)股价走高，截至发稿，该股涨超7%，报18.84美元。该股港股今日收涨 6.24%。消息面上，再鼎医药宣布，中国国家药品监督管理局已批准呫诺美林曲司氯铵胶囊（凯捷乐） 的新药上市申请，用于治疗成人精神分裂症。这是70余年来首个获批的具有全新作用机制的精神分裂症 疗法，为精神分裂症治疗带来了根本性突破。 ...

根据协议，恩华将负责瑞可妥、瑞百莱、美比瑞在中国大陆地区的独家经销与商业化，集团则继续持有 该三款产品的资产权、注册准证、全部知识产权等权利，并负责产品的生产和供货。协议期限为十年。 该协议签署后，恩华将向集团一次性支付不可退还的2000万美元授权费。此次合作标志着国内中枢神经 系统("CNS")领域两家领先企业强强联合，共同推进精神分裂症治疗市场的深度布局，为患者提供更全 面的治疗选择。 格隆汇12月24日丨绿叶制药(02186.HK)发布公告，集团的若干附属公司与江苏恩华药业股份有限公司的 附属公司江苏恩华和信医药营销有限公司("恩华")签署合作协议，授予恩华三款抗精神病药长效针剂产 品在中国大陆地区的独家商业化权利。该三款产品分别为瑞可妥(注射用利培酮微球(Ⅱ))、瑞百莱(棕榈 酸帕利哌酮注射液(Ⅱ))和美比瑞(棕榈酸帕利哌酮注射液)，均适用于精神分裂症的治疗。 ...

| ZLAB 再鼎医药 | | | | --- | --- | --- | | 17 480 4 -0.230 -1.30% | | 收盘价 12/23 16:00 美东 | | 18.250 ↑ 0.770 +4.41% | | 盘前价 12/24 04:06 美东 | | 三 7 24 华 S 9 日 ♥ B | | ● 快捷交易 | | 最高价 18.095 | 开盘价 17.710 | 成交量 60.72元 | | 最低价 17.370 | 昨收价 17.710 | 成交额 1065.68万 | | 平均价 17.549 | 市盈率ITM 亏损 | 总市值 19.33亿 (…) | | 振 幅 4.09% | 市盈率(静) 亏损 | 总股本 1.11亿 | | 换手率 0.56% | 市净率 2.543 | 流通值 18.99亿 | | 52周最高 44.340 | 委 比 -26.32% | 流通股 1.09亿 | | 52周最低 16.820 | 量 比 0.46 | 色 主 1股 | | 历史最高 193.540 | 股息TTM -- | 换股比率 10.00 | | 历史最低 13.480 | ...

根据协议，恩华将负责瑞可妥、瑞百莱、美比瑞在中国大陆地区的独家经销与商业化，集团则继续持有 该三款产品的资产权、注册准证、全部知识产权等权利，并负责产品的生产和供货。协议期限为十年。 该协议签署后，恩华将向集团一次性支付不可退还的2000万美元授权费。此次合作标志着国内中枢神经 系统(CNS)领域两家领先企业强强联合，共同推进精神分裂症治疗市场的深度布局，为患者提供更全面 的治疗选择。 恩华是国内领先的CNS领域专科公司，致力于全面构建精神和神经疾病综合解决方案，打造CNS诊疗一 体化的生态体系。在CNS领域，该公司不仅拥有丰富的产品矩阵，亦通过逾2000人规模的专业化营销团 队、依托覆盖全国上万家医院的商业化网络，将精神和神经类产品全面触达各级精神卫生中心、基层医 疗中心、民营医院、线上药店及连锁药店等多元销售终端，形成了全渠道营销网络优势。 集团董事会相信，集团的三款长效针剂形成差异化的产品组合，全面覆盖精神分裂症患者全病程各个阶 段的治疗所需，具备显着的临床价值。CNS是集团的核心战略领域之一，集团拥有中国最具竞争力的 CNS产品矩阵和平台化能力，通过优势资源合作，集团将加速各阶段产品管线价值兑现和解决 ...

根据协议，恩华将负责瑞可妥、瑞百莱、美比瑞在中国大陆地区的独家经销与商业化，集团则继续持有 该三款产品的资产权、注册准证、全部知识产权等权利，并负责产品的生产和供货。协议期限为十年。 该协议签署后，恩华将向集团一次性支付不可退还的2000万美元授权费。此次合作标志着国内中枢神经 系统("CNS")领域两家领先企业强强联合，共同推进精神分裂症治疗市场的深度布局，为患者提供更全 面的治疗选择。 格隆汇12月24日丨绿叶制药(02186.HK)发布公告，集团的若干附属公司与江苏恩华药业股份有限公司的 附属公司江苏恩华和信医药营销有限公司("恩华")签署合作协议，授予恩华三款抗精神病药长效针剂产 品在中国大陆地区的独家商业化权利。该三款产品分别为瑞可妥(注射用利培酮微球(Ⅱ))、瑞百莱(棕榈 酸帕利哌酮注射液(Ⅱ))和美比瑞(棕榈酸帕利哌酮注射液)，均适用于精神分裂症的治疗。 ...

消息面上，12月23日，再鼎医药宣布，中国国家药品监督管理局已批准呫诺美林曲司氯铵胶囊（凯捷 乐）的新药上市申请，用于治疗成人精神分裂症。这是70余年来首个获批的具有全新作用机制的精神分 裂症疗法，为精神分裂症治疗带来了根本性突破。 公开资料显示，2021年11月，再鼎医药以1.87亿美元从Karuna Therapeutics获得了在大中华区开发、生 产和商业化呫诺美林曲司氯铵胶囊的独家授权。NMPA此次批准呫诺美林曲司氯铵胶囊是基于在中国开 展的Ⅰ期药代动力学研究、中国的Ⅲ期临床研究（ZL-2701-001）以及三项全球EMERGENT临床研究的 数据支持。 智通财经APP获悉，再鼎医药(09688)早盘涨超4%，截至发稿，涨3.45%，报14.1港元，成交额5919.14万 港元。 ...

Core Insights - A new method to effectively improve negative symptoms of schizophrenia has been discovered by Dr. Han Yuyi from Harbin First Specialized Hospital, with results published in the international journal "Brain Stimulation" [1][2] Group 1: Research Findings - Schizophrenia patients experience both positive symptoms (hallucinations, delusions) and negative symptoms (emotional flatness, social withdrawal), with the latter often overlooked [1] - Current drug treatments are effective for positive symptoms but show limited efficacy for negative symptoms [1] - Non-invasive neurostimulation techniques, such as transcranial magnetic stimulation, are being explored for treating negative symptoms, but existing methods have significant limitations [1] Group 2: Clinical Study - The study involved 80 schizophrenia patients primarily exhibiting negative symptoms, divided into a true stimulation group and a sham stimulation group [2] - The true stimulation group received individualized accelerated intermittent theta-burst stimulation for 10 days, with four sessions daily, each consisting of 1800 pulses [1][2] - Results showed a significant reduction in negative symptoms in the true stimulation group after four weeks, with a response rate of 77.5% compared to 17.5% in the sham group [2] Group 3: Effectiveness and Future Plans - The average score for negative symptoms in the true stimulation group decreased by 4.10 points, with an effect size of 0.83, indicating moderate to high treatment effectiveness [2] - Neuroactivity changes in the left middle temporal gyrus and weakened functional connectivity between the midbrain and middle temporal gyrus were associated with symptom improvement [2] - Future plans include larger multi-center clinical studies to optimize treatment parameters for broader patient access [2]

Core Insights - The theme for World Mental Health Day 2025 is "Everyone enjoys mental health services," highlighting the increasing challenges in China's mental health sector [1] - The World Health Organization (WHO) reports approximately 24 million schizophrenia patients globally, with over 8 million in China, indicating a significant public health issue [1] - Schizophrenia is increasingly recognized as a chronic brain disease rather than a functional disorder, necessitating long-term treatment strategies [1][2] Treatment Challenges - Approximately 80% of schizophrenia patients experience onset between the ages of 16 and 35, a critical period for social integration [2] - Poor medication adherence is a major challenge in treating schizophrenia, with a treatment interruption rate of 75% in China, leading to high relapse rates of 77% within one year and 90% within two years [3] - Each relapse can increase direct medical costs by four times, emphasizing the need for improved adherence strategies [3] Long-Acting Injectable Medications - The recently updated "Chinese Schizophrenia Prevention and Treatment Guidelines (2025 Edition)" emphasizes the clinical value of long-acting injectable antipsychotics, recommending their early use while respecting patient preferences [4] - Long-acting injectables can significantly reduce medication frequency and improve adherence compared to oral medications [4] - Current clinical usage of long-acting injectables in China is less than 5%, compared to 25%-30% in Europe and the U.S., indicating a substantial gap [5] Government and Healthcare Initiatives - Efforts are underway to increase the clinical use of long-acting injectables in China, including enhanced education for healthcare providers and patients, as well as the inclusion of these medications in health insurance coverage [5] - Government subsidy programs in cities like Shanghai are providing free medication support to patients, aiming to improve treatment access and adherence [5]

Teva Pharmaceutical Industries Conference Call Summary Company Overview - **Company**: Teva Pharmaceutical Industries (NYSE: TEVA) - **Focus**: Development of Elanzapin LAI for the treatment of schizophrenia Key Industry Insights - **Schizophrenia**: A complex and progressive mental illness characterized by both positive and negative symptoms, cognitive implications, and mood disturbances, significantly impacting patients' quality of life [4][10] - **Market Opportunity**: High unmet needs in schizophrenia treatment, with a significant number of patients in both the U.S. and EU, particularly favoring long-acting injectables (LAIs) [12][10] Core Product Insights - **Elanzapin LAI**: A new formulation designed to prevent Post-Injection Delirium and Sedation Syndrome (PDSS), which has been a barrier to the use of Elanzapin in LAI form [5][17] - **Clinical Data**: Over 4,000 subcutaneous injections administered with no instances of PDSS reported, demonstrating both safety and efficacy [8][26] - **Efficacy Results**: Achieved a statistically and clinically meaningful improvement in symptoms across all doses in the Solaris Phase 3 study [8][17] Competitive Landscape - **Comparison with Existing Treatments**: Elanzapin LAI is positioned as a best-in-class option alongside Uzeti, targeting patients inadequately controlled on oral medications or other LAIs [10][11] - **Market Dynamics**: Anticipated quicker utilization and broader adoption of LAIs, with Elanzapin LAI expected to fulfill a significant treatment gap [12][32] Regulatory and Development Insights - **FDA Engagement**: Ongoing positive discussions with the FDA regarding the safety and efficacy data, with confidence in a favorable label for Elanzapin LAI [26][75] - **Lifecycle Management**: Potential for expanding indications to include bipolar disorder, building a comprehensive franchise around Elanzapin [27][32] Financial Projections - **Revenue Expectations**: Projected peak revenue for the Elanzapin franchise between $1.5 billion and $2 billion, with potential for higher sales based on historical performance of oral Elanzapin [51][70] - **Market Penetration**: Anticipated strong uptake in Europe due to higher existing usage of Elanzapin and LAIs [70][51] Additional Considerations - **Patient Journey**: Understanding the complexities of the patient journey in schizophrenia treatment is crucial for effective intervention and market strategy [12][13] - **Weight Management**: Weight gain associated with Elanzapin is manageable, with strategies in place to mitigate this risk through lifestyle interventions and potential co-prescriptions [37][39] Conclusion - **Strategic Positioning**: Teva is well-positioned to address significant unmet needs in schizophrenia treatment with the launch of Elanzapin LAI, leveraging its established neuroscience legacy and robust clinical data [3][82] - **Future Outlook**: The company expresses optimism about the potential impact of Elanzapin LAI on patient care and market dynamics, with a strong commitment to advancing treatment options in the psychiatric space [82][83]