更新于：2024-11-01

Schizoaffective disorder

分裂情感性障碍

更新于：2024-11-01

基本信息

别名

Disorder, Schizoaffective、Disorders, Schizoaffective、Psychosis;schizoaffective

+ [41]

简介

A disorder in which the individual suffers from both symptoms that qualify as schizophrenia and symptoms that qualify as a mood disorder (e.g., depression or bipolar disorder) for a substantial portion (but not all) of the active period of the illness; for the remainder of the active period of the illness, the individual suffers from delusions or hallucinations in the absence of prominent mood symptoms.

关联

项与分裂情感性障碍相关的药物

Lumateperone Tosylate

靶点

5-HT2A receptor x D2 receptor

作用机制

5-HT2A receptor拮抗剂 [+1]

在研机构

Intra-Cellular Therapies, Inc.

原研机构

Bristol Myers Squibb Co.

在研适应症

躁郁症 [+7]

非在研适应症

痴呆引起的激越 [+2]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2019-12-20

Valbenazine Tosylate

缬苯那嗪

靶点

VMAT2

作用机制

VMAT2抑制剂

在研机构

Mitsubishi Tanabe Pharma Corp. [+2]

原研机构

Neurocrine Biosciences, Inc.

在研适应症

亨廷顿舞蹈病 [+5]

非在研适应症

分裂情感性障碍 [+1]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2017-04-11

Ocrelizumab

奥瑞珠单抗

靶点

CD20

作用机制

CD20抑制剂 [+3]

在研机构

Roche Pharma (Schweiz) AG [+8]

原研机构

Genentech, Inc. [+1]

在研适应症

多发性硬化症 [+7]

非在研适应症

桥本脑炎 [+3]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2017-03-28

853

项与分裂情感性障碍相关的临床试验

NCT05457127 / Not yet recruitingN/AIIT

Obstructive Sleep Apnea Treatment in People Aging With Serious Mental Illness

Serious mental illnesses (SMI) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. A high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (OSA), but tend to be underdiagnosed and undertreated compared to the general population. This study aims to examine feasibility, acceptance, and impact of OSA treatment and how it affects cognitive function in people with SMI.

开始日期2025-01-01

申办/合作机构

University of California San Diego

NCT05416658 / Not yet recruitingN/AIIT

Examining the Effectiveness of a Shared Decision Making Intervention for Antipsychotic Medications to Improve Engagement in Treatment for People Experiencing Early Psychosis

This study aims to provide an evidence-based shared decision making intervention for antipsychotic medications, the Antipsychotic Medication Decision Aid (APM-DA), for individuals experiencing early psychosis and provide, for the first time, an understanding of the shared decision making mechanism of action.

开始日期2025-01-01

申办/合作机构

The New York State Psychiatric Institute

[+2]

NCT03974620 / Not yet recruitingN/AIIT

Individual Placement and Support (IPS) and Cognitive Remediation Therapy (CRT) as an Adjunct to Treatment as Usual (TAU) in Patients With Early Schizophrenia Spectrum Disorder: Study Protocol for a Randomized Controlled Feasibility Trial

This study aims to test the hypothesis that addition of Individual Placement and Support (IPS) and/or Cognitive Remediation Therapy (CRT) in addition to treatment as usual in patients with early psychosis will be feasible and acceptable in patients with early schizophrenia.

开始日期2024-12-01

申办/合作机构-

100 项与分裂情感性障碍相关的临床结果

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100 项与分裂情感性障碍相关的转化医学

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0 项与分裂情感性障碍相关的专利（医药）

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6,034

项与分裂情感性障碍相关的文献（医药）

2024-12-01·Psychiatry Research

The relationship between community-based psychiatric rehabilitation pathways and re-hospitalization trajectories: A three-decade follow-up

Article

作者: Amir, Noa Yakirevich ; Roe, David ; Neumark, Yehuda ; Rosca, Paola ; Florentin, Sharon ; Keller, Shikma ; Krivoy, Amir

Psychiatric rehabilitation is essential for the recovery of individuals with schizophrenia. However, re-hospitalization is sometimes inevitable. This study examined the association between varied community psychiatric rehabilitation services (PRS) and long-term re-hospitalization parameters. National registries provided data on 5163 adults diagnosed with schizophrenia and schizoaffective disorder. Patients with recurrent hospitalizations were tracked over three periods: before rehabilitation legislation (1991-2000), during rehabilitation implementation (2001-2009), and follow-up (2010-2017). Associations between PRS types and annual re-hospitalization days (ARHD) during follow-up were analyzed. Findings revealed that the rehabilitation group had a median time-to-readmission of 757 days, while the non-rehabilitation group had 321 days. Combined residential and vocational rehabilitation was associated with a 20-day decrease in ARHD, while residential or vocational rehabilitation alone were associated with reductions of 2 and 5 days, respectively. Higher levels of residential support were linked to reduced ARHD. Of the vocational rehabilitation types, supported-employment and sheltered-workshops showed association with the greatest reductions in ARHD (17 days). Overall, community-based PRS is linked to prolonged time-to-readmission and reduced re-hospitalization days. A combination of vocational and residential services is related to a synergistic decrease in re-hospitalization days. This suggests that recurrent hospitalization for patients who are using PRS is shorter and may be part of their recovery pathway.

2024-12-01·Psychiatry Research

Sex-dependent association study of complement C4 gene with treatment-resistant schizophrenia and hospitalization frequency

Article

作者: Teymouri, Kowsar ; Chen, Cheng C ; Zai, Clement C. ; Kennedy, James L ; Tiwari, Arun K ; Mohiuddin, Ayeshah G ; Mohiuddin, Ayeshah G. ; Pouget, Jennie G ; Sriretnakumar, Venuja ; Pouget, Jennie G. ; Ebrahimi, Mahbod ; Zai, Clement C ; Kennedy, James L. ; Tiwari, Arun K. ; Chen, Cheng C.

The complement component 4 (C4) gene, codes for two isotypes, C4A and C4B, and can exist in long or short forms (C4L and C4S). The C4AL variant has been associated with elevated schizophrenia (SCZ) risk. Here, we investigated the relationship between C4 variation and clinical outcomes in SCZ. N = 434 adults with SCZ or schizoaffective disorder were included in this retrospective study. A three-step genotyping workflow was performed to determine C4 copy number variants. These variants were tested for association with clinical outcome measures, including treatment-resistant SCZ (TRS), number of hospitalizations (NOH), and symptom severity (PANSS). Sex and ancestry stratified analyses were performed. We observed a marginally significant association between C4S and TRS in males only, and a negative association between C4S and NOH in the total sample. C4AS had negative association with NOH in males and non-Europeans. Lastly, C4A copy numbers and C4A predicted brain expression showed negative association with NOH in males only. Our study provides further support for sex-specific effect of C4 on SCZ clinical outcomes, and also suggests that C4S and C4AS might have a protective effect against increased severity. C4 could potentially serve as a genetic biomarker in the future, however, more research is required.

2024-12-01·Progress in Neuro-Psychopharmacology and Biological Psychiatry

Clozapine as a mood stabiliser for schizoaffective disorder: Effectiveness during a three-month follow-up

Article

作者: Benito, Ana ; Arnau-Peiró, Francisco ; Fuertes-Saiz, Alejandro ; Almodóvar-Fernández, Isabel ; Peraire, Marc ; Haro, Gonzalo

Clozapine has shown signs of effectiveness in treating symptoms of schizoaffective disorder, although little research has been carried out to specifically assess this question. The objective of this current work was to analyse the mood-stabilising effectiveness and tolerability of clozapine in patients with schizoaffective disorder. This was a prospective, longitudinal, and quasi-experimental trial with three months of follow-up in patients with refractory schizoaffective disorder (PANSS score exceeding 80). Clinical response was evaluated through monthly visits using the YMRS, MADRS, CDSS, CGI-S and UKU. Twenty-seven participants (63% men, 37% women) with a mean age of 32.56 years were included. Clozapine significantly reduced the symptoms of mania, as measured by the YMRS (pre-treatment: 16.19, post-treatment: 0.67; p < 0.01) as well as the symptoms of depression, quantified with the CDSS (pre-treatment: 6.11, post-treatment: 0.67; p < 0.01), MADRS (pre-treatment: 9.56, post-treatment: 1.07; p < 0.01), and CGI-S (pre-treatment: 4.74, post-treatment: 1.15; p < 0.01). The prescription of clozapine significantly reduced the average daily dose of neuroleptics, measured in mg of chlorpromazine (pre-treatment: 1253.55, post-treatment: 742.59; p < 0.01) and hypnosedatives, measured in mg of diazepam (pre-treatment: 33.88, post-treatment: 5.74; p < 0.05) required in these patients. Patient-perceived tolerability, measured with the UKU, also improved during follow-up (pre-treatment: 12.89, post-treatment: 8.14; p < 0.01). The efficacy of clozapine was significant for the affective symptoms of schizoaffective disorder, thereby improving patient tolerability and permitting reductions in the other medications the patients used.

项与分裂情感性障碍相关的新闻（医药）

2024-09-11

·PRNewswire

Study Conducted at Sheppard Pratt Reveals Lower Cognitive Functioning as Key Risk Factor for Natural Cause Mortality in Schizophrenia

BALTIMORE, Sept. 11, 2024 /PRNewswire/ -- JAMA Network Open recently published a first-of-its-kind study conducted at Sheppard Pratt identifying lower cognitive functioning as a significant risk factor for natural cause mortality among individuals with schizophrenia. The study underscores the urgent need for targeted interventions aimed at improving cognitive functioning in this vulnerable population. The study involved 844 participants diagnosed with schizophrenia or schizoaffective disorder who were followed up with for up to 24 years. Individuals were initially evaluated in person and later tracked using data from the National Death Index, a resource managed by the Centers for Disease Control and Prevention (CDC). Faith Dickerson, PHD, MPH, senior psychologist at Sheppard Pratt, led the study. "It is well established that reduced cognitive functioning in schizophrenia is associated with poorer outcomes," said Dr. Dickerson. "However, our study is among the first to demonstrate that these outcomes also include earlier natural cause mortality such as from cardiac disease or cancer. As a result of our study, I highly recommend that efforts should be focused on methods to improve cognitive functioning as this may give individuals with schizophrenia a chance to live longer, healthier lives." On average, individuals with schizophrenia die more than 10 years sooner than those within the general population. This prospective cohort study was co-authored by Robert Yolken, MD, professor of pediatrics at Johns Hopkins Medicine and was funded by The Stanley Medical Research Institute and Boehringer Ingelheim. "A majority of people with schizophrenia experience cognitive symptoms, which can greatly impact their daily life and yet are often underrecognized or underappreciated", said Michael Jablonski, PhD, vice president of clinical development and medical affairs at Boehringer Ingelheim. "We remain committed to expanding our understanding of schizophrenia as we strive to advance research to improve care for those living with serious mental illnesses." The comprehensive evaluation (at baseline) included a cognitive battery, clinical measures, and data on various health conditions and lifestyle factors. Schizophrenia is known for its adverse impact on neuropsychological functioning. These findings indicate that individuals with lower cognitive functioning face an increased risk of premature mortality from natural causes, such as cardiac disease and cancer. Other factors that were associated with natural cause mortality at follow-up were an elevated body mass index (BMI), tobacco use, divorced or separated marital status, a diagnosis of an autoimmune disorder, cardiac rhythm disorder, and COPD. Participants' cognitive functioning was assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which calculates scores for 5 indexes: immediate memory, visuospatial and constructional, language, attention, and delayed memory. Individuals who scored in the lowest half of the group on the RBANS cognitive battery demonstrated a heightened risk of premature death due to natural causes. The research program at Sheppard Pratt is dedicated to advancing the understanding and treatment of mental health conditions through cutting-edge research and clinical practice. It not only aims to enhance scientific knowledge but also to translate research findings into practical, evidence-based treatments, ultimately contributing to better mental health care and quality of life for individuals affected by these challenging conditions. For more information about Sheppard Pratt's research visit: sheppardpratt.org/research About Sheppard Pratt Sheppard Pratt is the largest private, nonprofit provider of mental health, substance use, developmental disability, special education, and social services in the country. A nationwide resource, Sheppard Pratt provides services across a comprehensive continuum of care, spanning both hospital- and community-based resources. Since its founding in 1853, Sheppard Pratt has been innovating the field through research, best practice implementation, and a focus on improving the quality of mental health care on a global level. Sheppard Pratt has been consistently recognized as a top national psychiatric hospital by U.S. News & World Report for more than 30 years. SOURCE Sheppard Pratt WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究

2024-08-28

·美通社

绿叶制药发布2024年中期业绩：净利劲增201%，5款新药密集获批

上海 2024年8月28日 /美通社/ -- 绿叶制药集团（2186.HK）发布2024年中期业绩及截至目前的业务进展。报告期内，集团营业收入约为30.7亿元（单位：人民币，下同），同比增长6%；毛利约为20.8亿元，同比增长7%；EBITDA约为11.6亿元，同比增长33%；净利润约为4.4亿元，同比增长201%；净利润率为14%，提高9个百分点。费用端方面：销售费用、管理费用、研发费用、财务费用四项费用合计占比较去年同期下降14个百分点。其中，产品销售费用率为31%，大幅下降9个百分点。自2021年起，集团围绕中枢神经系统（CNS）和肿瘤两大核心治疗领域推动13款新药在中、美、欧多国获批上市，持续强化产品组合竞争力；同时，集团积极推动研发战略及营销模式升级，优化财务结构，开源与节流并举，铺就未来三年明确的增长路径。 CNS ：构建优势产品组合，全球商业版图独具集团CNS领域收入约为8.2亿元，同比增长21%。凭借独树一帜的产品开发及商业策略，集团跻身国内CNS第一梯队，并向更高的全球目标进发，通过多款拳头产品，持续稳固市场地位，其中： 1类创新药若欣林 ® （盐酸托鲁地文拉法辛缓释片）今年上半年实现同比增长210%，成为近年来增长最快的抗抑郁新药之一；囊括利斯的明透皮贴剂（2次/W）等产品在内的贴剂业务高速增长；畅销多年的原研产品思瑞康 ® （富马酸喹硫平片、缓释片）市场表现稳定，集团通过其在51个国家和地区的销售网络不断夯实全球商业化版图。今年以来，集团3大CNS产品"接力"获批，为商业化引擎持续加码：在美国，每月给药一针、治疗精神分裂症和分裂情感性障碍的新药 ERZOFRI ® （帕利哌酮缓释混悬注射液）于7月获得FDA上市批准，进一步强化集团全球CNS产品组合的综合竞争力，打开海外业务增长新空间；在中国，治疗精神分裂症的美比瑞 ® （棕榈酸帕利哌酮注射液）、全球首个治疗帕金森病长效微球制剂金悠平 ® （注射用罗替高汀微球）相继于6月获批上市；肿瘤：新产品密集获批，激发放量势能集团肿瘤领域收入约为11.4亿元，同比增长25%。该板块自2021年以来持续回升，新产品放量逐步抵消政策端对成熟产品的影响。今年，集团即将迎来3款肿瘤产品获批上市，将协同公司肿瘤领域已上市产品，迅速提升肿瘤业务营收与利润贡献。3款新产品包括：博洛加 ® （地舒单抗注射液 120mg ）、米美欣 ® （羟考酮纳洛酮缓释片）已相继于5月和6月获批，米美欣 ® 有望成为新一代癌痛慢病化管理的标准治疗方案，引领中国癌痛市场。赞必佳 ® （注射用芦比替定，英文商品名： Zepzelca ® ）有望于下半年在中国内地获批，作为近27年来唯一获得美国FDA批准的用于治疗复发性小细胞肺癌的新分子实体，该产品率先在中国香港、中国澳门、粤港澳大湾区、海南博鳌投入临床应用并收获积极的临床反馈。心血管：成熟品种生命长青，增长空间广阔围绕心血管领域，集团多款独家品种在多年循证医学的积累和支持下获得临床广泛认可，生命周期长，差异化竞争优势独具，其中：血脂康 ® ：据IQVIA数据，该产品是2024年上半年国内最常用的治疗高胆固醇血症的天然药物和国内第五大常用调脂药；该产品深耕心血管疾病一级预防的蓝海市场，中长期增长潜力广阔；欧开 ® （七叶皂苷钠片）仍保持高速放量，为潜在十亿级大品种。公司治理：运营提质增效，助力高质量发展集团以研发创新聚焦、营销模式升级、财务结构优化为抓手，通过一系列切实有效的措施提升运营效能，助力集团盈利水平进阶：研发战略升级：聚焦研发资源，提升创新质量 ——实现在研产品向First-in-Class（同类首创）、Best-in-Class（同类最优）的全面升级，并通过对外授权剥离非核心品种，优化管线，提升重磅品种转化效率；营销模式变革：降低销售费率，提升增长质量 ——通过营销组织架构调整、人效提升、营销模式创新、统筹资源配置等多措并举，推动销售费用持续下降、销售效率显著提升。持续降债，改善财务结构 ——报告期内财务费用同比下降9.5%，2024年全年降债目标亦将如期达成。绿叶制药集团管理层表示："得益于新产品放量和公司治理策略的高效实施，集团盈利能力显著增强。我们相信，随着系列潜力新药的获批及放量，集团‘高潜力新药+稳增长成熟产品'的组合将为爆发性的业绩增长提供强力支撑，从2025年开始集团阶段性重磅新产品都将投入商业化，业绩有望创历史新高，并在未来三年内实现跨越式发展。" 关于绿叶制药集团绿叶制药集团是致力于创新药物的研发、生产和销售的国际化制药公司。绿叶制药在中国、美国和欧洲设有研发中心，拥有超过30个中国在研药物和10多个海外在研药物。绿叶制药在微球、脂质体、透皮释药等先进药物递送技术领域达到国际先进水平，在新分子实体、生物抗体领域收获多项创新成果，并在细胞治疗、基因治疗等领域进行了积极布局和开发。绿叶制药深度布局全球供应链体系，已在全球建有8大生产基地并建立了与国际接轨的GMP质量管理和控制体系。公司现有30余个上市产品，产品覆盖肿瘤、中枢神经系统、心血管、消化与代谢等治疗领域；业务遍及全球80多个国家和地区，其中包括中国、美国、欧洲、日本等全球主要医药市场，以及高速增长的各地新兴市场。

上市批准财报

2024-08-08

·药渡Daily

【药渡药闻报告-创新药篇】-2024年第30期/总第151期

全球药物批准/研发动态 01 全球新药批准情况根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）全球（不含中国）共有13个新药获批上市。其中，NDA批准1个，BLA批准1个，新适应症批准10个，新制剂批准1个。与上个统计周期相比，本次增加4个批准新药数量。 7月28日，绿叶制药宣布，FDA已批准ERZOFRI（帕潘立酮棕榈酸酯）缓释注射混悬液，用于治疗成人精神分裂症和成人分裂情感性障碍，单药治疗和作为心境稳定剂或抗抑郁药的辅助治疗。ERZOFRI每月给药一次，可有效提高患者的依从性，降低患者在医疗保健提供者不知情的情况下不遵守其给药方案的风险，是中国首个获得专利的帕潘立酮棕榈酸酯长效注射液。ERZOFRI在美国被批准为505(b)(2)通路的新药。 7月30日，罗氏宣布EC已批准Vabysmo®（Faricimab）用于治疗继发于视网膜静脉阻塞的黄斑水肿（RVO、分支RVO或中央RVO）引起的视力障碍。Vabysmo是唯一获批用于眼部的双特异性抗体，通过中和血管生成素-2（Ang-2）和血管内皮生长因子-A（VEGF-A）来恢复血管稳定性，靶向和抑制与许多威胁视力的视网膜疾病有关的两种信号通路。每月使用Vabysmo治疗可使BRVO和CRVO患者的视力得到早期和持续的改善，Vabysmo的耐受性良好，安全性与以前的研究一致。全球（不含中国）新药批准情况（部分） 02 全球新药申报进展根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）全球（不含中国）共有3个新药申报上市。其中，NDA申报2个，BLA申报1个。与上次统计周期相比，本次减少14个NDA/BLA申报。 8月1日，拜耳宣布已向FDA提交研究化合物Elinzanetant的新药上市申请，用于治疗与更年期相关的中度至重度血管舒缩症状。该申请基于OASIS 1、2和3 III期研究的积极结果：Elinzanetant（120mg，口服，每日1次）可显着降低中度至重度VMS的频率和严重程度，并显示出良好的安全性。 NDA/BLA申报（部分）根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）全球（不含中国）共有5个药物获监管机构特殊资格认定。其中，化学药3个，生物药3个，本次与上次统计周期获监管机构特殊资格认定药渡的药物数量持平。 7月31日，Immuneering Corporation宣布，FDA授予IMM-1-104快速通道资格，作为胰腺导管腺癌患者的一线治疗。2024年2月，IMM-1-104获得快速通道资格认定，作为既往一线治疗失败的PDAC患者的二线治疗。IMM-1-104旨在通过每日一次口服给药对MAPK通路的深度环状抑制来提供通用RAS活性。同日，Theriva™Biologics宣布FDA授予VCN-01罕见儿科药物资格，用于治疗视网膜母细胞瘤。VCN-01是Theriva的主要候选产品，是一种全身性、选择性、基质降解溶瘤腺病毒，旨在选择性和积极地在肿瘤细胞内复制并降解肿瘤基质，而肿瘤基质是癌症治疗的重要物理和免疫抑制屏障。全身给药使VCN-01能够对原发肿瘤和转移瘤发挥作用，VCN-01已在I期和研究者赞助的不同癌症临床试验中对80多名患者进行给药，包括PDAC（联合化疗）、头颈部鳞状细胞癌（使用免疫检查点抑制剂）、卵巢癌（使用CAR-T细胞疗法）、结直肠癌和视网膜母细胞瘤（通过玻璃体内注射）。特殊资格认定情况 03 全球新药研发进展根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）全球（不含中国）新药临床研发状态更新共计39条，涉及肿瘤、血液和淋巴疾病、遗传代谢病、神经疾病以及皮肤病等共计11个领域。其中，神经疾病领域临床进展更新居各领域之首，为13条：涉及化学药7条，生物药5条，细胞疗法1条。 7月29日，AstraZeneca公布AMPLIFY III期试验中期分析的积极高水平结果，Calquence（阿卡替尼）联合维奈托克，联合或不联合奥妥珠单抗，与标准护理化学免疫疗法相比，在以前未经治疗的慢性淋巴细胞白血病（CLL）成年患者中，无进展生存期（PFS）具有统计学意义和临床意义的改善。 Athira Pharma在7月28日至8月1日的2024年AAIC上展示了新的临床前数据，研究显示Fosgonimeton可以减轻淀粉样蛋白β诱导的自噬破坏，这是一个重要的细胞过程，在去除病理蛋白（如 pTau）方面起关键作用。自噬的改善可能部分解释了在这些模型中观察到的pTau减少，并表明Fosgonimeton可能对蛋白质病理学的关键指标以及阿尔茨海默病中的相关神经退化产生有益影响。全球新药研发进展详情（部分） 04 全球医药交易事件本次统计周期（2024.07.27-08.02）全球（含中国）医药交易时间共计38起，涉及药物权益转让、公司并购等多起交易事件。全球医药交易时间汇总表（部分）国内药物批准/研发动态 01 国内新药批准情况根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内共有1个新药获NMPA批准上市。其中，批准新复方1个。本次NMPA批准新药数量与上次统计周期相同。 7月29日，欧加隆中国宣布旗下创新降脂单片复方制剂益立妥®正式在中国上市，用于治疗高胆固醇血症和纯合子型家族性高胆固醇血症（HoFH）。益立妥®是首个在中国获批的依折麦布阿托伐他汀单片固定剂量复方制剂，可为血脂异常患者提供“联合降脂，一粒掌控”的原研进口新选择，改善治疗依从性，助力降脂达标。研究显示，依折麦布与阿托伐他汀的联用能够使低密度脂蛋白胆固醇（LDL-C）降幅达54%，且其安全性与服用阿托伐他汀单药相当。中国新药批准情况（部分） 02 国内新药临床默示许可进展根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内共有45个新药获临床默示许可，涉及73个受理号。其中，化学药24个，治疗用生物制品21个。与上个统计周期相比，本次减少25个临床默示许可获批受理号。本周国内新药临床默示许可进展（部分） 03 国内新药申报进展根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内共有8个新药申报上市，涉及18个受理号。其中，化药4个，治疗用生物制品4个。与上个统计周期相比，本次增加13个新药申报上市受理号。国内新药申报上市情况（部分）根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内共有41个新药申报临床，涉及58个受理号。其中，化学药10个，治疗用生物制品26个，预防用生物制品5个。与上个统计周期相比，本次减少17个临床申报受理号。国内新药临床申报情况（部分）根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内共有7个药物获NMPA特殊资格认定。其中，化学药2个，生物药4个。与上个统计周期相比，本次增加2个获监管机构特殊资格认定的药物。国内监管机构特殊资格认定药物（部分） 04 国内新药研发进展根据药渡数据统计分析，本次统计周期（2024.07.27-08.02）国内新药临床研发状态更新共计5条，涉及肿瘤、血液和淋巴系统疾病、眼部疾病和心血管疾病共计4个领域。其中，化学药3个，生物药2条。与上次统计周期相比，本次减少6条国内新药临床研发状态更新。国内新药研发进展（部分） 05 国内新药研发领域政策法规动态关于公开征求《嵌合抗原受体T细胞治疗淋巴血液系统恶性肿瘤临床试验技术指导原则（征求意见稿）》意见的通知我国已有多个嵌合抗原受体T细胞治疗产品上市用于治疗淋巴血液系统恶性肿瘤。该类产品兼具创新性和复杂性，与传统细胞毒药物、靶向治疗或其它肿瘤免疫治疗药物相比，在临床试验设计存在诸多不同考虑。国内尚无相关指导原则对这类产品的临床设计进行规范指导，我中心在充分调研国内外同品种研发情况以及相关临床试验技术要求基础上，起草了《嵌合抗原受体T细胞治疗淋巴血液系统恶性肿瘤临床试验技术指导原则（征求意见稿）》。我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。 06 国内新药研发领域热点新闻华东医药“猛虎下山”，打造自免“王者” 自免“隐形王者”华东医药，又双叒叕出手了。近日，华东医药全资子公司中美华东再度联手“自免第一股”荃信生物，就后者自研的IL-4Rα单抗QX005N签署合作开发及市场推广服务协议。已经在自免领域布局多年的华东医药，正在迎来大展身手的时刻。华东医药再出手，拿下IL-4Rα单抗QX005N 7月19日，华东医药全资子公司中美华东获得荃信生物QX005N产品在大中华区地区的独家权益。更多资讯，请阅读原文恒瑞医药加大海外攻势？近日，恒瑞医药发布公告称，根据经营发展需要，提名聘任徐学健为副总经理，另据第一财经消息，徐学健还将担任恒瑞医药首席质量官，全面负责质量管理工作。在加入恒瑞前，徐学健历任药明生物首席质量官和高级副总裁；药明康德质量部和美国药政部副总裁；美国FDA高级CMC评审员；美国PII制剂开发公司质量总监；创办上海福利康生物医药公司任总裁；美国惠氏（辉瑞）质量保证部高级主管；美国健赞公司高级科学家，值得一提的是，其在制药行业从业经历，多半除与质量相关，且与美国市场交集。更多资讯，请阅读原文征战ADC，艾伯维终将“守得云开见月明” 7月25日，艾伯维1类新药「ABBV-706注射用冻干粉」的临床试验申请获CDE受理。据公开资料，ABBV-706是一款靶向癫痫相关同源蛋白6（SEZ6）的ADC，有效载荷为新型拓扑异构酶1抑制剂（Top1i），被开发用于治疗小细胞肺癌（SCLC）等晚期实体瘤。癫痫相关同源蛋白6（SEZ6）是由位于17q11.2染色体的SEZ6基因编码的一种单次跨膜蛋白，是SEZ6家族中的一员，主要参与神经树突的形成、调控神经信号传递。此外，SZE6及其家族成员还可能具有与补体级联相关的活性。研究发现，SEZ6在大多数正常组织中极少表达，但选择性高表达在神经内分泌肿瘤细胞（NET）上，且与NET的进展密切相关。更多资讯，请阅读原文咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在药渡Daily公众号后台回复“0808创新药周报”，即可下载。

临床3期上市批准快速通道