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来源：Pharmacoepidemiology and Drug Safety (Pharmacoepidemiol Drug Saf) 医院药学研究 第5期（ 总第25期） 本期聚焦药物流行病学与用药安全领域的最新研究成果，涵盖大规模药物性肝损伤住院风险的筛查、真实世界中直接口服抗凝药的出血风险比较、质子泵抑制剂长期使用的安全性评估、多药联用与药物相互作用的不良结局分析以及处方级联的识别与管理等与医院药学安全实践密切相关的原创研究与系统评价。 ◆ 论文目录（中英对照） 1. [Original Research] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury 采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物 2. [Original Research] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) 使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价 3. [Original Research] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study 北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究 4. [Original Research] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study 英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较 5. [Systematic Review] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis 单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍采用自身对照树状扫描统计方法高通量筛选与严重急性肝损伤住院相关的药物 研究背景 药物性肝损伤（DILI）是导致药物撤市和药物相关住院的重要原因之一。传统上，肝毒性信号主要通过病例报告来识别，存在滞后性和低敏感性等局限。随着真实世界数据（RWD）的广泛应用，高通量筛查方法为早期识别潜在的肝毒性药物提供了新的可能。树状扫描统计方法（TreeScan）是一种数据驱动的主动监测方法，可在无预设假设的情况下同时筛查大量药物-不良事件关联。本研究利用美国退伍军人健康管理局（VHA）数据库，采用自身对照病例交叉设计，系统评估了TreeScan在无肝胆疾病患者和慢性肝病患者中识别严重急性肝损伤相关药物的性能，为医院药物安全管理提供了重要的方法学参考和临床证据。 核心发现 • 在12,860名无肝胆疾病和17,512名慢性肝病住院严重ALI患者中，分别评估了与450种和543种药物的潜在关联 • 无明显肝病患者中，雷尼替丁、奥美拉唑、昂丹司琼等药物与严重ALI显著相关；慢性肝病患者中，螺内酯、呋塞米、多种阿片类镇痛药和昂丹司琼等均与严重ALI显著相关 • 抗菌药物（阿莫西林/克拉维酸、环丙沙星、甲硝唑等）在两类患者中均显示出肝毒性信号 • 树状扫描统计方法作为一种高通量筛查工具，能够有效检测潜在肝毒性药物，为后续药物流行病学研究提供候选药物 领域意义 本研究为医院药学实践提供了重要的药物肝毒性风险信息。研究识别出的一系列可能与严重急性肝损伤相关的药物，涵盖了医院常用药如质子泵抑制剂（奥美拉唑）、止吐药（昂丹司琼）、利尿剂（螺内酯、呋塞米）和抗菌药物等，提醒医院药师在处方审核和药学监护中需特别关注这些药物的肝毒性风险。基于TreeScan的高通量筛查方法为医院建立主动式药物安全监测体系提供了新思路。对于已有肝病基础的患者群体，研究结果强调了更严格用药管理的重要性，有助于医院药学部门优化肝病患者用药方案。 英文摘要 (Abstract) Background: Medications associated with acute liver injury (ALI) are primarily identified by case reports. High-throughput screening of real-world data could be leveraged to detect hepatotoxicity signals. Objective: To apply tree-based scan statistics in real-world data to identify drugs associated with hospitalization for severe ALI among patients without liver/biliary disease and with chronic liver disease (CLD). Methods: We implemented a self-controlled case-crossover design in Veterans Health Administration data (2000-2023) among patients hospitalized for laboratory-confirmed severe ALI. We identified all newly dispensed drugs within 365 days prior to their hospitalization and used conditional Bernoulli tree-based scan statistics to identify potential associations (p < 0.3). We performed analyses separately in patients without liver/biliary disease and with CLD. Results: Among 12,860 patients without liver/biliary disease and 17,512 with CLD hospitalized for severe ALI, we evaluated associations with 450 and 543 drugs, respectively. Drugs associated with severe ALI among patients without liver/biliary disease included: acid-suppressives (ranitidine [p < 0.001], omeprazole [p = 0.004]), antiemetics (ondansetron [p < 0.001], promethazine [p = 0.06]), antibiotics (amoxicillin/clavulanate [p = 0.008], ciprofloxacin [p = 0.02], mupirocin [p = 0.032], ethambutol [p = 0.275]), anticoagulants (heparin [p = 0.015]), and chemotherapy (pazopanib [p = 0.275]). Drugs associated with severe ALI among CLD patients were: diuretics (spironolactone, furosemide [both p < 0.001]), antiemetics (ondansetron, metoclopramide, promethazine [all p < 0.001]), appetite stimulants (p < 0.001), analgesics (morphine, oxycodone, fentanyl [all p < 0.001]), chemotherapy (sorafenib [p < 0.001]), antibiotics (ciprofloxacin [p = 0.011], metronidazole [p = 0.020]), antipsychotics (prochlorperazine [p = 0.105]), vitamins (p = 0.134), acid-suppressives (omeprazole [p = 0.164]), and gastrointestinal/liver disease treatments (lactulose, senna, docusate, silicones, antiflatulents [all p < 0.001]; sucralfate [p = 0.005], albumin [p = 0.228]). Conclusions: High-throughput screening using tree-based scan statistics detected potentially hepatotoxic drugs for investigation in future pharmacoepidemiology studies. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD) Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍使用临床实践研究数据库的自体对照病例序列联合活性对照方法在药物安全信号检测中的性能评价 研究背景 药物安全信号检测是药物警戒的核心环节，及时准确地识别潜在的药品不良反应信号对于保障患者用药安全至关重要。基于电子健康档案（EHR）的真实世界数据为药物安全信号检测提供了丰富的资源，但如何在真实世界数据中实现高灵敏度和高特异性的信号检测仍是一个方法学挑战。自体对照病例序列（SCCS）设计因其可控制个体间混杂因素而备受关注，而引入活性对照可能进一步控制适应证导致的混杂偏倚。本研究以英国临床实践研究数据库（CPRD Aurum）为数据源，系统评价了SCCS设计在有无活性对照条件下的信号检测性能，为基于电子健康档案的药物警戒方法学发展提供了重要证据。 核心发现 • 构建了包含104个阳性对照和58个阴性对照的参考标准集，确保药物-结局配对在理论上适合SCCS设计 • 无活性对照的SCCS灵敏度为0.57、特异度为0.77；加入活性对照后特异度提高至0.89，但灵敏度下降至0.18 • 5个药物-结局配对在出现在药品标签之前即被SCCS方法识别为不平衡信号 • 使用大环内酯类和氟喹诺酮类抗生素作为目标药物，阿莫西林和头孢氨苄作为活性对照，覆盖全部器官类别的30个结局 领域意义 本研究对医院药物警戒工作具有直接的方法学指导价值。SCCS设计在CPRD数据库中展现出中等水平的信号检测性能，为医院药物不良反应监测提供了可借鉴的分析框架。研究表明活性对照可有效减少适应证混淆，但可能因统计效力下降而降低阳性信号的检出能力，这为医院药学科在真实世界药物安全研究中平衡特异度和灵敏度提供了重要参考。该方法学框架可应用于医院电子病历系统的药物不良反应主动监测中，帮助临床药师更精确地识别潜在药物安全问题。 英文摘要 (Abstract) Background: There is little evidence about signal detection using UK primary care electronic health records (EHRs). The self controlled case series (SCCS) is one of the most promising methods for drug safety signal detection using real world data, and incorporating active comparators could potentially improve its performance by addressing confounding by indication. Objectives: This study aims to evaluate the performance of the SCCS with and without active comparators for signal detection using the UK Clinical Practice Research Datalink (CPRD) Aurum. Methods: We applied the SCCS to macrolide and fluoroquinolone antibiotics, using amoxicillin and cefalexin as active comparators. In total seven drugs, and 30 outcomes from all organ classes were selected. We developed a reference set of 104 positive controls and 58 negative controls, using a taxonomy framework to ensure the selected drug outcome pairs are theoretically well suited to the SCCS design. Two-year observation periods with a 30-day risk window after each dispensing were used. Diagnostic performance was measured using sensitivity and specificity with respect to the product labels. Results: The sensitivity and specificity of the SCCS without active comparator in the 2017/2018 observation period were 0.57 and 0.77 when limited to pairs with satisfactory power. Specificity increased up to 0.89 with active comparators, however sensitivity decreased to 0.18. Five drug-outcome pairs were signals of disproportionality before they were present on labels. Conclusions: Using a carefully designed reference set of drug-outcome pairs well suited to the study design, the SCCS performed moderately well for signal detection in CPRD. Whilst active comparators effectively reduced confounding by indication, they also reduced the number of correctly identified positive controls, due to a reduction in power. We showed some evidence that SCCS is able to highlight SDRs before they were present on labels. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍北意大利直接口服抗凝药使用的预测因素：一项基于人群的研究 研究背景 直接口服抗凝药（DOACs）已成为房颤和静脉血栓栓塞症抗凝治疗的主流选择。然而，不同DOACs（阿哌沙班、利伐沙班、达比加群、艾多沙班）之间的头对头比较证据有限，临床实践中DOAC选择和转换的驱动因素尚不明确。临床指南通常不会明确推荐某一种DOAC优于其他DOAC，但在真实世界的处方实践中可能存在特定的处方模式。了解影响临床决策的因素对于优化抗凝治疗管理、促进合理用药和识别潜在的不当处方模式具有重要意义。本研究利用意大利伦巴第大区的卫生行政数据库，分析了2019-2022年间近16万例新起始DOAC使用者的处方模式、预测因素和转换情况。 核心发现 • 共识别159,993名DOAC新使用者，阿哌沙班使用比例从29.0%上升至34.3%，而达比加群从20.7%下降至11.5% • 高龄和女性性别是艾多沙班处方的预测因素；合并症主要与阿哌沙班使用相关；缺血性心脏病或心梗病史者优先使用达比加群 • DOAC总体转换率为5.6%，阿哌沙班是最常被选择的第二种DOAC；达比加群主要在有血管缺血性事件后被选为第二种DOAC • 有出血史的患者优先被处方阿哌沙班和艾多沙班，外周动脉疾病患者倾向于使用利伐沙班 领域意义 本研究为医院药学中抗凝药物管理提供了重要的真实世界证据。了解不同DOAC的处方预测因素有助于医院药师在抗凝治疗方案的制定和评估中发挥更积极的作用。研究发现阿哌沙班的处方偏好呈上升趋势，而达比加群使用量下降，这反映了真实临床实践中对抗凝药物的风险-获益评估趋势。出血史患者优先使用阿哌沙班和艾多沙班的模式提示临床医生对特定DOAC安全性的认知在影响处方决策。这些数据有助于医院药学部门制定基于证据的抗凝药物管理策略，优化个体化抗凝治疗方案，并为医院药事管理中抗凝药物的处方审核和药学监护提供参考。 英文摘要 (Abstract) Purpose: Evidence on head-to-head comparison between direct oral anticoagulants (DOACs) is lacking, and the reasons for choosing one type of DOAC and switching from one DOAC to another are scarce. This study investigated the use of DOACs in an unselected population in Northern Italy during a recent period. Methods: Using the health administrative database of the Lombardy region, subjects aged 45 years and older who started DOAC therapy between 2019 and 2022 were included in the analysis. Logistic regression analysis was used to evaluate predictors associated with DOAC prescription, and results were presented as ORs with 95% CI. DOAC switching was assessed by estimating the prevalence and cumulative incidence according to the first prescribed DOAC. Results: Overall, 159 993 new users for DOAC were identified. Apixaban users increased from 29.0% to 34.3%, whereas dabigatran users decreased from 20.7% to 11.5% over time. Across all pair-wise comparisons, older age and female sex were predictors for edoxaban prescription. Comorbidities were mainly associated with the use of apixaban; however, dabigatran was preferred in patients with a history of ischemic heart disease or myocardial infarction and rivaroxaban in those with peripheral artery disease. Both apixaban and edoxaban were preferentially prescribed to patients with a history of bleeding. The switching rate of DOACs was 5.6% with apixaban as the most preferred drug as a second choice. Dabigatran was mainly chosen as a second DOAC after a vascular ischaemic event. Conclusion: Given the lack of evidence on factors influencing clinician behavior in the use of DOACs, our findings provide insight into this topic in a real-world setting. As the use of these agents increases, further evidence is needed to better explore this issue. Our data could contribute to the development of recommendations in clinical practice. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Original Research Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Original Research ▍英国生物银行研究中自我报告用药数据与全科医师处方记录在阿片类药物暴露测量中的比较 研究背景 全球范围内阿片类药物的使用持续增长，使得研究其长期健康影响的重要性日益凸显。前瞻性队列研究通常依赖自我报告的用药数据，但这类数据可能因回忆偏倚、社会期望偏倚和药物识别能力有限等因素而存在偏差。相比之下，处方记录被视为更客观的用药暴露测量指标，但也可能遗漏非处方来源和未记录的实际使用情况。两种数据来源的一致性和差异对于药物流行病学研究的方法学质量具有重要影响。本研究利用英国生物银行（UK Biobank）大规模队列中171,813名参与者的数据，系统比较了自我报告规律用药与全科医师（GP）处方记录在阿片类药物暴露测量中的一致性。 核心发现 • 自我报告规律阿片类药物使用与处方记录之间一致性为中等至实质性，过去365天内≥3张处方的一致性最佳（Cohen's Kappa = 0.66） • 镇痛类阿片类药物一致性（Kappa = 0.43-0.63）显著优于非镇痛类阿片类药物（Kappa = 0.25-0.34） • 距末次处方记录时间越长，遗漏报告（omission）的概率越高；慢性疼痛患者遗漏率最低但错误报告率（commission）最高 • 自我报告可捕获来自未关联来源的阿片类药物使用情况，对于镇痛类阿片是一个有效的暴露评估指标 领域意义 本研究对医院药学中的药物利用研究和阿片类药物安全管理具有重要的方法学参考价值。研究结果提示，在进行药物流行病学研究中，自我报告数据和处方记录各有优劣，应根据研究目的和药物类别选择合适的暴露测量指标。对于医院药学部门开展的阿片类药物利用评价和风险管理，本研究的发现有助于理解不同数据来源可能导致的偏倚。在评估住院患者的院外用药史时，医院药师应注意仅依赖处方记录可能低估镇痛类药物的实际使用情况，而需要综合多种信息源进行全面评估。该研究也为医院建立阿片类药物监测体系提供了方法学依据。 英文摘要 (Abstract) Purpose: The ongoing global increase in opioid use necessitates studies examining long-term health impacts. Prospective cohorts frequently rely on self-reported medication use data which may be subject to several types of bias compared to more objective measurements. We evaluated the agreement between two opioid exposure measures in the UK Biobank (UKBB)-self-reported regular use and prescription-based indicators using linked general practitioner (GP) records. Methods: Our analysis included 171 813 UKBB participants with linked prescription records. At baseline, participants reported medications taken regularly (weekly, monthly, every 3 months). We assessed agreement between self-reported regular opioid use and opioid prescription records prior to enrollment across various look-back periods and prescription counts. Logistic regressions assessed factors associated with omission and commission. Results: Agreement was moderate to substantial between self-reported opioid use and prescription records. The strongest agreement was observed for ≥ 3 prescriptions in the past 365 days (Cohen's Kappa = 0.66). Subgroup analysis showed better agreement for analgesic opioids (Kappa = 0.43-0.63) than for non-analgesic opioids (Kappa = 0.25-0.34). Omission odds were highest with increasing months since the last record and lowest for individuals with chronic pain. Commission odds were highest for individuals with chronic pain and lowest in married/partnered individuals. Conclusions: This analysis indicates that self-reported regular opioid use in the UKBB could be a valid indicator for identifying individuals with repeated prescriptions for analgesic opioids in the past year, while also capturing opioid use from non-linked sources. However, agreement was low for non-analgesic opioids, suggesting limited utility of self-report for capturing use of these medications. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎Systematic Review Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis Pharmacoepidemiol Drug Saf 丨 2025-12-XX 丨 Systematic Review ▍单克隆抗体治疗中重度特应性皮炎的疗效与安全性：系统综述与网络荟萃分析 研究背景 特应性皮炎（AD）是一种慢性、复发性炎症性皮肤病，严重影响患者生活质量。近年来，针对AD免疫病理机制的单克隆抗体（mAb）治疗迅速发展，多种新型生物制剂相继获批上市或在临床试验中展现出良好的治疗效果。然而，不同单克隆抗体之间的疗效和安全性缺乏直接的头对头比较研究，临床决策面临如何选择最优治疗方案的挑战。网络荟萃分析（NMA）作为可同时比较多种干预措施的统计学方法，为综合评估各单克隆抗体在AD治疗中的相对疗效和安全性提供了重要工具。本研究对截至2024年11月的所有相关随机对照试验进行了系统检索和网络荟萃分析。 核心发现 • 纳入32项RCT共7,588例患者，全面比较了多种单克隆抗体在中重度AD中的疗效和安全性 • Spesolimab、Rademikibart、Dupilumab和Amlitelimab在EASI-50、EASI-75、EASI-90和IGA改善方面均显著优于安慰剂 • 根据SUCRA排序，Dupilumab在瘙痒NRS评分、EASI评分和SCORAD评分的百分比变化方面表现出相对较好的疗效 • Dupilumab的严重不良事件发生率显著低于安慰剂（RR = 0.43, 95% CI 0.30-0.63），其他安全性分析结果无统计学差异 领域意义 本系统综述对医院药学中生物制剂的管理和使用具有重要的临床指导价值。研究通过网状荟萃分析综合比较了多种单克隆抗体在AD中的相对疗效和安全性，为临床药师的药物选择和治疗方案制定提供了循证依据。Dupilumab在疗效综合排名和安全性方面表现突出，特别是其严重不良事件发生率显著低于安慰剂的发现，进一步支持了其在AD治疗中的优选地位。随着生物制剂的广泛使用，医院药学科在生物制剂的处方审核、药学监护和用药教育中需要基于最新的证据，本研究提供的比较疗效和安全性数据可作为重要的决策参考。 英文摘要 (Abstract) Objective: The aim of this study was to compare the efficacy and safety of monoclonal antibodies (mAb) for moderate-to-severe atopic dermatitis (AD). Methods: The randomized controlled trials (RCTs) of monoclonal antibodies in the treatment of moderate-to-severe AD were searched in the database of PubMed, Embase, Web of Science and Cochrane Library, up to November 2024. The control group included placebo. The efficacy indicators were the percentage of patients achieving 50%, 75%, 90% improvement in Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) and the percentage of patients with an Investigator Global Assessment (IGA) Score of 0 or 1 from baseline until the time of efficacy observation, and the percent change in Pruritus Numerical Rating Scale (NRS), EASI score, SCORing Atopic Dermatitis (SCORAD), and change in Percent Body Surface Area (BSA), Dermatology Life Quality Index (DLQI). The statistical analysis was performed by Stata14 and RevMan5.4. Data processing, network evidence plots, surface under the cumulative ranking curve (SUCRA) ranking, league plots and funnel plots were generated. Risk ratio (RR) and 95% confidence interval (95% CI) were used as effect sizes to analyze binary categorical variables. Results: This study included 32 RCTs with 7588 patients. Spesolimab, Rademikibart, Dupilumab, Amlitelimab were more effective than placebo in EASI-50 (RRs ranging between 1.31 and 22.65), EASI-75(RRs ranging between 1.51 and 36.58), EASI-90(RRs ranging between 3.72 and 5.49), and the percentage of patients in IGA score of 0 or 1 (RRs ranging between 1.78 and 13.36). Dupilumab showed relatively good efficacy according to SUCRA ranking on percent change in NRS, EASI, SCORAD. Dupilumab exhibited a lower incidence of serious adverse events than placebo, and the difference was statistically significant (RR = 0.43, 95% CI 0.30-0.63). Other safety analysis results showed no statistical difference. Conclusions: Through the analysis of the primary efficacy indicators, this network meta-analysis (NMA) study indicated that all monoclonal antibodies performed better than placebo. Based on the results of this study, Spesolimab, Rademikibart, Dupilumab, Amlitelimab were recommended treatment options with relatively good efficacy and safety. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ ▎参考文献·References [1] High-Throughput Screening Using the Self-Controlled Tree-Based Scan Statistic to Identify Medications Associated With Hospitalization for Severe Acute Liver Injury. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70275. https://doi.org/10.1002/pds.70275 [2] Performance of the Self-Controlled Case Series With Active Comparators for Drug Safety Signal Detection Using the Clinical Practice Research Datalink (CPRD). Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70243. https://doi.org/10.1002/pds.70243 [3] Predictors of Direct Oral Anticoagulant Use in Northern Italy: A Population-Based Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70300. https://doi.org/10.1002/pds.70300 [4] Measuring Exposure to Opioids Using Self-Reported Medication Use Data Versus General Practitioner Prescription Records in the UK Biobank Study. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70280. https://doi.org/10.1002/pds.70280 [5] Efficacy and Safety of All Monoclonal Antibodies in Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis. Pharmacoepidemiol Drug Saf. 2025-12-XX. doi: 10.1002/pds.70268. https://doi.org/10.1002/pds.70268 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ 医院药学研究导读丨聚焦全球医院药学前沿动态 关注我们，追踪全球药学前沿 第5期 丨 总第25期 丨 2026年6月

1. BMS-986489 (Atigotatug和Nivolumab固定剂量复方)注射液 企业名称：Bristol-Myers Squibb Company;Grand River Aseptic Manufacturing, Inc.; Bristol-Myers Squibb Company;Bristol Myers Squibb Co.; 治疗机制：BMS-986489是由Atigotatug（抗fuc-GM1单抗）和Nivolumab（纳武利尤单抗，抗PD-1单抗）组成的固定剂量复方制剂。Atigotatug结合于小细胞肺癌细胞高表达的fucosyl-monosialoganglioside-1（fuc-GM1），通过抗体依赖性细胞毒性（ADCC）、抗体依赖性细胞吞噬作用（ADCP）和补体依赖性细胞毒性（CDC）诱导肿瘤细胞死亡；Nivolumab通过阻断PD-1/PD-L1通路恢复T细胞抗肿瘤活性。两者通过互补的免疫机制增强抗肿瘤效应。 注册与分类：补充申请，注册分类1类 适应症：拟用于小细胞肺癌（SCLC）的治疗，包括广泛期小细胞肺癌（ES-SCLC）和局限期小细胞肺癌（LS-SCLC）的巩固治疗。目前处于全球III期临床研究阶段。 2.帕博利珠单抗注射液 企业名称：Merck Sharp & Dohme B.V.;Merck Sharp & Dohme B.V.;上海宏成药业有限公司; 治疗机制：帕博利珠单抗是一种人源化抗PD-1单克隆抗体，通过结合T细胞表面的PD-1受体，阻止其与肿瘤细胞表达的PD-L1和PD-L2结合，解除肿瘤对免疫系统的抑制作用，恢复机体自身的抗肿瘤免疫应答，从而杀伤肿瘤细胞。 注册与分类：生物制品 适应症：已获批多个适应症，包括黑色素瘤、非小细胞肺癌、食管癌、头颈部鳞状细胞癌、经典霍奇金淋巴瘤、尿路上皮癌、肾细胞癌、胃癌、三阴性乳腺癌、子宫内膜癌、宫颈癌、胆道癌、结直肠癌、肝细胞癌等多种恶性肿瘤。 3.利拉鲁肽二级标准品 企业名称：Novo Nordisk A/S;诺和诺德（中国）制药有限公司; 治疗机制：利拉鲁肽是一种胰高血糖素样肽-1（GLP-1）受体激动剂，通过激活GLP-1受体，以葡萄糖浓度依赖的方式增强胰岛素分泌、抑制胰高血糖素分泌，并能延缓胃排空，通过中枢性的食欲抑制来减少进食量。 注册与分类：生物制品 适应症：用于成人2型糖尿病患者的血糖控制；也可用于成人肥胖或超重患者的体重管理。本品为二级标准品，用于药品质量控制和检验。 4.司美格鲁肽二级标准品 企业名称：Novo Nordisk A/S;诺和诺德（中国）制药有限公司; 治疗机制：司美格鲁肽是一种长效胰高血糖素样肽-1（GLP-1）受体激动剂，通过选择性结合并激活GLP-1受体，以葡萄糖浓度依赖的方式刺激胰岛素分泌和抑制胰高血糖素分泌，同时延缓胃排空和减少食欲。半衰期长，每周只需给药一次。 注册与分类：生物制品 适应症：用于成人2型糖尿病患者的血糖控制；也可用于成人肥胖或超重患者的长期体重管理。本品为二级标准品，用于药品质量控制和检验。 5.肝素钠 1000IU/ml溶液 企业名称：Pharmaskan;Novo Nordisk A/S;Nordisk Alle;诺和诺德（中国）制药有限公司; 治疗机制：肝素钠是一种粘多糖硫酸酯类抗凝血药，通过激活抗凝血酶Ⅲ（AT-Ⅲ）而增强后者对活化的Ⅱ、Ⅸ、Ⅹ、Ⅺ和Ⅻ凝血因子的抑制作用，从而阻止血小板聚集和破坏，妨碍纤维蛋白原变成纤维蛋白，发挥抗凝作用。 注册与分类：生物制品 适应症：用于防治血栓形成或栓塞性疾病，如心肌梗死、血栓性静脉炎、肺栓塞等；也用于血液透析、体外循环、导管术、微血管手术等操作中及某些血液标本或器械的抗凝处理。 6. HXN6005注射液 企业名称：华深智药生物科技（苏州）有限公司; 治疗机制：HXN6005是华深智药研发的1类创新生物制品。具体靶点和作用机制尚未完全公开 注册与分类：新药，注册分类1类 适应症：具体适应症待确认。 7.乐德奇单抗注射液（乐德奇拜单抗/Rademikibart） 企业名称：先声药业有限公司; 治疗机制：乐德奇单抗是靶向白细胞介素-4受体α亚基（IL-4Rα）的全人源单克隆抗体。通过特异性结合IL-4Rα，同时阻断IL-4和IL-13两条关键的2型炎症信号通路，抑制Th2型炎症反应，从而发挥对特应性皮炎、哮喘等炎症性疾病的治疗作用。 注册与分类：新药，注册分类1类 适应症：拟用于治疗成人及青少年特应性皮炎。也在开发用于哮喘、慢性阻塞性肺疾病（COPD）等其他Th2型炎症相关疾病。 8. EA5注射液皮下制剂 企业名称：上海览屹医药科技有限公司; 治疗机制：EA5是一种靶向补体蛋白C5的人源化单克隆抗体。通过特异性结合C5蛋白，阻止其被裂解为C5a和C5b，从而抑制补体系统的末端通路，减少膜攻击复合物（MAC）的形成，防止细胞溶解和组织损伤。 注册与分类：新药，注册分类1类 适应症：拟用于治疗抗磷脂综合征（APS）伴复发性血栓，以及阵发性睡眠性血红蛋白尿症（PNH）、重症肌无力等补体相关疾病。目前处于I期临床研究阶段。 9.注射用BL-M07D1（T-Bren） 企业名称：四川百利药业有限责任公司;成都百利多特生物药业有限责任公司; 治疗机制：BL-M07D1是一种靶向HER2的抗体偶联药物（ADC）。由人源化抗HER2抗体曲妥珠单抗通过可裂解连接子与新型拓扑异构酶I抑制剂Ed-04（喜树碱衍生物）偶联而成，药物抗体比（DAR）为8。通过特异性结合肿瘤细胞表面的HER2，经内吞进入细胞后释放细胞毒性载荷，阻断DNA复制，诱导肿瘤细胞凋亡。 注册与分类：补充申请，注册分类1类 适应症：拟用于HER2阳性乳腺癌、胃癌/胃食管结合部腺癌、非小细胞肺癌、胆道癌、卵巢癌等多种HER2表达的实体瘤。已纳入突破性治疗品种，目前正在开展多项III期临床试验。 10.注射用LY4052031 企业名称：礼来苏州制药有限公司; 治疗机制：LY4052031是一种靶向Nectin-4的下一代抗体偶联药物（ADC）。由Fc沉默的IgG1抗体通过可切割肽连接子与新型拓扑异构酶I抑制剂Camp98偶联而成，药物抗体比（DAR）为8。通过特异性结合肿瘤细胞表面的Nectin-4蛋白，递送细胞毒性载荷至肿瘤细胞，发挥抗肿瘤作用。与已上市的Padcev（MMAE载荷）作用机制不同，可用于Padcev耐药患者。 注册与分类：补充申请，注册分类1类 适应症：拟用于治疗晚期或转移性尿路上皮癌，以及其他表达Nectin-4的实体瘤。目前处于I期临床研究阶段，2026年ASCO公布的数据显示ORR达42%-48%。 11. IBI363（PD-1/IL-2α-bias双特异性抗体融合蛋白） 企业名称：信达生物制药（苏州）有限公司; 治疗机制：IBI363是全球首创的PD-1/IL-2α-bias双特异性抗体融合蛋白。其PD-1结合臂能够阻断PD-1/PD-L1通路，解除肿瘤对T细胞的免疫抑制；IL-2臂采用独特的α-bias设计，选择性激活和扩增肿瘤特异性T细胞，同时降低传统IL-2疗法常见的毒性反应。通过"松开刹车+加油点火"双重机制，同时实现免疫检查点阻断和细胞因子激动效应。 注册与分类：补充申请，注册分类1类 适应症：拟用于治疗多种晚期实体瘤，包括非小细胞肺癌、黑色素瘤、肾细胞癌等，尤其针对PD-1耐药、冷肿瘤、PD-L1低表达肿瘤。目前正在开展多项临床研究，包括一线NSCLC的III期研究。2025年10月信达生物与武田制药达成114亿美元全球战略合作。 12.靶向GPC3嵌合抗原受体自体T细胞注射液（Ori-C101） 企业名称：原启生物医药（北京）有限责任公司;原启生物科技（上海）有限责任公司; 治疗机制：Ori-C101是一款靶向GPC3（磷脂酰肌醇蛋白聚糖-3）的嵌合抗原受体T细胞（CAR-T）疗法。通过基因工程技术将靶向GPC3的CAR结构导入患者自体T细胞，使T细胞能够特异性识别并结合肝癌细胞表面的GPC3抗原，激活T细胞杀伤机制，释放穿孔素、颗粒酶等细胞毒性物质，诱导GPC3阳性肿瘤细胞凋亡。搭载独特的Ori元件，可突破肿瘤微环境屏障。 注册与分类：补充申请，注册分类1类 适应症：拟用于治疗GPC3阳性晚期肝细胞癌（HCC）。I期临床数据显示，最高剂量组ORR显著优于传统疗法，总人群mOS达21.4个月，远高于现有二线治疗约10.6个月的历史数据。是全球首个进入II期确证性临床试验的肝癌CAR-T产品。 本日点评 IBI363是2026年7月2日CDE承办生物制品中最具突破性意义的药物，作为全球首创的PD-1/IL-2α-bias双特异性抗体融合蛋白，它代表了下一代肿瘤免疫疗法的重要发展方向。其创新之处在于将免疫检查点阻断与细胞因子激动两种机制巧妙结合，通过PD-1结合臂"松开刹车"解除免疫抑制，同时利用经过α-bias改造的IL-2臂"加油点火"选择性扩增肿瘤特异性T细胞，既解决了传统IL-2疗法毒性大的问题，又能有效应对PD-1耐药这一世界性医学难题。