The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.
The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

开始日期2025-04-15

申办/合作机构

河南省肿瘤医院

NCT06812260

/ Not yet recruiting临床2期

A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

开始日期2025-03-31

申办/合作机构

上海复宏汉霖生物技术股份有限公司

NCT06850103

/ Not yet recruiting临床2期IIT

A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases

Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.

开始日期2025-03-28

申办/合作机构

浙江大学医学院附属第一医院（浙江省第一医院）

100 项与斯鲁利单抗相关的临床结果

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100 项与斯鲁利单抗相关的转化医学

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100 项与斯鲁利单抗相关的专利（医药）

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项与斯鲁利单抗相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Zhang, Lingli ; Xu, Kai ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Gong, Jinhong ; Sun, Qingli ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

2025-05-01·BMJ Open

Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol

Article

作者: Bi, Nan ; Deng, Lei ; Cao, Jianzhong ; Wang, Jianyang ; Duan, Jianchun ; Wu, Yuqi ; Zhang, Tao ; Zhou, Xiaohong

Introduction:

With the inspiring results of the PACIFIC trial in non-small-cell lung cancer (NSCLC), and the CAPIAN and IMpower133 trials in extensive-stage small-cell lung cancer (SCLC), immunotherapy has increasingly gained attention. Serplulimab, a PD-1 inhibitor, showed great antitumour activity in the ASTRUM-005 trial and has been recommended as first-line therapy in extensive-stage SCLC. Whether serplulimab following hypofractionation radiotherapy and chemotherapy could bring better outcomes in limited-stage SCLC remains to be answered.

Methods and analysis:

We designed a prospective multicentre single-arm phase II clinical trial to evaluate both the efficacy and safety of chemoradiotherapy and consolidation by serplulimab in limited-stage SCLC. Eligible patients will receive standard chemotherapy for four cycles and concurrent thoracic radiotherapy with a total dose of 45 Gy in 3 weeks and a 3 Gy dose per fraction. Prophylactic cranial irradiation is recommended for responding patients. Serplulimab will be delivered afterwards every 3 weeks for up to 1 year. Based on sample size estimation, 55 patients will be enrolled in total.

Ethics and dissemination:

Ethics approval was obtained from the Independent Ethics Committee of National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (22/236-3438).

Trial registration number:

NCT05443646 .

2025-05-01·Journal of Thoracic Disease

First-line serplulimab-based immunochemotherapy in elderly patients with extensive-stage small cell lung cancer: a multicenter, real-world study

Article

作者: Yang, Wenyue ; Zhou, Yun ; Wang, Jialei ; Zhou, Xinli ; Xia, Xiaodong ; Zhou, Min ; Shi, Meiqi

Background:

While immune checkpoint inhibitors (ICIs) in combination with chemotherapy have improved outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC), elderly patients (≥70 years) are often underrepresented in clinical trials, and real-world evidence on their efficacy and safety remains scarce. We conducted a real-world study to supplement data on using serplulimab [a programmed cell death protein 1 (PD-1) inhibitor] with chemotherapy as first-line treatment for elderly (≥70 years) ES-SCLC patients.

Methods:

We gathered data on ES-SCLC patients aged 70 and above treated with first-line serplulimab, focusing on progression-free survival (PFS) as the primary endpoint. Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Kaplan-Meier survival curves were used for PFS and OS, and Cox proportional hazards models and accelerated failure time (AFT) models were used for the subgroup analyses. The baseline and post-4-cycle neutrophil-to-lymphocyte ratio (NLR) levels were also collected as exploratory endpoints.

Results:

Forty-three ES-SCLC patients with a median age of 73 years were included. Median PFS was 7.0 months [95% confidence interval (CI): 6.1-12.5]. Subgroup analysis indicated a significantly higher risk of disease progression in female patients (P=0.04) and those who had brain radiotherapy (P<0.001). OS rate was 94.7% (95% CI: 87.9-100.0%) at 6 months and 65.8% (95% CI: 50.0-86.5%) at 1 year. The ORR was 65.12% (95% CI: 49.07-78.99%), and the DCR was 97.67% (95% CI: 87.71-99.94%). AEs occurred in 19 patients (44.19%), mostly grade 1-2 (14 patients, 32.56%), with grade ≥3 AEs in 11.63% (5 patients). There was no significant difference in NLR levels before and after patient treatment.

Conclusions:

This study showed that combining serplulimab with chemotherapy improved survival and reduced toxicity in elderly ES-SCLC patients. Additionally, NLR may not be suitable as a biomarker for the elderly ES-SCLC population.

729

项与斯鲁利单抗相关的新闻（医药）

2025-06-27

·药学进展

行业动态 | 复宏汉霖H药汉斯状®日本小细胞肺癌桥接试验完成首例患者入组

“点击蓝字关注我们复宏汉霖H药汉斯状®日本小细胞肺癌桥接试验完成首例患者入组 PPS 2025年6月25日，复宏汉霖（2696.HK）宣布，公司自主研发的H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）在日本开展的桥接临床试验（NCT06812260）完成首例患者入组。H药汉斯状®是全球首个获批用于一线治疗小细胞肺癌（SCLC）的抗PD-1单抗，已在中国、英国、德国、新加坡、印度等近40个国家和地区获批上市，惠及逾11万患者。NCT06812260研究由关西医科大学附属医院Takayasu Kurata教授担任牵头主要研究者，此次桥接试验旨在评估该产品联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）在日本患者中的疗效及安全性，为后续H药在日本市场的注册申报奠定基础。肺癌是全球发病率和死亡率最高的癌症，据GLOBOCAN最新数据显示，肺癌是日本发病率第二大高发癌种，2022年日本肺癌新发病例13.6万余例，肺癌死亡病例逾8.3万例，位居该国癌症死亡人数第一[1]。SCLC占肺癌总数的15%-20%，具有恶性程度高、转移早、疾病进展迅速等特点，预后极差。SCLC分为局限期和广泛期，在被确诊为SCLC的日本患者中，约40-50%为ES-SCLC，而其中在确诊后存活5年的患者不足4%[2,3]。此前，复宏汉霖已针对H药汉斯状®用于一线治疗ES-SCLC开展一项随机、双盲、安慰剂对照的国际多中心III期临床研究（ASTRUM-005）。该研究结果于2022年美国临床肿瘤学会（ASCO）年会以口头报告方式首次发布，并于全球四大顶级医学期刊之一的《美国医学会杂志》（JAMA）在线发表，成为全球首个登上JAMA主刊的小细胞肺癌免疫治疗临床研究。2025年美国临床肿瘤学会（ASCO）年会上，ASTRUM-005研究公布研究结束分析结果，截至2024年12月31日（中位随访时间42.4个月），斯鲁利单抗组的4年总生存期（OS）率达21.9%，对照组为7.2%，且安全性可控，进一步夯实了H药能为ES-SCLC患者带来显著的长期生存获益。基于ASTRUM-005研究的优异结果，H药用于治疗ES-SCLC陆续在中国、东南亚多国、欧洲、英国和印度获批用于一线治疗ES-SCLC。复宏汉霖在全球范围内积极推进H药在获批上市进程，目前，公司正在美国开展一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验，以进一步支持H药在美国的上市申报。复宏汉霖将持续以科学证据为核心，通过本土化开发，推动精准治疗策略的落地，为日本乃至全球患者提供更贴合临床需求的治疗选择。参考文献：[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834[2] Sawabata N, Asamura H, Goya T, et al; Japanese Joint Committee for Lung Cancer Registry. Japanese Lung Cancer Registry Study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol. 2010 Sep;5(9):1369-75.[3] Oze I, Ito H, Nishino Y, et al. Trends in Small-Cell Lung Cancer Survival in 1993-2006 Based on Population-Based Cancer Registry Data in Japan. J Epidemiol. 2019 Sep 5;29(9):347-353.文章来源：复宏汉霖美编排版：陈鑫茹文章审核：杜雪丽陈鑫茹罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

临床结果ASCO会议临床3期上市批准免疫疗法

2025-06-26

·PMLiVE

MHRA approves Accord Healthcare’s Hetronifly to treat aggressive form of lung cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Accord Healthcare’s Henlius-partnered Hetronifly (serplulimab) as the first anti-PD-1 monoclonal antibody for an aggressive form of lung cancer. The drug has been authorised to treat adults with extensive-stage small cell lung cancer (SCLC) that has not previously been treated and has spread within the lungs or to other parts of the body. SCLC, a fast-growing cancer that typically develops in the airways of the lungs, accounts for up to 15% of all lung cancer cases and is often diagnosed at a late stage. Administered as an intravenous infusion, Hetronifly is designed to block the PD-1 protein to help immune cells recognise and destroy cancer cells more effectively. The approval was supported by positive results from the phase 3 ASTRUM-005 trial of 585 adults, who were randomised to receive either Hetronifly or placebo, alongside chemotherapy. Hetronifly-treated patients lived on average for 15.4 months, compared with 10.9 months for those receiving chemotherapy and placebo. Julian Beach, interim executive director of healthcare quality and access at the MHRA, said: “As the first and only anti-PD-1 monoclonal antibody approved in the UK for SCLC, this marks an important new treatment option for patients with this aggressive type of lung cancer who currently have limited choices and face a poor prognosis. “We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of this medicine have been met. As with all products, we will keep its safety under close review.” Serplulimab was originally developed by Henlius Biotech, which has granted Accord’s parent company Intas Pharmaceuticals exclusive rights to develop and commercialise the drug in over 50 countries across Europe and India. The MHRA’s decision comes just under six months after it approved Amgen’s antineoplastic agent Imdylltra (tarlatamab) to treat SCLC in adults whose disease has spread throughout the lungs, to other parts of the body, or both, and who have failed two other types of treatments.

临床结果临床3期上市批准引进/卖出

2025-06-25

·摩熵医药

49款新药IND获批！53款品种过评，石药集团中诺药业领跑

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。PART 01周报概述随着全球医药行业的快速发展，新药研发与创新已成为推动行业进步的重要动力。近期，根据摩熵医药数据统计，新药申请与审批获批频繁，显示出医药创新领域的活跃态势。本文将深入分析2025年6月16日至2025年6月22日期间，国内外新药申请、临床试验批准、仿制药一致性评价等多个方面的最新进展，为用户提供全面的行业资讯。PART 02国内49款新药IND获批根据摩熵医药数据库统计，2025年6月16日至6月22日期间共有73个创新药/改良型新药临床申请/上市申请获国家药品监督管理局药品审评中心（CDE）承办（按受理号统计，不含补充申请）。其中国产药品受理号39个，进口药品受理号34个。本周共计49款创新药/改良型新药临床试验申请获得“默示许可”，包括化学药29款，生物药20款，无中药。本周获批临床创新药/改良型新药部分信息速览（不含补充申请）注：完整数据可识别“文末”二维码下载查看PART 03本周全球TOP10创新药研发进展在全球创新药研发领域，6月17日，中国国家药监局药品审评中心（CDE）官网公示，默沙东（MSD）申报的clesrovimab注射液上市申请拟纳入优先审评，拟定适应症为：用于即将进入或出生在第一个呼吸道合胞病毒（RSV）流行季的新生儿和婴儿预防RSV所致的下呼吸道感染。公开资料显示，这是默沙东研发的长效单抗疗法，已经于今年6月9日获得美国FDA批准。该产品旨在为婴幼儿提供快速且持续5个月的保护，覆盖整个典型的RSV流行季节（通常从秋季延续至翌年春季）。无论患儿体重如何，均采用105毫克固定剂量，简化了临床应用流程。6月19日，中国国家药品监督管理局（NMPA）药品评审中心（CDE）官网显示，信达生物的IBI343拟纳入突破性疗法，用于至少接受过两种系统性治疗的Claudin（CLDN）18.2表达阳性的局部晚期或转移性胰腺癌。IBI343是信达生物研发的全球首创注射用重组抗CLDN18.2单克隆抗体-依喜替康（exatecan）偶联物。IBI343与表达CLDN18.2的肿瘤细胞结合后，发生CLDN18.2依赖性内化，随后可裂解的连接子降解，从而释放的药物引起DNA损伤，导致肿瘤细胞凋亡。游离药物也可以通过质膜扩散到达并杀死相邻肿瘤细胞，因此IBI343也具有较强的旁观者效应。作为创新型TOPO1i型ADC，IBI343在临床I期研究中展现出可控的安全性和令人鼓舞的疗效性信号，目前正在胃癌和胰腺癌等瘤种上探索IBI343的治疗潜力。此外，还有吉利德长效HIV-1预防药物来那帕韦获FDA批准上市；海和药物引进的口服紫杉醇新适应症申报上市，用于治疗乳腺癌（相关扩展阅读：明星抗肿瘤药物或再添重磅适应症！乳腺癌患者迎新希望）；先声药业引进的抗失眠新药达利雷生在中国获批（相关扩展阅读：5000万美元引进！先声药业抗失眠新药获批上市）等。本周全球 TOP10 创新药研发进展截图来源：摩熵咨询周报PART 04本周全球TOP10临床试验结果本周全球TOP10临床结果中，6月16日，礼来（Eli Lilly and Company）公司公布了其在研减重多肽疗法 eloralintide（LY3841136）的1期概念验证研究结果。Eloralintide是一款每周一次皮下注射的选择性长效胰淀素受体激动剂，具有良好的耐受性和明确的体重减轻效果。Eloralintide不同于其他胰淀素激动剂，其设计目标是在临床中最大程度减少降钙素相关活性。此次公布的结果显示，eloralintide的平均半衰期为13.9-15.8天。在疗效方面，第12周时eloralintide组患者的最小二乘均值体重百分比下降幅度达2.6%至11.3%，安慰剂组患者的体重则增加0.2%，显示该疗法具有明确的减重潜力，并支持eloralintide的进一步开发。安全性方面，大多数不良事件为轻度，未观察到死亡事件，1例严重不良事件与eloralintide无关。6月19日，德睿智药宣布，其自主研发的口服小分子GLP-1RA新药MDR-001片，在中国肥胖或超重受试者中开展的多中心24周2b期临床试验达到临床终点。研究结果显示，肥胖或超重受试者在接受MDR-001片治疗24周时给药组减重高达10.3%，安慰剂组减重为2.5%，经安慰剂调整后的平均减重范围为-7.1%至-7.8%，且安全性、耐受性优异。在该研究中，MDR-001片表现出良好的安全性和耐受性，试验期间无药物治疗相关严重不良事件（SAE）。MDR-001各治疗组主要不良事件为胃肠道反应，包括恶心、呕吐和腹泻，多为轻中度且集中发生在滴定期前6周内, 中位恢复时间约为1-5天。受试者整体肝脏方面安全性表现良好，值得注意的是，本研究给药组纳入了约20%既往病史肝功能异常和转氨酶升高的受试者，各组未观察到转氨酶升高的趋势，且相比安慰剂组，MDR-001治疗组的转氨酶较基线均有明显降低。本周全球 TOP10 积极/失败临床结果截图来源：摩熵咨询周报PART 0553款品种过评，石药集团中诺药业领跑根据摩熵医药数据库统计，2025年6月16日至6月22日期间共有116项仿制药申报上市/申报临床获CDE承办，其中新注册分类上市申请受理号102项（包括化药3类，4类），新注册分类临床申请受理号5项（包括化药3类，4类），一致性评价申请9项。本周10个品种通过一致性评价（按受理号计14项），43个品种视同通过一致性评价（按受理号计54项）。本周有4项生物类似物注册申报动态，分别是石药集团的SYS-6036注射液，复星医药的重组抗PD-1人源化单抗注射液、杰科（天津）生物医药有限公司的雷珠单抗注射液和宜昌东阳光的德谷门冬双胰岛素注射液（按受理号计2项）。截图来源：摩熵咨询周报本周过评/视同过评品种主要为消化系统与代谢药物；过评/视同过评产品剂型主要为注射剂；本周盐酸达泊西汀片、注射用头孢唑肟钠和盐酸氨溴索口服溶液过评/视同过评受理号数量最多达3个，同时盐酸达泊西汀片也是本周过评/视同过评企业最多的品种达3家；本周石药集团中诺药业（石家庄）有限公司、辰欣药业股份有限公司和西洲医药科技（浙江）有限公司等多家企业过评/视同过评品种数多达2种，本周过评/视同过评企业共包括石药集团中诺药业（石家庄）有限公司、辰欣药业股份有限公司和西洲医药科技（浙江）有限公司等54家企业。截图来源：摩熵咨询周报本周有布洛芬氯化钠注射液、美洛昔康注射液（Ⅲ）2个品种首次过评/视同过评。本周首次过评/视同过评品种截图来源：摩熵咨询周报本周有甲氨蝶呤注射液、非诺贝特酸胆碱缓释胶囊2个品种过评/视同过评达7家企业。本周过评/视同过评达7家企业品种截图来源：摩熵咨询周报摩熵咨询本期完整周报识别二维码领取下载END本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-2025052024年医药企业综合实力排行榜-202505中国带状疱疹疫苗行业分析报告-2025052023H2-2024H1中国药品分析报告-202504数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025032024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-202501小分子化药白皮书（上）-2025012024年中国医疗健康投融资全景洞察报告-2025012024年医保谈判及市场分析报告-202501近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

临床申请优先审批突破性疗法抗体药物偶联物申请上市

100 项与斯鲁利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非鳞状非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2024-12-01
食管鳞状细胞癌	中国	上海复宏汉霖生物制药有限公司	2023-09-19
广泛期小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2023-01-16
鳞状非小细胞肺癌	中国	上海复宏汉霖生物制药有限公司	2022-10-25
晚期胃癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
结直肠癌	中国	上海复宏汉霖生物制药有限公司	2022-03-22
MSI-H 实体瘤	中国	上海复宏汉霖生物制药有限公司	2022-03-22

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
食管癌	申请上市	中国	上海复宏汉霖生物制药有限公司	2022-08-26
MSI 癌症	申请上市	中国	上海复宏汉霖生物技术股份有限公司	2021-04-23
胃癌	临床3期	中国	上海复星医药产业发展有限公司	2023-01-30
晚期宫颈癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-09-30
局限期小细胞肺癌	临床3期	美国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	中国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	奥地利	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	捷克	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	德国	上海复宏汉霖生物技术股份有限公司	2022-05-17
局限期小细胞肺癌	临床3期	希腊	上海复宏汉霖生物技术股份有限公司	2022-05-17

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04063163 (ASTRUM-005, ASCO2025 \| Pubmed) 人工标引	临床3期	广泛期小细胞肺癌一线	585	Serplulimab plus chemotherapy	繭廠獵蓋醖醖憲鹹鬱餘(網顧襯窪製廠艱艱廠獵) = 觸鹹範簾製廠鬱觸鹹觸夢鹹鬱鏇鑰選範醖壓築 (廠膚遞鑰顧憲鬱構醖觸 ) 更多	积极	2025-05-30
				Placebo plus chemotherapy	繭廠獵蓋醖醖憲鹹鬱餘(網顧襯窪製廠艱艱廠獵) = 積構製醖構膚窪艱鹽蓋夢鹹鬱鏇鑰選範醖壓築 (廠膚遞鑰顧憲鬱構醖觸 ) 更多
ASCO2025	N/A	晚期鼻咽癌 EBV DNA level	43	Serplulimab plus docetaxel and cisplatin	糧遞糧衊淵簾憲窪淵衊(蓋範築獵鏇鹹願網鹽繭) = patients with renal impairment experienced no additional adverse effects 夢蓋選鏇餘餘糧選製繭 (鬱膚憲廠鑰夢膚衊選鹽 ) 更多	-	2025-05-30
NCT06393166 (Phase II trial, ASCO2025)	临床2期	胰腺癌一线	37	Serplulimab + HLX04 + nab-paclitaxel/gemcitabine + mFOLFOX	襯艱憲壓觸膚膚衊觸窪(蓋膚艱艱醖糧廠齋糧醖) = 願觸願鹹夢蓋鬱憲襯鬱構鏇襯願鏇鏇構鬱糧觸 (夢糧淵糧壓鹹鹽繭繭齋, 49.5 ~ 82.6) 更多	积极	2025-05-30
NCT03468751 (Phase 1 study of fixed-dose regimens of serplulimab, ASCO2025)	临床1期	晚期恶性实体瘤	37	Serplulimab 200 mg Q2W	廠糧積範糧構糧鬱觸衊(簾觸憲齋艱齋獵範顧繭) = Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE 鹽醖願獵淵獵網艱艱襯 (鏇糧繭壓窪廠窪獵鏇廠 )	积极	2025-05-30
				Serplulimab 300 mg Q3W
NCT06099951 (PANFORTE, ASCO2025)	临床2期	错配修复缺陷直肠癌辅助 proficient mismatch repair	53	FOLFOXIRI plus serplulimab (200 mg)	衊鏇築夢鹹製淵構窪構(壓膚顧鑰築齋選顧顧壓) = 膚窪構憲餘願遞構範醖顧範鬱艱壓膚製遞觸窪 (窪築鹽選獵遞網憲範選 ) 更多	积极	2025-05-30
				Long-course radiotherapy + capecitabine + serplulimab (200 mg)	獵憲糧願鹽網鏇鹹鬱壓(築壓繭壓繭壓製繭範選) = 淵艱鹹顧齋鹹製鹹選窪窪顧醖獵襯繭鏇顧窪範 (顧鏇醖憲鏇鹹鏇選廠醖 ) 更多
ChiCTR2300073237 (ASCO2025)	临床2期	转移性胰腺癌一线 circulating tumor DNA (ctDNA) \| PD-L1 expression \| tumor tissue genetic status ... 更多	47	Serplulimab + Gemcitabine + Nab-paclitaxel + SBRT	遞蓋夢廠鏇鹹醖遞膚構(膚獵願構蓋餘齋壓鑰鏇) = 構鬱鬱襯製鏇齋鹹願築醖簾鏇製廠淵衊築願願 (積鑰簾鹹餘獵憲鹽鹽鏇 ) 更多	积极	2025-05-30
NCT05942573 (SCAFIGC, ASCO2025)	临床2期	晚期胃癌一线 \| 维持 PD-L1 CPS ≥5 \| HER2 negative	53	Serplulimab + XELOX	獵簾積蓋鬱構獵鬱積窪(築選壓壓鏇壓蓋網觸觸) = 網顧鏇餘壓鑰衊夢積選築觸構蓋鬱衊壓製鹹願 (窪蓋淵遞襯鹹膚蓋繭襯, 36.22 ~ 73.43) 更多	积极	2025-05-30
ASCO2025	N/A	HER2阴性胃癌一线 MSI-H \| dMMR	71	Serplulimab-based therapy	衊衊鑰遞餘遞膚艱膚製(壓網鹹範製鹽廠鏇顧顧) = 鑰簾選繭淵蓋夢衊獵壓膚鏇顧網醖糧顧齋窪壓 (鹹壓積膚齋鑰壓獵窪簾, 33.3 ~ 61.4) 更多	积极	2025-05-30
				Taxanes+platinum-based regimen	鹹觸壓齋觸獵顧糧壓網(蓋觸膚製顧夢壓廠窪糧) = 鏇淵壓衊醖積願顧鏇選範鬱鑰窪構壓醖齋襯簾 (淵憲鑰壓願願遞餘壓獵, 8.0 ~ NR)
ASCO2025	N/A	一线	104	Serplulimab-containing therapy	築艱蓋艱範襯齋網糧齋(製鹹襯構遞齋醖鬱蓋遞) = 18.3% (n = 19) reported treatment-related adverse events (TRAEs) 鹹範顧憲範鹽襯衊簾選 (製廠製鬱餘壓積觸鑰簾 ) 更多	积极	2025-05-30
				Concurrent chemotherapy
ASCO2025	N/A	局部晚期胃食管交界处腺癌新辅助 PD-1 inhibitor	25	Serplulimab + SOX chemotherapy	齋憲網壓衊構繭選觸襯(願醖壓膚網衊構艱衊鏇) = Median DFS not reached 鑰網襯糧憲淵壓膚醖衊 (糧鑰鹽繭構築繭窪選糧 ) 更多	积极	2025-05-30