Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.
This study includes 2 parts:
Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).
Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.
Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.

开始日期2025-12-31

申办/合作机构

中国医学科学院肿瘤医院

NCT07277842

/ Not yet recruiting临床3期IIT

A Multicenter, Prospective, Phase III Randomized Controlled Trial of PD-1 Antibody Plus FOLFOXIRI Combined With Radiotherapy Versus CAPOX Combined With Radiotherapy as Total Neoadjuvant Therapy for pMMR Locally Advanced Low Rectal Cancer

The goal of this clinical trial is to find out if adding a PD-1 antibody (serplulimab) to FOLFOXIRI chemotherapy and radiotherapy works better than CAPOX chemotherapy with radiotherapy as total neoadjuvant therapy for adults with pMMR locally advanced low rectal cancer. It will also look at the safety of these treatments and how they affect long-term outcomes such as organ preservation and survival.
The main questions it aims to answer are:
Does PD-1 antibody plus FOLFOXIRI with radiotherapy improve 3-year event-free survival compared with CAPOX with radiotherapy?
Does this treatment increase the chance of clinical complete response and avoiding a permanent stoma (sphincter-preserving or non-surgical "watch-and-wait" management)?
What side effects and medical problems occur during and after these treatments?
Researchers will compare:
Group A (experimental group): PD-1 antibody (serplulimab) plus FOLFOXIRI chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Group B (control group): CAPOX chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Participants will:
Sign an informed consent form and have screening tests (physical exam, blood tests, ECG, imaging such as MRI/CT, endoscopy) to confirm they can join the trial.
Be randomly assigned (like drawing lots) to Group A or Group B. Receive several cycles of chemotherapy together with a 5-week course of pelvic radiotherapy before surgery; the experimental group will also receive PD-1 antibody during part of the chemotherapy and radiotherapy period.
Have regular clinic visits for checkups, blood tests, and assessment of side effects during treatment.
After neoadjuvant therapy, have MRI/CT and endoscopy to assess tumor response. Depending on the response, they may:
Receive surgery to remove the rectal tumor, or
If a clinical complete response is achieved and both doctor and patient agree, enter a "watch-and-wait" program instead of immediate surgery.
Provide blood samples and allow tumor tissue to be collected (for example, from biopsy and surgery) for future research (such as building PDX models and testing blood markers).
Be followed regularly for at least 5 years with clinic visits, blood tests (including CEA), imaging, and colonoscopy to check for tumor recurrence, side effects, and quality of life.

开始日期2025-12-29

申办/合作机构

中山大学

NCT07231445

/ Not yet recruiting临床1期

A Phase Ib Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer

This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.

开始日期2025-12-23

申办/合作机构

苏州泽璟生物制药股份有限公司

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: Xu, Kai ; Zhang, Lingli ; 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.

2025-12-01·Lancet Respiratory Medicine

First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial

Article

作者: Zhong, Aihong ; Li, Qingshan ; Sun, Meili ; Luo, Feng ; Cao, Bangwei ; Li, Manxiang ; Bai, Yuansong ; Zhao, Hui ; Huang, Yunchao ; Zhang, Liangming ; Fan, Ming ; Lin, Lin Haifeng ; Lv, Dongqing ; Hao, Yanrong ; Sun, Guoping ; An, Guangyu ; Li, Youlun ; Zhou, Jianying ; Fang, Jian ; Li, Zhengguo ; Chang, Jianhua ; Li, Yarong ; Ying, Kejing ; Li, Wen ; Wang, Fen ; Chen, Xi ; Wen, Zhenping ; Zhuang, Wu ; Yuan, Xueli ; Hao, Xuezhi ; Meng, Rui ; Wu, Xiaohong ; Huang, Xiaoping ; Ye, Min ; Jin, Chuan ; Chen, Zhendong ; Chen, Jun ; Yu, Haoyu ; Shi, Yuankai ; Nie, Ligong ; Wang, Xiang ; Zang, Aimin ; Li, Jing ; Ma, Rui ; Zhong, Diansheng ; Huang, Haixin ; Mao, Yimin ; Yu, Guohua ; Wu, Jinsheng ; Zhang, Yiping ; Wang, Yan ; Zhu, Zhitu ; Chen, Dongji ; Wu, Lin ; Ma, Zhiyong ; Ji, Youxin ; Jia, Zhongyao ; Shi, Jinsheng ; Luo, Hui ; Ren, Xiubao ; Zhu, Jun ; Lv, Tangfeng ; Wang, Xicheng ; Liang, Jun ; Jiang, Liyan ; Shi, Jianhua ; Li, Na ; Hu, Yanping ; Chen, Bi ; Li, Xingya ; Zhang, Wei ; Su, Haichuan ; Tan, Yan ; Li, Baolan ; Li, Yong ; Pan, Yueyin ; Sun, Hongmei ; Cui, Jiuwei ; Ma, Huiwen ; Ji, Yinghua ; Wang, Qingyu ; Chen, Chun ; Wang, Mengzhao ; Wang, Lin ; Li, Jingchang ; Ni, Hongyan

BACKGROUND:

Whether the addition of bevacizumab to a programmed cell death protein-1 (PD-1) inhibitor plus chemotherapy can provide further survival benefits as first-line treatment in non-squamous non-small-cell lung cancer (NSCLC) without EGFR sensitising mutations, or ALK/ROS1 rearrangements, is unknown. We evaluated serplulimab (an anti-PD-1 antibody) plus HLX04 (a bevacizumab biosimilar) and chemotherapy in non-squamous NSCLC.

METHODS:

ASTRUM-002 is a randomised, double-blind, multicentre, phase 3 trial with a three-arm design. Patients (aged ≥18 years and ≤75 years) with locally advanced or metastatic non-squamous NSCLC without EGFR sensitising mutations or ALK/ROS1 rearrangements and previous systemic therapy were randomly assigned (1:1:1; stratified by PD-L1 expression, smoking history, and brain metastasis) to receive serplulimab (4·5 mg/kg intravenously) plus HLX04 (15 mg/kg intravenously) and chemotherapy (pemetrexed and carboplatin; group A), serplulimab plus chemotherapy plus HLX04 placebo (group B), or chemotherapy plus serplulimab placebo plus HLX04 placebo (group C). The primary endpoint was the blinded independent central review assessed progression-free survival per the Response Evaluation Criteria in Solid Tumors version 1.1, assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03952403, and is complete.

FINDINGS:

Between Nov 25, 2019, and June 15, 2022, 642 patients were enrolled across 72 hospitals in China; six in the safety run-in phase and the remaining 636 patients were randomised to group A (212 patients), B (214), or C (210). 465 (73%) were male, 171 (27%) were female, and 599 (94%) were of Han ethnicity. By the data cutoff date of June 15, 2023, the median follow-up duration was 23·4 months (95% CI 21·6-24·9) in group A, 23·1 (21·4-25·6) in group B, and 23·0 (20·7-25·6) in group C. Median progression-free survival was 12·6 months (95% CI 8·7-14·0; 123 events) in group A, 11·0 months (95% CI 8·4-12·7; 130 events) in group B, and 5·6 months (95% CI 4·8-6·8; 156 events) in group C. A significant reduction was seen in risk of progressive disease or death for patients in group B compared with group C (hazard ratio [HR] 0·55, 95% CI 0·43-0·69; p<0·0001). No significant improvement in progression-free survival was seen for group A compared with group B (HR 0·86, 0·67-1·11; p=0·25). Treatment-related serious adverse events occurred in 82 (39%) patients in group A, 79 (37%) in group B, and 51 (24%) in group C. Grade 3 or worse treatment-related adverse events occurred in 149 (71%) patients in group A, 142 (66%) in group B, and 119 (57%) in group C. Treatment-related adverse events leading to death occurred in ten (5%) patients in group A, five (2%) in group B, and seven (3%) in group C.

INTERPRETATION:

The addition of serplulimab to chemotherapy led to significantly longer progression-free survival in patients with locally advanced or metastatic non-squamous NSCLC compared with chemotherapy alone and represents an alternative first-line treatment option for this patient population. HLX04 plus serplulimab and chemotherapy did not confer further statistical benefit compared with serplulimab plus chemotherapy.

FUNDING:

Shanghai Henlius Biotech.

2025-10-24·MEDICINE

Two cases of immune checkpoint inhibitor-associated diabetes mellitus induced by serplulimab: Case reports

作者: Gao, Yuan ; Lin, Meiyuan ; Deng, Jun

Rationale::

Immune checkpoint inhibitors have shown promising efficacy in treating various malignancies; however, their use is associated with immune-related adverse events, including rare but severe immune checkpoint inhibitor–induced diabetes mellitus (ICI-DM). Serplulimab-induced ICI-DM has been rarely reported, and its clinical presentation can be heterogeneous.

Patient concerns::

We report 2 patients with small cell lung cancer who developed serplulimab-induced ICI-DM, both complicated by diabetic ketoacidosis (DKA). Case 1 developed delayed-onset ICI-DM after 2 years of treatment, with elevated glycated hemoglobin and moderate C-peptide deficiency. Case 2 developed ICI-DM earlier, with severe insulin deficiency and classic type 1 diabetes features. Neither patient tested positive for diabetes-related autoantibodies.

Diagnoses::

Both patients were diagnosed with serplulimab-induced ICI-DM, confirmed by hyperglycemia, C-peptide deficiency, and DKA during ongoing programmed cell death protein 1 inhibitor therapy.

Interventions::

Standard DKA management was administered for both patients. They were transitioned to subcutaneous insulin therapy and continued serplulimab treatment under close glucose monitoring.

Outcomes::

Both patients’ DKA was successfully controlled. They continued serplulimab and insulin therapy after discharge, with no recurrence of acute DKA.

Lessons::

These cases highlight the clinical heterogeneity and diagnostic challenges of ICI-DM. Routine blood glucose and glycated hemoglobin monitoring before and during immunotherapy may aid early detection. Clinicians should maintain a high index of suspicion for ICI-DM, even in patients without typical risk factors. Early recognition and insulin initiation are essential to prevent life-threatening complications of DKA. This report contributes to the limited literature on serplulimab-induced ICI-DM and provides practical insights into its diagnosis and management.

1,043

项与斯鲁利单抗相关的新闻（医药）

2025-12-12

·丁香园 Insight 数据库

首个！复宏汉霖 H 药新适应症申报上市

12 月 12 日，CDE 官网显示，复宏汉霖斯鲁利单抗（H 药）新适应症上市申请获受理。根据临床试验进展，丁香园 Insight 数据库推测用于胃癌围手术期治疗。来源：CDE 官网此前 10 月，复宏汉霖宣布，H 药联合化疗新辅助/单药辅助治疗胃癌的 III 期临床研究（ASTRUM-006）期中分析达到了主要研究终点无事件生存期（EFS），成为全球首个胃癌围术期（术前/术后）以免疫单药取代术后辅助化疗的治疗方案。 ASTRUM-006 是一项针对早期胃癌患者的随机、双盲、多中心的 III 期临床研究，旨在评估 H 药联合化疗对比安慰剂联合化疗新辅助/单药辅助治疗早期胃癌患者的临床有效性及安全性。根据独立数据监察委员会（IDMC）的期中分析结果显示：该研究达到预设的优效性标准。与安慰剂联合化疗相比，H 药联合化疗显著改善 EFS，病理完全缓解（pCR）率是对照组 3 倍多，患者复发风险明显降低。同时，该治疗方案安全性良好，未发现新的安全性信号。作为复宏汉霖的核心抗肿瘤药物，H 药不仅具备更强的 PD-1 内吞作用，可减少 T 细胞表面 PD-1 受体，实现快速、强效的免疫激活；还能减少 PD-1 对共刺激分子 CD28 的募集，从而更大程度保留 CD28 信号传导，增强下游 AKT 蛋白活性，促进 T 细胞持续活化。目前，H 药已获批用于治疗鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）、食管鳞状细胞癌（ESCC）和非鳞状非小细胞肺癌（nsNSCLC) 适应症，在中国、英国、德国、新加坡、印度等 40 多个国家获批上市，覆盖全球近半数人口。 Insight 数据库整理了 2025 年全球新药申报上市清单，扫描下方二维码 👇，回复关键词新药报上市即可免费获取（每月初更新一次，目前更新至 11 月）。封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期上市批准

2025-12-11

·雪球

复星医药目前最核心的战略画像

复星医药目前最核心的战略画像。根据最新的行业动态和公司表现，复星医药确实在**小分子创新药、生物药（含ADC）、细胞治疗（CAR-T）**这三条技术路线上，分别在海外市场验证了其研发实力。以下我为你详细拆解这“三条技术线”是如何具体跑通全球竞争力的：###1.小分子创新药：源头创新获国际巨头“定价”这是你提到的“卖给辉瑞”这条线，代表了复星在**早期研发**和**源头创新**上的突破。***核心事件：**就在2025年12月，复星医药旗下的药友制药将其口服小分子GLP-1（一种热门的减肥/降糖药）项目**YP05002**的全球权益授权给了全球制药巨头**辉瑞（Pfizer）**。***交易价值：**这笔交易的总潜在价值高达**20.35亿美元**（约1.5亿美金首付）。对于辉瑞这种级别的买家来说，愿意花重金锁定一个处于I期临床阶段的资产，说明复星在小分子设计和筛选上的能力已经达到了国际前沿水平。***战略意义：**这不仅是资金上的收获，更是国际同行对复星“自研能力”的硬核认可。目前，复星的小分子平台已经不再局限于仿制药，而是切入了全球竞争最激烈的GLP-1赛道，并具备了定义未来药物的潜力。###2.生物药（含ADC）：在欧盟等主流市场“拿批文”这是复星“出海”的传统强项，目前正从单纯的“产品出口”向“全球注册与商业化”升级。***欧盟拿批文：**复星旗下的复宏汉霖（Henlius）在生物类似药和创新生物药方面进展迅速。例如，其核心产品**斯鲁利单抗**（PD-1抑制剂）已经相继在**欧盟、英国、新加坡**等多个国家和地区获批上市。此外，曲妥珠单抗（汉曲优）等产品也已获得欧盟和美国的批准。***全球商业化布局：**复星不仅自己卖，还通过授权（License-out）让跨国药企帮它卖。除了辉瑞，复星还与Sandoz（山德士）、Abbott（雅培）等巨头合作，将产品推向美国、欧洲、东南亚等市场。***技术延伸（ADC）：**在抗体偶联药物（ADC）这一热门领域，复星也有多款产品（如HLX43）在美国、日本、澳大利亚等地获批临床，正在构建“全球多中心临床试验”的能力。###3.CAR-T细胞治疗：在国内“走通支付路径”这是复星在高端疗法领域的落地实践，虽然你提到的是“国内”，但这对于其全球资产变现至关重要。***产品落地：**复星引进的**阿基仑赛注射液**（奕凯达）是中国首款获批的CAR-T产品。***支付创新：**CAR-T疗法价格昂贵，最大的难点在于“怎么让患者用得起”。复星通过积极的商业运作，已将该产品纳入了**超过110款**省市惠民保和**超过90项**商业保险。***全球竞争力映射：**这种成熟的商业化和支付体系，证明了复星不仅有引进技术的能力，更有在中国这种复杂市场环境下实现“产品变现”的运营能力。这种能力正在向海外复制，例如其产品已在香港等地使用，并探索跨境医疗合作。###总结：复星医药的“全球竞争力”拼图为了让你更直观地理解这三条线的布局，我整理了下表：|技术路线|核心代表产品/资产|海外验证方式|竞争力体现||:---|:---|:---|:---||**小分子创新**|YP05002(GLP-1)|**卖给辉瑞**(20亿美金级BD交易)|**源头创新能力**：早期管线获得国际巨头真金白银的认可。||**生物药/ADC**|斯鲁利单抗(PD-1)、汉曲优|**欧盟/英国/东南亚拿批文**|**全球注册能力**：产品符合欧美严苛的监管标准，实现全球销售。||**细胞治疗**|奕凯达(CAR-T)|**国内走通支付**(商保/惠民保)|**商业化变现能力**：解决了高价值创新药的市场准入和支付难题。|**一句话概括：**复星医药现在已经不仅是“中国的药企”，而是真正具备了从**研发源头（小分子卖给辉瑞）**到**全球落地（生物药在欧盟获批）**，再到**商业变现（CAR-T打通支付）**的完整全球化闭环能力。

细胞疗法免疫疗法抗体药物偶联物引进/卖出上市批准

2025-12-11

·研发客

ESMO Asia | 复宏汉霖乳腺癌管线双进击：帕妥珠单抗HLX11与拉索昔芬片HLX78两项研究数据亮相

在2025年欧洲肿瘤内科学会亚洲年会（ESMO Asia 2025）期间，复宏汉霖正式发布两项乳腺癌领域的临床研究最新数据，涵盖已在美国获批上市的帕妥珠单抗生物类似药HLX11（美国商品名：POHERDY®）的关键III期等效性试验（NCT05346224）数据，以及创新型内分泌疗法 HLX78（拉索昔芬片）在健康中国女性中的I期研究药代动力学与安全性结果。两项研究的发布进一步夯实了公司在乳腺癌领域的全程全域治疗布局，以高质量研发推动更多治疗选择惠及全球患者。 HLX11是复宏汉霖遵照中国、欧盟和美国生物类似药相关法规自主开发的帕妥珠单抗生物类似药，其适应症包括HER2阳性早期乳腺癌的新辅助和辅助治疗，以及HER2阳性转移性乳腺癌治疗。2025年11月，基于NCT05346224等一系列头对头比较原研的研究，HLX11（美国商品名：POHERDY®）获美国食品药品监督管理局（FDA）批准上市，成为美国首个帕妥珠单抗生物类似药，并可与原研药互换使用。目前，其上市许可申请亦已获得中国国家药监局（NMPA）、加拿大卫生部（Health Canada）与欧洲药品管理局（EMA）受理。在本次ESMO大会小型口头报告（Mini Oral, 65MO）中，由中山大学孙逸仙纪念医院刘强教授牵头开展的HLX11关键III期等效性试验（NCT05346224）公布了最新分析结果。NCT05346224是一项多中心、随机、双盲、平行对照的III期临床试验，旨在比较HLX11与原研帕妥珠单抗用于HER2阳性、HR阴性的早期或局部晚期乳腺癌患者新辅助治疗的疗效和安全性。合格的受试者按1:1的比例随机分为两组，分别接受HLX11或原研帕妥珠单抗联合曲妥珠单抗和多西他赛的治疗，每三周一次，共四个周期。研究的主要终点为由独立评审委员会（IRC）评估的总体病理完全缓解（tpCR）率。此次分析的次要终点包括由研究者评估的tpCR率、乳腺组织病理完全缓解（bpCR）率、客观缓解率（ORR）、无事件生存期（EFS）、无病生存期（DFS）、安全性、药代动力学和免疫原性。在2022年4月25日至2024年1月30日期间，共有908例HER2阳性、HR阴性早期或局部晚期乳腺癌受试者入组，研究结果显示：HLX11在tpCR方面达到与欧盟来源参考帕妥珠单抗的等效性标准，相对风险比值（RR）为1.01（90% CI: 0.90–1.14），相对风险差值（RD）为0.47%（95% CI: -5.99%–6.92%）。两组在bpCR、ORR、EFS等次要终点方面亦表现出相似趋势。HLX11的安全性、药代动力学（PK）及免疫原性与原研帕妥珠单抗高度一致，且从原研帕妥珠单抗单次转换至HLX11未观察到额外风险。在乳腺癌内分泌治疗方向，HLX78（拉索昔芬片）是复宏汉霖自 Sermonix Pharmaceuticals 引进的一款新型选择性雌激素受体调节剂（SERM），已在既往ELAINE-1与ELAINE-2研究中显示出对ESR1突变人群的抗肿瘤活性。目前，HLX78的国际多中心III期临床已完成中国首例患者给药，并在美国、加拿大和欧盟等地同步推进。在线壁报展示（192eP）环节中，由东莞市人民医院关灵教授牵头的I期研究公布了HLX78的PK与安全性数据。本研究旨在评价拉索昔芬片在中国健康成人女性受试者中的安全性和药代动力学特征，并与既往研究中的白种人和日本人数据进行对比，从药代动力学角度进一步评估拉索昔芬在不同种族人群（中国人、日本人及高加索人）中的敏感性和 III期关键研究（Elaine 3）拟定剂量（5mg）对于中国受试者的合理性，并为拉索昔芬片在中国受试者中的临床应用提供依据。本研究共入组16名受试者，研究结果显示，口服单剂量5 mg拉索昔芬片后，绝经前/围绝经与绝经后人群之间的药物暴露差异不显著，与既往研究中的白种人和日本人数据趋势亦一致，提示种族敏感性风险较低；所有治疗期间不良事件（TEAE）均为1–2级，无≥3级不良事件或严重不良事件报告，安全性良好。复宏汉霖深耕乳腺癌治疗领域，通过自主研发与合作引进，已建立覆盖乳腺癌全程全域的多元化治疗管线。公司的核心产品曲妥珠单抗汉曲优®（美国商品名：HERCESSI™，欧洲商品名：Zercepac®）已在全球50多个国家和地区获批上市；HER2阳性强化辅助治疗药物汉奈佳®（奈拉替尼）可与汉曲优®实现续贯协同；帕妥珠单抗POHERDY®为美国首款且唯一获批的PERJETA生物类似药，并同步推进中国、欧洲及加拿大注册进程；创新CDK4/6抑制剂复妥宁®在中国已获批用于晚期HR+/HER2-乳腺癌治疗。与此同时，公司加速推进HER2新表位单抗HLX22、创新内分泌疗法HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2 ADC HLX87等创新分子的开发，持续强化管线协同，为全球乳腺癌患者构建贯穿全域全程的综合治疗生态。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在全球获批上市10款产品，4个上市申请分别获中国药监局和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、国内首个生物类似药汉利康®（利妥昔单抗）、地舒单抗生物类似药Bildyos®和Bilprevda®，以及帕妥珠单抗POHERDY®。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

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
-	斯鲁利单抗	-	-

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, CTgov)	临床3期	广泛期小细胞肺癌	585	HLX10+Etoposide+Carboplatin (A Groups)	積衊蓋觸襯鹽築構蓋鹹(鏇壓糧窪願製夢鏇構襯) = 鹽鏇憲範糧夢積鏇範衊糧製選壓廠醖糧醖獵蓋 (糧製製構艱餘構簾鏇壓, 鏇觸膚積繭鑰夢願製壓 ~ 製餘餘製製觸醖憲網繭) 更多	-	2025-12-09
				Placebo+Etoposide+Carboplatin (B Groups)	積衊蓋觸襯鹽築構蓋鹹(鏇壓糧窪願製夢鏇構襯) = 餘鹹艱衊鑰鬱壓遞艱顧糧製選壓廠醖糧醖獵蓋 (糧製製構艱餘構簾鏇壓, 醖鬱蓋膚齋壓鬱鑰製築 ~ 範鬱選構膚簾膚襯範願) 更多
NCT03952403 (ASTRUM-002, ESMO2025)	临床3期	晚期非小细胞肺癌一线	636	Serplulimab + HLX04 + chemo	壓遞衊繭齋獵夢網鏇鑰(築繭膚鏇網膚構顧構襯) = 製餘膚襯觸艱鑰簾蓋艱蓋積獵網齋選鹹鏇鏇艱 (壓繭窪齋壓顧淵艱憲製, 20.5 ~ 27.5) 更多	积极	2025-10-17
				Serplulimab + chemo	壓遞衊繭齋獵夢網鏇鑰(築繭膚鏇網膚構顧構襯) = 繭鹹壓夢網遞憲鏇製遞蓋積獵網齋選鹹鏇鏇艱 (壓繭窪齋壓顧淵艱憲製, 21.2 ~ 30.9) 更多
ChiCTR2300069000 (ESMO2025)	临床2期	局部晚期胃食管交界处腺癌新辅助	30	serplulimab + S-1 + oxaliplatin	艱齋繭顧積築廠衊壓壓(夢鏇鹹繭廠壓簾範齋鏇) = 顧鏇鹹鑰艱鬱觸繭構構窪構鹹鹽糧願鑰鹹鑰築 (膚顧顧齋餘蓋淵鏇積襯, 19.9 ~ 56.1) 更多	积极	2025-10-17
NCT05731726 (SCAR, ESMO2025)	临床2期	局部晚期直肠癌新辅助 pMMR	22	Serplulimab combined with capeOX and celecoxib	構遞網膚鹹憲築獵壓膚(夢衊憲觸鏇觸襯糧製鹽) = 鬱鹹鏇選艱鏇鹹蓋膚齋範構製簾廠選餘簾築衊 (鬱觸廠窪醖襯鑰鹽選製, 49.8 ~ 89.3) 更多	积极	2025-10-17
NCT05766800 (ESMO2025)	临床2期	不可切除的非小细胞肺癌	100	serplulimab + platinum-based doublet chemotherapy (Surgery)	衊製簾鹹願夢齋窪範築(襯壓膚膚艱簾壓鹹醖簾): HR = 0.38 (95.0% CI, 0.14 ~ 1.01) 更多	积极	2025-10-17
				serplulimab + platinum-based doublet chemotherapy (Radiotherapy)
ASTRUM-006 (Company_Website) 人工标引	临床3期	早期胃癌	-	HANSIZHUANG + Chemotherapy as neoadjuvant, then HANSIZHUANG as adjuvant	艱憲鑰範簾鹽壓餘艱築(膚餘糧願淵網齋壓淵衊) = Compared with placebo plus chemotherapy, HANSIZHUANG plus chemotherapy significantly prolonged EFS, with a significant reduction in the risk of recurrence. 繭鹹膚壓壓鏇蓋膚選襯 (鏇鹹齋齋廠鹽壓築壓願 ) 达到更多	积极	2025-10-09
				Placebo + Chemotherapy as neoadjuvant, then Placebo as adjuvant
NEWS 人工标引	N/A	广泛期小细胞肺癌一线	-	斯鲁利单抗+标准化疗 (MRD阳性组)	顧憲觸襯觸簾網製齋衊(簾廠糧壓壓簾廠鹽選鏇) = 鹹憲憲選積蓋壓網鏇製製夢築壓觸積觸觸鏇糧 (憲遞構積鬱構醖憲鏇獵 )	积极	2025-09-10
				斯鲁利单抗+标准化疗 (MRD清除组)	-
NEWS 人工标引	临床2期	非鳞状非小细胞肺癌	-	斯鲁利单抗+贝伐珠单抗+培美曲塞+卡铂	壓積簾餘襯鹽窪網醖繭(網齋廠鑰願觸鹹憲顧鹹) = 鑰窪構夢餘餘網繭膚築壓夢廠鏇壓壓遞網淵襯 (獵窪願構蓋餘齋鹹觸積 ) 更多	积极	2025-09-10
WCLC2025 人工标引	临床2期	非小细胞肺癌一线	27	HLX07 800 mg+ serplulimab（300mg）+ chemo	顧積廠願壓顧鏇築遞憲(鬱構餘夢繭範醖鏇壓醖) = 範衊蓋鏇餘獵積獵鬱願築淵鏇製壓醖壓餘製蓋 (壓網壓餘鹹淵繭網鏇醖, 38.6 ~ 90.9) 更多	积极	2025-09-10
				HLX07 1000 mg+ serplulimab（300mg）+ chemo	顧積廠願壓顧鏇築遞憲(鬱構餘夢繭範醖鏇壓醖) = 糧淵顧觸構蓋襯淵壓遞築淵鏇製壓醖壓餘製蓋 (壓網壓餘鹹淵繭網鏇醖, 41.9 ~ 91.6) 更多
WCLC2025	-	非小细胞肺癌新辅助	55	Serplulimab+Platinum containing dual drug chemotherapy	顧淵選範蓋艱鏇觸淵選(繭網醖遞鬱選膚夢簾廠) = 衊觸廠艱壓廠網繭齋遞艱鬱鏇壓齋廠艱淵膚觸 (艱夢廠顧選築壓鏇築膚 ) 更多	积极	2025-09-08