Pimurutamab(Shanghai Henlius Biotech, Inc.)

“点击蓝字 关注我们复宏汉霖H药 汉斯状®肺癌和消化道肿瘤领域十余项最新研究结果发布PPS 2025年6月1日，复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）肺癌和消化道肿瘤领域十余项研究最新结果在2025年美国临床肿瘤学会（ASCO）年会上发布。H药 汉斯状®是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、欧洲和东南亚等30多个国家和地区获批上市。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，截至目前，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）。此外，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人。全面覆盖肺癌一线治疗，SCLC长期随访数据验证生存获益围绕H药，公司临床布局已全面覆盖肺癌一线治疗，除已获批的sqNSCLC、ES-SCLC和nsNSCLC外，公司正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。入选该次大会壁报展示的肺癌领域研究，包括由吉林省肿瘤医院程颖教授牵头开展的H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的III期临床研究（ASTRUM-005）研究结束分析，此次发布的数据中位随访为42.4个月，并首次公布四年OS数据；还包括一项由广东省人民医院吴一龙教授牵头开展的一项H药联合HLX07一线治疗鳞状非小细胞肺癌（sqNSCLC）的II期研究的更新数据。论文题目：斯鲁利单抗对比安慰剂联合化疗一线治疗广泛期小细胞肺癌：国际III期ASTRUM-005研究结束分析的疗效与安全性结果结果：2019年9月12日至2021年4月27日期间，585例患者完成随机分组（斯鲁利单抗组389例，安慰剂组196例）。两组患者分别接受4.5 mg/kg斯鲁利单抗（斯鲁利单抗组）或安慰剂联合化疗。所有患者均接受了至少一次研究治疗，纳入了疗效和安全性分析。截至数据截止日期2024年5月7日，斯鲁利单抗组280例（72.0%）和安慰剂组166例（84.7%）患者发生OS事件。与既往报道一致，斯鲁利单抗联合化疗组在OS、PFS、ORR及DOR方面均明显优于安慰剂联合化疗组：中位OS分别为15.8个月 vs. 11.1个月（分层风险比[HR] 0.60，95% CI 0.49–0.73）；两组4年OS率（95% CI）分别为21.9%（17.6–26.6）和7.2%（3.8–12.1）。基于盲态独立中心评估委员会根据RECIST v1.1标准评估的中位PFS分别为5.8个月 vs. 4.3个月（分层HR 0.47，95% CI 0.38–0.57）。亚组分析显示，按年龄、性别、种族、ECOG体能状态、吸烟史、脑转移或PD-L1表达水平划分的患者亚组中，斯鲁利单抗组OS均呈现一致的改善趋势。安全性特征与既往研究一致。斯鲁利单抗组和安慰剂组分别有136例（35.0%）和57例（29.1%）患者发生≥3级治疗相关不良事件。未发现新的安全性信号。结论：研究结束分析表明，斯鲁利单抗联合化疗持续为既往未经治疗的ES-SCLC患者带来长期生存获益，且安全性可控。这些结果支持斯鲁利单抗联合化疗作为ES-SCLC的一线治疗方案。论文题目：一项HLX07联合斯鲁利单抗（有或无化疗）对比斯鲁利单抗联合化疗作为晚期或复发性鳞状非小细胞肺癌一线治疗的II期研究结果：截至2024年12月31日，共有27例患者参与并随机分配至研究第3部分的A组（n=13）和B组（n=14）。两组患者分别接受800 mg HLX07（A组）或1000 mg HLX07（B组）联合300 mg斯鲁利单抗和化疗。15例（55.6%）患者患有转移性疾病。中位随访为16.0个月情况。A组和B组中，盲态独立中心评估委员会根据RECIST 1.1评估的确认ORR分别为69.2%（95% CI 38.6–90.9）和71.4%（95% CI 41.9–91.6），疾病控制率分别为92.3%（95% CI 64.0–99.8）和100%（95% CI 76.8–100.0）。A组的中位PFS为15.1个月（95% CI 4.1–不可评估），B组中位PFS尚未达到。截至数据截止日期，两组的中位总生存期和持续缓解时间均未达到。两组所有患者均报告了治疗期间不良事件（TEAEs）。结论：HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。IIT/真实世界研究验证消化道肿瘤治疗潜力在消化道肿瘤领域，公司持续深化H药的临床探索，除已获批的ESCC，亦积极推进H药联合化疗用于新辅助/辅助治疗胃癌III期临床研究以及H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心III期临床研究（ASTRUM-015）。此外，H药在消化道肿瘤领域的12项IIT/真实世界研究最新数据也以壁报等形式在该次大会上发布，广泛覆盖胃癌、食管鳞癌、肝癌、胰腺癌、直肠癌和鼻咽癌等瘤种。论文题目：一项关于斯鲁利单抗联合曲妥珠单抗和强化疗在晚期HER2阳性胃癌患者中的II期临床试验：安全性、有效性及生物标志物分析结果：从2022年7月到2024年9月，共招募了40名晚期1L HER2阳性胃癌患者，接受斯鲁利单抗（HLX10）联合曲妥珠单抗生物类似药（HLX02）和DOS化疗进行治疗。中位随访7.9个月。其中10名为女性，30名为男性，中位年龄为59岁（范围31-74岁）。37名患者进行了疗效评估。客观缓解率（ORR）为92%（95% CI: 0.87-0.96）。中位无进展生存期尚未达到。38名患者（95%）出现了任何级别的不良事件（AEs）。3级及以上的AEs发生率为35%。其中2名患者出现4级AEs（1例为血小板减少，1例为骨髓抑制）。未观察到5级事件。最常见的AEs包括贫血（35%）、中性粒细胞减少（23%）、恶心和呕吐（20%）以及白细胞减少（20%）。15名患者（38%）因AEs导致剂量中断，但无人因AEs停止治疗。结论：斯鲁利单抗联合曲妥珠单抗及三药化疗在晚期HER2+胃癌患者中显示出显著的疗效，客观缓解率（ORR）很高，且毒性可控。肿瘤HER2拷贝数变异（CNV）和循环肿瘤DNA（ctDNA）的动态监测与治疗疗效相关。论文题目：斯鲁利单抗联合仑伐替尼和紫杉醇治疗既往PD-1/PD-L1抑制剂一线治疗后疾病进展的晚期胃或胃食管结合部腺癌的疗效及安全性：一项多中心、单臂II期临床试验结果：该研究纳入了来自8个中心的 47 例患者，所有的患者在PD-1/PD-L1抑制剂为基础的联合化疗治疗失败后，接受斯鲁利单抗联合仑伐替尼和紫杉醇进行晚期2线治疗。CPS≥1和CPS≥5的患者分别占 55.3%（26/47）和 29.8%（14/47）。中位随访6.3个月，在至少接受过一次疗效评估的 41 例患者中， 客观缓解率（ORR）为 51.2%（21/41，95% Cl：35.1%-67.1%）。mPFS为 7.1个月（95% CI：6.1-NR），mOS为 13.7个月（95% CI：11.6 - NR）。不良事件（AEs）总发生率为 72.3%，其中 17.0% 的患者发生 3-4 级治疗相关不良事件。最常见的不良事件包括白细胞减少、中性粒细胞减少和麻木。结论：在晚期一线免疫联合化疗治疗失败的胃癌患者中，二线使用斯鲁利单抗联合仑伐替尼和紫杉醇进行免疫再挑战治疗显示出有前景的疗效和可控的安全性。这一治疗方案为一线免疫化疗失败的患者提供了一种潜在的新治疗选择。论文题目：斯鲁利单抗联合化疗跨线治疗晚期胃或胃食道结合部腺癌的疗效及安全性研究的初步结果结果：截至2024年11月，纳入晚期一线胃癌患者53例，其中中位年龄62岁，≥60岁患者32例（60.38%）。在可评估肿瘤反应的46例患者中，客观缓解率（ORR）52.17%（95% CI：36.95%-67.11%），包含3例完全缓解（CR）；疾病控制率（DCR）82.61%（95% CI：68.58%-92.18%）。中位无进展生存期（PFS）为13.73个月（95% CI：6.43-未达到），12个月PFS率达51.57%（95% CI：36.22%-73.43%），数据截止时已有4例患者PFS超过1年。中位缓解持续时间（DOR）与总生存期（OS）尚未成熟。患者治疗耐受性良好，≥3级治疗相关不良事件（TRAEs）发生率为9.43%（5例），最常见为中性粒细胞计数降低（3.77%）。结论：晚期胃癌患者接受斯鲁利单抗联合化疗一线治疗，展现出具有前景的临床疗效和可控的安全性。论文题目：抗PD-1单抗联合胸腺法新及SOX方案新辅助治疗cIII期胃癌或食管胃结合部腺癌的有效性与安全性研究（NAPTSOX24）：一项前瞻性、开放标签、单臂、II期临床试验结果：该研究共纳入30例局晚期胃癌患者，接受3个周期斯鲁利单抗、胸腺法新联合SOX方案治疗。末次治疗后2-6周内实施根治性胃切除术+D2淋巴结清扫术。患者中位年龄66岁，男性占比90%（27/30），食管胃结合部肿瘤占46.7%（14/30）。目前53.3%（16/30）患者已完成根治性胃切除术，其中病理完全缓解（pCR）率25.0%（4/16），主要病理缓解（MPR）率37.5%（6/16）。Lauren肠型患者显示出显著更优的肿瘤退缩情况。值得注意的是，获得pCR/MPR患者的CD3+ T细胞数量变化显著更高（P=0.036），提示其预测病理学缓解的价值可能优于PD-L1表达和微卫星不稳定状态。治疗相关不良事件（TRAEs）发生率为66.7%（20/30），最常见为腹泻（46.7%，14/30），未发生5级TRAEs。免疫相关不良事件发生率仅为10%（3/30）。结论：抗PD-1单抗联合胸腺肽α1及SOX方案在局部进展期胃癌/食管胃结合部癌新辅助治疗中显示出具有前景的疗效和可控的毒性，且疗效不受PD-L1表达水平影响。目前正在进行后续随访以进一步评估其临床获益与安全性（临床试验注册号：NCT06461910）。论文题目：斯鲁利单抗为基础的治疗方案在HER2阴性晚期胃癌中的有效性与安全性：一项真实世界研究结果：该研究共纳入71例患者，其中49例（69.0%）接受一线斯鲁利单抗为基础的治疗，22例（31.0%）为后线治疗患者。患者中位年龄65岁（范围：35-80岁），男性占71.8%（51例）。78.9%患者（56例）联合化疗，其中紫杉类+铂类方案（42.3%，30例）最为常见，其次为氟尿嘧啶+紫杉类（21.1%，15例）、氟尿嘧啶+铂类（11.3%，8例）以及氟尿嘧啶+紫杉类+铂类三药联合方案（4.2%，3例）。疗效评估结果显示，客观缓解率（ORR）为47.2%（95%CI：33.3-61.4），疾病控制率（DCR）达90.6%（95%CI：79.3-96.9）。截至2024年12月23日，中位随访时间8.4个月。所有患者中位真实世界无进展生存期（rwPFS）为10.6个月（95%CI：7.2-未达到），其中紫杉类+铂类方案组为15.9个月（95%CI：8.0-未达到），氟尿嘧啶+紫杉类方案组达23.7个月（95%CI：23.7-未达到）。生存分析显示，中位总生存期（OS）尚未达到。一线治疗组1年OS率显著优于后线组（93.8% vs 49.6%），且氟尿嘧啶+紫杉类方案组1年OS率达100%，显著高于紫杉类+铂类组的81.3%。中位缓解持续时间（DoR）为8.5个月（95%CI：4.3-未达到）。安全性方面，42.3%患者（30例）报告任何级别不良事件，16.9%（12例）发生3-4级不良事件，其中骨髓抑制（10.9%，6例）最为常见。结论：这项真实世界研究证实，斯鲁利单抗为基础的治疗方案在HER2阴性晚期胃癌患者中展现出良好的疗效和可接受的安全性，其长期疗效仍有待进一步随访观察。论文题目：重组人源化抗 PD -1单克隆抗体和FOLFOXIRI 化疗联合适形调强放疗全程新辅助治疗pMMR 局部进展期低位直肠癌的单臂 II 期临床试验（PANFORTE）结果：截至2024年6月，纳入22例pMMR局部进展期低位直肠癌患者，接受斯鲁利单抗联合FOLFOXIRI 化疗和适形调强放疗进行全程新辅助治疗。中位年龄59岁，中位肛缘4cm。86.3%（19/22）的患者完成了完整的TNT方案。在符合终点评估条件的20例患者中，总CR率为75%(15/20)，括约肌保存率为95%（19/20）。实现cCR的11例（55%）患者选择观察等待。9例患者接受根治性手术。20%（4/20）达到pCR， 25%（5/20）肿瘤消退等级（TRG）为2级。最常见的严重毒性是中性粒细胞减少症(3级，27.3% [6/22])。scRNA测序显示，非cr患者表现出较低的T细胞浸润和较弱的MHC-I/II信号。结论：与既往数据相比，TNT模式显着提高了pMMR LALRC的CR率和肛门保存，具有可接受的安全性。可能为强烈希望保肛的LALRC患者提供了另一种治疗选择。论文题目：一线联合斯鲁利单抗治疗转移性或局晚不可切食管癌患者的真实世界有效性与安全性研究结果：共纳入104例患者，平均年龄68岁（男性81例，占77.9%）。组织学亚型：食管鳞癌（ESCC）80.8%、小细胞癌合并腺癌9.6%、混合性神经内分泌-非神经内分泌肿瘤5.8%、神经内分泌肿瘤3.8%。97例（93.3%）患者接受联合化疗，10例（9.6%）联合靶向治疗，21例（20.2%）联合放疗。在90例可评估患者中，客观缓解率（ORR）达40.0%（95%CI：29.8-50.9），疾病控制率（DCR）高达97.8%（95%CI：92.2-99.7）。中位随访6.8个月（范围：0.6-25.4个月），中位真实世界无进展生存期（rwPFS）为12.0个月（95%CI：8.9-未达到），中位真实世界总生存期（rwOS）尚未达到（95%CI：13.3-未达到），12个月生存率为73.5%（95%CI：60.4-89.3）。安全性方面，55.8%患者（58例）出现不良事件，其中18.3%（19例）为治疗相关不良事件（TRAEs），1.9%（2例）发生严重不良事件（SAEs），包括高钾血症和白细胞减少症。结论：这项真实世界研究证实了斯鲁利单抗在不同组学亚型及不同临床特征的转移性或局部晚期食管癌（EC）一线治疗中的疗效。研究观察到的疗效及安全性数据均与既往RCT研究数据一致，未发现新的安全性问题。论文题目：潜在可切除食管鳞癌的新辅助治疗：一项全国性真实世界研究的见解结果：截至2023年12月，共纳入了95例接受了斯鲁利单抗为基础的新辅助治疗并随后接受根治手术的食管癌患者。大多数为男性（n = 86, 90.53%），中位年龄为63岁。93例（97.89%）为鳞状细胞癌（SCC），大部分位于胸中段食管（n = 68, 71.58%）。患者通常表现为肿瘤负担较重，88名患者（92.63%）处于T3/4期，90名患者（94.74%）淋巴结阳性。89名接受了R0切除，R0率为93.68%。pCR率为23.16%，MPR率为41.05%。肿瘤和淋巴结的降期率分别为56.84%和61.05%。逻辑回归显示，PD-L1阳性患者实现pCR的几率显著提高（OR = 12.73，P = 0.016）和MPR（OR = 2.95，P = 0.031）。整体不良事件（AE）发生率为96.84%，其中28.42%的患者经历了3级及以上的不良事件。最常见的3级及以上不良事件是肺炎，发生率为22.11%。未发现新的安全信号，患者通常对治疗耐受良好。结论：该研究是针对以斯鲁利单抗为基础的新辅助治疗食管癌的全国性大规模真实世界调查。研究结果突显了以斯鲁利单抗为基础的新辅助治疗的疗效，并具有可控毒性的潜力。论文题目：一项评估肝动脉灌注化疗联合HLX10和HLX04作为晚期肝细胞癌患者一线治疗的前瞻性、观察性II期临床研究结果：截至2024年9月，该研究共入组35例符合标准的患者，接受肝动脉灌注化疗联合HLX10（斯鲁利单抗）和HLX04（贝伐珠单抗生物类似药）。28例（80.0%）患者完成≥3个周期治疗。在35例患者中，32例至少接受过一次疗效评估，最佳疗效表现为：部分缓解（PR）17例（53.1%），疾病稳定（SD）12例（40.0%），客观缓解率（ORR）与疾病控制率（DCR）分别达53.1%和90.6%。值得注意的是，在完成≥3个周期治疗的患者中（n=17），ORR提升至63.0%。另有5例患者在完成≥3个周期治疗后成功实施肝切除术，术后病理评估显示切除标本存在广泛肿瘤坏死。中位随访8.4个月，6例（18.8%）患者出现疾病进展，1年无进展生存（PFS）率达70.5%（95% CI：47.0%–85.0%）。安全性方面，17例患者（48.6%）发生≥3级不良事件（AE），最常见为淋巴细胞计数降低（20%）。结论：HLX10（斯鲁利单抗）联合HLX04（贝伐珠单抗生物类似药）及肝动脉灌注化疗（HAIC）作为晚期肝细胞癌（HCC）一线治疗方案显示出显著疗效，尤其在完成≥3个周期治疗的患者中更为突出。该联合治疗方案安全性良好，不良事件（AEs）可控，值得通过更大规模临床试验进一步验证。论文题目：AG 方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及立体定向体放疗（SBRT）一线治疗转移性胰腺癌的 II 期临床研究结果：截至2025年1月，共入组47例晚期一线胰腺癌患者，接受AG 方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及立体定向体放疗（SBRT）进行治疗。其中41例已完成超过6个月的随访。所有47例患者均按方案完成疗效评估，6个月无进展生存（PFS）率为78.48%。客观缓解率（ORR）达74.47%（35/47例），包括1例完全缓解（CR）和34例部分缓解（PR）；其中12例为疾病稳定（SD）,疾病控制率（DCR）为100%。中位无进展生存期（mPFS）为8.6个月，中位总生存期（mOS）为15.5个月。常见的3级药物相关不良事件包括中性粒细胞减少（20/47，42.55%）、白细胞减少（19/47，40.43%）、食欲减退（18/47，38.30%）及乏力（11/47，23.40%）。生物标志物与疗效及预后的相关性仍需进一步分析。  结论：这项II期研究达到了预设的主要终点，6个月无进展生存（PFS）率为78.48%。SGSBRT方案展现出显著疗效，安全性可控且具有预期的抗肿瘤活性。该联合治疗方案或可成为中国转移性胰腺导管腺癌（mPDAC）患者一线治疗的潜力选择。论文题目：斯鲁利单抗和贝伐珠单抗联合AG序贯mFOLFOX化疗一线治疗晚期胰腺癌的一项II期研究结果：该研究入组了37例晚期一线胰腺癌患者，接受斯鲁利单抗和贝伐珠单抗生物类似药（HLX04）联合AG序贯 mFOLFOX化疗一线治疗。患者平均年龄为62岁，22例（59.5%）为男性。34例患者中有91.9%患者伴远处转移，其中70.3%的患者伴肝脏转移。主要研究终点ORR为 67.6% (95% CI, 49.5-82.6), 其中1例达到CR。只有1名患者进展（PD），疾病控制率（DCR）为97.1%（95% CI，84.7-99.9）。随访6.1个月时,中位无进展生存期（PFS）为10.5个月（95% CI，9.7-未达到），6个月PFS率为80.0%（95% CI，65.5-97.7）。中位应答时间（TTR）为1.5个月，中位应答持续时间（DOR）为9.3个月。总生存期（OS）仍然不成熟。≥3级治疗相关不良事件（TRAE）发生率为46.0%。血液毒性是最常见的治疗后出现的不良事件（TEAEs），且未观察到致死性不良事件（AE）。结论：斯鲁利单抗和贝伐珠单抗生物类似物联合AG序贯 mFOLFOX化疗方案一线治疗晚期胰腺癌显示了临床可行性和令人鼓舞的初步结果。需要进一步的随访以确认生存益处，并且需要进一步的分析以探讨这一新方案疗效背后的机制。论文题目：斯鲁利单抗联合TP诱导化疗序贯放疗联合尼妥珠单抗治疗局部晚期鼻咽癌有效性及安全性的真实世界回顾性研究结果：39例符合入选标准的患者中，年龄中位数为51岁；EBV DNA水平中位数为554.0拷贝/ml。通过TNM分期，11例（28%）患者归为T4, 12例（31%）患者归为N3。19例（49%）患者处于III期，20例（51%）患者处于IVA期。截至2024年12月31日，中位随访时间为17个月。38例PPS患者，CR为71%，PR为29%，ORR和DCR均为100%（95% CI 91-100）。中位OS和PFS均未达到。由于1例患者不明原因死亡，1年总生存率为97.4%。安全性与先前的报告一致，此外，基线肾功能损伤患者没有出现额外的不良反应。结论：斯鲁利单抗联合多西他赛和顺铂诱导化疗后放疗联合尼妥珠单抗治疗LANPC显示出良好的疗效和耐受性晚期实体瘤论文题目：一项评估抗PD-1抗体斯鲁利单抗固定剂量方案治疗晚期实体瘤的1期临床研究结果：截至2024年1月5日，37例患者接受了至少一次斯鲁利单抗治疗（200 mg Q2W组9例、300 mg Q3W组9例、400 mg Q4W组10例、600 mg Q6W组9例）。所有患者均为亚洲人，70.3%为男性，中位年龄60.0岁（范围：33~88岁）。患者肿瘤类型包括头颈癌（10例，27.0%）、食管癌（6例，16.2%）、结直肠癌（4例，10.8%）及其他类型。多数患者（64.9%）患有转移性癌症。所有患者均接受过系统性抗癌治疗，其中4例（10.8%）既往接受过免疫治疗，既往接受过≥3线治疗的患者占51.4%。37例患者均纳入安全性、药代动力学（PK）和药效学（PD）分析，35例疗效可评估的患者纳入有效性分析。无患者报告剂量限制性毒性，最大耐受剂量（MTD）尚未确定。19例患者（51.4%）发生了治疗相关不良事件（TRAE），其中7例（18.9%）发生了≥3级TRAE。各剂量组的TRAE发生率相似。多次输注后，几何平均稳态半衰期（t½, ss）为341.1–751.3小时，几何平均稳态清除率（CLss）为0.006–0.009升/小时。7例患者（18.9%）检测到治疗期抗药抗体（ADA）。ADA阳性与阴性患者的安全性和PK特征无明显差异。外周血CD3+ T细胞的PD-1受体占有率及白细胞介素-2刺激比在各剂量组间相似，提示功能性阻断作用与剂量无关。6例患者（300 mg Q3W组4例，400 mg Q4W组2例）达到部分缓解，300 mg Q3W和400 mg Q4W组的客观缓解率分别为44.4%和22.2%。达到了缓解的患者中，12个月持续缓解率为66.7%（95% CI：19.5–90.4）。中位无进展生存期为2.3个月（95% CI：1.9–5.1）。结论：斯鲁利单抗固定剂量显示出良好的安全性、PK和PD特征及初步抗肿瘤活性，支持进一步研究。文章来源：复宏汉霖美编排版：朱玲欣文章审核：隋艾蓉 朱玲欣 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2025年6月1日，复宏汉霖（2696.HK）宣布，公司自主研发的创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）肺癌和消化道肿瘤领域十余项研究最新结果在2025年美国临床肿瘤学会（ASCO）年会上发布。H药 汉斯状®是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、欧洲和东南亚等30多个国家和地区获批上市。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，截至目前，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）。此外，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人。全面覆盖肺癌一线治疗SCLC长期随访数据验证生存获益围绕H药，公司临床布局已全面覆盖肺癌一线治疗，除已获批的sqNSCLC、ES-SCLC和nsNSCLC外，公司正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。入选本次大会壁报展示的肺癌领域研究，包括由吉林省肿瘤医院程颖教授牵头开展的H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的III期临床研究（ASTRUM-005）研究结束分析，此次发布的数据中位随访为42.4个月，并首次公布四年OS数据；还包括一项由广东省人民医院吴一龙教授牵头开展的一项H药联合HLX07一线治疗鳞状非小细胞肺癌（sqNSCLC）的II期研究的更新数据。斯鲁利单抗对比安慰剂联合化疗一线治疗广泛期小细胞肺癌：国际III期ASTRUM-005研究结束分析的疗效与安全性结果结果：2019年9月12日至2021年4月27日期间，585例患者完成随机分组（斯鲁利单抗组389例，安慰剂组196例）。两组患者分别接受4.5 mg/kg斯鲁利单抗（斯鲁利单抗组）或安慰剂联合化疗。所有患者均接受了至少一次研究治疗，纳入了疗效和安全性分析。截至数据截止日期2024年5月7日，斯鲁利单抗组280例（72.0%）和安慰剂组166例（84.7%）患者发生OS事件。与既往报道一致，斯鲁利单抗联合化疗组在OS、PFS、ORR及DOR方面均明显优于安慰剂联合化疗组：中位OS分别为15.8个月 vs. 11.1个月（分层风险比[HR] 0.60，95% CI 0.49–0.73）；两组4年OS率（95% CI）分别为21.9%（17.6–26.6）和7.2%（3.8–12.1）。基于盲态独立中心评估委员会根据RECIST v1.1标准评估的中位PFS分别为5.8个月 vs. 4.3个月（分层HR 0.47，95% CI 0.38–0.57）。亚组分析显示，按年龄、性别、种族、ECOG体能状态、吸烟史、脑转移或PD-L1表达水平划分的患者亚组中，斯鲁利单抗组OS均呈现一致的改善趋势。安全性特征与既往研究一致。斯鲁利单抗组和安慰剂组分别有136例（35.0%）和57例（29.1%）患者发生≥3级治疗相关不良事件。未发现新的安全性信号。结论：研究结束分析表明，斯鲁利单抗联合化疗持续为既往未经治疗的ES-SCLC患者带来长期生存获益，且安全性可控。这些结果支持斯鲁利单抗联合化疗作为ES-SCLC的一线治疗方案。一项HLX07联合斯鲁利单抗（有或无化疗）对比斯鲁利单抗联合化疗作为晚期或复发性鳞状非小细胞肺癌一线治疗的II期研究结果：截至2024年12月31日，共有27例患者参与并随机分配至研究第3部分的A组（n=13）和B组（n=14）。两组患者分别接受800 mg HLX07（A组）或1000 mg HLX07（B组）联合300 mg斯鲁利单抗和化疗。15例（55.6%）患者患有转移性疾病。中位随访为16.0个月情况。A组和B组中，盲态独立中心评估委员会根据RECIST 1.1评估的确认ORR分别为69.2%（95% CI 38.6–90.9）和71.4%（95% CI 41.9–91.6），疾病控制率分别为92.3%（95% CI 64.0–99.8）和100%（95% CI 76.8–100.0）。A组的中位PFS为15.1个月（95% CI 4.1–不可评估），B组中位PFS尚未达到。截至数据截止日期，两组的中位总生存期和持续缓解时间均未达到。两组所有患者均报告了治疗期间不良事件（TEAEs）。结论：HLX07联合斯鲁利单抗和化疗一线治疗晚期sqNSCLC患者显示出令人鼓舞的初步疗效，且安全性可控，支持对该治疗方案的进一步评估。IIT/真实世界研究验证消化道肿瘤治疗潜力在消化道肿瘤领域，公司持续深化H药的临床探索，除已获批的ESCC，亦积极推进H药联合化疗用于新辅助/辅助治疗胃癌III期临床研究以及H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心III期临床研究（ASTRUM-015）。此外，H药在消化道肿瘤领域的12项IIT/真实世界研究最新数据也以壁报等形式在本次大会上发布，广泛覆盖胃癌、食管鳞癌、肝癌、胰腺癌、直肠癌和鼻咽癌等瘤种。一项关于斯鲁利单抗联合曲妥珠单抗和强化疗在晚期HER2阳性胃癌患者中的II期临床试验：安全性、有效性及生物标志物分析结果：从2022年7月到2024年9月，共招募了40名晚期1L HER2阳性胃癌患者，接受斯鲁利单抗（HLX10）联合曲妥珠单抗生物类似药（HLX02）和DOS化疗进行治疗。中位随访7.9个月。其中10名为女性，30名为男性，中位年龄为59岁（范围31-74岁）。37名患者进行了疗效评估。客观缓解率（ORR）为92%（95% CI: 0.87-0.96）。中位无进展生存期尚未达到。38名患者（95%）出现了任何级别的不良事件（AEs）。3级及以上的AEs发生率为35%。其中2名患者出现4级AEs（1例为血小板减少，1例为骨髓抑制）。未观察到5级事件。最常见的AEs包括贫血（35%）、中性粒细胞减少（23%）、恶心和呕吐（20%）以及白细胞减少（20%）。15名患者（38%）因AEs导致剂量中断，但无人因AEs停止治疗。结论：斯鲁利单抗联合曲妥珠单抗及三药化疗在晚期HER2+胃癌患者中显示出显著的疗效，客观缓解率（ORR）很高，且毒性可控。肿瘤HER2拷贝数变异（CNV）和循环肿瘤DNA（ctDNA）的动态监测与治疗疗效相关。斯鲁利单抗联合仑伐替尼和紫杉醇治疗既往PD-1/PD-L1抑制剂一线治疗后疾病进展的晚期胃或胃食管结合部腺癌的疗效及安全性：一项多中心、单臂II期临床试验结果：本研究纳入了来自8个中心的 47 例患者，所有的患者在PD-1/PD-L1抑制剂为基础的联合化疗治疗失败后，接受斯鲁利单抗联合仑伐替尼和紫杉醇进行晚期2线治疗。CPS≥1和CPS≥5的患者分别占 55.3%（26/47）和 29.8%（14/47）。中位随访6.3个月，在至少接受过一次疗效评估的 41 例患者中， 客观缓解率（ORR）为 51.2%（21/41，95% Cl：35.1%-67.1%）。mPFS为 7.1个月（95% CI：6.1-NR），mOS为 13.7个月（95% CI：11.6 - NR）。不良事件（AEs）总发生率为 72.3%，其中 17.0% 的患者发生 3-4 级治疗相关不良事件。最常见的不良事件包括白细胞减少、中性粒细胞减少和麻木。结论：在晚期一线免疫联合化疗治疗失败的胃癌患者中，二线使用斯鲁利单抗联合仑伐替尼和紫杉醇进行免疫再挑战治疗显示出有前景的疗效和可控的安全性。这一治疗方案为一线免疫化疗失败的患者提供了一种潜在的新治疗选择。斯鲁利单抗联合化疗跨线治疗晚期胃或胃食道结合部腺癌的疗效及安全性研究的初步结果结果：截至2024年11月，纳入晚期一线胃癌患者53例，其中中位年龄62岁，≥60岁患者32例（60.38%）。在可评估肿瘤反应的46例患者中，客观缓解率（ORR）52.17%（95% CI：36.95%-67.11%），包含3例完全缓解（CR）；疾病控制率（DCR）82.61%（95% CI：68.58%-92.18%）。中位无进展生存期（PFS）为13.73个月（95% CI：6.43-未达到），12个月PFS率达51.57%（95% CI：36.22%-73.43%），数据截止时已有4例患者PFS超过1年。中位缓解持续时间（DOR）与总生存期（OS）尚未成熟。患者治疗耐受性良好，≥3级治疗相关不良事件（TRAEs）发生率为9.43%（5例），最常见为中性粒细胞计数降低（3.77%）。结论：晚期胃癌患者接受斯鲁利单抗联合化疗一线治疗，展现出具有前景的临床疗效和可控的安全性。抗PD-1单抗联合胸腺法新及SOX方案新辅助治疗cIII期胃癌或食管胃结合部腺癌的有效性与安全性研究（NAPTSOX24）：一项前瞻性、开放标签、单臂、II期临床试验结果：本研究共纳入30例局晚期胃癌患者，接受3个周期斯鲁利单抗、胸腺法新联合SOX方案治疗。末次治疗后2-6周内实施根治性胃切除术+D2淋巴结清扫术。患者中位年龄66岁，男性占比90%（27/30），食管胃结合部肿瘤占46.7%（14/30）。目前53.3%（16/30）患者已完成根治性胃切除术，其中病理完全缓解（pCR）率25.0%（4/16），主要病理缓解（MPR）率37.5%（6/16）。Lauren肠型患者显示出显著更优的肿瘤退缩情况。值得注意的是，获得pCR/MPR患者的CD3+ T细胞数量变化显著更高（P=0.036），提示其预测病理学缓解的价值可能优于PD-L1表达和微卫星不稳定状态。治疗相关不良事件（TRAEs）发生率为66.7%（20/30），最常见为腹泻（46.7%，14/30），未发生5级TRAEs。免疫相关不良事件发生率仅为10%（3/30）。结论：抗PD-1单抗联合胸腺肽α1及SOX方案在局部进展期胃癌/食管胃结合部癌新辅助治疗中显示出具有前景的疗效和可控的毒性，且疗效不受PD-L1表达水平影响。目前正在进行后续随访以进一步评估其临床获益与安全性（临床试验注册号：NCT06461910）。斯鲁利单抗为基础的治疗方案在HER2阴性晚期胃癌中的有效性与安全性：一项真实世界研究结果：本研究共纳入71例患者，其中49例（69.0%）接受一线斯鲁利单抗为基础的治疗，22例（31.0%）为后线治疗患者。患者中位年龄65岁（范围：35-80岁），男性占71.8%（51例）。78.9%患者（56例）联合化疗，其中紫杉类+铂类方案（42.3%，30例）最为常见，其次为氟尿嘧啶+紫杉类（21.1%，15例）、氟尿嘧啶+铂类（11.3%，8例）以及氟尿嘧啶+紫杉类+铂类三药联合方案（4.2%，3例）。疗效评估结果显示，客观缓解率（ORR）为47.2%（95%CI：33.3-61.4），疾病控制率（DCR）达90.6%（95%CI：79.3-96.9）。截至2024年12月23日，中位随访时间8.4个月。所有患者中位真实世界无进展生存期（rwPFS）为10.6个月（95%CI：7.2-未达到），其中紫杉类+铂类方案组为15.9个月（95%CI：8.0-未达到），氟尿嘧啶+紫杉类方案组达23.7个月（95%CI：23.7-未达到）。生存分析显示，中位总生存期（OS）尚未达到。一线治疗组1年OS率显著优于后线组（93.8% vs 49.6%），且氟尿嘧啶+紫杉类方案组1年OS率达100%，显著高于紫杉类+铂类组的81.3%。中位缓解持续时间（DoR）为8.5个月（95%CI：4.3-未达到）。安全性方面，42.3%患者（30例）报告任何级别不良事件，16.9%（12例）发生3-4级不良事件，其中骨髓抑制（10.9%，6例）最为常见。结论：这项真实世界研究证实，斯鲁利单抗为基础的治疗方案在HER2阴性晚期胃癌患者中展现出良好的疗效和可接受的安全性，其长期疗效仍有待进一步随访观察。重组人源化抗 PD -1单克隆抗体和FOLFOXIRI 化疗联合适形调强放疗全程新辅助治疗pMMR 局部进展期低位直肠癌的单臂 II 期临床试验（PANFORTE）结果：截至2024年6月，纳入22例pMMR局部进展期低位直肠癌患者，接受斯鲁利单抗联合FOLFOXIRI 化疗和适形调强放疗进行全程新辅助治疗。中位年龄59岁，中位肛缘4cm。86.3%（19/22）的患者完成了完整的TNT方案。在符合终点评估条件的20例患者中，总CR率为75%(15/20)，括约肌保存率为95%（19/20）。实现cCR的11例（55%）患者选择观察等待。9例患者接受根治性手术。20%（4/20）达到pCR， 25%（5/20）肿瘤消退等级（TRG）为2级。最常见的严重毒性是中性粒细胞减少症(3级，27.3% [6/22])。scRNA测序显示，非cr患者表现出较低的T细胞浸润和较弱的MHC-I/II信号。结论：与既往数据相比，TNT模式显着提高了pMMR LALRC的CR率和肛门保存，具有可接受的安全性。可能为强烈希望保肛的LALRC患者提供了另一种治疗选择。一线联合斯鲁利单抗治疗转移性或局晚不可切食管癌患者的真实世界有效性与安全性研究结果：共纳入104例患者，平均年龄68岁（男性81例，占77.9%）。组织学亚型：食管鳞癌（ESCC）80.8%、小细胞癌合并腺癌9.6%、混合性神经内分泌-非神经内分泌肿瘤5.8%、神经内分泌肿瘤3.8%。97例（93.3%）患者接受联合化疗，10例（9.6%）联合靶向治疗，21例（20.2%）联合放疗。在90例可评估患者中，客观缓解率（ORR）达40.0%（95%CI：29.8-50.9），疾病控制率（DCR）高达97.8%（95%CI：92.2-99.7）。中位随访6.8个月（范围：0.6-25.4个月），中位真实世界无进展生存期（rwPFS）为12.0个月（95%CI：8.9-未达到），中位真实世界总生存期（rwOS）尚未达到（95%CI：13.3-未达到），12个月生存率为73.5%（95%CI：60.4-89.3）。安全性方面，55.8%患者（58例）出现不良事件，其中18.3%（19例）为治疗相关不良事件（TRAEs），1.9%（2例）发生严重不良事件（SAEs），包括高钾血症和白细胞减少症。结论：这项真实世界研究证实了斯鲁利单抗在不同组学亚型及不同临床特征的转移性或局部晚期食管癌（EC）一线治疗中的疗效。研究观察到的疗效及安全性数据均与既往RCT研究数据一致，未发现新的安全性问题。潜在可切除食管鳞癌的新辅助治疗：一项全国性真实世界研究的见解结果：截至2023年12月，共纳入了95例接受了斯鲁利单抗为基础的新辅助治疗并随后接受根治手术的食管癌患者。大多数为男性（n = 86, 90.53%），中位年龄为63岁。93例（97.89%）为鳞状细胞癌（SCC），大部分位于胸中段食管（n = 68, 71.58%）。患者通常表现为肿瘤负担较重，88名患者（92.63%）处于T3/4期，90名患者（94.74%）淋巴结阳性。89名接受了R0切除，R0率为93.68%。pCR率为23.16%，MPR率为41.05%。肿瘤和淋巴结的降期率分别为56.84%和61.05%。逻辑回归显示，PD-L1阳性患者实现pCR的几率显著提高（OR = 12.73，P = 0.016）和MPR（OR = 2.95，P = 0.031）。整体不良事件（AE）发生率为96.84%，其中28.42%的患者经历了3级及以上的不良事件。最常见的3级及以上不良事件是肺炎，发生率为22.11%。未发现新的安全信号，患者通常对治疗耐受良好。结论：本研究是针对以斯鲁利单抗为基础的新辅助治疗食管癌的全国性大规模真实世界调查。研究结果突显了以斯鲁利单抗为基础的新辅助治疗的疗效，并具有可控毒性的潜力。一项评估肝动脉灌注化疗联合HLX10和HLX04作为晚期肝细胞癌患者一线治疗的前瞻性、观察性II期临床研究结果：截至2024年9月，本研究共入组35例符合标准的患者，接受肝动脉灌注化疗联合HLX10（斯鲁利单抗）和HLX04（贝伐珠单抗生物类似药）。28例（80.0%）患者完成≥3个周期治疗。在35例患者中，32例至少接受过一次疗效评估，最佳疗效表现为：部分缓解（PR）17例（53.1%），疾病稳定（SD）12例（40.0%），客观缓解率（ORR）与疾病控制率（DCR）分别达53.1%和90.6%。值得注意的是，在完成≥3个周期治疗的患者中（n=17），ORR提升至63.0%。另有5例患者在完成≥3个周期治疗后成功实施肝切除术，术后病理评估显示切除标本存在广泛肿瘤坏死。中位随访8.4个月，6例（18.8%）患者出现疾病进展，1年无进展生存（PFS）率达70.5%（95% CI：47.0%–85.0%）。安全性方面，17例患者（48.6%）发生≥3级不良事件（AE），最常见为淋巴细胞计数降低（20%）。结论：HLX10（斯鲁利单抗）联合HLX04（贝伐珠单抗生物类似药）及肝动脉灌注化疗（HAIC）作为晚期肝细胞癌（HCC）一线治疗方案显示出显著疗效，尤其在完成≥3个周期治疗的患者中更为突出。该联合治疗方案安全性良好，不良事件（AEs）可控，值得通过更大规模临床试验进一步验证。AG 方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及立体定向体放疗（SBRT）一线治疗转移性胰腺癌的 II 期临床研究结果：截至2025年1月，共入组47例晚期一线胰腺癌患者，接受AG 方案（白蛋白紫杉醇+吉西他滨）联合斯鲁利单抗及立体定向体放疗（SBRT）进行治疗。其中41例已完成超过6个月的随访。所有47例患者均按方案完成疗效评估，6个月无进展生存（PFS）率为78.48%。客观缓解率（ORR）达74.47%（35/47例），包括1例完全缓解（CR）和34例部分缓解（PR）；其中12例为疾病稳定（SD）,疾病控制率（DCR）为100%。中位无进展生存期（mPFS）为8.6个月，中位总生存期（mOS）为15.5个月。常见的3级药物相关不良事件包括中性粒细胞减少（20/47，42.55%）、白细胞减少（19/47，40.43%）、食欲减退（18/47，38.30%）及乏力（11/47，23.40%）。生物标志物与疗效及预后的相关性仍需进一步分析。  结论：这项II期研究达到了预设的主要终点，6个月无进展生存（PFS）率为78.48%。SGSBRT方案展现出显著疗效，安全性可控且具有预期的抗肿瘤活性。该联合治疗方案或可成为中国转移性胰腺导管腺癌（mPDAC）患者一线治疗的潜力选择。斯鲁利单抗和贝伐珠单抗联合AG序贯mFOLFOX化疗一线治疗晚期胰腺癌的一项II期研究结果：本研究入组了37例晚期一线胰腺癌患者，接受斯鲁利单抗和贝伐珠单抗生物类似药（HLX04）联合AG序贯 mFOLFOX化疗一线治疗。患者平均年龄为62岁，22例（59.5%）为男性。34例患者中有91.9%患者伴远处转移，其中70.3%的患者伴肝脏转移。主要研究终点ORR为 67.6% (95% CI, 49.5-82.6), 其中1例达到CR。只有1名患者进展（PD），疾病控制率（DCR）为97.1%（95% CI，84.7-99.9）。随访6.1个月时,中位无进展生存期（PFS）为10.5个月（95% CI，9.7-未达到），6个月PFS率为80.0%（95% CI，65.5-97.7）。中位应答时间（TTR）为1.5个月，中位应答持续时间（DOR）为9.3个月。总生存期（OS）仍然不成熟。≥3级治疗相关不良事件（TRAE）发生率为46.0%。血液毒性是最常见的治疗后出现的不良事件（TEAEs），且未观察到致死性不良事件（AE）。结论：斯鲁利单抗和贝伐珠单抗生物类似物联合AG序贯 mFOLFOX化疗方案一线治疗晚期胰腺癌显示了临床可行性和令人鼓舞的初步结果。需要进一步的随访以确认生存益处，并且需要进一步的分析以探讨这一新方案疗效背后的机制。斯鲁利单抗联合TP诱导化疗序贯放疗联合尼妥珠单抗治疗局部晚期鼻咽癌有效性及安全性的真实世界回顾性研究结果：39例符合入选标准的患者中，年龄中位数为51岁；EBV DNA水平中位数为554.0拷贝/ml。通过TNM分期，11例（28%）患者归为T4, 12例（31%）患者归为N3。19例（49%）患者处于III期，20例（51%）患者处于IVA期。截至2024年12月31日，中位随访时间为17个月。38例PPS患者（表），CR为71%，PR为29%，ORR和DCR均为100%（95% CI 91-100）。中位OS和PFS均未达到。由于1例患者不明原因死亡，1年总生存率为97.4%。安全性与先前的报告一致，此外，基线肾功能损伤患者没有出现额外的不良反应。结论：斯鲁利单抗联合多西他赛和顺铂诱导化疗后放疗联合尼妥珠单抗治疗LANPC显示出良好的疗效和耐受性晚期实体瘤一项评估抗PD-1抗体斯鲁利单抗固定剂量方案治疗晚期实体瘤的1期临床研究结果：截至2024年1月5日，37例患者接受了至少一次斯鲁利单抗治疗（200 mg Q2W组9例、300 mg Q3W组9例、400 mg Q4W组10例、600 mg Q6W组9例）。所有患者均为亚洲人，70.3%为男性，中位年龄60.0岁（范围：33~88岁）。患者肿瘤类型包括头颈癌（10例，27.0%）、食管癌（6例，16.2%）、结直肠癌（4例，10.8%）及其他类型。多数患者（64.9%）患有转移性癌症。所有患者均接受过系统性抗癌治疗，其中4例（10.8%）既往接受过免疫治疗，既往接受过≥3线治疗的患者占51.4%。37例患者均纳入安全性、药代动力学（PK）和药效学（PD）分析，35例疗效可评估的患者纳入有效性分析。无患者报告剂量限制性毒性，最大耐受剂量（MTD）尚未确定。19例患者（51.4%）发生了治疗相关不良事件（TRAE），其中7例（18.9%）发生了≥3级TRAE。各剂量组的TRAE发生率相似。多次输注后，几何平均稳态半衰期（t½, ss）为341.1–751.3小时，几何平均稳态清除率（CLss）为0.006–0.009升/小时。7例患者（18.9%）检测到治疗期抗药抗体（ADA）。ADA阳性与阴性患者的安全性和PK特征无明显差异。外周血CD3+ T细胞的PD-1受体占有率及白细胞介素-2刺激比在各剂量组间相似，提示功能性阻断作用与剂量无关。6例患者（300 mg Q3W组4例，400 mg Q4W组2例）达到部分缓解，300 mg Q3W和400 mg Q4W组的客观缓解率分别为44.4%和22.2%。达到了缓解的患者中，12个月持续缓解率为66.7%（95% CI：19.5–90.4）。中位无进展生存期为2.3个月（95% CI：1.9–5.1）。结论：斯鲁利单抗固定剂量显示出良好的安全性、PK和PD特征及初步抗肿瘤活性，支持进一步研究。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，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA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国内首个生物类似药汉利康®（利妥昔单抗）、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®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、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®）以及汉奈佳®（奈拉替尼）。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。Latest Results of Serplulimab in Lung and Gastrointestinal Cancer Released at ASCO 2025Shanghai, China, June 1, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results from over ten studies on lung and gastrointestinal cancer of Henlius’ self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. HANSIZHUANG is the first anti-PD-1 mAb for the first-line treatment of SCLC and has been approved in over 30 countries and regions including China, Europe and Southeast Asia.Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. Up to date, HANSIZHUANG has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,900 subjects enrolled in China, the U.S., Japan, Turkey, Poland, Georgia and other countries and regions.Covering first-line treatment of lung cancer, SCLC long-term follow-up confirming survival benefitsAs for serplulimab, Henlius covers the full range of first-line treatment of lung cancer. In addition to approved indications for sqNSCLC, ES-SCLC and nsNSCLC, the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). At this conference, several research studies in the field of lung cancer were selected for poster presentations. These include the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC led by Professor Ying Cheng from Jilin Cancer Hospital, with the results from the final analysis and 42.4 months of median follow-up data, as well as the first publication of the four-year OS data. Additionally, updated data from a phase 2 study of HLX07 plus serplulimab as first-line treatment for sqNSCLC led by Professor Yi-Long Wu from Guangdong Provincial People’s Hospital was released.Title: Serplulimab versus placebo plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: efficacy and safety from the end-of-study analysis of the international phase 3 ASTRUM-005 studyResults: Between Sep 12, 2019 and Apr 27, 2021, 585 patients were randomized (serplulimab group, n = 389; placebo group, n = 196) and received either 4.5 mg/kg of serplulimab (serplulimab group) or placebo plus chemo. All 585 patients received at least one dose of study treatment and were included in efficacy and safety analyses. As of data cutoff on May 7, 2024, OS events occurred in 280 (72.0%) patients in the serplulimab arm and 166 (84.7%) in the placebo arm. Consistent with previous reports, marked improvement in OS, PFS, ORR, and DOR were achieved by patients receiving serplulimab plus chemo than those receiving placebo plus chemo. Median OS was 15.8 vs.11.1 months (stratified HR 0.60, 95% CI 0.49–0.73) for respective arms; estimated 4-year OS rate (95% CI) was 21.9% (17.6–26.6) and 7.2% (3.8–12.1). Median PFS according to independent radiology review committee (IRRC) assessment per RECIST v1.1 was 5.8 vs 4.3 months (stratified HR 0.47, 95% CI 0.38–0.57), respectively. Subgroup analysis of OS by age, sex, race, ethnicity, ECOG PS, smoking history, brain metastasis, or PD-L1 expression level revealed similar trends of improvement in the serplulimab arm across subgroups. The safety profile was consistent with previous findings. Serplulimab/placebo-related treatment-emergent adverse events of grade 3 or higher occurred in 136 (35.0%) and 57 (29.1%) patients in respective arms. No new safety signals were identified in this study.Conclusion: This end-of-study analysis showed that addition of serplulimab to chemo continued to confer survival benefit to previously untreated patients with ES-SCLC along with manageable safety. These results support serplulimab plus chemo for first-line treatment of ES-SCLC.Title: A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced or recurrent squamous non-small cell lung cancerResults: As of 31 December 2024, 27 patients were enrolled and randomly assigned to group A (n=13) and group B (n=14) in part 3. Two groups of patients received HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy. 15 (55.6%) patients had metastatic disease. With a median follow-up of 16.0 months, IRRC-assessed confirmed ORR per RECIST 1.1 was 69.2% (95% CI 38.6–90.9) in group A and 71.4% (95% CI 41.9–91.6) in group B. Disease control rate was 92.3% (95% CI 64.0–99.8), and 100% (95% CI 76.8–100.0), respectively. Median PFS was 15.1 (95% CI 4.1–not available) months in group A and not reached in group B. The median overall survival and duration of response were not reached in either group as of the data cutoff date. All the patients in both groups reported treatment-emergent adverse events (TEAEs).Conclusion: First-line HLX07 plus serplulimab and chemotherapy showed encouraging preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation.IIT/Real-world studies validating therapeutic potential for gastrointestinal tumoursIn the field of gastrointestinal cancers, the company continues to deepen its clinical exploration of serplulimab. In addition to the approved indication for ESCC, the company is actively advancing a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the international multi-centre phase 3 clinical trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC). Besides, the latest data on 12 IIT/real-world studies of serplulimab in gastrointestinal tumours were also presented at the congress, covering gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, rectal cancer and nasopharyngeal carcinoma.Title: Safety, efficacy and biomarker analysis from a phase II trial of intensive chemotherapy combined with serplulimab, trastuzumab in patients with advanced HER2-positive gastric cancerResults: From July 2022 to September 2024, 40 patients with unresectable locally advanced or metastatic HER2-positive gastric cancer were recruited to receive serplulimab, trastuzumab and the DOS regimen. The median follow-up was 7.9 months. There were 10 females and 30 males, with a median age of 59 (31-74). 37 patients were eligible for efficacy assessment. The objective response rate (ORR) was 92% (95% CI: 0.87, 0.96). Median progression free survival has not been reached. 38 patients (95%) experienced adverse events (AEs) of any grade. Grade 3 or above AEs occurred in 14 patients (35%), 2 patients with grade 4 AEs (1 with thrombocytopenia and 1 with myelosuppression). No grade 5 events were observed. The most common AEs were anemia (35%), neutropenia (23%), nausea and vomiting (20%) and leukopenia (20%). 15 (38%) patients had dose interruptions due to AEs, with no treatment discontinuation.Conclusion: This regimen demonstrated remarkable efficacy with a high ORR and manageable toxicity. Tumor HER2 CNV and ctDNA dynamic monitoring correlated with treatment efficacy. Title: Efficacy and safety of second-line therapy with serplulimab, lenvatinib, and paclitaxel in patients with gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) for whom immunochemotherapy failed: A multicenter, single-arm, phase II trial (STILL).Results: 47 second-line gastric cancer patients for whom immunochemotherapy failed from 8 centers were enrolled to use serplulimab combined with lenvatinib. Patients with CPS ≥1 and ≥5 account to 55.3% (26/47) and 29.8% (14/47). Median follow-up duration was 6.3 months. Among the 41 patients who had underwent at least one assessment, the ORR was 51.2% (21/41, 95% CI: 35.1%-67.1%). The mPFS was 7.1 months (95% CI: 6.1-NA) and the median OS (mOS) was 13.7 months (95% CI: 11.6-NA). The overall incidence of adverse events (AEs) was 72.3%, with 17.0% of patients had grade 3-4 treatment-related AEs. The most common AEs were leukopenia, neutropenia, and numbness.Conclusion: Continual immunotherapy with serplulimab, combined with lenvatinib and paclitaxel, demonstrated promising efficacy and manageable safety in patients with GC/GEJC. This regimen represents a potential new treatment option for patients who have failed first-line immunochemotherapy.Title: Continuation of serplulimab-based therapy beyond first progression in advanced gastric/gastroesophageal junction (G/GEJ) cancer: Preliminary results from the SCAFIGC trialResults: As of November 2024, 53 first-line patients with advanced G/GEJ cancer patients were enrolled, with a median age of 62 years, and 32 patients (60.38%) were aged ≥60 years. Among the 46 patients evaluable for tumor response, the ORR was 52.17% (95% CI: 36.95%-67.11%), with 3 patients achieving complete response (CR), and the disease control rate (DCR) was 82.61% (95% CI: 68.58%-92.18%). The median PFS was 13.73 months (95% CI: 6.43-not reached), with a 12-month PFS rate of 51.57% (95% CI: 36.22%-73.43%), and four patients had PFS of more than one year at the data cut-off date. Median DOR and OS were not yet mature. Patients tolerated treatment well, with grade ≥3 treatment-related adverse events (TRAEs) reported in 5 patients (9.43%), the most common being decreased neutrophil count (3.77%).Conclusion: Patients with advanced G/GEJ cancer demonstrate promising clinical efficacy and manageable safety after receiving first-line serplulimab combined with chemotherapy.Title: Efficacy and safety of anti-PD-1 combined with thymosin and SOX in neoadjuvant treatment of cStage III gastric or esophagogastric junctional adenocarcinoma (NAPTSOX24): A prospective, open-label, single-arm, phase II clinical study.Results: 30 patients with locally advanced gastric cancer were enrolled to receive 3 cycles of serplulimab, thymosin α1 and SOX regimen. Radical gastrectomy plus D2 lymphadenectomy were performed 2–6 weeks post-treatment. Median age of all the 30 cases was 66 years, 90% (27/30) were male, and 46.7% (14/30) had EGJ tumors. Till now, 53.3% (16/30) patients have undergone curative gastrectomy, with 25.0% (4/16) achieving pCR and 37.5% (6/16) demonstrating MPR. Patients with intestinal Lauren type exhibited a significantly better drug response. The variation in CD3+ T cell count was significantly higher in patients with pCR/MPR (P=0.036), suggesting a better predictive value for pathological responses than PD-L1 expression and microsatellite instability status. TRAEs were reported in 66.7% (20/30) cases, with diarrhea (46.7%, 14/30) being the most frequent. No grade 5 TRAEs occurred. Immune-related adverse events were only reported in 10% (3/30) cases.Conclusion: Combination of anti-PD-1, thymosin α1, and SOX regimen promising efficacy with manageable toxicity in the neoadjuvant setting of locally advanced G/EGJ cancer, independent of PD-L1 expression. Ongoing follow-up will further assess its clinical benefits and safety. (ClinicalTrials.gov identifier: NCT06461910).Title: Efficacy and safety of serplulimab-based therapy in HER2-negative advanced gastric cancer: A real-world studyResults: 49 patients (49/71, 69.0%) received first-line serplulimab-based therapy, and 22 (22/71, 31.0%) treated in the later lines were included in this analysis. The median age was 65 years (range 35-80) and 71.8% (n=51) were males. The majority received a combination of chemotherapy (n=56, 78.9%), with taxanes+platinum-based (n=30, 42.3%) regimen being the most common, followed by fluorouracil+taxanes-based (n=15, 21.1%), fluorouracil+platinum-based (n=8, 11.3%), and fluorouracil+taxanes+platinum-based (n=3, 4.2%) regimen. The ORR and DCR were 47.2% (95% CI: 33.3-61.4) and 90.6% (95% CI: 79.3-96.9), respectively. As of December 23, 2024, the median follow-up duration was 8.4 months. The median rwPFS of all patients was 10.6 months (95% CI: 7.2-NR), 15.9 months (95% CI: 8.0-NR) for patients who received taxanes+platinum-based regimen, and 23.7 months (95% CI: 23.7-NR) for patients treated with fluorouracil+taxanes-based regimen. Median OS was not reached; the first-line serplulimab treatment showed a superior 1-year OS rate than in later lines (93.8% vs. 49.6%), and patients treated with the fluorouracil+taxanes-based therapy achieved a higher 1-year OS rate than taxanes+platinum-based regimen (100.0% vs. 81.3%). The median DoR was 8.5 months (95% CI: 4.3-NR). A total of 30 patients (42.3%) reported any grade AEs; 12 (16.9%) experienced grade 3-4 AEs, and myelosuppression (n=6, 10.9%) was the most common.Conclusion: Our real-world study demonstrated that serplulimab-based therapy has a favorable efficacy and acceptable toxicity in HER2-negative advanced gastric cancer patients, and long-term follow-up is needed.Title: Phase ll trial of anti PD-1 monoclonal antibody and FOLFOXIRI combined with long-course radiotherapy as the total neoadjuvant treatment for proficient mismatch repair, locally advanced, low rectal cancer(PANFORTE)Results: As of June 2024, 22 patients with pMMR locally advanced low rectal cancer were enrolled to receive FOLFOXIRI plus serplulimab in combination with long-course radiotherapy as the total neoadjuvant treatment, with a median age of 59 years and a median DAV of 4 cm. 86.3% (19/22) patients completed the full TNT regimen. Among the 20 patients eligible for endpoint assessments, the overall CR rate was 75% (15/20), and the sphincter preservation rate was 95% (19/20). 11 (55%) patients achieving cCR opted for a watch-and-wait approach, whereas 9 patients underwent radical surgery. 20% (4/20) achieved pCR and 25% (5/20) had a tumor regression grade (TRG) of 2. The most common severe toxicity was neutropenia (grade 3, 27.3% [6/22]. The scRNA sequencing indicated that non-CR patients exhibited lower T cell infiltration and weaker MHC-I/II signaling.Conclusion: TNT regimen significantly enhances CR rates and anal preservation in pMMR LALRC compared to historical benchmarks, with an acceptable safety profile. May be an alternative treatment option for LALRC patients who strongly desire anal preservation.Title: Real-world effectiveness and safety of first-line serplulimab in patients with metastatic or locally advanced esophageal carcinomaResults: A total of 104 patients were included, with a mean age of 68 years (81 [77.9%] male). Histological subtypes comprised ESCC (80.8%), combined small cell and adenocarcinoma (9.6%), mixed neuroendocrine–non-neuroendocrine neoplasms (5.8%), and neuroendocrine neoplasm (3.8%). Of these, 97 patients (93.3%) received concurrent chemotherapy, 10 (9.6%) underwent targeted therapy, and 21 (20.2%) received radiotherapy. Among 90 evaluable patients, the ORR was 40.0% (95% CI: 29.8–50.9), while the DCR was 97.8% (95% CI: 92.2–99.7). After a median follow-up of 6.8 months (range: 0.6–25.4), the median rwPFS was 12.0 months (95% CI: 8.9–NE), and the median rwOS was not reached (95% CI: 13.3–NE). The estimated 12-month survival rate was 73.5% (95% CI: 60.4–89.3). Overall, 55.8% of patients (n=58) experienced AEs, 18.3% (n=19) reported treatment-related adverse events (TRAEs), and 1.9% (n=2) experienced serious adverse events (SAEs), including hyperkalemia and leukopenia.Conclusion: This real-world study supports the efficacy of serplulimab as a first-line treatment for metastatic or locally advanced EC, encompassing a wide range of histological subtypes and diverse patient populations. The observed outcomes align with those from randomized controlled trials. The safety profile was consistent with previous findings, with no new safety concerns identified.Title: Preoperative treatment for potentially resectable esophageal cancer: Insights from a nationwide real-world studyResults: As of December 2023, a total of 95 EC patients who received serplulimab-based neoadjuvant therapy followed by radical surgery were included. The majority were male (n = 86, 90.53%), with a median age of 63 years. SCC accounted for 93 cases (97.89%) of the primary tumors, with most located in the middle thoracic esophagus (n = 68, 71.58%). Patients generally presented with heavy tumor burden, with 88 patients (92.63%) at stage T3/4 and 90 patients (94.74%) with positive lymph nodes. 89 underwent R0 resection, resulting in an R0 rate of 93.68%. The pCR rate was 23.16%, and the MPR rate was 41.05%. Tumor and nodal downstaging rates were 56.84% and 61.05%, respectively. Logistic regression showed that PD-L1-positive patients had significantly higher odds of achieving pCR (OR = 12.73, P = 0.016) and MPR (OR = 2.95, P = 0.031). The overall AE incidence was 96.84%, with 28.42% experiencing grade ≥3 AEs. The most common grade ≥3 AE was pneumonia, which occurred in 22.11% of patients. No new safety signals were identified, and patients generally tolerated the treatment well.Conclusion: This study represents the large-scale nationwide real-world investigation of serplulimab-based neoadjuvant therapy for esophageal cancer. The findings highlight the potential of serplulimab-based neoadjuvant therapy with manageable toxicity.Title: A prospective, observational Phase II clinical study evaluating hepatic artery infusion chemotherapy in combination with HLX10 and HLX04 as first-line treatment for patients with advanced hepatocellular carcinomaResults: As of September 2024, a total of 35 eligible patients were enrolled in the study to receive hepatic artery infusion chemotherapy in combination with HLX10 and HLX04. 28 (80.0%) patients had received at least 3 cycles of treatment. Of the 35 patients, 32 underwent at least one assessment of treatment response, with the best outcomes as follows: 17 (53.1%) achieved partial remission (PR), and 12 (40.0%) had stable disease (SD). The ORR and DCR were 53.1% and 90.6%, respectively. Notably, among patients who had received at least 3 cycles of treatment, 17 patients achieved PR, resulting in an ORR of 63.0%. Moreover, 5 patients underwent successful hepatectomy after at least 3 cycles of treatment, and postoperative pathological evaluation revealed extensive tumor necrosis in the excised tissues. The median follow-up duration was 8.4 months, during which 6 (18.8%) patients experienced disease progression, yielding a one-year PFS rate of 70.5% (95% CI: 47.0%–85.0%). In terms of safety, 17 patients (48.6%) experienced at least one grade 3 or 4 adverse event (AE), with the most frequent being decreased lymphocyte count (20%).Conclusion: The combination of HLX10, HLX04, and HAIC as first-line treatment for advanced HCC has demonstrated promising efficacy, particularly in patients completing three or more cycles. The safety profile of this combination therapy was acceptable, with manageable AEs. Further investigation in larger trials is warranted.Title: Phase II trial of serplulimab combined with gemcitabine plus nab-paclitaxel (GnP) and SBRT for metastatic pancreatic cancer as the first-line treatmentResults: As of January 2025, 47 patients with metastatic pancreatic cancer were enrolled to receive to serplulimab and GnP plus SBRT (SGSBRT) as the first-line treatment. 41 patients have been followed for more than 6 months, with all 47 patients achieving efficacy according to the protocol. The 6-month PFS rate was 78.48%. The ORR was 74.47% (35/47), including 1 complete response (CR) and 34 partial responses (PR), and the DCR was 100%, with 12 stable disease (SD). The median PFS was 8.6 months, and the median OS was 15.5 months. The frequent grade 3 drug-related AEs were neutropenia (20/47, 42.55%), leukopenia (19/47, 40.43%), anorexia (18/47, 38.30%), and fatigue (11/47, 23.40%). The correlation between biomarkers and efficacy and prognosis are under-analyzed.Conclusion: This phase II study has met our preset primary endpoint with 78.48% in 6-month PFS rate, and SGSBRT presented promising efficacy with manageable safety profile and expected antitumor activity. This combination might be a promising option as first-line therapy for Chinese patients with mPDAC.Title: First-line serplulimab and bevacizumab combined with nab-paclitaxel/gemcitabine followed by mFOLFOX in advanced pancreatic cancer: A phase II trialResults: 37 patients with advanced pancreatic cancer were enrolled to receive first-line serplulimab and HLX04 (a bevacizumab biosimilar) combined with nab-paclitaxel plus gemcitabine (nab-P/Gem), followed by modified FOLFOX. The average age of the patients was 62 years, and 22 of them (59.5%) were male. Distant organ metastases were present in 34 patients (91.9%), with the liver being the most common site (n=26, 70.3%). The confirmed ORR was 67.6% (95% CI, 49.5-82.6), including 1 patient with a complete response (CR), meeting the primary endpoint. Only 1 patient had progressive disease (PD) as the best response, yielding a DCR of 97.1% (95% CI, 84.7-99.9). the median follow-up was 6.1 months. At the 6.1-month follow-up, the median PFS was 10.5 months (95% CI, 9.7-not reached), with a 6-month PFS rate of 80.0% (95% CI, 65.5-97.7). The median time to response (TTR) was 1.5 months, and the median duration of response (DOR) was 9.3 months. The OS remains immature. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 46.0% of patients. Hematologic toxicities were the most common treatment-emergent adverse events (TEAEs), and no fatal AE were observed.Conclusion: First-line serplulimab and bevacizumab biosimilar combined with nab-P/Gem-mFOLFOX demonstrates clinical feasibility and promising preliminary outcomes in advanced PC. Further follow-up is required to confirm the survival benefits, and following analyses are needed to explore the mechanisms underlyingthe efficacy of this novel regimen.Title: Efficacy and safety of serplulimab with DP induction chemotherapy followed by nimotuzumab and IMRT in locally advanced nasopharyngeal carcinoma: A retrospective studyResults: Among the 39 patients meeting eligibility criteria, the median age was 51 years; the median EBV DNA level was 554.0 copies/ml. Via TNM staging, 11(28%) patients were classified as T4 and 12(31%) patients as N3. 19(49%) patients were in stage III, and 20(51%) patients were in stage IVA. As of 31 Dec 2024, the median follow-up was 17 months. Among 38 patients in PPS(table), The CR was 71%, PR was 29%, with ORR and DCR both at 100%(95% CI 91-100). Median OS and PFS were not reached. The 1-year OS rate was 97.4% due to the unexplained death of one patient. Lower CR was noted among patients with T4 disease. Safety profile was consistent with previous reports, furthermore, patients with renal impairment experienced no additional adverse effects.Conclusion: Serplulimab plus docetaxel and cisplatin induction chemotherapy followed by nimo with IMRT demonstrates promising efficacy and tolerability in treating LANPC.Advanced solid tumoursTitle: A phase 1 study of fixed-dose regimens of serplulimab, an anti-PD-1 antibody, in patients with advanced solid tumorsResults: As of Jan 5, 2024, 37 patients received at least one dose of serplulimab at 200 mg Q2W (n = 9), 300 mg Q3W (n = 9), 400 mg Q4W (n = 10), or 600 mg Q6W (n = 9). All patients were Asian, 70.3% male; median age was 60.0 yrs (range 33–88). Patients had head and neck cancer (n = 10, 27.0%), esophageal cancer (n = 6, 16.2%), colorectal cancer (n = 4, 10.8%) or other types of tumor. Most patients had metastatic disease (64.9%). All patients had prior systemic cancer treatment, including 4 (10.8%) with prior immunotherapy; 51.4% had ≥ 3 prior lines of therapy. All 37 patients were included in safety, pharmacokinetic (PK), and pharmacodynamics (PD) analyses; 35 response-evaluable patients were included in efficacy analysis. No dose-limiting toxicity was reported, and maximum tolerated dose (MTD) has not been determined. Treatment-related adverse events (TRAEs) were observed in 19 patients (51.4%), including 7 (18.9%) reporting grade ≥ 3 TRAE. TRAE incidence was similar across regimen groups. Following multiple infusions, the geometric mean t½,ss was from 341.1–751.3 h, and geometric mean CLss was 0.006–0.009 L/h. Treatment-emergent anti-drug antibody (ADA) was detected in 7 (18.9%) patients. No difference in safety or PK was noted between ADA-positive and -negative patients. Profiles of PD-1 receptor occupancy in circulating CD3+ T cells and interleukin-2 stimulation ratio were similar across dose groups, suggesting dose-independent functional blockade. Six patients (300 mg Q3W, 4; 400 mg Q4W, 2) achieved partial response, resulting in an ORR of 17.1%. Among the responders, 12-month duration of response rate was 66.7% (95% CI confidence interval, 19.5–90.4). Median progression-free survival was 2.3 months (95% CI, 1.9–5.1).Conclusion: Fixed-dose regimens of serplulimab showed favorable safety, PK, and PD characteristics and preliminary anti-tumor activity, supporting its further investigation.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看