Pembrolizumab biosimilar(Henlius)

HLX43食管鳞癌概念验证数据首发，为其广谱抗肿瘤价值再添有力新证 初步临床疗效优异且安全性良好，优势人群获益潜力显著，3mg/kg剂量组ORR和DCR分别达61.5%和100%，cORR达38.5% 潜在BIC的PD-L1 ADC，“高效低毒”构筑明确差异化优势 2026年1月9日，复星医药子公司复宏汉霖（2696.HK）在2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）上，首度公布了其PD-L1 ADC HLX43治疗复发/转移性食管鳞癌（ESCC）的II期概念验证（POC）数据，该研究由山东省肿瘤医院于金明院士牵头开展。本次发布的数据初步验证了HLX43在经治的晚期ESCC患者中的治疗潜力，展现出令人鼓舞的疗效及良好的安全性。HLX43已在非小细胞肺癌、宫颈癌、食管鳞癌及胸腺癌等多项实体瘤适应症中观察到持续且一致的疗效和安全性趋势，其广谱抗肿瘤潜力正通过临床实践逐步得到验证，为后续拓展更多适应症奠定重要基础。 食管癌是全球范围内常见的恶性肿瘤，2022年全球新发食管癌约51.1万例，死亡约44.5万例[1]。中国是该疾病最为高发的国家，根据2022年肿瘤登记数据，我国食管癌年发病22.4万例，死亡18.8万例，发病与死亡人数占全球近一半[2]。其中食管鳞癌（ESCC）是主要的病理类型。尤其在中国等高发地区，ESCC占比高达90%以上[3]。近年来，免疫联合化疗已成为中外权威指南推荐的标准一线方案，显著改善了患者生存。但对免疫化疗失败后的难治人群，多西他赛、伊立替康等二线化疗的客观缓解率（ORR）仅约7%，中位总生存期（mOS）仅为5-7个月[4, 5]，疗效极为有限。对于二线治疗再次失败的患者，目前全球范围内尚无标准的三线治疗方案，可见ESCC的后线治疗仍存在巨大的未满足临床需求。 本次发布基于一项评估 HLX43 在复发/转移性食管鳞癌中有效性和安全性的多中心、随机的II 期临床研究。研究入组了经组织学或细胞学确诊的复发/转移性ESCC的患者，接受一线化免治疗后进展或不耐受，并按1:1:1的比例随机分组，接受每3周一次静脉注射2 mg/kg、2.5 mg/kg或3 mg/kg 的HLX43。主要终点为研究者根据RECIST v1.1评估的客观缓解率（ORR）和无进展生存期。次要终点包括其他有效性终点、安全性、药代动力学、免疫原性和生物标志物探索。 截至数据截止日期2025年11月25日，共有37名患者随机分组并接受HLX43治疗，剂量分别为2 mg/kg（n = 12）、2.5 mg/kg（n = 12）和3 mg/kg（n = 13）。大多数患者的ECOG PS评分为1（86.5%）。既往抗肿瘤治疗线数中位数为2（范围，1–4）。全部患者（100%）接受过化疗及免疫治疗，27.0%的患者接受过靶向治疗，CPS≥1患者占75.7%，中位随访时间为3.5个月。 33例疗效可评估的患者中，观测到了积极信号，ORR为30.3%，DCR为81.8%。尤为值得关注的是，在3 mg/kg剂量组的13例疗效可评估的患者中，8例患者达到了部分缓解，ORR为61.5%，DCR为100.0%，确认的ORR（cORR）为38.5%；3 mg/kg剂量下，CPS≥1的PD-L1阳性患者（n = 10）中，ORR为60.0%，DCR为100%；CPS＜1的PD-L1阴性患者（n=2）ORR为50%，DCR为100%，初步提示HLX43疗效不限患者PD-L1表达限制，但仍待后续更大样本量的随机对照研究进一步验证。 安全性方面，33例患者（89.2%）发生了治疗相关不良事件（TRAEs），其中11例患者（29.7%）报告了≥3级TRAEs，最常见的≥3级TRAEs（发病率≥5%）包括贫血（13.5%）、白细胞计数下降（13.5%）、淋巴细胞计数降低（8.1%）、中性粒细胞计数降低（8.1%）、肺炎（5.4%）等。TRAEs导致1例（2.7%）患者用药剂量减少，1例（2.7%）患者永久停药，1例患者死亡。其中，在疗效信号更为显著的3mg/kg剂量组中，HLX43安全性良好，5例患者（38.5%)报告了≥3级TRAEs，1例患者(7.7%) 因TRAEs导致用药剂量减少，无患者（0%）因TRAE导致永久停药或死亡。 综上所述，HLX43 在复发/转移性食管鳞癌（ESCC）的后线治疗中展现出可控的安全性和令人鼓舞的初步疗效，尤其在3.0 mg/kg 剂量下疗效更为显著，值得进一步研究。 HLX43是一款潜在同类最优及疾病领域最优的广谱抗肿瘤ADC，兼具免疫检查点阻断与载荷细胞毒性的双重作用机制。临床前研究显示，HLX43在PD-1/PD-L1单抗耐药的非小细胞肺癌、宫颈癌、食管鳞癌等多个瘤种中展现出治疗潜力，且耐受性良好。其I期临床数据于2025美国临床肿瘤学会（ASCO）年会及2025 世界肺癌大会（WCLC）上先后发布，在NSCLC等实体瘤中展现出“高效、低毒”的显著疗效，尤其在NSCLC的治疗上，HLX43展现了全人群覆盖的潜力。 目前，复宏汉霖已累计开展约10项HLX43治疗多项实体瘤中的临床研究，在全球入组超过500例患者，广泛覆盖肺癌、宫颈癌等晚期妇科肿瘤、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃癌/胃食管交界部癌、胰腺导管腺癌、肝细胞癌等，其中NSCLC患者超过300例。后续，HLX43在鼻咽癌、头颈鳞癌等实体瘤中的概念验证数据也将在2026 ASCO、ESMO等大会上陆续读出。单药之外，基于HLX43展现出的IO疗效，公司积极探索HLX43与其他多元分子如公司自研创新抗EGFR单抗HLX07的联合治疗潜力，不断挖掘和最大化该产品在临床中的应用价值。 未来，复宏汉霖将持续聚焦患者未满足的临床需求，立足于HLX43等核心创新管线，不断放大产品的差异化治疗潜力，加速推动更大临床价值的释放，为全球患者带来更具突破疗效的治疗方案。 【参考文献】 [1] Siegel RL，Giaquinto AN，Jemal A.Cancer statistics，2024.CA Cancer J Clin.2024;74(1):12-49. [2] Han B, Zheng R, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. [3] 中华肿瘤杂志(Chinese Journal of Oncology). 2019;41(1):19-28. [4] Kojima T, Shah MA, et al. KEYNOTE-181 Investigators. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol. 2020 Dec 10;38(35):4138-4148.  [5] Huang J, Xu J, et al. ESCORT Study Group. Camrelizumab versus investigator's choice of chemotherapy as second-line therapy for advanced or  metastatic oesophageal squamous cell carcinoma (ESCORT): a multicentre, randomised, open-label, phase 3 study. Lancet Oncol. 2020 Jun;21(6):832-842. Henlius Debuts Phase 2 Results for Its Broad Anti-tumor PD-L1 ADC HLX43 in Esophageal Squamous Cell Carcinoma at ASCO GI 2026 The company first unveiled HLX43's proof-of-concept data in esophageal squamous cell carcinoma, providing compelling new evidence for its broad anti-tumor potential. It has demonstrated encouraging preliminary efficacy and a favorable safety profile, with significant potential benefit in target populations. In the 3 mg/kg cohort, the ORR and DCR reached 61.5% and 100%, respectively, with a cORR of 38.5%. As a potential best-in-class PD-L1 ADC, its “high efficacy and low toxicity” profile establishes a clear differentiated advantage. Shanghai, China, January 9, 2026—Shanghai Henlius Biotech, Inc. (2696.HK) today announced the first presentation of Phase II proof-of-concept (POC) data for its PD-L1 antibody-drug conjugate (ADC), HLX43, in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO GI). The study was led by Professor Jinming Yu from Shandong Cancer Hospital. The data suggest that HLX43 holds therapeutic potential in pretreated advanced ESCC, demonstrating encouraging efficacy with a manageable safety profile. Consistent clinical activity has been observed across multiple solid tumors—including non-small cell lung cancer(NSCLC), cervical cancer(CC), ESCC, and thymic carcinoma (TC)—supporting its broad anti-tumor profile and underpinning further indication expansion. Esophageal cancer is a prevalent malignancy worldwide, with approximately 511,000 new cases and 445,000 deaths globally in 2022 [1]. China bears the highest disease burden, reporting 224,000 new cases and 188,000 deaths in 2022, accounting for nearly half of the global incidence and mortality [2]. Esophageal squamous cell carcinoma (ESCC) is the predominant histologic subtype, representing over 90% of cases in high-incidence regions including China [3]. While immunotherapy combined with chemotherapy significantly improving patient survival and has become the recommended first-line standard, therapeutic options are limited for those who progressed. Second-line chemotherapies such as docetaxel or irinotecan achieve an objective response rate (ORR) of only about 7%, with a median overall survival (mOS) of 5–7 months [4,5]. For patients who further progressed beyond second-line therapy, there is currently no established standard regimen globally, highlighting a substantial unmet medical need in the later-line treatment of ESCC. This randomized, multi-center phase 2 study evaluated the efficacy and safety of HLX43 in previously treated recurrent/metastatic ESCC. Patients with histologically or cytologically confirmed recurrent/metastatic ESCC who progressed on or are intolerant to first-line chemoimmunotherapy were enrolled and randomized 1:1:1 to receive intravenous HLX43 at 2 mg/kg, 2.5 mg/kg, or 3 mg/kg once every 3 weeks. The primary endpoints were investigator-assessed objective response rate (ORR) and progression-free survival per RECIST v1.1. Secondary endpoints included other efficacy endpoints, safety, pharmacokinetics, immunogenicity, and biomarker explorations. As of data cutoff date Nov 25, 2025, 37 patients were randomized to and received HLX43 at 2 mg/kg (n = 12), 2.5 mg/kg (n = 12) and 3 mg/kg (n = 13) groups. Most enrolled patients had an Eastern Cooperative Oncology Group performance status score of 1 (86.5%). Patients received a median line of prior anti-tumor therapy of 2 (range, 1–4). All (100%) patients received chemotherapy and immunotherapy, 27.0% received targeted therapy, 75.7% had a PD-L1 combined positive score ≥ 1, and the median follow-up time was 3.5 months. Among all of the 33 response-evaluable patients, promising efficacy results were observed，with an ORR of 30.3% and a DCR of 81.8%. Notably, in the 3 mg/kg group(n=13), the ORR was 61.5%( 8 partial response) and DCR was 100.0%, with a confirmed ORR (cORR) of 38.5%.In this dose group，patients with a PD-L1 CPS ≥ 1 (n=10) had an ORR of 60.0% and a DCR of 100%, compared with an ORR of 50.0% and a DCR of 100% in those with a CPS < 1 (n=2). HLX43 conferred promising efficacy regardless of PD-L1 expression. Large-scale randomized studies are required for definitive conclusion. In terms of safety, treatment-related adverse events (TRAEs) were reported in 33 patients (89.2%,grade ≥3, 29.7%). Most common grade ≥3 TRAEs (≥5% in incidence) included anemia (13.5%), white blood cell count decreased (13.5%), lymphocyte count decreased(8.1%)，Neutrophil count decreased(8.1%) and Pneumonia(5.4%).  TRAEs led to a dose reduction in 1 patient (2.7%), treatment discontinuation in 1 patient (2.7%), and death in 1 patient（2.7%）. In the 3 mg/kg dose group, where more pronounced efficacy signals were observed, the treatment demonstrated a favorable safety profile.Grade ≥3 TRAEs were reported in 5 patients (38.5%). One patient (7.7%) required a dose reduction due to TRAEs, and no patient discontinued treatment or died due to TRAEs. In conclusion, HLX43 conferred promising efficacy, particularly at 3 mg/kg dose, along with a manageable safety profile in patients with previously treated recurrent/metastatic ESCC. Further investigation is warranted. HLX43 is a potential best-in-class broad anti-tumor ADC candidate targeting PD-L1, which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data have shown that HLX43 has potent anti-tumor effects and a favorable tolerability profile in NSCLC, cervical cancer (CC), esophageal squamous cell carcinoma (ESCC), and other tumor types that were PD-1/L1 mAb-resistant. The results from the phase 1 clinical trial of HLX43 were released at the 2025 ASCO Annual Meeting and 2025 WCLC, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. To date, Henlius has initiated about 10 clinical studies of HLX43, covering lung cancer, CC, ESCC, head and neck squamous cell carcinoma (HNSCC), nasopharyngeal carcinoma (NPC), colorectal cancer, gastric/gastroesophageal junction cancer (G/GEJ), pancreatic ductal adenocarcinoma (PDAC), and hepatocellular carcinoma (HCC), with over 500 patients enrolled globally, including more than 300 patients with NSCLC. Proof-of-concept (PoC) results in NPC and HNSCC are also expected to be released on the upcoming international academic conferences including the 2026 ASCO and ESMO. Building on its intrinsic immuno-oncology (IO) activity, Henlius is exploring combination therapies, such as with the in-house anti-EGFR antibody HLX07, to maximize HLX43's clinical value. Guided by its commitment to address unmet medical needs, Henlius will continue to advance its core pipeline including HLX43 to deepen the differentiated therapeutic potential of our products, accelerate the delivery of greater clinical value, and ultimately deliver more breakthrough treatment options to patients worldwide.

News市场消息◆A股连续录得16根阳线。◆中国人民银行部署2026年重点工作，要求灵活高效运用降准降息等多种货币政策工具，保持流动性充裕。◆我国外汇储备创十年新高，黄金储备14个月连增。◆高盛研报展望2026年中国经济，预计GDP增速超预期，建议高配A股港股，2026-2027年两市年涨15%-20%。◆2025年12月新能源乘用车批发157万辆，全年累计增长25%。◆桥水基金创始人瑞·达利欧：人工智能热潮正处于早期泡沫阶段。◆2026年1月6日，证监会召开资本市场财务造假综合惩防体系跨部门工作推进座谈会。◆上海二手房成交量创四年新高，成都二手房成交量破历史纪录。◆2025年我国民航旅客运输量达7.7亿人次，创历史新高。◆国家数据局2026年将推出30余项数据领域国家标准，涵盖智能体、具身智能等前沿方向。◆脑机接口“独角兽”强脑科技完成约20亿元人民币融资，为该领域除马斯克旗下的Neuralink以外全球第二大规模融资。本次融资投资人阵容强大，其中包括IDG、英特尔CEO陈立武旗下华登国际、蓝思科技、领益智造等。◆昔日私募大佬徐翔、文峰股份前董事长徐长江，再次因操纵证券市场，被法院一审判决赔偿投资者损失。A股蓝筹500公司要闻●贵州茅台：已斥资1.2亿元回购8.7万股。●两大能源央企官宣重组：中石化与中航油合并。●平安人寿近日增持1401.25万股招商银行H股股份，持股比例达到该行H股股本的20%，第四次触发举牌。●比亚迪：2025年新能源汽车累计销量460万辆，同比增长7.73%。●赛力斯：2025年新能源汽车销量同比增长10.63%。●江铃汽车：2025年累计销量同比增长10.56%。●江淮汽车：向特定对象发行股票申请获中国证监会同意批复；2025年12月销量同比增长42.24%。●万华化学：烟台产业园乙烯一期装置技改复产。●龙蟠科技：拟投资20亿元建设高性能锂电池正极材料项目。●三峡能源：控股股东累计增持1.87亿股，增持金额达7.99亿元。●优刻得：与远东股份、远东电气签署战略合作协议。●牧原股份：2025年12月商品猪销售收入96.67亿元，同比下降36.06%。●口子窖：2025年净利同比预降50%-60%，核心利润来源高端窖产品销量大幅下滑。●新希望：2025年12月销售生猪180.89万头，生猪销售收入21.51亿元。●伊利股份：董事长拟减持不超0.98%公司股份，用于偿还股票质押融资借款。●来伊份：控股股东拟减持不超过3%公司股份。●陕国投A：拟参与长安银行增资，增资金额不超过8亿元。●华友钴业：2025年净利润同比预增40.8%-55.24%。●宁波港：2025年预计累计完成集装箱吞吐量同比增长11.2%。●方大炭素：终止参与杉杉集团及其全资子公司实质合并重整。●亿纬锂能回应港股招股书失效：将尽快重递，不影响IPO进程。●时代新材：签署约33.2亿元风电叶片销售合同。●和而泰：控股股东刘建伟拟减持不超2%股份。●亿晶光电：2025年度净利润预亏。●高能环境：预计2025年净利润同比增长55.66%-86.79%。●孚能科技：股东深圳安晏拟减持不超过2%公司股份。●川金诺：2025年净利同比预增144.24%-172.64%。●万科A：因到龄退休，董事、执行副总裁郁亮辞职。●华夏幸福：控股股东及实控人王文学被申请仲裁，涉案金额约64亿元生物医药●恒瑞医药：获得HRS9531注射液、HRS-5817注射液药物临床试验批准通知书。●复星医药：丁二酸复瑞替尼胶囊药品注册申请获受理。●仟源医药：子公司获得药品注册证书及化学原料药上市申请批准通知书。●ST人福：HW221043片获得药物临床试验批准通知书。●神州细胞：向特定对象发行股票注册申请获中国证监会同意批复。●迪安诊断：子公司参与的呼吸道感染快速诊断研究取得新突破。●翔宇医疗：脑机接口神经调控康复治疗与临床研究转化中心揭牌成立。●海正药业：参股子公司博锐生物向香港联交所递交上市申请。●亿帆医药：子公司易黄汤颗粒药品注册申请获受理。●丽珠集团：莱康奇塔单抗注射液被纳入优先审评审批程序。●微芯生物：西达本胺片获批在澳门上市。●以岭药业：子公司获得盐酸伐昔洛韦片药品注册证书。●维力医疗：2025年归母净利润同比减少57%-66%。港股公司要闻锦欣生殖：2025年上半年业绩较2024年同期下滑8.0%。康宁医院：2025年度门诊人次数目约72.02万，同比增加29%。科伦博泰生物-B：核心产品TROP2ADC芦康沙妥珠单抗(SAC-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获NMPA突破性疗法认定。融创中国：2025年累计实现合同销售金额约368.4亿元，同比减少21.85%。★风险提示★天普股份上交所对天普股份及有关责任人予以监管警示。登云股份实控人涉嫌非法吸收公众存款罪被逮捕。信邦制药公司涉嫌单位行贿罪，收到贵州省开阳县人民法院送达的检察院《起诉书》三博脑科2连板三博脑科：目前不涉及脑机接口产品的研发、生产及销售。翔宇医疗2连板翔宇医疗：目前主要聚焦非侵入式脑机接口技术，截至2025年末尚未实现规模化销售国际公司要闻英伟达2026开年遇挫，华尔街对其6万亿市值目标仍存分歧。马斯克表示，旗下Neuralink将于2026年开始对脑机接口植入设备进行“大规模生产”。在CES2026上，一款叫做Neo的家务人形机器人成为了媒体关注焦点。这款机器人来自挪威-美国合资公司1XTechnologies，标志着家庭自动化进入新时代。英特尔发布全球首款1.8纳米AIPC芯片及年度旗舰AIPC芯片。三星电子联席首席执行官表示，公司计划在今年将搭载谷歌Gemini大模型的移动设备产量翻倍至8亿台。雀巢在至少50个国家和地区召回部分婴幼儿配方奶粉。现代汽车2025年全球销量同比减少0.1%，为413.82万辆。诺和诺德在美国正式推出全球首款成人减重GLP-1口服药。鸿海2025年12月销售额8628.6亿新台币，同比增长31.8%。蔚来李斌：2026年汽车行业最大的成本压力是内存涨价。有消息称字节跳动旗下“豆包AI眼镜”即将进入出货阶段。智元机器人与MiniMax达成合作，MiniMax将为智元机器人提供文本到语音全流程AI技术支持。宇树科技：相关报道不实，IPO正常推进中免责声明：本文基于公司法定披露内容和已公开的资料信息整理，文章不构成投资建议仅供参考。往期推荐：片仔癀的变与不变蔚来出走，江淮汽车回归原形看财报｜招商银行，省钱“省”出的增长泸州老窖百亿借款引股东利益扩张前景争议