Trastuzumab biosimilar(Shanghai Henlius Biotech, Inc.)

2025年美国临床肿瘤学会（ASCO）年会将于5月30日-6月3日在美国芝加哥隆重召开。本届学术会议上，复星医药将携手控股子公司复宏汉霖重磅发布近20项最新研究成果，涵盖肺癌、乳腺癌等核心治疗领域，包含芦沃美替尼（FCN-159）、HLX43（PD-L1靶向ADC）、HLX22（抗HER2单抗）、H药汉斯状（抗PD-1单抗，斯鲁利单抗）等创新管线。作为一家创新驱动的全球化医药健康产业集团，复星医药的创新产品聚焦肿瘤（实体瘤、血液瘤）、免疫炎症等核心治疗领域，重点强化抗体/ADC、细胞治疗、小分子核心技术平台，并与产业基金合作布局核药、RNA、基因治疗、AI药物研发等前沿技术，推动更多重磅产品加速研发进程，早日实现商业化。芦沃美替尼（FCN-159）芦沃美替尼（FCN-159）是复星医药自主研发的一款创新型小分子口服药。作为一种高效的MEK1/2选择性抑制剂，芦沃美替尼通过抑制MAPK信号通路中的MEK1/2蛋白活性，阻止肿瘤细胞的增殖和生长。该药物已开展多项针对恶性肿瘤及罕见病的研究，拟主要用于治疗晚期实体瘤、1型神经纤维瘤病、树突状细胞和组织细胞肿瘤、低级别脑胶质瘤等。截至目前，芦沃美替尼片已有2项适应症的上市申请先后获国家药监局受理，并被纳入优先审评程序，分别是用于治疗成人树突状细胞和组织细胞肿瘤、以及治疗2岁及2岁以上儿童1型神经纤维瘤病（NF1）相关的丛状神经纤维瘤（PN）。该新药用于治疗成人1型神经纤维瘤病于中国境内（不包括港澳台地区，下同）处于III期临床试验阶段，用于治疗低级别脑胶质瘤、颅外动静脉畸形、儿童朗格汉斯组织细胞增生症于中国境内均处于II期临床试验阶段，其中，用于治疗组织细胞肿瘤、无法手术或术后残留/复发的NF1相关的丛状神经纤维瘤成人患者、儿童朗格汉斯组织细胞增生症三项适应症均已被国家药监局药品审评中心纳入突破性治疗药物程序。作为国产MEK抑制剂的代表，芦沃美替尼将填补国内在这些罕见肿瘤治疗方案上的空白，尤其在组织细胞肿瘤等难治性疾病领域具有重要意义。HLX43（PD-L1靶向 ADC）其中HLX43是一款靶向程序性死亡-配体1（PD-L1）的新型ADC候选药物，由全人源IgG1抗PD-L1抗体与创新连接子-拓扑异构酶抑制剂荷载偶联而成，其药物抗体比（drug-to-antibody ratio, DAR）约为8。HLX43兼具毒素精准杀伤和肿瘤免疫作用的复合功能，其毒素不仅能够藉靶点内吞进入肿瘤细胞后进行释放，并在肿瘤微环境中释放后借助旁观者效应进入肿瘤细胞，阻断DNA复制，从而导致肿瘤细胞凋亡。此外，HLX43的PD-L1靶向抗体可激活免疫调节机制，发挥协同抗肿瘤效应。临床前研究表明，HLX43在单药及联合治疗中均展现出显著抗肿瘤活性，有望为PD-1/PD-L1疗法耐药或无效的恶性肿瘤患者提供全新的治疗选择。HLX22（抗HER2单抗）HLX22是一款靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得该产品能够与曲妥珠单抗同时结合至HER2，促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，进而产生更强的HER2受体阻断效果。HLX22联合汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）治疗HER2阳性胃癌的II期临床研究结果显示，在汉曲优®联用化疗的基础上加入HLX22可提高HER2阳性G/GEJ癌患者一线治疗的生存期和抗肿瘤反应，且安全性可控。目前，HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临床研究（HLX22-GC-301）分别获得中国、美国、日本和澳大利亚等地药监机构的新药临床试验（IND）许可，并完成首例患者给药。此外，HLX22于2025年获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。继胃癌之后，HLX22与德曲妥珠单抗的联合疗法已拓宽至乳腺癌疾病领域，有望为更多肿瘤患者带来新的治疗选择。H药 汉斯状®（抗PD-1单抗，斯鲁利单抗）H药 汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），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、欧盟以及多个东南亚国家获批上市。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药已在中国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）。H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国积极推进一项H药对比一线标准治疗阿替利珠单抗的头对头桥接试验。H药的4项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）、Cancer Cell和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。

2025年5月9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®）两项胃癌领域的最新研究结果入选第16届国际胃癌大会（International Gastric Cancer Congress, IGCC 2025）。其中，斯鲁利单抗同步放化疗新辅助治疗胃食道结合部腺癌的II期研究最新结果以口头报告形式在大会上发布。据GLOBOCAN数据显示，2022年全球约100万胃癌/胃食管连接部（G/GEJ）癌新发病例，已成为全球公共卫生领域的一大挑战。在中国，G/GEJ的新发和死亡病例在全部恶性肿瘤中分别位居第5位和第3位，其中2022年新发病例逾35.9万，死亡病例逾26万[1]。H药 汉斯状®为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，也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，惠及患者超过10万人。以临床需求为导向，公司就H药在消化道肿瘤和肺癌领域进行了差异化、多维度布局。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）。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）。本次IGCC 2025大会上发布的研究数据详情如下：口头报告论文题目Neoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated Results斯鲁利单抗同步放化疗新辅助治疗胃食道结合部腺癌的II期研究数据试验设计可切除的胃食道结合部腺癌（临床分期cT3-4或N+M0）符合条件的患者，在第一周期接受新辅助治疗斯鲁利单抗 300 mg联合SOX方案（奥沙利铂130 mg/㎡；替吉奥40-60 mg），随后在第二、三周期采用斯鲁利单抗联合同步放化疗（奥沙利铂100 mg/㎡，替吉奥40-60 mg；放疗剂量45 Gy/25）。放化疗结束后6-8周内实施手术。主要研究终点包括病理完全缓解（pCR）和主要病理缓解（MPR）。结果2023年3月至2024年11月期间，共纳入24例患者，其中19例接受根治性手术。R0切除率达100%，pCR率为26.3%，MPR率为36.8%。肿瘤T分期降期率为78.9%，术后淋巴结阴性率达89.5%。中位无病生存期尚未达到。所有患者均为微卫星稳定状态。PD-L1 CPS表达分布：<1占5.3%，1-5占42%，>5占52.6%（其中>10占31.6%）。PD-L1表达与病理反应显著相关，CPS>5组MPR率达57.1%，而CPS≤5组仅为14.3%。治疗前微小残留病灶阳性率（MRD+）为68.7%，6例MRD+患者经新辅助治疗后转阴。≥3级治疗相关不良事件发生率为33.3%，所有不良事件均可控。结论斯鲁利单抗联合同步放化疗新辅助治疗在局部晚期可切除胃食道结合部腺癌中显示出显著疗效。R0切除率和术后淋巴结阴性率（ypN0）的提升，可能为该模式的治疗手段提供依据。后续随访将重点评估生物标志物与长期预后的相关性。壁报展示论文题目Efficacy and Safety of Neoadjuvant Anti-PD-1, Thymosin, and SOX in cStage III Gastric CancerPD-1抑制剂联合胸腺法新和SOX在cⅢ期胃癌中的疗效及安全性研究试验设计2024.6至2024.11共入组30例患者，接受斯鲁利单抗+SOX（Q3W）联合胸腺法新（4.8 mg SC，biweekly）治疗。新辅助治疗后2-6周后接受胃癌根治术。主要研究终点为病理缓解情况（pCR/MPR）和TRAEs。结果入组患者的中位年龄为66岁（37-75岁），90%为男性。46.7%为胃食管交界部癌。PD-L1 CPS的中位数为3（0-30），93.3%为pMMR/MSS。患者分为A组（12例仍在接受新辅助治疗）、B组（7例已完成新辅助治疗，等待手术中）和C组（11例已完成手术治疗）。66.7%的患者发生TRAE，其中腹泻最常见（46.7%），没有出现5级AE。B+C组（n=18）的ORR为83.3%，DCR为94.4%。C组所有患者均接受了R0切除，pCR 18.2%、mPR 45.5%。相较于PD-L1和MSI，CD3+CD4+T细胞计数更能预测pCR/MPR（P=0.041/0.029）。结论斯鲁利单抗、胸腺法新联合SOX方案在局部进展期胃癌患者中显示出了良好的疗效及可控的安全性。正在进行长期随访，确定临床获益。【参考文献】[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.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 Gastric Cancer Released at IGCC 2025Shanghai, China, May 9, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results on Henlius’ self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) were presented at the congress. Among them, a phase 2 study evaluating serplulimab combined with concurrent chemoradiotherapy as neoadjuvant treatment for resectable esophagogastric junction adenocarcinoma will be orally presented at the 16th International Gastric Cancer Congress (IGCC 2025). Among them, a phase 2 study evaluating serplulimab combined with concurrent chemoradiotherapy as neoadjuvant treatment for resectable esophagogastric junction adenocarcinoma was orally presented.According to GLOBOCAN data, in 2022 there were around 1 million new cases of gastric/gastroesophageal junction (G/GEJ) cancer worldwide, posing a major challenge to global public health. In China, the incidence and mortality of G/GEJ rank fifth and third among all malignant tumors, respectively, with over 358,600 new cases and 260,300 deaths in 2022 [1].HANSIZHUANG (serplulimab), Henlius’ first self-developed innovative anti-PD-1 mAb, is the world’s first anti-PD-1 mAb for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Up to date, it has been approved in over 30 countries and regions, including China, Europe and Southeast Asia, benefiting over 100,000 patients. Underpinned by the patient-centric strategy, Henlius has carried out a differentiated and multi-dimensional layout in the field of gastrointestinal cancer and lung cancer, covering a wide variety of indications. Up to date, it has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC). In 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).The latest data of the studies released at IGCC 2025 are as follows:Oral presentationTitleNeoadjuvant Serplulimab with Concurrent Chemoradiotherapy in Resectable Esophagogastric Junction Adenocarcinoma: Phase 2 Updated ResultsStudy designEligible patients with resectable EGJ（cT3-4 or N+M0）adenocarcinoma received neoadjuvant Serplulimab (300 mg) plus SOX (oxaliplatin 130 mg/㎡; TS1 40-60 mg) for the first cycle, followed by Serplulimab with concurrent chemoradiotherapy (oxaliplatin 100 mg/㎡, TS1 40-60 mg; radiotherapy dose 45 Gy/ 25 fractions) during the second and third cycles. Surgery was performed 6-8 weeks after chemoradiotherapy.ResultsFrom March 2023 to November 2024, 24 patients were enrolled and 19 patients underwent radical resection. The R0 rate was 100%. pCR rate was 26.3%, MPR rate was 36.8%. T downstaging rate 78.9%, ypN0 89.5%. The median DFS was not reached. Microsatellite stable status was 100%. PD-L1 CPS expression: <1 (5.3%), 1-5 (42%), >5 (52.6%), >10 (31.6%). PD-L1 expression was associated with pathological response, with MPR rates of 57.1% for CPS >5 and 14.3% for CPS ≤5. Minimal residual disease positivity (MDR+) before enrollment was 68.7%, and 6 MRD+ patients converted to MRD- after neoadjuvant therapy. Grade ≥3 adverse events occurred in 33.3% of patients, with manageable treatment-related adverse events.ConclusionNeoadjuvant Serplulimab with concurrent chemoradiotherapy showed promising efficacy for locally advanced resectable EGJ adenocarcinoma. Improved R0 and ypN0 rate may change the surgical procedure in the future. Follow-up will assess correlations between biomarkers and outcomes.Poster PresentationTitleEfficacy and Safety of Neoadjuvant Anti-PD-1, Thymosin, and SOX in cStage III Gastric CancerStudy designBetween June and November 2024, all 30 participants were enrolled. Patients received three cycles of serplulimab (300 mg IV, Q3W), thymosin α-1 (4.8 mg SC, biweekly), and the SOX regimen, followed by radical gastrectomy with D2 lymphadenectomy 2–6 weeks post-treatment. Key outcomes included pathological responses (pCR/MPR) and treatment-related adverse events (TRAEs).ResultsMedian age was 66 years (37–75), 90% were male, and 46.7% had gastroesophageal junction tumors. The median PD-L1 CPS was 3 (0–30), and 93.3% were pMMR/MSS. Patients were categorized as group A (under treatment, n=12), B (completed neoadjuvant phase, awaiting surgery, n=7), and C (post-surgery, n=11). TRAEs occurred in 66.7% patients, with diarrhea being most common (46.7%), and no grade 5 events reported. Among groups B+C (n=18), the ORR was 83.3%, and the disease control rate reached 94.4%. In group C cases (n=11), 100% achieved R0 resection, pathological responses included 18.2% pCR (TRG=0) and 45.5% MPR. Higher CD3+ CD4+ T cell counts correlated with pCR/MPR (P=0.041/0.029), outperforming PD-L1 and MSI as predictors.ConclusionCombination of anti-PD-1, thymosin α-1, and SOX demonstrated promising efficacy and manageable toxicity in neoadjuvant setting for locally advanced gastric cancer, independent of CPS selection. Further follow-up is ongoing to confirm long-term clinical benefits.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