Bevacizumab biosimilar(Shanghai Henlius)

2025年5月26日，复宏汉霖（2696.HK）宣布，公司创新型抗HER2单抗HLX22获得欧盟委员会（EC）授予的孤儿药资格认定（ODD），用于胃癌的治疗。这是HLX22全球开发进程中的又一里程碑突破，标志着其成为全球首款同时获得欧盟和美国孤儿药资格认定的胃癌抗HER2靶向疗法，揭示了其在胃癌领域的巨大治疗潜力。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）目前已获得中国、美国、欧盟国家德国、日本、澳大利亚、韩国等地药监机构的新药临床试验（IND）许可，并完成全球首例患者给药。此次HLX22获得欧盟孤儿药认定基于欧洲药品管理局（EMA）孤儿药委员会（COMP）的积极意见。根据EC的定义，孤儿药(Orphan Medicinal Product)被用于诊断、预防或治疗那些危及生命或者非常严重的疾病，并且患者比例不超过欧盟人口总数万分之五。欧盟《孤儿药法规》确立了孤儿药资格认定的集中审批程序，并为孤儿药的研发和上市制定了激励措施，包括但不限于 (1)获得临床研究方案协助(EMA为获得认定的孤儿药提供专门的科学建议)；(2)可享受药品集中审批程序（企业可直接向EMA提交上市/有条件批准申请，由此获得的欧盟委员会建议或决议在所有欧盟国家均有效）；(3)上市后享有10年市场独占权；(4)监管活动费用减免(涉及方案协助、上市许可申请与核查、上市后变更申请和年费)。据GLOBOCAN数据显示，2022年全球约有100万胃癌新发病例，逾66万死亡病例，疾病负担呈现显著地域不平衡[1]，构成了一大健康问题。多数胃癌患者早期症状隐匿，确诊时已处于疾病晚期，总体预后不良，5年生存率仅为6%[2,3]。其中，HER2阳性患者占比约为12-23%，且其预后较HER2阴性患者更差[2,4]。目前，对于HER2阳性的局部晚期/转移性G/GEJ患者，其标准一线疗法为曲妥珠单抗联用化疗，针对PD-L1 阳性（PD-L1 CPS≥1）的患者，一些指南亦推荐进一步叠加联用免疫治疗，但持续疗效和预后仍有待进一步改善[5]。HLX22是一款靶向HER2的创新型单克隆抗体。其具有差异化的分子设计和作用机制，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，使得该产品能够与和曲妥珠单抗同时结合至HER2，有效促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，将HER2的内吞效率提高了40%-80%，进而产生更强的HER2受体阻断效果。一项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（HLX22-GC-201）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[6-8]，有望重塑晚期胃癌的一线标准治疗，该研究最新结果已于2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）发布[9]，并将2025 ASCO年会上进一步更新，同时其 III期临床HLX22-GC-301的研究设计也会在ASCO上发布。除胃癌外，复宏汉霖近期亦启动了一项HLX22联合德曲妥珠单抗二线治疗HER2低表达HR 阳性乳腺癌的II期临床研究（HLX22-BC201）并于中国境内完成首例患者给药。未来，复宏汉霖将继续秉持“以患者为中心”的理念，加速推进HLX22的全球研发布局，早日将这一创新疗法带给全球患者。同时，公司也将持续深耕肿瘤领域，推动更多创新药物的研发，带来更多高质量、可负担的治疗选择。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。Henlius Receives Orphan Drug Designation for Its Innovative Anti-HER2 mAb HLX22 in the European Union for Gastric CancerShanghai, China, May 26, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Commission (EC) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. At present, HLX22 is the world's first anti-HER2-targeted therapy to receive ODD approvals from both the FDA and the EC, suggesting its significant therapeutic potential in the treatment of gastric cancer. The Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC has obtained investigational new drug (IND) approvals in China, the U.S, Japan, Australia, Korea and EU Germany, etc., and has completed its first patient dosing in China, Japan, and Australia.This ODD granted by EC follows the positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). According to the EC, orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the EU. The EU Regulation on orphan medicinal products establishes a centralised procedure for the designation of orphan medicinal products and puts in place incentives for their research, development and marketing, certain policy support, including but not limited to 1) protocol assistance for clinical studies; 2) access to the centralised authorization procedure; 3) ten years of protection from market exclusivity once approved for marketing; 4) fee reductions for regulatory activities.Until now, gastric cancer still constitutes a major global health problem with marked geographic disparities. According to GLOBOCAN 2022, there were around 1 million new cases and over 660 thousand new deaths of gastric cancer in 2022 globally[1]. Most patients with gastric cancer have insidious biological behavior and often diagnosed at an advanced stage, with a poor prognosis and a 5-year relative survival rate of only 6% [2,3]. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease used to be even worse than those with HER2-negative disease [2,4]. Currently, for patients with HER2-positive locally advanced/metastatic G/GEJ cancer, the current standard first-line treatment is trastuzumab plus chemotherapy. Immunotherapies are recommended to be added for tumours with PD-L1 expression levels by CPS (Combined Positive Score) of greater than 1. However, the effectiveness and prognosis for these treatments need to be further improved [5].HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab via differentiated molecular design and mechanism of action, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, resulting in a 40%–80% increase in HER2 internalisation. thereby strengthening the blockade of HER2-mediated signaling pathways. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) demonstrate that the addition of HLX22 to trastuzumab plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[6-8], expected to redefine the first-line standard treatment for advanced gastric cancer. Updated results were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI)[9]. Further updates will be released at the upcoming 2025 ASCO Annual Meeting, while the study design of its phase 3 clinical trial HLX22-GC-301 will also be released at the conference. In addition to gastric cancer, a phase 2 clinical trial of HLX22 in combination with trastuzumab deruxtecan (T-DXd) has completed the first patient dosing for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer in China. Looking forward, Henlius will adhere to patient-centricity, accelerating the multi-regional clinical trials of HLX22 to deliver this innovative therapy to patients worldwide. Meanwhile, the company will continue to delve into the oncology field, driving the development of more innovative therapeautics to provide high-quality and affordable treatment options.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.References[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.[2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92.[3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70.[4] Gravalos C. et al. Ann Oncol 2008;19(9):1523-9.[5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.1.2024[6] Zhu X, Ding Y, Wang Q, Yang G, Zhou L, Wang Q. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs. 2023;41(3):473-482.[7] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study. JCO 42, 354-354(2024).[8] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482[9] Li, Jin, et al. "HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients." (2025): 440-440.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