复宏汉霖抗HER2单抗HLX22国际多中心III期的新药临床试验申请已获得美国FDA许可

发布时间:2024-05-06 资源来原于： 浏览量：

知识由来：复宏汉霖


2025年的5月6日，复宏汉霖（2696.HK）正式，总部多元化型抗HER2单抗HLX22的时代国际多平台III期的药物临床药理试验检测（IND）请求就已经有国外产品放射性药品监察工作管理处（FDA）经营，拟主要于聯合曲妥珠单抗及放化疗闽东南治愈HER2阳型胆襄癌直肠癌。当今，全国尚未差不多主要于治愈HER2阳型直肠癌的HER2双靶向物理疗法物理疗法将建准出现。



迄今为止，胃癌/胃食管连接部（G/GEJ）癌依旧构成了一大全球健康问题。据GLOBOCAN数据显示，2022年全球约有100万新发病例[1]。多数G/GEJ癌患者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]，这其中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为复宏汉霖自AbClon, Inc.许可引进、并后续自主研发的靶向HER2的创新型单克隆抗体。与曲妥珠单抗类似，HLX22可结合在HER2的亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得HLX22和曲妥珠单抗能够同时与HER2结合，从而产生更强的HER2受体阻断效果。临床前研究表明，HLX22与曲妥珠单抗联合治疗可抑制表皮生长因子（EGF）和HRG1（Histidine-Rich Glycoprotein 1）诱导的细胞增殖，增强体外和体内的抗肿瘤活性。此前，HLX22针对HER2过表达的晚期实体瘤的I期临床研究数据显示，HLX22在HER2过表达的晚期实体瘤患者中具有良好的安全性和耐受性[6]。2024年1月，HLX22联合汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）治疗HER2阳性胃癌II期临床研究数据首次发布于2024年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI），该研究结果显示，在HLX02（曲妥珠单抗）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[7]。


将来，集团公司也将仍在奉行以客户为中央，集中未做到的临床检验治疗供给，积极向上探寻升级优化HER2抗体阳性肿癌携手方式并推广HLX22的更好知名临床检验治疗注册网站，为各国更好客户带去福利。
【选取论文论文参考文献】
[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. doi:10.1007/s10637-023-01338-7 [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).DOI:10.1200/JCO.2024.42.3_suppl.354

关于复宏汉霖

复宏汉霖（2696.HK）不是家国.际化的科技技术技术创新海洋生物工程技术制作保健药品机构的，秉承于为世界病患提供了可负税的高品性海洋生物工程技术药，软件合并癌肿、政治意识免疫检测妇科常见疾病、眼科医生妇科常见疾病等范围，已在国家挂牌成功面市5款软件，在国.际挂牌成功面市2款软件，19项适合症新批，6个挂牌成功面市申办依次获国家保健药品监督管理工作局和欧洲联盟EMA核发。自20十五年注册成立今年以来，复宏汉霖已建设一身化海洋生物工程技术制作保健药品网上app，便捷及科技技术技术创新的自主化中央作用包括研制开发、产生及企业楼运行全工业链。机构的已确立更加完善便捷的世界科技技术技术创新中央，确定国.际保健药品产生效率水平管理工作技术规范（GMP）基准使用产生和效率水平监督控制，持续不断扎实一身化一体化产生网上app，当中，机构的企业楼化产生工厂已纷纷赢得国家、欧洲联盟和国外GMP认证证书。


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50多个分子，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。继国内首个生物类似药汉利康®（利妥昔单抗）、中国首个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）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16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 Dual HER2 Blockade Therapy Receives Phase 3 MRCT IND Approval from U.S. FDA


Shanghai, China, May 6, 2024-Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug application (IND) for phase 3 international multicenter clinical study of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved by the United States Food and Drug Administration (FDA). As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally.


Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022 [1]. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with 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. 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 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. Pre-clinical studies have showed that the combination therapy of HLX22 and trastuzumab inhibits the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 is well tolerated and has good safety profiles. In January 2024, results from the phase 2 study of HLX22 combined with HANQUYOU (trastuzumab for injection, HLX02, trade name in Europe: Zercepac®) and chemotherapy for the first-line treatment of HER2-positive G/GEJ cancer was first released at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI), which showed that adding HLX22 to HLX02 (trastuzumab for injection) + XELOX improved survival and antitumor response in patients with HER2-positive G/GEJ cancer in the first-line setting, with a manageable safety profile [7].


Moving forward, the company will continue to uphold a patient-centric approach, focus on unmet medical needs, and actively explore the optimization of combination therapies for HER2-positive cancer. This includes advancing clinical trials and registrations worldwide for HLX22 to bring hope to more patients around the world.

About Henlius

Henlius (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, 5 products have been launched in China, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 6 marketing applications have been accepted for review in China 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the first China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.    






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