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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 内部由来于： 浏览量：

项目来源于：复宏汉霖


202历经四年7月6日，复宏汉霖（2696.HK）表态，司技术创最新科技抗HER2单抗HLX22的国际上多心中III期的仿制药临床护理校正（IND）申报都刷快瑞典物品医疗耗材行政监督管控局（FDA）可证，拟代替联席曲妥珠单抗及肿瘤化疗二线根治HER2阳型肺麟癌食道癌。迄今为止，世界十大尚未有相同代替根治HER2阳型食道癌的HER2双靶点療法应用准主板上市。



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]。


未來，机构也将立即牢固树立以女性为基地，聚焦点未考虑的临床检验药学供给，正极经历调整HER2抗体阳性癌肿整合辽法并积极推进HLX22的更好香港国际临床检验药学公司注册，为国内更好女性带去基督。
【学习期刊论文】
[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）就是一家展览化的去去创新技术菌物化工机构，着手于于为世界各国人出具可付出的及高品质性能菌物药，產品覆盖率肺部肿瘤、政治意识免疫细胞重大妇科疾病、眼科医生重大妇科疾病等这个领域，已在我国销售5款產品，在展览销售2款產品，19项应用症应用，6个销售报名区别获我国放射性药品监督服务管理局和欧盟委员会委员会EMA授理。自2012年建起开始，复宏汉霖已建起混合式化菌物化工网络平台网站，有效率及去去创新技术的自主性重点实力贯彻研制、产量及企业服务营运全企业链。机构已建立联系健全完善有效率的世界各国去去创新技术主，都按照展览放射性药品产量性能服务管理要求（GMP）的标准实现产量和性能防范，逐渐增强混合式化网络综合产量网络平台网站，在当中，机构企业服务化产量研学基地已会相继提升我国、欧盟委员会委员会和美利坚GMP企业认证。


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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