ASCO GI | 复宏汉霖H药汉斯状®和抗HER2单抗HLX22最新研究结果入选

复宏汉霖

2025/01/09

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PD-1 HER2 斯鲁利单抗小细胞肺癌上海复宏汉霖生物技术股份有限公司

2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）将于1月23日至25日在加利福尼亚州旧金山举行。此届大会上，复宏汉霖将以壁报形式分享公司自主研发的抗PD-1单抗H药汉斯状^®和创新型抗HER2单抗HLX22的三项最新研究成果。

H药汉斯状^®（斯鲁利单抗）是复宏汉霖首个自主研制的创新型单抗药，也是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，目前已在中国和多个东南亚国家获批。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）等适应症。此外，H药一线治疗ES-SCLC的上市申请也已获得欧洲药品管理局（EMA）受理，并已获得EMA人用药品委员会积极意见。同时，公司围绕H药在全球同步开展10余项肿瘤免疫联合疗法临床试验，累计入组逾4800名受试者。

HLX22为复宏汉霖自AbClon, Inc.许可引进、并后续自主研发的创新型抗HER2单克隆抗体。与曲妥珠单抗类似，HLX22可结合HER2的亚结构域IV，但HLX22所结合的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）和富组氨酸糖蛋白（HRG1）诱导的细胞增殖，增强体外和体内的抗肿瘤活性。HLX22的I期临床试验证实产品安全且可耐受^[1]。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/胃食管交界部（G/GEJ）癌II期临床研究（HLX22-GC-201）结果显示，在曲妥珠单抗联合化疗的基础上加入HLX22可提高患者一线治疗的生存期和抗肿瘤反应，且安全性可控^[2-4]。该研究结果相继于2024年ASCO GI、欧洲肿瘤学会胃肠道肿瘤研讨会（ESMO GI）和Cell Press细胞出版社旗下的综合性医学旗舰期刊Med发布。

此次将展示的三项临床研究包括：

H药汉斯状^®

论文题目：Updated efficacy and subgroup analysis of first-line serplulimab plus bevacizumab and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: a phase 2/3 study

一线斯鲁利单抗联合贝伐单抗和XELOX对比安慰剂联合贝伐单抗和XELOX治疗转移性结直肠癌的更新疗效和亚组分析：一项2/3期研究

场次：Poster Session C: Cancers of the Colon, Rectum, and Anus

编号：170

现场展示时间：美国太平洋标准时间1月25日

牵头主要研究者：徐瑞华，中山大学肿瘤防治中心

论文题目：Safety and efficacy of perioperative chemotherapy combined with PD-1 inhibitor versus chemotherapy with D2 gastrectomy plus PAND in gastric cancer with PALD metastasis: A single-center retrospective cohort study

PD-1抑制剂联合化疗对比化疗围手术期治疗胃癌腹主动脉旁淋巴结转移序贯D2根治术联合腹膜后淋巴结清扫疗效和安全性的一项单中心、回顾性研究

场次：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

编号：368

现场展示时间：美国太平洋标准时间1月23日

牵头主要研究者：杜义安，浙江省肿瘤医院

HLX22

论文题目：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

HLX22联合曲妥珠单抗和XELOX用于HER2阳性局部晚期或转移性胃/胃食管交界部癌的一线治疗：包含更多患者的更新结果

场次：Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

编号：440

现场展示时间：美国太平洋标准时间1月23日

牵头主要研究者：李进，上海高博肿瘤医院

【参考文献】

[1] 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

[2] 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

[3] 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

[4] Li N, Qiu M, Zhang Y, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2. doi:10.1016/j.medj.2024.06.004

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，3款产品在国际获批上市，4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。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）以及汉奈佳^®（奈拉替尼）。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 to Present Latest Clinical Data of HLX10 and HLX22 at 2025 ASCO GI

Shanghai, China, January 9th, 2025 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, the anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and an innovative anti-HER2 mAb HLX22, will be presented in posters at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 23-25.

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 China and several Southeast Asian countries. 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. In China, it has been approved by the NMPA for the treatment including squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, esophageal squamous cell carcinoma (ESCC) and non-squamous non-small cell lung cancer (nsNSCLC), etc. Furthermore，the marketing application of the first-line treatment for ES-SCLC is under review by the European Medicines Agency (EMA). Besides, the company has initiated more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,800 subjects enrolled worldwide.

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. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit 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^[1]. Results from HLX22-GC-201, a phase 2 study of HLX22 in combination with trastuzumab injection (HLX02) and XELOX, as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients were subsequently presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and on Med, a flagship medical journal by Cell Press, respectively. Updated results and study data showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety^[^2-4].

Details of the results to be presented at 2025 ASCO GI are as follows:

HLX10

Title: Updated efficacy and subgroup analysis of first-line serplulimab plus bevacizumab and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: a phase 2/3 study

Session: Poster Session C: Cancers of the Colon, Rectum, and Anus

Presentation Number: 170

Onsite Poster display date: 2025/1/25

Leading PI: Rui-Hua Xu, Sun Yat-sen University Cancer Center

Title: Safety and efficacy of perioperative chemotherapy combined with PD-1 inhibitor versus chemotherapy with D2 gastrectomy plus PAND in gastric cancer with PALD metastasis: A single-center retrospective cohort study

Session: Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

Presentation Number: 368

Onsite Poster display date: 2025/1/23

Leading PI: Yian Du, Zhejiang Cancer Hospital

HLX22

Title: 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

Session: Poster Session A: Cancers of the Esophagus and Stomach and Other Gastrointestinal Cancers

Presentation Number: 440

Onsite Poster display date: 2025/1/23

Leading PI: Jin Li, Shanghai GoBroad Cancer Hospital

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, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, and 4 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 over 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), 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 16 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