ASCO GI | 复宏汉霖将携2款创新产品最新研究成果首发亮相

2024年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）将于1月18日到20日在美国旧金山召开。此届大会上，复宏汉霖将以壁报形式分享创新型抗HER2单抗HLX22、抗PD-1单抗H药汉斯状®的最新研究成果。

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，且HLX22的I期临床试验证实产品安全且可耐受。目前，全球尚无同类用于治疗HER2阳性胃癌的HER2双靶点疗法获批准上市。

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。自2022年3月获批上市以来，H药已在中国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。2023年12月，H药正式获得印度尼西亚药品管理局批准用于ES-SCLC的治疗。H药用于治疗ES-SCLC和非鳞状非小细胞肺癌（nsNSCLC）的上市申请也已分别获得欧盟EMA和中国NMPA受理。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，适应症广泛覆盖肺癌、食管鳞癌、头颈鳞癌和胃癌等高发大癌种，在全球范围内累计入组逾3600名受试者。

此次将展示的两项临床研究包括：

HLX22-GC-201

论文题目：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

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

编号：354

现场展示时间：美国太平洋标准时间1月18日

牵头主要研究者：李进，上海市东方医院

HLX10-015-CRC301

论文题目：First-line serplulimab plus HLX04 and XELOX versus placebo plus bevacizumab and XELOX in metastatic colorectal cancer: A phase 2/3 study

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

编号：124

现场展示时间：美国太平洋标准时间1月20日

牵头主要研究者：徐瑞华，中山大学肿瘤防治中心

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，已在中国上市5款产品，在国际上市2款产品，19项适应症获批，3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，上海徐汇基地和松江基地（一）均已获得中国和欧盟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20多种创新单克隆抗体，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欧双批单抗药物汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）、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 to Release Clinical Data at 2024 ASCO GI 

Shanghai, China, January 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, HLX22, an innovative anti-HER2 mAb, and the approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), will be presented in posters at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 18-20.

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. As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally.

HANSIZHUANG (serplulimab) is the first innovative mAb developed by Henlius. Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small-cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). In December 2023, HANSIZHUANG was approved in Indonesia for the treatment of ES-SCLC. The marketing applications of the first-line treatment for non-squamous non-small cell lung cancer (nsNSCLC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. 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, such as lung cancer, ESCC, head and neck squamous cell carcinoma and gastric cancer, etc. To date, more than 3,600 subjects have been enrolled worldwide for HANSIZHUANG clinical trials.

Details of the results to be presented at 2024 ASCO GI are as follows:

1. HLX22-GC-201

Title: 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

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

Presentation Number: 354

Onsite Poster display date: 2024/1/18

Leading PI: Jin Li, Shanghai East Hospital, School of Medicine, Tongji University

2. HLX10-015-CRC301

Title: First-line serplulimab plus HLX04 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: 124

Onsite Poster display date: 2024/1/20

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

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 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 3 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 centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) 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 in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, 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 worlds first anti-PD-1 mAb for the first-line treatment of SCLC. Whats more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.