复宏汉霖创新型抗EGFR单抗治疗晚期皮肤鳞癌临床试验申请获美国FDA批准2022年9月29日，复宏汉霖（2696.HK）宣布公司自主开发的创新型单抗HLX07（重组抗EGFR人源化单克隆抗体注射液）正式获得美国食品药品监督管理局（FDA）临床试验许可，拟用于局部晚期或转移性皮肤鳞状细胞癌（CSCC）的治疗。 HLX07是复宏汉霖自主研发的针对EGFR靶点的创新型生物药。基于公司成熟的抗体工程改造平台，在西妥昔单抗的基础上，通过将HLX07的Fab区人源化，同时使该产品聚糖含量降至最低，以具备更低的免疫原性和良好的靶点亲和力。临床前研究表明，HLX07的EGFR靶点亲和力与西妥昔单抗相似且安全性良好，表现出更优的生物活性，并在不同肿瘤模型中均能显著抑制肿瘤细胞的生长，与公司自主研发的创新抗PD-1单抗H药汉斯状®具有协同作用。 复宏汉霖已就HLX07在中国、美国、欧盟、澳大利亚、日本等多个知识产权区获得专利，并在中国和美国获得临床试验许可。目前，HLX07治疗实体瘤的Ib/II期临床研究正在中国进行中。同时，公司围绕HLX07和肿瘤免疫核心产品H药积极开展联合疗法，HLX07联合H药用于复发或转移性头颈部鳞状细胞癌（HNSCC）、EGFR高表达鳞状非小细胞肺癌（sqNSCLC）等多种实体瘤治疗的II期临床研究已于中国完成首例患者给药；HLX07联合H药联合汉贝泰®（贝伐珠单抗）一线治疗晚期肝细胞癌（HCC）的Ⅱ期临床试验申请已获国家药品监督管理局（NMPA）批准。 复宏汉霖从临床需求出发，目前在PD-1/L1、CTLA-4、LAG-3等免疫检查点全面布局，为免疫联合治疗的探索创造更多可能。同时，公司充分运用自有管线覆盖肿瘤特异性靶点、抗血管生成靶点和肿瘤免疫靶点等多个类别的特点，助力H药与自有单抗产品、化疗等治疗手段开展联合治疗，已广泛覆盖肺癌、食管癌、头颈鳞癌和胃癌等适应症，有助于充分挖掘免疫疗法的治疗潜力。未来，复宏汉霖将持续推动更多创新产品的临床研究，积极探索更多疗效更好的治疗方案，期待早日为更多患者带来质高价优的生物药。 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1款产品，13项适应症获批，5个上市注册申请获得中国药监局受理。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，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国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，其鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌3项适应症的上市注册申请也正在审评中。公司亦同步就13个产品、11个免疫联合治疗方案在全球范围内开展20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。
Shanghai, China, September 29th, 2022 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the investigational new drug (IND) application for its HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). HLX07 is an innovative drug targeting EGFR independently developed by Henlius. Adopting the self-developed advanced antibody engineering platform, Henlius re-engineered cetuximab by humanizing its Fab regions and minimizing its glycan contents to generate HLX07 to reduce the immunogenicity and maintain high affinity of the product. Pre-clinical studies have shown that HLX07 binds EGFR with similar affinity and has better bioactivity compared to cetuximab. HLX07 can significantly inhibit the growth of tumour cells in different tumour models and synergize with immune checkpoint inhibitors such as HANSIZHUANG (serplulimab). As of now, Henlius holds patents of HLX07 in several jurisdictions including China, the United States, the European Union, Australia, and Japan. Moreover, Henlius has received clinical trial approvals for HLX07 in China and the United States,. The phase 1b/2 clinical trial has been conducted in China for the treatment of solid tumours. As for used in the combination immunotherapies with HANSIZHUANG (serplulimab), the first patients were dosed in China in phase 2 clinical trials of HLX07 in combination with HANSIZHUANG (serplulimab) for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck (HNSCC) and EGFR high expression squamous non-small cell lung cancer (sqNSCLC). In addition, the IND for the phase 2 clinical trial of HLX07 in combination with HANSIZHUANG (serplulimab) and HANBEITAI (bevacizumab biosimilar) for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). Underpinned by the patient-centric strategy, Henlius has achieved an overall layout of the immune checkpoint products of PD-1/L1, CTLA-4, LAG-3, etc., proactively exploring immuno-oncology combination therapy. Meanwhile, Henlius actively promotes HANSIZHUANG in conjunction with in-house products of the company such as tumour-specific target, angiogenesis target, immunotherapeutic target, etc. and chemotherapy drugs to conduct immune combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer. Looking forward, Henlius will continue conducting clinical studies for more innovative products and exploring therapies with improved efficacy to provide patients with quality and affordable biologics. 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, 1 approved for marketing in overseas markets, 13 indications approved worldwide, and 5 New Drug Applications (NDAs) accepted for review in China. 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 Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China 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, 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 and its NDAs for the treatment of squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) are under review. What's more, Henlius has conducted over 20 clinical studies for 13 products and 11 combination therapies, expanding its presence in major markets as well as emerging markets. |