2022年10月28日，复宏汉霖(2696.HK)宣布，公司自主研制的帕妥珠单抗生物类似药HLX11(重组抗HER2结构域II人源化单克隆抗体注射液)的临床试验申请在欧盟国家西班牙获批开展国际多中心III期临床研究，拟用于HER2阳性且HR阴性的早期或局部晚期乳腺癌新辅助治疗。目前，HLX11的III期临床研究(HLX11-BC301)已于中国完成首例受试者给药。与此同时，公司已陆续向波兰、保加利亚、匈牙利、捷克等其他欧盟国家递交了HLX11的临床试验申请，预计将于近期陆续获批。

HLX11为复宏汉霖遵照中国及欧盟生物类似药相关法规自主开发的帕妥珠单抗生物类似药，其潜在适应症主要包括联合曲妥珠单抗和化疗用于HER2阳性早期乳腺癌的新辅助治疗和辅助治疗，以及联合曲妥珠单抗和多西他赛治疗HER2阳性转移性或不可切除的局部复发性乳腺癌患者。HLX11可与HER2的细胞外二聚化结构域(亚结构域II)发生特异性结合，从而阻断HER2与其他HER家族成员(包括EGFR、HER3和HER4)生成配体依赖型异源二聚体，进而抑制配体启动的细胞内信号转导，导致肿瘤细胞生长停滞和细胞凋亡，同时通过抗体依赖性细胞介导的细胞毒性作用(ADCC)达到增强免疫细胞对肿瘤细胞的杀伤能力。

复宏汉霖深耕抗HER2治疗领域，积累了丰富的研究成果与经验，公司自主开发的丰富管线覆盖多款靶向HER2的抗体生物药，也为相关双特异性抗体、抗体偶联药物(ADC)产品等新型抗体的研发奠定了扎实的基础。其中，复宏汉霖自主开发与生产的曲妥珠单抗汉曲优(欧洲商品名：Zercepac，澳大利亚商品名：Tuzucip和Trastucip)是中国首个自主研发的中欧双批单抗药物，目前已在全球30多个国家获批上市，为全球HER2阳性乳腺癌及胃癌患者的“金标准”治疗方案增添了新的选择。公司正处于II期临床研究阶段的创新型产品HLX22(一款针对HER2靶点开发的人源化lgG1单克隆抗体注射液)也有望进一步提升HER2阳性乳腺癌及胃癌患者的治疗效果，带给患者更大的生存获益。HLX11也有潜力与汉曲优、HLX22联合应用，助力复宏汉霖打造更高效的治疗方案。

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未来，公司将持续推动HLX11相关研究在全球范围的临床布局，并以不断的创新与突破为全球病患带来更多质高价优的生物。

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，15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。

Henlius Pertuzumab Biosimilar HLX11Received Clinical Trial Approval in EU for the Phase3MRCT Shanghai,China,Oct,28th,2022-Shanghai Henlius Biotech,Inc.(2696.HK)announced that the international multicentre phase3clinical trial for the company’s pertuzumab biosimilar HLX11,a recombinant anti-human epidermal growth factor receptor2(HER2)subdomain II humanized monoclonal antibody injection,for the neoadjuvant therapy in patients with HER2-positive,HR-negative early or locally advanced breast cancer has been approved by the Spanish Agency of Medicines and Medical Devices(AEMPS).At present,the phase3clinical trial is currently underway for HLX11in China.Additionally,Henlius has submitted clinical trial applications for HLX11in other EU countries including Poland,Bulgaria,Hungary,and the Czech Republic,and such applications are expected to be approved soon.

HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China and the European Union(EU),which can be potentially used in combination with trastuzumab and chemotherapy as neoadjuvant or adjuvant treatment for HER2-positive early breast cancer and in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic or unresectable locally recurrent breast cancer patients.HLX11can specifically bind with the subdomain II of HER2extracellular domain and inhibit the heterodimerisation of HER2and other HER family receptors,i.e.,EGFR,HER3,and HER4.This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells.In the meantime,HLX11can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity.

With the accumulated results and experience from extensive anti-HER2research,Henlius has a well-established product pipeline in anti-HER2treatment and built a solid foundation for discovering and developing anti-HER2bispecific/multi-target antibodies and antibody-drug conjugates(ADC).Up to now,the company’s independently developed and manufactured trastuzumab biosimilar HANQUYOU(Zercepac,trade names in Australia:Tuzucip and Trastucip),the first Chinese mAb biosimilar entering both the EU and China market,has been successfully launched in more than30countries and regions,providing a new standard treatment option for global HER2positive breast and gastric cancer patients.Besides,HLX22,an anti-human epidermal growth factor receptor-2(HER2)humanized monoclonal antibody injection in phase2clinical trial,has the potential to further improve treatment outcomes for HER2positive breast cancer and gastric cancer patients.And HLX11also has the potential to be used in combination with HANQUYOU and HLX22to help Henlius to create more beneficial course of treatment for patients.

In the future,Henlius will continue to speed the launch of this clinical trial in more countries and regions,as well as innovate and seek breakthroughs to bring more affordable and quality biologics to patients around the globe.

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,5products have been launched in China,1approved for marketing in overseas markets,15indications approved worldwide,and5New Drug Applications(NDAs)accepted for review in China.Since its inception in2010,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 over20innovative monoclonal antibodies(mAbs)and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG(anti-PD-1mAb)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 over20clinical studies for13products and11combination therapies.