复宏汉霖抗PD-1单抗联合抗EGFR单抗医治计划方案得到国家食药监局临床试验准许

2019年12月9日，复宏汉霖（香港交易所编码：2696）公布，企业独立研发的HLX10（资产重组抗PD-1人源化单克隆抗体注射剂）联合HLX07（资产重组抗EGFR人源化单克隆抗体注射剂）用以发作或转移癌头颈鳞状细胞癌医治的药物临床试验申请办理（IND）获国家药监局准许。值得一提的是，早就在2018年9月，复宏汉霖HLX10联合其独立产品研发的HLX04（贝伐珠单抗微生物相近药）用以末期实体瘤的医治计划方案已得到IND准许，变成中国首例获IND准许的国内双单抗联合医治计划方案。本次HLX10联合HLX07单抗医治计划方案是复宏汉霖的第二个国内双单抗联合疗法，该计划方案的获准进一步贯彻了复宏汉霖的免疫力联合疗法发展战略，推动中国单抗联合医治的发展趋势。以便改进抗PD-1产品做为单药应用高效率较低的状况，在单药基本上开发设计联合疗法已变成全世界发展趋势。凭着强劲的人才储备和综合性一体化的产品研发服务平台，复宏汉霖贯彻“Combo + Global”的纵向一体化，以已有产品HLX10和HLX20（抗PD-L1单抗）为关键，积极主动联合别的产品，打造出多样化的、根据已有产品的联合疗法，同歩在全世界好几个國家和地域进行临床试验。将来，企业将不断落实仿创融合的产品开发设计对策，掌握将来肿瘤免疫机会，为病人出示更可承担的、功效更强的医治挑选。有关HLX10及联合疗法HLX10是复宏汉霖独立产品研发的技术创新单克隆抗体新项目，可用以多种多样实体瘤的医治，正进一步探寻其用以医治慢性乙型肝炎的概率。现阶段，HLX10已陆续得到英国、台湾及中国内地的临床试验准许，单药已经进到2期临床试验环节。HLX10还可联合别的产品进行免疫力联合疗法。HLX10联合HLX04、HLX07的联合疗法均已获国家食药监局临床试验准许，HLX10联合HLX04医治末期肝脏癌病人的2期临床试验已在我国进行第一例病人给药。HLX10联合放疗一线医治部分末期/转移癌食道鳞癌（ESCC）、部分末期或转移癌鳞状非小细胞肺癌（sqNSCLC）及普遍期小细胞肺癌（ES-SCLC）的三个3期临床实验早已在中国进行第一例病人给药。有关HLX07HLX07的功效靶点为细胞生长因子蛋白激酶（Epidermal Growth Factor Receptor; EGFR），是复宏汉霖产品研发的具备独立专利权的改进型（Biobetter）自主创新产品，在其专利药西妥昔单抗基本上开展了抗体工程更新改造，将来可用以结直肠癌、颈部癌等几种实体瘤的医治。HLX07已所有得到中国内地、台湾和英国三地的临床试验准许，并已经在台湾开展临床医学1a期实验。2018年8月，HLX07已在中国起动1b/2期临床试验。有关复宏汉霖复宏汉霖（2696.HK）是一家我国领跑的生物制药公司，致力于为全世界病人出示质天价优秀的自主创新生物药，产品遮盖恶性肿瘤、本身免疫系统疾病等行业。自2010年创立至今，企业以全世界连动、融合自主创新为产品开发设计核心理念，在我国上海市、中国台北和美国德州均下设产品研发管理中心，具有了协作提质增效的突显优点。复宏汉霖关键的产品开发设计对策是仿创融合，从微生物相近药发展，逐渐开发设计技术创新单抗产品，融合独立开发设计的抗PD-1和PD-L1单抗，在中国首先发布免疫力联合疗法，创新性合理布局了一个多样化、自主创新单抗及肿瘤免疫联合疗法管道，打造科学研究、开发设计、产品化生产制造的综合型生物技术产业链服务平台。2019年9月25日，复宏汉霖香港联合交易中心有限责任公司创业板上市，股票号：2696.HK。目前为止，复宏汉霖现有1个产品取得成功发售，2个产品得到我国药物发售申请办理审理，1个产品得到欧洲共同体药物发售申请办理审理，14个产品、6个联合医治计划方案在全世界范围之内进行20多种临床试验。在其中，企业第一款重磅消息产品汉利康®（利妥昔单抗注射剂）于2019年2月获国家食药监局药物发售申请注册准许，变成我国首例获准发售的微生物相近药。HLX03（阿达木单抗注射剂）与HLX02（注射用曲妥珠单抗）已获国家食药监局药物发售申请办理审理，已经列入优先选择评审程序流程。HLX02陆续在中国内地、俄罗斯、欧洲共同体芬兰和泰国全面铺开国际性多管理中心3期临床试验，变成中国首例进行国际性多管理中心3期临床实验的微生物相近药，并且于2019年6月获欧州药物管理处发售申请办理审理。除此之外，企业已相继就HLX10与已有产品HLX04、HLX07及其放疗合用进行多种肿瘤免疫联合疗法，在全世界范围之内进行好几个临床实验。The Anti-PD-1 Monoclonal Antibody Combined with Anti-EGFR Monoclonal Antibody Therapy of Henlius Received Approvals to Conduct Clinical Trials by NMPAShanghai, China, December 9, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the company has received approvals from the National Medical Products Administration (NMPA) for its investigational new drug (IND) applications for the combination therapy of HLX10, a recombinant humanised anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) injection, and HLX07, a recombinant anti-epidermal growth factor receptor (EGFR) humanised mAb injection, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.It is worth mentioning that Henlius has received the IND approvals of HLX10 in combination with HLX04, a bevacizumab biosimilar developed by Henlius independently, for the treatment of advanced solid tumors in September 2018. This is the first domestic dual mAbs combination therapy that has received IND approval in China. As the second domestic dual mAbs combination therapy of Henlius, HLX10 in combination with HLX07 further implements the combination immunotherapy strategy of Henlius and leads the development of mAbs combination therapies in China.Development of combination therapies with anti-PD-1 mAbs has become a main trend globally to improve the efficacy of anti-PD-1 mono-therapies. Relying on its formidable talent reserve and integrated R&D platform, Henlius implements the differentiation strategy of “Combo plus Global” with its proprietary HLX10 and HLX20 (anti-PD-L1 mAbs) as backbones in combination with other therapies to conduct global multi-center clinical trials. Looking forward, the company will continue implementing the product development strategy and capturing future immunotherapy opportunities to provide more affordable and better therapeutic options for all patients.About HLX10 and Combination TherapyHLX10, an innovative mAb developed by Henlius independently, can be widely used in the treatment of solid tumors and also further developed for the treatment of chronic hepatitis b infection. Currently, HLX10 has received clinical trial approvals in the US, Taiwan China and Mainland China successively, with its phase 2 clinical study being conducted as mono-therapy. HLX10 in combination with other therapies can bewidely applied to immuno-oncology combination therapies for various solid tumors. Recently, first patient was dosed in a phase 2 clinical trial of HLX10 plus HLX04 for the treatment of advanced hepatocellular carcinoma. The IND application of HLX10 in combination with HLX04 and the IND application of HLX10 in combination with HLX07 have both received approval by the NMPA. First patient has been dosed in phase 3 clinical trials of HLX10 in combination with chemotherapy for the treatment of locally advanced/metastatic esophageal squamous-cell carcinomas (ESCC), squamousnon-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC).About HLX07HLX07, which targets the EGFR, is a biobetter of cetuximab developed by Henlius with independent intellectual property rights. HLX07 is bioengineer