近日，复宏汉霖收到《受理通知书》，其研制的HLX10——重组抗PD-1人源化单克隆抗体注射液联合HLX04——重组抗VEGF人源化单克隆抗体注射液用于晚期实体瘤的治疗方案（以下简称“该治疗方案”）获国家药品监督管理局临床试验注册审评受理。
据悉，这是国内首个获IND申请受理的国产单抗联合治疗方案，该方案不仅是复宏汉霖联合治疗战略的进一步落地，更是国内联合治疗领域的重要里程碑事件。
复宏汉霖总裁兼首席执行官刘世高博士表示：“ 复宏汉霖肿瘤联合治疗战略的迅速推进，有赖于公司产品管线中丰富的单抗产品。打一个形象的比喻，如果说产品的联合治疗就像法国大厨精心烹饪的大餐，那唯有丰富的食材来源才能组合成各种美味的菜品。”
截至2018年3月，复宏汉霖HLX10用于治疗实体瘤适应症已全部获得中国大陆、台湾和美国三地临床试验许可，临床I期试验现于台湾顺利开展。作为复宏汉霖首个创新型免疫抗体，HLX10未来可广泛应用于肿瘤的联合治疗。2015年12月及2016年5月，复宏汉霖HLX04适用于转移性结直肠癌与非小细胞肺癌的治疗已先后获得国内临床批准；2017年12月，HLX04新增湿性年龄相关性黄斑变性和糖尿病性视网膜病变适应症获国家食药监总局临床试验注册审评受理。2018年4月，HLX04已于中国境内（不包括港澳台地区）正式启动转移性结直肠癌适应症临床III期试验。
关于单抗联合治疗
目前治疗肿瘤最新的趋势，就是以免疫治疗为骨架，外加一两个抗体，做联合治疗。HLX10（PD-1单抗）与HLX20（PD-L1单抗）作为复宏汉霖单抗创新药产品管线中极具代表性的产品，可广泛用于肿瘤的免疫疗法，在复宏汉霖肿瘤联合治疗战略中占据重要地位。
而联合治疗面临的潜在问题主要还是高昂的治疗费用。欧美医药企业的抗体研发及生产成本非常高，造成患者单疗程治疗费用高达约十万美金，使得联合治疗可及性大大降低，即便是发达国家的患者也难以负担。
此时复宏汉霖的价格优势就凸显出来，在严格控制研发生产成本下复宏汉霖产品的联合治疗费用可与其他企业单个产品费用相近，可大幅度提高患者的可负担性来促进联合治疗的普及化。未来，在以HLX10、HLX20为代表的免疫治疗抗体的基础上，配合复宏汉霖产品管线中的多种单抗形成丰富的产品组合，将为更多病患提供可负担的、疗效更好的治疗方案。
关于复宏汉霖
上海复宏汉霖生物技术股份有限公司由复星医药与海外科学家团队于2009年12月合资组建，公司主要致力于应用前沿技术进行单克隆抗体生物类似药、生物改良药以及创新型单抗的研发及产业化。
截至目前，复宏汉霖已完成11个产品、16项适应症的IND申报，并在国内率先推出一种新的治疗方案（联合治疗）。公司共计获得13个临床批件，其中1个生物类似药产品临床III期试验已顺利完成，4个生物类似药产品进入临床III期试验, 4个创新药产品进入临床I期试验。复宏汉霖已成为估值破百亿的生物医药独角兽企业。
Henlius Submits First Combination Immunotherapy Treatment with Its Anti-VEGF and Anti-PD-1 Monoclonal Antibodies in China
Recently, Henlius has received acceptance notifications from China Drug Administration (CDA) for its investigational new drug (IND) applications of a combination therapy that contains 2 monoclonal antibodies, i.e. HLX10, a Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection, and HLX04, a Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection, for the treatment of advanced solid tumors.
As the first IND combining 2 domestic monoclonal antibodies to treat cancer accepted by CDA, it is not only a historical step of Henlius’ combo-therapy strategy implementation and also an important milestone for cancer combination treatment in China.
“The rapid development of Henlius’ combo-therapy strategy depends on the mature product pipeline with rich monoclonal antibodies of the company.” said Dr. Scott Liu, the President and Chief Executive Officer of Henlius, “Just like the French chefs dedicatedly cooking a meal, only rich sources of ingredients can make a variety of delicious dishes.”
As of March 2018, HLX10 was approved to conduct clinical trials for solid tumors in Mainland China, Taiwan and the United States , and its phase I study was conducted successfully in Taiwan. Henlius separately submitted IND applications for HLX04 to the China Food and Drug Administrations (CFDA) to treat the patients with metastatic Colorectal Cancer (mCRC) and Non-Small Cell Lung Cancer (NSCLC), and gained the approvals in December 2015 and May 2016. In December 2017, HLX04 has been filed to the CFDA for 2 new indications to treat wet Age-related Macular Degeneration (wAMD) and Diabetic Retinopathy (DR). As of April 2018, a phase III clinical trial of HLX04 for mCRC had been initiated in Mainland China already.
·About Combination Therapy
HLX10 and HLX20 (anti-PD-L1 antibody) are both strategic programs of Henlius novel mAb portfolio, with the potential use as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Continued efforts to enhance outcomes such as achieving better clinical efficacy and safety with immunotherapy agents have led to the development of combination (1 to 2 mAbs) immunotherapies with synergistic antitumor activity using immune checkpoint blockage such as anti-PD-1/L1 when response rates with single-agent immunotherapy are deemed suboptimal.
The cost of manufacturing biological product remains high and costly in many Europe and the United States pharmaceutical companies, resulting in approximately over $100,000 USD per year for a single course of immunotherapy, and over $200,000 USD a year for combination immunotherapy. Immuno-oncology treatment is expensive and the cost is a huge financial burden to the patients even in the developed countries.
With the innovative “combination immunotherapy”, Henlius manages to reduce the manufacturing costs to make all of its products more cost-effective. Henlius believes that its combination therapy which contains 2-3 mAbs will be no more expensive than a single imported mAb. Following the Henlius vision for the “affordable innovation”, company hopes to increase the accessibility of combination immunotherapy treatments globally.
·About Henlius
Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in December 2009, specializes in the discovery, development, manufacturing and commercialization of high-quality biological therapeutics to treat a range of chronic and often life-threatening diseases.
As of now, Henlius has completed IND filings of 11 products with 16 indications, submitted a combination immunotherapy, and obtained 13 clinical approvals in China. One of the products has accomplished its phase III clinical trial, meanwhile, 4 biosimilar products and 4 novel mAbs have entered phase III and Phase I studies respectively.
