近日，复宏汉霖正式收到国家药品监督管理局关于其自主开发的创新型单抗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的临床批准。
复宏汉霖总裁兼首席执行官刘世高博士表示：
复宏汉霖在开发优质靶向生物药，打造丰富的单抗产品管线的同时，将充分利用公司产品管线中的产品，积极探索单抗产品的联合治疗方案，从而引领并推动国内单抗联合治疗的发展。
关于HLX10
自2017年6月起，复宏汉霖就HLX10分别向中国大陆、台湾和美国三地药监单位递交了临床试验申请。截至2018年3月，HLX10已全部获得来自三地的临床试验许可，未来可广泛应用于癌症的免疫疗法。目前，HLX10临床1期试验已在台湾开展。
关于单抗联合治疗
肿瘤免疫联合疗法是治疗肿瘤的最新趋势，即以免疫治疗为骨架，外加一至两个抗体，开展联合疗法。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免疫治疗抗体产品，可广泛用于肿瘤的治疗，在复宏汉霖肿瘤联合治疗战略中占据重要地位。
肿瘤免疫联合疗法面临的潜在问题仍是高昂的治疗费用。欧美药企的抗体研发、生产成本较高，使得患者单药疗程治疗费用超过每年十万美金，联合治疗费用更是超过每年二十万美金，造成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更为凸显。复宏汉霖通过对研发、生产成本的严格把控，将肿瘤免疫联合疗法费用控制在与其他企业单个产品费用相近，大幅度提高了患者的可负担性，从而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肿瘤免疫联合疗法组合，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生物类似药、生物改良药以及创新型单抗的研发及产业化，在中国上海、台北和美国加州均设有研发中心，产品覆盖肿瘤、自身免疫性疾病等领域。
截至目前，复宏汉霖12个产品、1个联合治疗方案已完成20项适应症的临床试验申请，累计获得全球范围内25个临床试验许可（中国15个，美国3个，中国台湾3个，欧盟、澳大利亚、乌克兰和菲律宾各1个）。
Important News! Henlius Combination Therapy Received Approval to Conduct Clinical Trials in China
Recently, Henlius has received an approval from National Medical Products Administration (NMPA) for its combination therapy with HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) and HLX04 (recombinant anti-VEGF humanized monoclonal antibody injection) to treat advanced solid tumors.
“Henlius is committed to developing high-quality biologics to build a robust monoclonal antibody portfolio and proactively leveraging this portfolio to explore the combination therapy of monoclonal antibody (mAb) products in order to lead and promote the development of combination therapy in China.” said Dr. Scott Liu, the President and Chief Executive Officer of Henlius.
About HLX10
Since June 2017, Henlius submitted clinical trial applications for HLX10 to the Food and Drug Administrations in mainland China, Taiwan and the United States respectively. As of March 2018, HLX10 was approved to conduct clinical trials for solid tumors in all the three locations with its phase I study being conducted successfully in Taiwan.
About Combination Therapy
Combination of immune checkpoint blockage such as anti-PD-1/L1 with 1 or 2 monoclonal antibodies to achieve synergistic antitumor activity is one of the latest trends in tumor treatment.HLX10 (anti-PD-1 antibody) and HLX20 (anti-PD-L1 antibody) are both strategic products 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.
The high treatment expense is the potential issue for combination therapy. The cost of manufacturing biological products remains high in many pharmaceutical companies in Europe and the United States, resulting in approximately over $100,000 USD per year for a single course of immunotherapy, and over $200,000 USD per year for combination immunotherapy. The high expenses is a huge financial burden to the patients even in the developed countries. In contrast, Henlius’ advantage in terms of pricing becomes significant. 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, leading to the greater patients’ affordability and accessibility.
Moving forward, with the existing signature products HLX10 and HLX20, Henlius will be dedicating to fully utilize its robust product portfolio to come up with more affordable and efficacious combination therapies for more patients.
About Henlius
Shanghai Henlius Biotech, Inc., a joint venture company co-founded by Fosun Pharma and a team of overseas scientists in December 2009, with its R&D footprint in Shanghai, Taipei and California, USA, specializes in the discovery, development, manufacturing and commercialization of high-quality biologics including biosimilar, bio-better and novel monoclonal antibody, to treat tumor and autoimmune disease.
As of now, Henlius has completed IND/CTA filings of 12 products and 1 combination therapy with 20 indications and obtained 25 successful IND/CTA filings (15 approvals from China; 3 from the United States; 3 from Taiwan; 1 from the European Union; 1 from Ukraine; 1 from Philippines and 1 from Australia).
媒体联系人
周文婷：021-33395800*6093
陈迪：021-33395800*6053
邮箱：PR@Henlius.com