复宏汉霖与Getz Pharma就阿达木单抗汉达远达成商业化授权合作，覆盖亚非欧11个新兴市场国家 | 新闻稿
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资讯来源：研发客 + 订阅账号
发布时间：
2022-02-25
2022年2月23日，复宏汉霖（2696.HK）宣布与Getz Pharma (Private) Limited及其联属公司Getz Pharma International FZ-LLC（统称为“Getz Pharma”）订立许可及供应协议，授予其在巴基斯坦、菲律宾、越南、缅甸、柬埔寨、尼日利亚、肯尼亚、斯里兰卡、乌克兰、哈萨克斯坦和乌兹别克斯坦11个国家以及互相商定的任何其他地区针对阿达木单抗
汉达远
®
的商业化等权益。
汉达远®是复宏汉霖自主开发的阿达木单抗生物类似药，也是公司首款治疗自身免疫疾病的产品，已于国内获批用于类风湿关节炎、强直性脊柱炎、银屑病、葡萄膜炎等自身免疫疾病的治疗，国内的商业化销售由江苏万邦负责。阿达木单抗在全球范围内已获批十余项适应症，其显著疗效已得到普遍认可，获得北美、欧洲多个临床实践指南一致推荐，也是全球最为畅销的药物之一。
当前新兴市场国家生物制剂的普及率较低，如类风湿关节炎药物仍以传统改善病情抗风湿药（DMARDs）作为主要治疗手段，治疗需求远未被满足。此次签约区域总人口约8.4亿，存在较大的阿达木单抗用药需求。借助Getz Pharma在南亚、东南亚、非洲、独联体国家的强大业务网络，汉达远®的商业化布局将扩展更多新兴市场国家，为这些国家和地区的病患带来更多可负担的优质治疗选择，进一步加快公司商业化全球布局。
包括此项合作在内，复宏汉霖已就4款上市产品汉利康®（利妥昔单抗）、汉曲优®（曲妥珠单抗，欧盟商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）及2款在研产品HLX04-O（重组抗VEGF人源化单克隆抗体注射液）、H药斯鲁利单抗（创新型抗PD-1单抗）同多家知名药企达成合作，覆盖全球主流生物药市场及众多新兴市场国家。未来，复宏汉霖也将继续秉持“可负担的创新”这一初心，携手更多国际合作伙伴，最大化生物类似药价值的同时，加速多元化创新，开发更多基于临床和市场需要的创新型产品，为全球病患带来更多可负担的优质生物药。
关于Getz Pharma
Getz Pharma (Private) Limited于1995年成立于巴基斯坦伊斯兰共和国，主要从事各种药品的配方开发、生产和销售。截止目前，Getz Pharma (Private) Limited在南亚、中亚、东南亚、中东和非洲地区超过25个国家开展业务，在全球拥有6000多名员工。
Getz Pharma International FZ-LLC于2006年成立于阿拉伯联合酋长国，主要从事医药产品销售、营销、和出口业务，目前业务范围广泛分布在中东、非洲、东南亚及独联体国家。
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4款产品，在欧盟上市1款产品，3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研发中心，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，位于上海徐汇的生产基地已获得中国和欧盟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单抗斯鲁利单抗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，欧盟商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序，HLX01利妥昔单抗类风湿关节炎新适应症、斯鲁利单抗鳞状非小细胞肺癌适应症的上市注册申请也正在审评中。公司亦同步就11个产品、9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 Entered into a Collaboration with Getz Pharma to Commercialise Adalimumab Biosimilar 汉达远, Covering 11 Emerging Markets in Asia, Africa and Europe
Shanghai, China, 23rd February, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company has entered into a licensing and supply agreement with Getz Pharma (Private) Limited and its affiliated company, Getz Pharma International FZ -LLC (together, “Getz Pharma”), pursuant to which, the company agreed to grant a license to Getz Pharma to commercialise adalimumab biosimilar 汉达远® in Islamic Republic of Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan and Uzbekistan, and any other territories to be mutually agreed.
汉达远® is the company's first self-developed monoclonal antibody in autoimmune treatment. 汉达远® was approved by the NMPA for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis (Ps) and uveitis (UV). Jiangsu Wanbang is responsible for the commercial sales of 汉达远® in China. Adalimumab has been approved for over 10 indications worldwide. Due to its significant efficacy, it has been recommended by guidelines for different autoimmune diseases in North America and Europe, and it is also one of the world's best-selling drugs.
The penetration rate of biologics in emerging markets is relatively low. For example, DMARDs are still the main treatment for RA, and the treatment needs are far from being met. The total population of the signed region is about 840 million, and there is a large unmet demand for adalimumab. Leveraging Getz Pharma's strong business network in South Asia, Southeast Asia, Africa and the CIS, the commercial layout of 汉达远® will be expanded to emerging markets, and Henlius will bring more high-quality treatment options to patients in these countries and regions, accelerating Henlius’ global commercialisation and enhance brand awareness in emerging markets.
Up to now, 4 marketed products, 汉利康® (rituximab), 汉曲优® (trastuzumab, Zercepac® in EU), 汉达远® (adalimumab), 汉贝泰® (bevacizumab), and 2 under development products, HLX04-O (recombinant anti-VEGF humanized monoclonal antibody) and Serplulimab (innovative anti-PD-1 monoclonal antibody) have reached cooperation with a number of leading pharmaceutical companies, covering the global major market as well as emerging market. In the future, with the long-term commitment to “affordable innovation”, Henlius will actively collaborate with more global industry leaders, maximizing the value of biosimilars and accelerating diversified innovation to develop more products based on clinical and market needs to deliver more affordable products to patients worldwide.
Getz Pharma (Private) Limited was established in the Islamic Republic of Pakistan in 1995, which mainly specializes in the formulation development, manufacturing and marketing of a wide range of pharmaceutical products. It currently operates in more than 25 countries in South Asia, Central Asia, South East Asia, the Middle East and Africa and has more than 6,000 employees worldwide.
Getz Pharma International FZ-LLC was established in the United Arab Emirates in 2006, which mainly specializes in sales, marketing, export and distribution of a wide range of pharmaceutical products in the Middle East, Africa, Southeast Asia and CIS countries.
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, 4 products have been launched in China, 1 in the European Union (EU), 3 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 commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (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 serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU, 汉达远® (adalimumab) and 汉贝泰® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What's more, Henlius has conducted over 20 clinical studies for 11 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.
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