达成TROP2抗体中国独家许可协议，复宏汉霖提前布局抗肿瘤新兴靶点
2021年1月14日，复宏汉霖（2696.HK）宣布与Chiome Biosescience, Inc.（简称“Chiome”）就抗TROP2抗体签订了一项独家许可协议，复宏汉霖获得该项目在中国（包括香港特别行政区、澳门特别行政区和台湾地区）进行研究、开发、生产和商业化的独家权利和项目背景知识产权。TROP2（Trophoblast cell-surface antigen 2，滋养层细胞表面抗原2）在三阴性乳腺癌、非小细胞肺癌、尿路上皮癌和多种类型的实体瘤中都呈现过表达，有望成为具有广谱抗肿瘤作用的治疗靶点，且在抗体偶联药物（ADC）、双特异性抗体、组合疗法等方向皆具开发潜力。
TROP2是一类最早发现于侵袭性滋养层细胞表面的生物标志物，研究显示其能够在细胞增殖和迁移、自我更新和维持基底膜的完整性中发挥调节功能[1] 。大量研究结果表明，相对于正常细胞中的表达水平，TROP2在很多不同类型的人类肿瘤中都呈现高表达，且其在肿瘤发生、发展和侵袭中具有重要作用。临床前研究表明，靶向抑制TROP2的抗体能够在动物癌症模型中有效抑制多种肿瘤细胞生长，且与多种抗肿瘤疗法展现出了协同效果[2] 。近期的多项临床试验也证实靶向TROP2的抗体偶联药物（ADC）对包括三阴性乳腺癌在内的多种实体瘤可能有积极临床疗效[3] 。
根据协议，复宏汉霖将获得抗TROP2抗体的独家许可权，可在许可区域内对该项目进行人用药及诊断应用（不包括放射免疫治疗和光免疫治疗领域）的研究、开发、生产、商业化等，并有权将该项目转让给第三方。同时，Chiome还授予复宏汉霖在全球其他地区独家开发、生产和商业化该项目的优先选择权。
相信通过TROP2靶点产品的引进，复宏汉霖已有的丰富产品管线将得到进一步扩展。凭借丰富的靶点开发经验和成熟的一体化研发平台，公司也将围绕TROP2靶点进行全面研发，充分发挥其在多项实体瘤治疗中的潜力，积极开发更多、疗效更好的治疗方案。
关于Chiome
Chiome是一家处于临床阶段的生物技术公司，致力于发现与开发医疗需求尚未满足的疾病领域的抗体治疗方案，尤其是肿瘤领域的关键疗法。目前，Chiome拥有名为ADLib®的抗体研发技术平台，且多个项目正处于早期研发、临床前开发及临床开发阶段，其管线中的产品CBA-1205正在日本开展首项1期临床研究。Chiome于2005年在日本东京成立，现已于东京证券交易所创业板上市。
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质高价优的创新生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。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。公司在全球已建立完善的研发中心，按照国际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HLX10的肿瘤免疫联合疗法。截至目前，公司已成功上市3个单抗生物药，包括国内首个生物类似药汉利康®（利妥昔单抗）、首个中欧双批的国产生物类似药汉曲优®（曲妥珠单抗，欧盟商品名：Zercepac®）以及公司首个自身免疫疾病治疗产品汉达远®（阿达木单抗）。此外，HLX04贝伐珠单抗及HLX01利妥昔单抗类风湿关节炎新适应症的上市注册申请正在审评中，公司亦同步就10个产品、8个联合治疗方案于全球范围内开展20多项临床试验，产品对外授权全面覆盖欧美主流生物药市场和众多新兴国家市场。
Henlius Has Reached an Exclusive License Agreement with Chiome for Antibodies Targeting Human TROP2
Shanghai, China, Jan, 14th, 2021 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Company has entered into an exclusive license agreement with Chiome Biosescience, Inc. (“Chiome”), pursuant to which, Chiome agreed to grant Henlius an exclusive right and license to antibodies targeting human TROP2 (the “Licensed Products”) and related intellectual property rights to research, develop, manufacture and commercialize the Licensed Products in China (including Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region). TROP2 (Trophoblast cell-surface antigen 2) is overexpressed in triple-negative breast cancer, non-small cell lung cancer, urothelial cancer and several other types of solid tumours, potentially to become a druggable target with a broad coverage of different types of tumours in various drug modalities including antibody-drug conjugates (ADC), bispecific antibodies and combination therapies.
TROP2 was first discovered as a cell surface marker for invasive trophoblast cells. It has a role in regulating cell proliferation and migration, self-renewal, and maintenance of basement membrane integrity[1] . Studies showed that TROP2 is highly expressed on a wide variety of human tumours compared to normal tissues，and plays an critical role in tumourigenesis, tumour progression and invasion. Preclinical in vitro and in vivo studies showed that antibodies targeting TROP2 can significantly inhibit the growth of multiple types of tumour cells in animal models and exhibit synergistic effects in combination with other cancer therapies[2]. More importantly, multiple recent clinical trials of TROP2-targeted antibody-drug conjugates (ADC) have demonstrated potential clinical efficacy in the treatment of triple-negative breast cancer and other solid tumours[3] .
According to the agreement, Henlius will obtain the exclusive right to research, develop, manufacture and commercialize the Licensed Products in all human therapeutics and diagnostics applications (except radioimmunotherapy and photoimmunotherapy) in the licensed territory, and right to sublicense to third parties. Henlius also has an exclusive licensee option to the global right excluding China.
With this license agreement of the anti-TROP2 antibodies, Henlius’ product pipeline will be further expanded. The company will leverage its R&D experience and integrated biopharmaceutical platform to accelerate the development of TROP2-targeted antibody drugs with the aim to realize the full potential of the Licensed Products in cancer treatments and to provide more effective therapies for cancer patients worldwide.
About Chiome
Chiome Biosescience is a clinical stage biotechnology company. Chiome’s focus is on discovery and development of antibody-based therapeutics in the disease areas with unmet medical needs, especially in oncology field. Chiome has proprietary antibody generating technology named ADLib® System and has several antibody discovery, preclinical and clinical programs. The first-in-human Phase 1 study for its pipeline CBA-1205 is ongoing in Japan. Chiome was founded in 2005, is listed in Tokyo stock exchange Mothers (code: 4583), and located in Tokyo, Japan.
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. 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 centers and a Shanghai-based manufacturing facility certificated by China and the European Union (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 HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched three mAbs developed independently: 汉利康® (HLX01, rituximab), the first China-developed biosesimilar, 汉曲优® (HLX02, trastuzumab, Zercepac® in the EU), the first China-developed mAb biosesimilar approved both in China and in the EU and 汉达远® (HLX03, adalimumab), the Company's first product indicated for autoimmune diseases. In addition, the New Drug Applications of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review, and Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.
参考文献
[1] Mcdougall A R A, Tolcos M, Hooper S B, et al. Trop2: From development to disease. Developmental Dynamics, 2015, 244(2):99-109.
[2] Zaman S, Jadid H, Denson A C, et al. Targeting TROP2 in solid tumors: future prospects. OncoTargets and therapy, 2019, 12: 1781-1790.
[3] Goldenberg D M, Stein R, and Sharkey R M. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget, 2018 9(48):28989-29006.