2021年1月14日，复宏汉霖（2696.hk）宣布与chiome bioscience, 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 。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 。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 。
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 bioscience, 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 . 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. 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 .
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.
chiome bioscience 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.
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 biosimilar, 汉曲优® (hlx02, trastuzumab, zercepac® in the eu), the first china-developed mab biosimilar 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.
 mcdougall a r a, tolcos m, hooper s b, et al. trop2: from development to disease. developmental dynamics, 2015, 244(2):99-109.
 zaman s, jadid h, denson a c, et al. targeting trop2 in solid tumors: future prospects. oncotargets and therapy, 2019, 12: 1781-1790.
 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.