達成TROP2抗體中國獨家許可協議，復宏漢霖提前布局抗腫瘤新興靶點
2021年1月14日，復宏漢霖（2696.HK）宣布與Chiome Bioscience, Inc.（簡稱“Chiome”）就抗TROP2抗體簽訂了一項獨家許可協議，復宏漢霖獲得該項目在中國（包括香港特別行政區、澳門特別行政區和臺灣地區）進行研究、開發、生產和商業化的獨家權利和項目背景知識產權。TROP2（Trophoblast cell-surface antigen 2，滋養層細胞表面抗原2）在三陰性乳腺癌、非小細胞肺癌、尿路上皮癌和多種類型的實體瘤中都呈現過表達，有望成為具有廣譜抗腫瘤作用的治療靶點，且在抗體偶聯藥物（ADC）、雙特異性抗體、組合療法等方向皆具開發潛力。
TROP2是一類最早發現于侵襲性滋養層細胞表面的生物標志物，研究顯示其能夠在細胞增殖和遷移、自我更新和維持基底膜的完整性中發揮調節功能[1] 。大量研究結果表明，相對于正常細胞中的表達水平，TROP2在很多不同類型的人類腫瘤中都呈現高表達，且其在腫瘤發生、發展和侵襲中具有重要作用。臨床前研究表明，靶向抑制TROP2的抗體能夠在動物癌癥模型中有效抑制多種腫瘤細胞生長，且與多種抗腫瘤療法展現出了協同效果[2] 。近期的多項臨床試驗也證實靶向TROP2的抗體偶聯藥物（ADC）對包括三陰性乳腺癌在內的多種實體瘤可能有積極臨床療效[3] 。
根據協議，復宏漢霖將獲得抗TROP2抗體的獨家許可權，可在許可區域內對該項目進行人用藥及診斷應用（不包括放射免疫治療和光免疫治療領域）的研究、開發、生產、商業化等，并有權將該項目轉讓給第三方。同時，Chiome還授予復宏漢霖在全球其他地區獨家開發、生產和商業化該項目的優先選擇權。?
相信通過TROP2靶點產品的引進，復宏漢霖已有的豐富產品管線將得到進一步擴展。憑借豐富的靶點開發經驗和成熟的一體化研發平臺，公司也將圍繞TROP2靶點進行全面研發，充分發揮其在多項實體瘤治療中的潛力，積極開發更多、療效更好的治療方案。?
關于Chiome
Chiome是一家處于臨床階段的生物技術公司，致力于發現與開發醫療需求尚未滿足的疾病領域的抗體治療方案，尤其是腫瘤領域的關鍵療法。目前，Chiome擁有名為ADLib®的抗體研發技術平臺，且多個項目正處于早期研發、臨床前開發及臨床開發階段，其管線中的產品CBA-1205正在日本開展首項1期臨床研究。Chiome于2005年在日本東京成立，現已于東京證券交易所創業板上市。
關于復宏漢霖
復宏漢霖（2696.HK）是一家國際化的創新生物制藥公司，致力于為全球患者提供質高價優的創新生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域。自2010年成立以來，復宏漢霖已建成一體化生物制藥平臺，高效及創新的自主核心能力貫穿研發、生產及商業運營全產業鏈。公司在全球已建立完善的研發中心，按照國際GMP標準進行生產和質量管控，位于上海徐匯的生產基地已獲得中國和歐盟GMP認證。
復宏漢霖前瞻性布局了一個多元化、高質量的產品管線，涵蓋20多種創新單克隆抗體，并全面推進基于自有抗PD-1單抗HLX10的腫瘤免疫聯合療法。截至目前，公司已成功上市3個單抗生物藥，包括國內首個生物類似藥漢利康®（利妥昔單抗）、首個中歐雙批的國產生物類似藥漢曲優®（曲妥珠單抗，歐盟商品名：Zercepac®）以及公司首個自身免疫疾病治療產品漢達遠®（阿達木單抗）。此外，HLX04貝伐珠單抗及HLX01利妥昔單抗類風濕關節炎新適應癥的上市注冊申請正在審評中，公司亦同步就10個產品、8個聯合治療方案于全球范圍內開展20多項臨床試驗，產品對外授權全面覆蓋歐美主流生物藥市場和眾多新興國家市場。
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[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 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.
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: 漢利康® (HLX01, rituximab), the first China-developed biosimilar, 漢曲優® (HLX02, trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 漢達遠® (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.
參考文獻
[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.