Henlius Reaches 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: 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.

[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.