Shanghai, China, Nov, 6th, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application of HLX71, an ACE2-Fc fusion protein independently discovered and developed by the Company, for the treatment of COVID-19 has been approved by the U.S. Food and Drug Administration (FDA) recently. This is the second drug candidates developed by Henlius for the treatment of COVID-19 and approved for clinical trial in the US.

HLX71 is a recombinant human angiotensin converting enzyme 2 (hACE2) fusion protein with IgG1 Fc at the C-terminal, which is independently discovered and developed by Henlius. Binding of the RBD domain on the S1 subunit of the viral spike protein with hACE2 will lead to cell endocytosis of the virus, which is a critical step for viral entry^[1,2]. The ACE2 part of HLX71 can act as a bait to bind with the viral RBD domain with a high affinity, preventing the binding of virus and host cell ACE2. Via this mechanism, the ACE2-Fc fusion protein can inhibit SARS-CoV-2 virus infection and can be potentially used in the treatment of COVID-19.

Non-clinical pharmacology, pharmacokinetics and toxicology studies were performed by Henlius to evaluate the efficacy and safety of HLX71 according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Results from these studies showed that HLX71 can significantly inhibit SARS-CoV-2 virus infection with a good safety profile via intravenous injection. HLX70, an anti-SARS-CoV-2 neutralizing antibody also developed by Henlius can inhibit SARS-CoV-2 virus infection via binding with the viral RBD domain as well. Henlius is simultaneously exploring the combination therapy of HLX71 with HLX70 and preliminary preclinical results have demonstrated synergistic effect of HLX71 and HLX70 in blocking the binding between viral RBD domain and hACE2. Henlius is now having further evaluation of HLX70, HLX71 and their combination therapy while also preparing for possible clinical studies.

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 and autoimmune 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 three R&D facilities in Shanghai, Taipei and California 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 (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched two products, 汉利康^® (HLX01, rituximab injection) , the first biosimilar approved in China and 汉曲优^® (HLX02, trastuzumab injection, Zercepac^® in the EU), the first Chinese mAb biosimilar launched in both China and Europe. 汉曲优^® will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. Two products (HLX03, adalimumab injection and HLX04, bevacizumab injection) were accepted for New Drug Application (NDA) review by the NMPA with HLX03 to be potentially launched within 2020. What’s more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding presence in mainstream market as well as emerging market.

参考文献

[1] Gallagher T M, Buchmeier M J. Coronavirus spike proteins in viral entry and pathogenesis[J]. Virology, 2001, 279(2): 371-374.

[2] Yan R, Zhang Y, Li Y, et al. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2[J]. Science, 2020, 367(6485): 1444-1448.