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- Investigational New Drug Application of Henlius SARS-CoV-2 Neutralizing Antibody HLX70 Approved by US FDA
Investigational New Drug Application of Henlius SARS-CoV-2 Neutralizing Antibody HLX70 Approved by US FDA
Shanghai, China, Oct, 4th, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application of the SARS-CoV-2 neutralizing antibody HLX70 for the treatment of COVID-19 and acute respiratory distress syndrome (ARDS) or multiple organ failure caused by COVID-19 has been approved by the U.S. Food and Drug Administration (FDA). With this IND application, Henlius becomes the first Chinese biopharmaceutical company that has independently filed an IND application for a SARS-CoV-2 neutralizing antibody to the U.S. FDA and has received the approval.
HLX70 is a genetically engineered fully humanized monoclonal antibody that targets the receptor-binding domain (RBD) of the S1 subunit of SARS-CoV-2 spike protein (S protein) and is a typical IgG1 Kappa immunoglobulin. Binding of virus RBD domain with human angiotensin II converting enzyme 2 (hACE2) will lead to cell endocytosis of the virus, which is a critical step for viral entry [1,2]. HLX70 can competitively bind with the viral RBD domain with higher affinity and thus block the binding between viral RBD and hACE2 protein, therefore protecting the cells from virus infection.
With the spread of the pandemic of COVID-19, Henlius has reached a collaboration with Sanyou Biopharmaceuticals and Shanghai ZJ Bio-Tech to co-develop fully humanized antibody candidates for the treatment of COVID-19 in May 2020. Based on the company's entensive experience in R&D of innovative antibodies and its integrated platform of R&D, manufacturing and commercialisation, Henlius has taken a leading role in the development and manufacturing of the candidate antibody. Nonclinical pharmacology, pharmacokinetics and toxicology studies were performed by Henlius to evaluate the efficacy and safety of HLX70 according to The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. The in vitro studies showed that HLX70 has a strong specific binding affinity to RBD of the S1 subunit of SARS-CoV-2 and can significantly block the binding of SARS-CoV-2 S1 with the hACE2 at both protein and cell levels. HLX70 also exhibited high neutralizing activity against different strains of SARS-CoV-2 virus on Vero cells. The in vivo study in hACE2 transgenic mice model demonstrated that HLX70 is a potent neutralizing antibody, which is effective in protection of hACE2 transgenic mice against SARS-CoV-2. Repeated dose toxicity study in vivo demonstrated that HLX70 is well tolerated following intravenous injection.
In addition to HLX70, Henlius is also accelerating the preclinical study of another independently developed ACE2-Fc receptor fusion protein HLX71 for the treatment of COVID-19. As of now, two relevant projects of HLX70 and HLX71 have already received support from the National Major Research and Development Plan of "Public Safety Risk Prevention and Control and Emergency Technical Equipment". Meanwhile, Henlius has also submitted relevant patent applications for HLX71 and HLX70/HLX71 combination therapy in China. As the first Chinese biopharmaceutical company that independently filed an IND application for a SARS-CoV-2 neutralizing antibody to the U.S. FDA and has received the approval, Henlius highlights the company’s speed and determination in the research and development of antibody and fusion protein against COVID-19, and actively takes on corporate social responsibilities. In the future, Henlius will collaborate with partners to further speed up the development of SARS-CoV-2 neutralizing antibody to make sure that the antibody has strong neutralization effect, is fully evaluated in vivo and in vitro and can be manufactured in large scale. Henlius will also continue to explore the possibility of global clinical research in more countries around the world to contribute more in the fight against COVID-19.
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. Products have been licensed out to nearly 100 countries and regions.
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.