Good News | Sanyou Biopharmaceuticals In Tripartite Cooperation Agreement with ZJ Bio-Tech and Henlius In Research and Development of Fully Human Antibody Drugs Against COVID-19.
On May 6, 2020, Sanyou Biopharmaceuticals reached a project cooperation agreement with ZJ Bio-Tech and Henlius, in cooperative R&D of fully human antibody drugs against COVID-19.
The candidate antibody drug developed during this cooperation can neutralize the virus by specifically blocking the combination of S protein on the SARS-CoV-2 surface and ACE2 receptor on the human cell surface. It has the advantages of higher safety probability and lower immunogenicity probability as a fully human antibody, compared with chimeric antibody and humanized antibody.
With a quick response at the early stage of the pandemic, Sanyou Biopharmaceuticals and ZJ Bio-Tech screened out the candidate antibody drugs with good blocking activity within only 16 days by use of Sanyou Biopharmaceuticals's "sub-trillion fully human phage display antibody library". At present, the validation of neutralizing activity of live virus has been completed at the cell level and transgenic animal level for the candidate antibody drugs related to this project, and the candidate antibody has shown excellent antiviral activity, without any toxic and side effects, proving that it has the potential to be developed into a specific drug against COVID-19.
The preclinical study of this project is ongoing at full speed. Henlius will play the leading role in subsequent development and production. With the success of the preclinical study, this project will seek possibility of international research in addition to clinical study application in China.
Since this pandemic, Sanyou Biopharmaceuticals has actively assumed its corporate social responsibility seeking avenues to prevent and control the epidemic. On January 21, 2020, a research team was formed. Many employees voluntarily gave up their Luner New Year Festival holiday in order to return to their three shifts of active R&D of antibody drugs and diagnostic reagents against COVID-19. In addition to the R&D of antibody drugs, Sanyou Biopharmaceuticals has also provided a series of SARS-CoV-2 antibodies and protein reagents for more than 200 units in more than 10 countries and regions in an effort to prevent and control the global pandemic.
Henlius (2696.HK) is an international innovative biopharmaceutical company, aiming to provide innovative biologic drugs with high quality and preferential prices for patients around the world,in treatment of tumors, autoimmune diseases, etc. Since its establishment in 2010, the companyadopted globalization and integrated innovation as its product development concept and hasestablished R&D centers in Shanghai, Taipei of China, and California of USA, which providedoutstanding synergy advantages for the company. Its main product development strategy is to gradually develop the innovative monoclonal antibody products with biologically similar drugs, in combination with self-developed anti-PD-1 and PD-L1 monoclonal antibodies, in order to first launch the combined immunotherapy in China and arrange a diversified, innovative monoclonal antibody with tumor immunotherapy pipeline in a forward-looking way, creating a comprehensive biopharmaceutical industry chain platform for R&D and commercial production.
Up to now, one of Henliu’s products has been successfully marketed, and two have been accepted by the application for new drug marketing in China, another one product has been accepted by the application for new drug marketing in EU, with more than 20 clinical trials carried out for 15 products and 8 combined regimens worldwide. Its first blockbuster product, Hanlikang®(rituximab injection), was approved by the National Medical Products Administration (NMPA) for new drug marketing registration in February 2019, becoming the first biologically similar drug approved for marketing in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab injection) have been accepted by the NMPA for new drug marketing registration, and are now included in the priority review procedure. The phase 3 international multi-center clinical trials of HLX02 have been successively initiated in China mainland, Ukraine, EU, Poland, and the Philippines. HLX02 has become the first biologically similar drug in China to carry out the phase 3 international multi-center clinical study, which was accepted by the European Medicines Evaluation Agency (EMEA) in June 2019. In addition, it has successively carried out a number of combined tumor immunotherapies for the combination of HLX10 with its own products HLX04 (biologically similar drug: bevacizumab), HLX07 (anti-EGFR monoclonal antibody) and chemotherapy, with a number of clinical studies around the world.
About ZJ Bio-Tech
Founded in 2005, Shanghai ZJ Bio-Tech Co., Ltd. (834839.OC) is a high-tech enterprise specializing in the R & D, production and sales of gene diagnostic products, serving as one of the leading enterprises in the production of molecular diagnostic reagents in China. It has been consecutively voted as "Patent Pilot Enterprise" and "Little Giant Enterprise of Technology" in Shanghai. In 2015, it was successfully listed in the National Equities Exchange and Quotations (the New Third Board). With R&D centers and production plants in Pujiang Hi-Tech Park andZhangjiang Hi-Tech Park Medical Device Park in Shanghai Caohejing Development Zone, and its American R&D center in San Diego as one of the three major life science bases in the United States, the company focuses on the R&D of new technologies and products and the expansion of the global market, especially the American market. Its real-time fluorescent PCR detection reagents are indicated for all legal infectious diseases in China, including more than 30 products which have obtained the national Class III medical device registration certificate and have been exported to more than 70 countries and regions including those from Europe and the United States. Its detection kits have played an active role in disease monitoring and prevention in major public events e.g. SARS, H1N1, Ebola, MERS, Zika, and cervical cancer screening. As the first product approved by the NMPA, these kits have been exported to more than 30 countries and played an important role in pandemic prevention and control at home and abroad during this COVID-19 pandemic.