Zhongyuan Xiehe new anticoagulant drug "new vermiculin (EH)" has been approved

  Recently, exciting news came from the State Food and Drug Administration (CFDA): Beijing sanyiheze Biotechnology Co., Ltd., a subsidiary of Zhongyuan Xiehe, and the Institute of radiation and radiation medicine, Academy of Military Medical Sciences of the people's Liberation Army jointly developed and applied the new anticoagulant drug "new vermiculin" (EH), which has passed the CFDA review and officially obtained the approval document for clinical trials of drugs Enter phase I clinical This not only marks a milestone step towards the final approval and listing of the new drug, but also becomes an important driving force for Zhongyuan Xiehe to accelerate the layout of the pharmaceutical industry Wu Zuze, chief scientist and academician of Chinese Academy of Sciences, promoted the research and development of new anticoagulant drugs with low bleeding and anticoagulant "new vermiculin (EH)", which is a major achievement of Beijing sanyiheze Biotechnology Co., Ltd and Institute of Radiology and radiation medicine of Military Academy of Medical Sciences of the people's Liberation Army after years of in-depth cooperation With the unremitting persistence and efforts of the research team led by the project leader, senior general consultant and chief scientist, academician of Chinese Academy of Sciences, and Academician Wu Zuze, the father of stem cell transplantation in China, the drug registration application was accepted by the State Food and Drug Administration in August 2013 (acceptance No.: cxsl1300060 Army), and passed the site investigation in September 2013 The research of new vermiculin (EH) has obtained the rolling funding of the national "11th Five Year Plan" and "12th Five Year Plan" major projects of "new drug creation" Zhongyuan Xiehe has also invested about 11.81 million yuan in R & D expenses New vermiculin (EH) has the characteristics of low bleeding, and overcomes the risk of systemic bleeding caused by heparin, low molecular weight heparin, hirudin and other anticoagulants It has a unique role in improving the therapeutic effect of cardiovascular and cerebrovascular embolism The product has independent intellectual property rights, and has obtained the invention patent certificates of China, the European Union, the United States and Japan in advance New vermiculin (EH) will become a new tool in the treatment of cardiovascular and cerebrovascular embolism, which has become an important disease endangering human health and life Anticoagulation or antithrombotic therapy is the main means to treat this kind of disease At present, the commonly used anticoagulants include vitamin K antagonists such as warfarin for chronic treatment, heparin and low molecular weight heparin mainly for acute treatment However, the anticoagulant effect of these two kinds of drugs is indirect Their pharmacodynamics and pharmacokinetics are not stable It is difficult to predict the response of patients Long term clinical monitoring and dose adjustment are needed In addition, heparin or low molecular weight heparin often induce antithrombin Ⅲ and thrombocytopenia, as well as bleeding and other side effects Hirudin is the most powerful thrombin natural specific inhibitor, which has a good effect on many thrombotic diseases However, its side effects are high and the risk of clinical use is high Therefore, the research and development of new antithrombotic drugs with small side effects has an urgent and huge social demand Beijing Sanyi Heze Biotechnology Co., Ltd and Institute of Radiology and radiation medicine of PLA Academy of Military Medical Sciences have carried out active research and development based on the above needs The researchers found that by introducing a small peptide into the amino terminal of hirudin, the anticoagulant activity of hirudin could be blocked The small peptide can be broken down by activated coagulation factors at the site of thrombosis in vivo, which can release the anticoagulant activity of hirudin locally and prevent thrombosis New hirudin (EH), a new low bleeding antithrombotic drug, has been successfully developed The results of pharmacodynamic experiments showed that the bleeding side effects of new hirudin were lower under the same antithrombotic effect as low molecular weight heparin and hirudin The results of pharmacological and toxicological experiments show that the use of new hirudin will not cause serious side effects Therefore, in the future, EH is expected to replace hirudin and become the first choice in the treatment of cardiovascular and cerebrovascular embolism There are data showing that: there are 2.5 million people suffering from thrombosis every year in China, and in recent years, the patients suffering from cardiovascular and cerebrovascular embolism also appear the trend of youth Therefore, new vermiculin (EH) will have a huge clinical and market demand According to a statistics of sales revenue and best-selling drugs of major global pharmaceutical companies in 2015, among the top 25 best-selling drugs in the world in 2015, xarlto (rivaroxaban), a new oral anticoagulant approved by FDA in 2011, had a global sales volume of more than 4 billion US dollars in 2015 alone In the future, anticoagulant drugs will have a market share of tens of billions of dollars If the new hirudin (EH) is finally approved and listed, it will produce huge economic benefits China's biopharmaceutical industry ushers in the outbreak period, and the in-depth layout of source consonance takes the lead Biopharmaceutical industry is one of the top ten emerging industries supported by national industrial policies On March 4, 2016, the general office of the State Council issued the guiding opinions on promoting the healthy development of the pharmaceutical industry, which pointed out that: to stimulate the innovation vitality of the pharmaceutical industry, continue to promote the development of new drugs, promote large-scale cell culture and purification, antibody coupling, serum-free and protein-free medium culture And other biotechnology R & D and engineering, to improve the technology level of long-term, slow controlled release, targeting and other new preparations Guided by the clinical drug demand, in the fields of tumor, cardiovascular and cerebrovascular diseases, diabetes, neurodegenerative diseases, mental diseases, high incidence immune diseases, major infectious diseases, rare diseases, etc., we will focus on the development of targeted, highly selective and new mechanism of action therapeutic drugs, and accelerate the development and industrialization of new antibodies, proteins and peptides and other biological drugs These contents are releasing a clear signal that China's pharmaceutical industry will usher in a new round of explosive growth As the only listed company in China that is driven by "cell + gene" dual core, Zhongyuan Xiehe has built a life science and technology "6 + 1" industrial chain platform focusing on large health industry, including: cell resource storage, gene detection and clinical diagnosis, tumor immunotherapy, anti-aging beauty and health care, pharmaceutical industry, life bank card and fund, covering the storage and production from the upstream of the industry The research and development of technology in the middle reaches of the industry and the transformation of the achievements into the clinical application in the lower reaches of the industry Strengthening independent innovation and developing new drug R & D and application are just the important core for the company to expand the downstream market of the industry At present, the company's immune regulation, nerve injury repair and other related products are also actively developing and preparing to register with CFDA In the future, Zhongyuan Xiehe will focus on building a regenerative medicine ecotype company with advanced cell and gene technologies as the core Through independent research and development, as well as the introduction and acquisition of foreign advanced technologies and projects, it will work with relevant enterprises in the same industry to promote the development of China's life science and technology industry, transform and apply the most advanced technologies to clinical practice as soon as possible, and benefit the vast number of patients People "New vermiculin (EH)" was approved to enter the first phase of clinical practice from the 11th Five Year Plan in 2009 to 2016 It is not only a landmark event to accelerate the "6 + 1" industrial chain layout, but also a significant promotion for the development and progress of China's biomedical industry.