Bayer hemophilia is the next city in the field of hemophilia, and keyuech ® has been approved rapidly in China!

Bayer announced today that the National Drug Administration has approved the use of recombinant human coagulation factor Ⅷ for injection in the treatment of adult and children with hemophilia A (routine prevention, on-demand treatment, management of perioperative bleeding) Coleridge ® is a full-length recombinant human coagulation factor Ⅷ product Prior to that, the drug review center (CDE) of the State Drug Administration has incorporated the registration application of the drug into the priority review procedure Hemophilia A A, also known as hemophilia A A, is a kind of hereditary lifelong disease Most of the patients lack of coagulation factor Ⅷ from birth, and they will bleed if touched slightly In severe patients, spontaneous bleeding can also occur without obvious trauma Long term repeated bleeding of muscles and joints will cause disability, serious bleeding and even death At present, in our country, the standard treatment rate of hemophilia is low and the long-term prognosis is poor, which leads to more than 90% of hemophilia children have joint diseases of different degrees The new approved recombinant human coagulation factor Ⅷ for injection can be used for the treatment of adult and child patients with hemophilia (routine prevention, on-demand treatment, management of perioperative bleeding) Professor Zhao Yongqiang of Peking Union Medical College Hospital said that hemophilia is one of the diseases with clear diagnosis and treatment path among all rare diseases Keyuech ® is the only recombinant eight factor in China that clearly obtains the conventional prevention indications of adult hemophilia A, which will help hemophilia children continue to receive better treatment, maintain normal joint and muscle functions and return to normal life in adulthood Keyueqi ® was approved on the basis of three international multicenter clinical studies (Leopold) in patients with severe hemophilia (coagulation factor Ⅷ < 1%), and evaluated the safety and effectiveness of this product in the on-demand treatment and control of bleeding events, perioperative bleeding management and regular preventive treatment "In the Leopold series of studies, routine prevention of keyuech ® for children and adults with hemophilia A can control bleeding and significantly reduce the frequency of bleeding," said Yang renchi, Professor of Hematology hospital, Chinese Academy of Medical Sciences "Keyuech ® has a higher degree of sialylation, which makes it have a longer half-life than other recombinant eight factors, and can protect the joints of hemophilia patients more permanently 。 At the same time, the unique 20 nanometer virus filtration technology of keyuech ® can remove potential impurities, with higher security Its approval will provide more treatment options for Chinese adults and children with hemophilia a " Mr Jiang Wei executive vice president of Bayer prescription medicine business department and President of China and Asia Pacific Region "Bayer company has been engaged in the research of hemophilia for more than 20 years Keyuech ® is another innovative product researched and developed by Bayer company Through Bayer's unremitting efforts, we are very proud to develop new treatment options for hemophilia patients, provide longer joint protection for patients, and constantly improve the quality of life of hemophilia patients Finally, we can Enough to return to normal life In the future, Bayer will continue to devote itself to the research and development of hemophilia and fulfill its commitment of "technology creates a better life." The approval of keyuech ® relies on Bayer's increasing hemophilia product line, including the first recombinant human coagulation factor Ⅷ - bycoech ® listed in China and the long-term recombinant factor Ⅷ still under development Bayer is also looking for alternative intravenous therapies in preclinical and early clinical development, such as TFPI and gene therapy.