Good news for Chinese patients! Global "king of medicine": Abbott's product sumerial ® is approved in China to treat adult moderate and severe active Crohn's disease!

January 15, 2020 / BIOON / -- abbvie recently announced that China's National Drug Administration (nmpa) has approved xiumeile ® (adamumumab injection) for the treatment of adult patients with moderate or severe active Crohn's disease who are not fully responded, tolerated or taboo to adequate corticosteroids and / or immunosuppressive therapy This is the fifth indication approved by sumac in China It also marks that sumac has entered a new treatment field after rheumatism, immunology, skin and pediatrics gastrointestinal diseases Sumil ® (adamumumab injection) is the first all human anti-tumor necrosis factor (tnfi) monoclonal antibody that can be used to treat Crohn's disease in China The approval is based on the results of two key clinical studies, including a phase 3 study to assess the efficacy and safety of adalimumab (Sumerian ®) in inducing and maintaining clinical remission in patients with moderate to severe active Crohn's disease in China Studies have shown that adalimumab (Sumerian ®) is used for the treatment of moderate to severe active Crohn's disease (CDAI > = 220 to < = 450) in which the previous treatment of corticosteroids and / or immune agents failed and the high-sensitivity C-reactive protein increased (> = 3 mg / L) Compared with placebo group, Chinese adult patients can induce and maintain clinical remission of moderate and severe active Crohn's disease in China, which is consistent with the global clinical research results The overall safety characteristics of sumerial ® (adamumumab injection) were similar to those of placebo, and no unexpected safety signal was observed in the Chinese population "Crohn's disease is a chronic, progressive, inflammatory gastrointestinal disease, which has a long course and is easy to repeat At present, there is no radical method, which brings great challenges to patients' daily life." Professor Chen Min Hu, chairman of the digestive branch of the Chinese Medical Association, vice president of the First Affiliated Hospital of Sun Yat sen University, leader of the digestive medicine discipline, and lead researcher of the third phase study of Crohn's disease in China, said, "a number of clinical studies and real world research data show that all human anti TNF monoclonal antibodies-- Sumeriab ® (adamumumab injection) can effectively improve the symptoms of Crohn's disease, promote mucosal healing and fistula closure, with good safety, low incidence of side effects and good patient tolerance In addition, sumil ® (adamumumab injection) is administered subcutaneously through a pre filled injection device, which is convenient to use and saves time Sumil ® (adamumumab injection) provides a good treatment option for patients, which is expected to help patients control disease progress, improve quality of life and return to normal life " Symptoms of Crohn's disease include chronic diarrhea, abdominal pain, weight loss, loss of appetite, fever and rectal bleeding, which seriously affect the quality of life of patients According to Meta analysis, the prevalence of Crohn in China is 2.29 per 100 thousand people, with an incidence rate of 0.848 cases per 100 thousand people, which has been increasing rapidly in recent years At present, Crohn's disease can't be cured clinically It needs innovative treatment methods and drugs to control the progress of the disease, reduce complications and improve the quality of life of patients "We are very pleased that sumerial ® can provide a new and effective treatment option for patients with moderate to severe active Crohn's disease in China," said o'slang, general manager of Aberdeen China This approval once again reflects the commitment of abwi to continuously improve the treatment of patients with global immune-mediated diseases Sumac ® has more than 15 globally approved indications related to immune-mediated diseases We will continue to make efforts to introduce more indications and other innovative products of Sumeria into China faster to meet the needs of the vast number of Chinese patients At the same time, we will spare no effort to actively work with all parties in society to make these innovative treatment programs truly benefit many Chinese patients " Sumerial ® (adamumumab injection) for Crohn's disease was approved in the United States and the European Union in 2007 In the United States, the indications of sumac ® Crohn's disease were approved under the "fast track design" of the U.S Food and Drug Administration (FDA) Sumil ® (adamumumab injection) is the first all human anti TNF monoclonal antibody approved for marketing in the world The inflammatory excess of various immune-mediated diseases in human is related to tumor necrosis factor - α (TNF - α) Xiumeile ® (adamumumab injection) can selectively combine with TNF - α molecules, prevent its attachment to healthy cells, and thus reduce the damage caused by excessive TNF - α Based on this principle, sumerial ® (adamumumab injection) can be used to treat a variety of immune-mediated diseases Since it was launched in 2003, sumil ® (adamumumab injection) has helped many patients with immune diseases all over the world At present, sumerial ® (adamumumab injection) has 17 approved indications in the world At least one indication has been approved in more than 100 countries and regions around the world Now, more than 1 million patients worldwide are being treated with sumerial ® (adamumumab injection) In the world, sumerial ® (adamumumab injection) has more than 20 years of research data, more than 100 clinical studies, covering more than 33000 patients Sumil ® (adamumumab injection) is administered in two ways: pre filled injection and pre filled injection pen ("sumil pen") The pre filled pen is easy to use, and patients can inject themselves under the guidance of professional medical staff In China, sumerial ® (adamumumab injection) was launched in 2010 and has been approved for five indications: rheumatoid arthritis indication in 2010, ankylosing spondylitis indication in 2013, moderate and severe plaque psoriasis indication in 2017, multiple joint juvenile idiopathic arthritis indication in 2019, moderate and severe active adult Croce in 2020 Well, ill In 2018, China National Drug Administration (nmpa) approved xiumeile ® (adamumumab injection) to change the applicable population of adult psoriasis to "adult moderate and severe chronic plaque psoriasis patients who need systematic treatment", from clinical second-line systematic treatment to clinical first-line systematic treatment At the same time, nmpa also approved xiumeile ® (adamumumab injection) to add the research results of clinical trials of silverfiligree nail in the Chinese manual At present, sumil ® (adamumumab injection) has been listed in the catalogue of drugs for national basic medical insurance, work injury insurance and maternity insurance The indications that can be covered include rheumatoid arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis In the future, sumerial ® (adamumumab injection) is expected to continue to expand new indications and dosage forms Xiumeile ® (adamumumab injection) has been included in the list of the second batch of clinically urgent overseas new drugs in China Source: Aberdeen