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Amgen China announced today that Angavi (generic name: diastoidal injection) has been approved by the State Drug Administration for the treatment of non-surgical lysis or surgical removal of bone cytomegaloomas that can cause severe dysfunction, including adults and adolescent patients with mature bones (at least 1 mature bone and weighing up to 45 kg).
Angarve is a human immunoglobulin G2 (IgG2) monoclonal antibody. In 2018, Angavi will be included in the clinically urgentlist list (first batch) of new drugs from outside the country and will be placed on the National Drug Administration's fast-track review channel. The approval makes Angawi the first and only drug currently used in the treatment of osteocyte.
osteoblastoma is a heliological benign, but often invasive bone tumor, good in the 20-40-year-old young people, the incidence rate of women is slightly higher than men. Globally, osteoblastoma accounts for about 4% to 5% of all primary bone tumors, and is more common in China than in Europe and the United States, accounting for about 20% of all primary bone tumors. Although the vast majority of osteoblastomas are benign tumors, failure to treat often causes complete bone damage to the affected bones, leading to fractures, joint dysfunction, or amputation."
The current treatment for osteoblastoma mainly includes surgery and radiotherapy, " said Professor Niu Xiaohui, director of the Department of Osteopathic Oncology at The Water tank hospital in Beijing and chairman of the Sarcoma Expert Committee of the Chinese Society of Clinical Oncology. For patients who cannot have surgery or surgical excision that can cause severe functional impairment, there is no previously effective treatment approved by Chinese regulators. The approval of dissemoth means that patients with osteocyte stokuoma in China are looking forward to the arrival of innovative treatment options for a long time, and its dual effectofing tumor growth and reducing bone damage, as well as good tolerance, will bring patients the benefits of disease treatment and quality of life. The
Angarve's indication is based on the results of two open-label trials for patients with recurrent, unremovable or planned surgical removals that are likely to cause severe dysfunction. The latest analysis, presented at the 2017 annual meeting of the European Society of Oncology, showed that 80 percent of patients who could undergo surgical removal improved after receiving neo-assisted sabutatic therapy: 44 percent underwent surgery with less functional impact and 37 percent avoided surgery. In patients who could not be surgically removed, geostocym led to effective long-term disease control, with a 5-year survival rate of 88%.
it is understood that Mr. Angawi has previously been approved by the U.S. Food and Drug Administration (FDA), the European Commission (EC) and others.
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