Breakthroughs have been made in the study of biosynthesic drugs for the treatment of severe spina boutitis
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Last Update: 2020-12-27
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Source: Internet
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Author: User
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a breakthrough in a biosynthete drug for the treatment of severe spina boutitis led by Tsinghua University's School of Clinical Medicine, the results of phase III clinical trials show that the clinical equivalent of the new drug and the original drug is established. The results were recently published in the international academic journal The Lancet Rheumatology.
is a chronic rheumatoid immune disease, mainly infringing on the spinal joints and outer joints, severe can occur spinal malformations and joint straightness. The prevalence rate in China was about 0.3%, mostly among adolescent men, and the total disability rate was 15% to 20%.
Xu Huji, a professor at Tsinghua University's School of Clinical Medicine, was responsible for the multi-center, randomized, double-blind phase III study, involving 20 domestic medical centers. The subjects were over 18 years of age, nonsteroidal anti-inflammatory drugs for more than 4 weeks of treatment of poor efficacy, ineffective or inability to withstand the active severe spina brysitis patients.
results show that China's independent research and development of Adamo monobial-like drug IBI303, in the treatment of strong spina blinitis efficacy, safety can be compared with foreign original research drugs, domestic patients with strong spina blinitis in the future will have more drug options.
it is understood that both biosimilars and chemical generics fall into the generic category, but the time and cost of developing biosimilars are much higher than chemical generics. The former State Administration of Food and Drug Administration issued the Technical Guidelines for the Development and Evaluation of Biosynthic Drugs (Trial) in 2015, which greatly promoted the development of biosynthic drugs in China. (Source: Xinhua News Agency, Dong Ruifeng)
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