Yosibi Siminja ® (Pesseli Pearl mono-anti-injection) approved by the State Drug Administration
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, it has been reported that the global bio
pharmaceutical(http://company(http://Yushibi announced that its Ximinja ® (Pesseli pearl mono-injection) has been approved by the NationalDrug(http://Regulatory Authority (NMPA) for the treatment of moderate to severe active rheumatoid arthritisXi Minjia ®
Ximinjia ® is the first biological agent introduced by Yushibi to China, and the approval of Ximinjia ® marks the official entry of Yuminbi into the field of immune system diseases in China, as well as an important milestone in the strategic adjustment of Yuminbi in ChinaThe approval of the Ximinjia ® is based on two Phase 3 clinical trials of RAPID-C and RAPID-C OLE (RAPID-C Open Label AmplificationTrial(http://) to evaluate the efficacy and safety of the Peselyzumab monoantigenThe results of the 24-week RAPID-C clinical trial showed that in Chinese patients with rheumatoid arthritis who had previously under-responded to methotrexate (MTX), the pesely-pearl mono-injection combined methotrexate (MTX) responded quickly, sustainably and significantly to alleviate symptoms, effectively improving the signs of rheumatoid arthritis In addition, in the listing application, Uber also submitted the results of two first clinical trials (CRIB2 and CRADLE3) for women of childbearing age
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