Xi'an Jansen Gussetiuzumab injection approved in China
Release date: 2019-12-27 Views: 0
On December 27, the State Food and Drug Administration issued a document stating that it has approved the import registration application of Gussetiuzumab injection (trade name: Tenoyar) for Janssen-Cilag International NV for moderate to severe plaques suitable for systemic treatment. Adult patients with massive psoriasis.
Gussetiuzumab injection is the world's first monoclonal antibody against human interleukin-23 (IL-23) approved for psoriasis. It blocks IL-23 and cell surface IL-23 Receptor binding disrupts IL-23-mediated signaling, activation, and cascade of cytokines, inhibits IL-23 biological activity, and exerts efficacy on plaque psoriasis.
The approval of Gussetiuzumab injection was approved by Janssen-Cilag International NV, the agent of Xi'an Yangsen Pharmaceutical Co., Ltd., and the product was included in the country's first batch of clinically-needed overseas new drugs. The State Food and Drug Administration has speeded up the approval of the variety to be marketed in accordance with the priority review and approval process. So far, the State Food and Drug Administration has approved the import and marketing of 25 drugs on the list of clinically needed overseas new drugs.
Source: State Drug Administration
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