Beijing News (Reporter Zhang Xiulan) On March 6, the State Food and Drug Administration** showed that Boehringer Ingelheim's innovative targeted biologics for rare diseases, the subcutaneous injection of the Shenglizo family (generic name: pesolimab), was approved to reduce the onset of generalized pustular psoriasis (GPP) in adolescents aged 12 years and above (weighing 40kg) and **. This is also the first innovative drug developed by a multinational pharmaceutical company in multiple centers and approved in China, earlier than the United States, the European Union and Japan.
GPP is a rare, severe, or persistently occurring disease with a prevalence of 1403 100,000 people, according to this estimate, there are about 20,000 GPP patients in China. Unlike psoriasis vulgaris, GPP is clinically characterized by widespread outbreaks of pustules with pain, and may be accompanied by systemic symptoms such as high fever. GPP is reversed or persistent during the course of the disease, which can lead to hospitalization** and may even be accompanied by serious life-threatening complications, including heart failure, kidney failure, and sepsis.
It is the first monoclonal antibody of its kind to block the activation of the interleukin-36 receptor (IL-36R), which can specifically inhibit the interleukin-36 (IL-36) pathway, which is closely related to the onset of GPP, and block the inflammatory response produced by IL-36 by binding to the IL-36 receptor, thereby inhibiting the inflammatory signaling pathway of GPP, achieving rapid clearance of pustules and skin lesions, and reducing GPP attacks. The drug has previously been approved for the use of GPP attacks in China, and up to now, the two approved indications have been approved by the State Food and Drug Administration for breakthrough recognition and priority review and approval.
Professor Zheng Min, director of the Department of the Second Affiliated Hospital of Zhejiang University School of Medicine and chief investigator of the EFFISAYIL2 clinical trial in China, said that China contributed nearly 20% of the subjects in the study, and this study is a breakthrough milestone in the field of GPP**, combined with the previously approved **GPP onset indications, The approval of pesolimab for the indication of seizure reduction provides a full-cycle disease management regimen for GPP patients.
Proofreading by Zhai Yongjun.