Boehringer Ingelheim, the first of its kind in research immunological new drug Spesolimab, obtained CDE breakthrough therapeutic drug designation

June 25, Boehringer Ingelheim announced that its investigational immunization has been the national drug Spesolimab Drug Administration Bureau Center for Drug Evaluation (CDE) recognized as a breakthrough therapy for the treatment of generalized pustular psoriasis (GPP)

The breakthrough therapy drug qualification is set up to speed up the development of new drugs for serious diseases that have been shown in pre-clinical trials in terms of efficacy or safety to be significantly better than existing treatments.

GPP is a rare and life-threatening systemic inflammatory disease

According to China’s past reports, the prevalence of psoriasis in China is 0.

In our country, the public’s awareness of GPP is seriously insufficient, which not only delays the early diagnosis and treatment of many patients , but also causes such diseases to be absent from the rare disease catalog.

Spesolimab is an IL-36R monoclonal antibody that can block the action of interleukin-36 receptor (IL-36R) and is the first treatment of its kind under development

Based on the positive results of Spesolimab's Phase I clinical trial for GPP indications, the global pivotal Phase II clinical trial was launched in May 2020

Boehringer Ingelheim is currently developing the drug for the treatment of a variety of immune disease indications.

Dr.