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Boehringer Ingelheim's first-in-class immune drug Spesolimab submitted a marketing application in China for the treatment of generalized pustular psoriasis

 Last Update: 2021-12-09
 Source: Internet
 Author: User

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Shanghai, October 26, 2021/PRNewswire/ - On October 25, 2021, Boehringer Ingelheim announced that it has formally submitted a listing application for the new immune drug Spesolimab to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration , Used to treat the onset of generalized pustular psoriasis (GPP)
.

Previously, based on the superior performance of Spesolimab in its treatment of GPP Phase I and Phase II clinical trials, CDE has granted Spesolimab breakthrough therapy drug designation on June 25 this year

GPP is a rare, recurrent or persistent skin disease[i,ii].
According to statistics, only 1 to 2 of about 100,000 people in China suffer from GPP[iii]
.

GPP is different from psoriasis vulgaris.

In recent years, studies have found that pustular psoriasis is related to the interleukin-36 (IL-36) pathway
.

Spesolimab is a monoclonal antibody that blocks the IL-36 receptor.

Dr.
Zhang Wei, Head of Medicine and Clinical R&D of Boehringer Ingelheim Greater China, said: "We have been committed to accelerating the deployment of global innovative drugs in China, so that Chinese patients can benefit from them as soon as possible
.

Thanks to the reform of China's new drug approval system and the company With the implementation of the'China Critical' project, China has participated in and successfully completed Spesolimab's global pivotal Phase II clinical trial, enabling us to simultaneously submit applications for Spesolimab for the treatment of GPP onset indications in China

ii.

iii.

Source: Boehringer Ingelheim

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