AstraZeneca's (AZN.US) MEK inhibitor selumetinib has been submitted for approval in China for a new indication.

On February 20, China's National Medical Products Administration (NMPA) Drug Review Center (CDE) announced that the application for the marketing authorization of AstraZeneca's (AZN.US) capsule of hydrochloric acid simeprevir has been accepted. According to public information, simeprevir is a MEK inhibitor jointly developed by AstraZeneca and Merck (MRK.US). It has been approved in China for the treatment of pediatric patients with type 1 neurofibromatosis (NF1) aged 3 years and above who have symptomatic, inoperable plexiform neurofibromas (PNs). According to public information, it is speculated that the new indication in China may be: the treatment of symptomatic, inoperable PNs in adult patients with NF1. The screenshot source: CDE's website Simeprevir (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2) involved in promoting cell growth. In NF1, these enzymes are overactive, leading to unregulated growth of tumor cells and the formation of so-called plexiform neurofibromas (PNs). By blocking these enzymes, simeprevir slows the growth of tumor cells and thus slows the growth of PN. In July 2017, AstraZeneca and Merck announced a global strategic collaboration to jointly develop and commercialize simeprevir. Simeprevir has been approved in the United States, the European Union (EU), Japan, and China for the treatment of symptomatic, inoperable pediatric NF1 type PN patients.