Guselkumab Injection (Tremfya®) Approved in China for Moderate-to-Severe Plaque Psoriasis as Part of Clinical Urgent Need Drug Initiative

Yi ValleyNews: On December 27, the National Medical Products Administration (NMPA) announced that it had recently approved the import registration application for guselkumab injection (brand name: Tremfya) from Janssen-Cilag International NV, indicated for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Guselkumab injection is the first anti-human interleukin-23 (IL-23) monoclonal antibody approved globally for the treatment of psoriasis. It exerts therapeutic effects on plaque psoriasis by blocking the binding of IL-23 to cell surface IL-23 receptors, thereby disrupting IL-23-mediated signal transduction, activation, and cytokine cascades, and inhibiting IL-23 biological activity. It was approved by the FDA in July 2017 for the treatment of moderate-to-severe plaque psoriasis. In February 2019, it received FDA approval for a self-injectable version (One-Press Patient-Controlled Injector) for the treatment of plaque psoriasis in adults. To date,Guselkumab InjectionApproved in multiple countries and regions worldwide for the treatment of adult patients with moderate to severe plaque psoriasis.

Psoriasis is a common, chronic, non-contagious, painful, disfiguring, and disabling immune-mediated inflammatory disease, classified as an autoimmune chronic skin disorder. Up to 125 million people worldwide are affected by psoriasis. In terms of global prevalence by country, it is most common among populations in Northern Europe and Australia, less common in East Asian populations, with approximately 6 million patients in China.

Currently, biologic agents for the treatment of psoriasis are divided into two major categories: one comprises drugs with broader indications, such as adalimumab, etanercept, and infliximab; the other includes mainstream agents, such as ustekinumab and secukinumab.

Source: CPhI Pharmaceutical Online

The guselkumab injection approved this time was submitted by Xian Janssen Pharmaceutical Ltd. on behalf of Janssen-Cilag International NV. This product was included in the first batch of the National List of Clinically Urgent Overseas New Drugs in 2018. Its therapeutic indications include: erythrodermic psoriasis, plaque psoriasis, pustular psoriasis, psoriatic arthritis, and vulgaris psoriasis. The National Medical Products Administration (NMPA) accelerated the approval of this product for market launch under the priority review and approval procedure. To date, the NMPA has approved the import and marketing of 25 drugs listed in the Clinical Urgent Overseas New Drugs List.