Novartis Submits New Indication Application for Secukinumab Injection in China

On May 12, the CDE official website showed,NovartisNovartis' Secukinumab Injection New Indication Marketing Application Accepted.This is the 6th indication for the product's marketing application in China, with a registration classification of Category 3.1., namely overseasProduced OverseasMarketed, Not marketed in ChinaBiological Products ApplicationListed。

Source: CDE Official Website

Secukinumab is the world's first approved fully human interleukin (IL)-17A inhibitor, which can specifically neutralize IL-17A from various sources and inhibit its pro-inflammatory effects.

In January 2015, the product was first launched in the United States and has been approved so far.AdultModerate to Severe Plaque PsoriasisDisease,Adult Ankylosing Spondylitis, Adult Active Psoriatic Arthritis, Adult Radiographic Negative Axial Spondyloarthritis, 6 Years and AboveModerate to Severe Plaque Psoriasis in Children, Aged 2 Years and AbovePsoriatic Arthritis, 4 Years and AboveEnthesitis-related Arthritis and Adult Hidradenitis Suppurativa。

April 2019Month,Secukinumab enters the Chinese market,For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Since its launch, secukinumabHave been successively approved for 5 itemsIndications, as shown in the figure below.

Source: Insight Database

Insight database shows that Novartis completed in February 2025SecukinumabChinese III Phase Clinical Study for the Treatment of Radiographic Negative Axial Spondyloarthritis

Source: Insight Database

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