诺华制药(NVS.US)司库奇尤单抗新适应症在华获批

Core Viewpoint - Novartis' innovative biologic Cosentyx (secukinumab) has received approval from the National Medical Products Administration (NMPA) for a new indication to treat adult patients with active radiographic axial spondyloarthritis (nr-axSpA) who have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) [1][2] Group 1: Product Approval and Indications - The new indication for nr-axSpA is the sixth approved indication for Cosentyx in China, following approvals for moderate to severe plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and hidradenitis suppurativa [1] - Cosentyx, an IL-17A inhibitor, specifically neutralizes IL-17A from various sources, alleviating symptoms of nr-axSpA and providing long-term benefits to patients [1] Group 2: Market Performance and Sales - Cosentyx has over 10 years of clinical experience in the axSpA, psoriasis, and psoriatic arthritis fields globally, supported by 5 years of long-term clinical research and real-world evidence [2] - Since its initial FDA approval in December 2014, Cosentyx achieved sales of $1.128 billion in 2016, with global sales projected to reach $6.141 billion in 2024, maintaining a double-digit growth rate of 23.31% [2] - In China, Cosentyx was approved in 2019, with the initial price set at 2,998 yuan per injection, which decreased to 1,188 yuan after being included in the medical insurance in 2020, and further to 870 yuan in 2023, leading to significant market success with sales reaching 4.092 billion yuan in 2023, capturing over 40% of the IL inhibitor market [2]