CSPC：Cosentyx®Secukinumab Injection marketing application submitted
On June 17, the CDE official website showed that the New Drug Application (NDA) for CSPC Pharmaceutical Group’s Secukinumab Injection has been accepted, with a registration classification of Category 3.3.
Secukinumab, originally developed by Novartis, specifically binds to IL-17A and blocks IL-17 receptor signaling, with global sales reaching $6.668 billion in 2025. In China, secukinumab has been approved for indications including plaque psoriasis in patients aged 6 years and older, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and non-radiographic axial spondyloarthritis, under the brand name Cosentyx®.
The secukinumab biosimilar developed by CSPC Pharmaceutical Group (development code: SYS6012) is a biosimilar to Cosentyx®. CSPC conducted the R&D of SYS6012 in accordance with biosimilar guidelines and performed a head-to-head equivalence study with the reference product. This was a multicenter, randomized, double-blind, parallel, active-controlled equivalence Phase III trial designed to verify the consistency of efficacy between the product and the reference product in the treatment of patients with moderate-to-severe plaque psoriasis. Patients with moderate-to-severe plaque psoriasis were randomized 1:1 to either the experimental arm or the control arm, with the primary endpoint being the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12.
In December 2025, CSPC Pharmaceutical Group announced topline data from the equivalence Phase III trial of SYS6012 in moderate-to-severe plaque psoriasis. Statistical analysis demonstrated that SYS6012 is clinically equivalent to the reference product, with a favorable safety profile and no new or unexpected safety signals, suggesting that it may meet the long-term safety needs of patients. Detailed results from the study will be published at a future academic conference and in a journal.
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