Shijiazhuang Pharma's Secukinumab Biosimilar, Second in China, Files for Market Approval Amid $5.6B Domestic Sales Surge

This article is reprinted from the following article sourced from Yaozhi.com, authored by Douzi

Recently,CSPC’s Marketing Authorization Application for Secukinumab Injection Accepted by NMPA, Becoming the Second Biosimilar of This Drug to Be Filed for Marketing in China

Interleukin-17 (IL-17) is a class of pro-inflammatory cytokines that play a key role in host immune defense, tissue repair, and inflammatory diseases. Among them, IL-17A serves as the core effector molecule of the Th17 cell pathway,Plays a key role in the pathological processes of autoimmune diseases such as psoriasis, ankylosing spondylitis, and psoriatic arthritis.

Novartis's secukinumab (Cosentyx) is the world’s first marketed IL-17A inhibitor, with global sales reaching $6.7 billion in 2025.

In China, the drug has been approved for indications including adult psoriasis, pediatric psoriasis, ankylosing spondylitis, psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthritis.In 2025, its domestic sales in China amounted to nearly RMB 4 billion.

Secukinumab Domestic Sales Revenue

Currently, the core sequence patent for secukinumab in China has expired.Bio-Thera’s BAT2306 is the first secukinumab biosimilar to be filed for marketing approval in China.

CSPC’s secukinumab injection is the second domestically produced Cosentyx biosimilar to be submitted for market approval.

This marketing authorization application is based on a Phase I clinical study comparing pharmacokinetic (PK) similarity in healthy subjects and a Phase III equivalence clinical study in patients with psoriasis. The study results demonstrated that this product exhibits high similarity to Cosentyx in terms of efficacy, safety, PK, and immunogenicity profiles.

Furthermore, in the IL-17A therapeutic arena, domestically developed innovative drugs have risen rapidly in recent years, shifting from a “blue ocean” of market expansion to a “red ocean” of intense competition.

In 2024,GENRIX BIO's SelicrelumabandHengrui Pharma's FunakizumabTheir successive approvals for market launch have broken the monopoly of foreign companies on IL-17A monoclonal antibodies.

In 2026,Guojian Pharmaceutical's Anmuqita monoclonal antibodyandAkeso's GumoqizumabApproved for Market Launch: A New Heavyweight Contender Enters China’s IL-17A Arena

The market launch of biosimilars and a growing pipeline of domestically developed innovative drugs will further reduce the treatment burden on patients and improve medication accessibility for patients in China.

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