Novartis' Secukinumab (Cosentyx) Nears Approval in China for Ankylosing Spondylitis

By Cai Cai

Recently, the marketing application for a new indication of Novartis’ secukinumab (commonly known as “Su Jin Dan Kang”; acceptance number: JXSS1900025) has been updated to “under review,” with approval expected in the near future. Secukinumab was first approved for marketing by the NMPA in March 2019; this current application represents its second indication, for the treatment of ankylosing spondylitis.

(Source: NMPA)

Novartis "Best-Selling Drug of 2019"

Secukinumab (trade name: Cosentyx/Ke Shan Ting, commonly known as "Su Jin Dan Kang") is a fully human IgG1κ monoclonal antibody targeting IL-17A developed by Novartis. It was approved by the FDA for market launch in 2015 and is currently available in more than 80 countries and regions, including EU member states and the United States. It has been approved for indications such as plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.

IL-17A is a core pathogenic factor involved in the inflammation and disease progression of psoriasis (PsO), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). IL-17A can be produced via both IL-23-dependent and IL-23-independent pathways by various cells of the innate and adaptive immune systems. By directly targeting IL-17A from diverse sources, secukinumab has demonstrated sustained efficacy and safety across all domains of psoriasis, including nail, scalp, palmoplantar, and joint involvement.

Secukinumab has emerged as a rising star, achieving remarkable success in the treatment of psoriasis and ankylosing spondylitis. In particular, the success of the head-to-head clinical trial comparing secukinumab with ustekinumab demonstrated that secukinumab offers superior clinical benefits over ustekinumab for psoriasis indications, significantly boosting its reputation. In 2019, secukinumab maintained rapid growth and became Novartis’ best-selling drug.

Although secukinumab has been on the market for only five years, it became Novartis’s best-selling drug in 2019, with global sales reaching $3.55 billion, a year-on-year increase of 25%.

First Indication Launched in China

Secukinumab is one of the first batch of overseas new drugs urgently needed for clinical use in China. It was approved by the National Medical Products Administration (NMPA) in March 2019 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and was officially launched in China in May of the same year.

(Source: NMPA)

Information on ClinicalTrials.gov indicates that secukinumab has completed two clinical studies involving Chinese patients, for the indications of plaque psoriasis and ankylosing spondylitis, respectively. Among these, the international multicenter Phase III clinical trial for ankylosing spondylitis was completed on March 19, 2019.

The Second Indication Is About to Be Approved

The new indication for ankylosing spondylitis (Acceptance No.: JXSS1900025) was submitted for marketing approval in May 2019 and included in the priority review program in August.

Ankylosing spondylitis is a chronic inflammation occurring in the patient's spine, with a long course of disease. After the condition worsens, patients will lose most of their mobility. Susceptible genes and family medical history are the main pathogenic factors for ankylosing spondylitis, so the number of ankylosing spondylitis patients in China remains relatively stable.

According to the Frost & Sullivan report, the number of patients with ankylosing spondylitis in China increased from 3.76 million in 2014 to 3.85 million in 2018, representing a compound annual growth rate (CAGR) of 0.6% during this period. The number of patients with ankylosing spondylitis in China is expected to reach 3.955 million by 2023, with a CAGR of 0.5% during this period. Subsequently, the patient population will continue to grow at a CAGR of 0.4%, reaching 4.054 million by 2030.

Prevalence of Ankylosing Spondylitis in China, 2014–2030

(Source: Bio-Thera Solutions’ prospectus, Frost & Sullivan)

Secukinumab demonstrates superior safety and efficacy compared to other marketed large-molecule drugs in this field in China; however, its domestic sales still face significant challenges. The domestically produced product Etanercept (Yisaipu), developed by 3SBio, holds a first-mover advantage. Currently included in the National Reimbursement Drug List, Etanercept commands approximately 60.9% of the domestic market share across rheumatoid arthritis, ankylosing spondylitis, and psoriasis indications, with annual sales exceeding RMB 1 billion, thereby maintaining absolute market dominance.

Original Title: Antibody | Novartis’ “Best-Selling Drug of 2019” Secukinumab’s New Indication to Be Approved in China Soon!