Novartis' Cosentyx (Secukinumab) Approved in China as One of the First Overseas Drugs Deemed Clinically Urgent

Recently, the National Medical Products Administration updated the review status of Novartis’s IL-17A monoclonal antibody Cosentyx (secukinumab), with its processing status now changed to “Approval Completed – Pending Certificate Issuance.” The newly approved indication is expected to be moderate-to-severe psoriasis.

It is worth noting that secukinumab was one of the first batch of 40 urgently needed overseas new drugs officially released by the Center for Drug Evaluation (CDE) on November 1 last year. In accordance with CDE requirements, it was exempt from domestic clinical trials and could directly apply for market approval, while benefiting from a specialized channel to expedite review. On September 21, 2018, the marketing application for secukinumab was accepted and included in the priority review process. Nearly six months later, secukinumab was approved for market launch.

It is understood that secukinumab is a fully human monoclonal antibody targeting IL-17A, developed by Novartis. It selectively binds to interleukin-17A (IL-17A), a pro-inflammatory cytokine primarily produced by T helper 17 (Th17) cells. Upon binding to the IL-17 receptor, IL-17A induces pro-inflammatory responses. Its high expression levels are closely associated with certain autoimmune diseases, such as psoriasis. Secukinumab inhibits the interaction between IL-17A and its receptor, thereby suppressing its ability to trigger inflammatory responses in autoimmune diseases.

To date, secukinumab has been approved for multiple indications, including psoriasis, psoriatic arthritis, and ankylosing spondylitis. It was first approved by Japan’s PMDA on December 26, 2014, followed by approval from the European EMA on January 15, 2015, and by the US FDA on January 21 of the same year. Secukinumab has now gained marketing approval in more than 80 countries and regions worldwide. As the first globally launched IL-17A monoclonal antibody, secukinumab achieved sales of $1.128 billion in its second year after FDA approval. Its sales surpassed $2 billion in 2017, and reached $750 million in the third quarter of 2018 (a year-on-year increase of 37%), making it the most market-potential new drug launched by Novartis in recent years.

On March 4 this year, Novartis presented data from a Chinese Phase III clinical study of secukinumab for the treatment of moderate-to-severe plaque psoriasis at the 2019 American Academy of Dermatology Annual Meeting (AAD 2019). This study (NCT03066609) was a randomized, double-blind, placebo-controlled, international, multicenter trial lasting 52 weeks, primarily evaluating the efficacy and safety of secukinumab in patients with moderate-to-severe chronic plaque psoriasis, with or without psoriatic arthritis. A total of 441 Chinese patients were randomly assigned to three groups: subcutaneous injection of secukinumab 300 mg (n=221), secukinumab 150 mg (n=110), or placebo (n=110). The primary endpoints were the proportion of patients achieving PASI 75 (≥75% improvement in Psoriasis Area and Severity Index) and IGA 2011 score of 0/1 (Investigator’s Global Assessment modification score of 0/1) at Week 12. The secondary endpoint was the proportion of patients achieving PASI 90 (>90% improvement in Psoriasis Area and Severity Index, indicating clear or almost clear skin) at Week 12.

Final results demonstrated that secukinumab exhibited a rapid onset of action and superior efficacy in Chinese patients. Clinical improvement was evident as early as Week 3 of treatment, with therapeutic effects becoming more pronounced over time. Among patients treated with secukinumab 300 mg, 97.7% achieved PASI 75 at Week 16, and nearly 90% achieved PASI 90. In terms of safety, Cosentyx was well tolerated, with an incidence of adverse events consistent with previous studies.

ChinaMedicineZhang Jianzhong, Former Chairman of the Dermatology and Venereology Branch, served as the principal investigator for the aforementioned clinical trial. He stated, “The data from this clinical trial in China are highly encouraging, with efficacy and safety profiles even surpassing some international data. Secukinumab not only contributes to the elevation of overall treatment goals—raising the therapeutic target for psoriasis from PASI 75 to PASI 90 or even PASI 100—but also demonstrates a favorable safety profile. Previously, biologics were considered only after phototherapy and systemic treatments had failed; however, this treatment sequence is likely to be rewritten in the future, with biologics potentially becoming first-line agents for systemic therapy. This shift would enable more patients with moderate-to-severe psoriasis to receive better and safer treatments at an earlier stage.”

However, some argue that although secukinumab has gained significant renown in the field of psoriasis, its sales in the Chinese market may face challenges. This is because Etanercept, a domestically produced product by 3SBio (Shengsheng Guojian), holds a first-mover advantage. Currently, Etanercept is included in the National Reimbursement Drug List and occupies an absolutely dominant position in the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis. According to 3SBio’s 2018 financial report, Etanercept generated annual revenue of RMB 1.111 billion in 2018, capturing a market share of 64%.