Kelun Pharma Achieves Dual First-to-File Generic Approvals for Safinamide Mesylate and Siponimod Tablets

Highlights

Recently,Kelun PharmaceuticalFour generic drugs were approved for production on the same day and deemed to have passed the consistency evaluation. Among them, Safinamide Mesylate Tablets and Siponimod Tablets are the first generics approved in China (including jointly approved cases), while Ceftizoxime Sodium for Injection/Sodium Chloride Injection and Ibrutinib Tablets are the second approved in China.

Siponimod Tablets is a sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Notably, it is the first oral disease-modifying therapy (DMT) approved globally for active secondary progressive multiple sclerosis.

Novartis's siponimod tablets were first approved for marketing in China in May 2020 and have been included in Class B of the National Reimbursement Drug List. The products from Kelun and Qilu Pharmaceutical received acceptance for their marketing applications under the new registration classification in February 2023 and January 2024, respectively. Both were successfully approved recently, jointly securing the first domestic generic approval in China.

Menet DataData show that siponimod tablets are the fourth immunosuppressant approved for Kelun. In recent years, sales of immunosuppressants (chemical drugs) across China's three major terminals and six major markets (see the end of this article for the statistical scope) have consistently exceeded RMB 17 billion.

Sales Performance of Immunosuppressants (Chemical Drugs) in China's Three Major Terminals and Six Major Markets in Recent Years (Unit: RMB 10,000)

Safinamide mesylate tablets (safinamide mesylate tablets) are a highly selective, reversible third-generation monoamine oxidase B (MAO-B) inhibitor developed by Zambon/Newron. It was first approved in China in December 2024 for the treatment of idiopathic Parkinson's disease in patients experiencing motor fluctuations while on a stable dose of levodopa.

Regarding generic drug submissions, Nanjing Chia Tai Tianqing's product was the first to file for production approval under the new registration classification; unfortunately, it failed to obtain approval. Kelun followed closely and recently secured approval, claiming the first generic in China. Additionally, Yangzijiang, Shiyao Group, Qilu Pharmaceutical, Huahai,North China PharmaceuticalThe products of 18 other companies are under review for production approval.

Year-to-date, Kelun (excluding its associate companies) has obtained approval for one improved new drug formulation, specifically brexpiprazole orally disintegrating film. The company has previously secured approvals for multiple orally disintegrating film products, including ondansetron and sildenafil citrate orally disintegrating films; 18 drug varieties have been approved for production and deemed to have passed the consistency evaluation, primarily comprising nervous system drugs.

Selected Kelun Products Approved for Market Launch So Far This Year

Note: MENET's “Competitive Landscape of Pharmaceuticals in China's Three Major Terminals and Six Major Markets”, Statistical Scope: urban public hospitals and county-level public hospitals, urban community health centers and township health centers, urban brick-and-mortar pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, and county, township, and village pharmacies; the aforementioned sales figures are calculated based on the average retail price of products at the terminal level. Data is current as of May 28. Please feel free to point out any omissions or inaccuracies!