Kelun-Biotech Achieves Two First Generics in One Day! Siponimod Tablets and Safinamide Mesylate Tablets Approved by NMPA
Recently, good news keeps coming. According to the announcement published by the NMPA, Hunan Kelun-Biotech obtains the first generic approval for Siponimod tablets. In addition, Sichuan Kelun-Biotech’s Safinamide mesylate tablets also successfully gain approval, securing the first generic in China. With two first generics obtained on the same day, Kelun-Biotech further expands its product portfolio in the generic drug field.
Siponimod, developed by Novartis, treats adult relapsing forms of multiple sclerosis. It is the world’s first and currently only oral disease-modifying therapy (DMT) approved for active secondary progressive multiple sclerosis. The drug entered the Chinese market in 2020 and was subsequently included in the National Reimbursement Drug List. Data shows that the sales of originator Siponimod steadily increase, reaching $357 million globally in 2022 and further growing to $390 million in 2023, demonstrating strong market competitiveness.
Safinamide mesylate tablets, co-developed by Italy’s Zambon Group and Newron Pharmaceuticals, treat idiopathic Parkinson’s disease in patients experiencing motor fluctuations while on a stable dose of levodopa. Parkinson’s disease is the second most common neurodegenerative disorder after Alzheimer’s disease.
After the drug gained approval in China in December 2024, more than 20 companies—including Kelun-Biotech, Qilu Pharmaceutical, Huahai Pharmaceutical, and Yangtze River Pharmaceutical—enter the race for the first generic, fully reflecting the significant appeal of the Parkinson’s disease drug market. Kelun-Biotech’s successful approval this time will undoubtedly intensify market competition further.
