Beijing News (Reporter Kalu Wang) At the beginning of the new year, Qilu Pharmaceutical submitted the market application for the rare disease drug Siponimod Tablets, competing for the "first generic" of this variety. This is also the first product that Qilu Pharmaceutical has applied for marketing this year, used to treat multiple sclerosis.
Siponimod tablets are a sphingosine-1-phosphate (S1P) receptor modulator, originally developed by Novartis. In 2019, siponimod tablets were approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis, including active secondary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, and clinically isolated syndrome. In 2021, global sales of siponimod tablets reached $280 million, representing a 65% year-over-year increase; in 2022, sales reached $400 million, marking a 27% year-over-year growth.
In May 2020, the National Medical Products Administration approved the original drug Siponimod tablets (trade name: Mayzent) for marketing through a priority review and approval process. With China's increasing attention to rare diseases and continuously optimized medical insurance policies, Siponimod tablets were included in the National Reimbursement Drug List in the same year of its approval, leading to a surge in sales. Data from CIC OPEN shows that the total sales of Siponimod tablets in the Chinese market were 30.22 million yuan, 84 million yuan, and 39.71 million yuan for the years 2021, 2022, and the first half of 2023, respectively.
Kelon Pharmaceutical is the first company in China to submit a generic drug marketing application for Siponimod Tablets, which was accepted by the Center for Drug Evaluation of the National Medical Products Administration on February 7, 2023. Qilu Pharmaceutical is the second company to submit a generic drug application for this product, forming a "first-to-market" competition with Kelon Pharmaceutical.
In recent years, driven by policies, the registration threshold for generic drugs has been raised, with strong policy support for high-quality generics, leading to a major market reshuffle. Varieties with large market sizes, fewer competitors, and high barriers to imitation have become key targets for leading pharmaceutical companies. "First-to-market generics" attract numerous top pharmaceutical firms due to favorable policies and market share advantages. Once successfully securing the "first-to-market" status, companies can leverage price advantages to quickly capture the original drug’s market. For varieties still under patent protection, first-to-market generics that succeed through patent challenges and gain approval can enjoy a 12-month exclusive market period, allowing them to compete directly with the original drug.
On the "first generic drug" track, Qilu Pharmaceutical has shown outstanding performance. In 2023, Qilu Pharmaceutical obtained the domestic "first generic" for five chemical drug generics in China: Olaparib Tablets, Pazopanib Tablets, Injectable Octreotide Acetate Microspheres, Dolutegravir Sodium Tablets, and Paliperidone Palmitate Injection. In terms of the number of "first generics," Qilu Pharmaceutical ranks second alongside Zhengda Tianqing, with just one less than Kelun Pharmaceuticals, which ranks first.
Proofread by Zhai Yongjun