Multiple sclerosis (MS) is a severe, lifelong, progressive, and highly disabling autoimmune chronic disease of the central nervous system (CNS). It commonly affects the periventricular region, juxtacortex, optic nerve, spinal cord, brainstem, and cerebellum, exhibiting spatial and temporal dissemination. Incidence and prevalence are correlated with geographic distribution and ethnicity.
On May 21, 2026, according to the latest information on the official website of the National Medical Products Administration (NMPA) of China, Qilu Pharmaceutical Co., Ltd. 's application for sinimod tablets was approved for marketing. Public information shows that sinimod tablets are a sphingosine-1-phosphate (S1P) receptor modulator used to treat relapsing-remitting multiple sclerosis in adults , including active secondary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, and clinically isolated syndrome. It is worth mentioning that on the same day, Kelun Pharmaceutical's application for sinimod tablets was also approved for marketing , making both pharmaceutical companies the first generic versions of this drug in China on the same day.

Public information shows that siponimod is a new generation of selective sphingosine monophosphate (S1P) receptor modulator. By binding with high affinity to the S1P1 and S1P5 subtype receptors in lymphocytes, it prevents lymphocytes from escaping from lymph nodes, reduces the number of peripheral blood lymphocytes, and thus inhibits their entry into the central nervous system of patients with multiple sclerosis, thereby achieving an anti-inflammatory effect.
Sinimod possesses a unique dual mechanism: on the one hand, it prevents lymphocytes from entering the central nervous system of MS patients, exerting an anti-inflammatory effect; on the other hand , it can directly exert a neuroprotective effect by promoting myelin regeneration in the central nervous system. Compared to first-generation S1P receptor modulators, sinimod exhibits higher selectivity for S1P1 and S1P5 receptor subtypes, a characteristic that may result in better safety profiles while effectively controlling disease progression.

Sinimod (trade name: Mayzent) is a next-generation selective sphingosine monophosphate (S1P) receptor modulator developed by Novartis. Studies have shown that sinimod tablets can prevent neurodegenerative changes at nerve synapses and promote myelin regeneration in the central nervous system (CNS). It has the potential to alter disease progression. In March 2019, it was approved by the FDA in the United States as an oral tablet in 0.25 mg and 2 mg strengths for the treatment of adult patients with relapsing-remitting multiple sclerosis (RMS), including relapsing-remitting disease and active secondary progressive disease (active SPMS).
In May 2020, the original drug , sinimod tablets, was approved for marketing in China under the brand name Wanlineng. It was successfully included in the National Reimbursement Drug List in the same year of approval and transferred to the regular National Reimbursement Drug List in 2024. As a high-value drug for rare diseases, the generic version of sinimod tablets has attracted much attention from the industry . In 2023 and 2024, Kelun Pharmaceutical and Qilu Pharmaceutical submitted marketing applications for sinimod tablets, respectively . After more than two years, Kelun and Qilu successfully obtained approval on May 21, 2026, becoming the first domestic manufacturers and the first generic manufacturers to achieve this milestone.
Multiple sclerosis (MS) is a disease characterized by chronic inflammatory autoimmune reactions in the central nervous system. Its pathological mechanism involves the immune system's attack on the myelin sheath of nerve fibers, leading to impaired nerve signal transmission. MS typically presents with recurrent episodes, and as the disease progresses, most patients experience irreversible neurological damage, even leading to lifelong disability, placing a heavy physical and psychological burden and economic loss on patients and their families.
It is understood that there are currently as many as 14 approved drugs for the treatment of multiple sclerosis (each type of beta-interferon is counted as one), while my country has only approved 4 DMT drugs, including interferon beta-1b, teriflunomide, fingolimod, and sinimod. Therefore, improving the accessibility and treatment rate of DMT drugs for multiple sclerosis in China is particularly important and urgent.
Sinimod, a drug with significant selectivity and affinity for sphingosine 1-phosphate receptor (S1PR) types 1 and 5, treats multiple sclerosis (MS) primarily through its S1PR-dependent mechanism. Sinimod reduces central inflammatory responses and improves neurodegenerative changes by inhibiting lymphocyte influx into the central nervous system and promoting myelin regeneration.
This time, the sinimod tablets submitted by Kelun Pharmaceutical and Qilu Pharmaceutical were successfully approved for marketing , becoming the first domestic manufacturer and the first generic version to receive such approval on the same day. This not only breaks Novartis' monopoly but also provides more treatment options for MS patients.

https://mp.weixin.qq.com/s/EBOGUiJ3IUPJDUW5mJJvKg