Parkinson's disease is a common neurodegenerative disease that causes great inconvenience to patients' lives. Especially in the middle and late stages, patients often face severe deterioration of motor function, such as recurrent episodes of muscle stiffness, tremors, and difficulty moving, which greatly reduces their quality of life.
On June 9, 2026 , according to the latest information on the official website of the National Medical Products Administration ( NMPA ) of China, salfedipine mesylate tablets , submitted by Qilu Pharmaceutical Co., Ltd. under Category 4 of chemical drug registration , were approved for marketing and are considered to have passed the evaluation. It is mainly used to treat idiopathic Parkinson's disease in patients who experience motor fluctuations after receiving stable doses of levodopa.
Safinamide mesylate tablets are a selective inhibitor of monoamine oxidase type B (MAO-B) with a unique mechanism of action that reduces dopamine degradation and regulates glutamate release, thereby improving motor symptoms in patients with Parkinson's disease.
From the perspective of mechanism of action, salfedipine belongs to the third generation of monoamine oxidase B (MAO-B) inhibitors. Compared with the first and second generation MAO-B inhibitors, salfedipine has higher selectivity for MAO-B and its effect is reversible. The physiological activity of MAO-B can be fully restored 8 hours after drug withdrawal.
Clinical studies have shown that salfedipine mesylate can significantly improve motor symptoms in Parkinson's disease patients, such as bradykinesia, rigidity, resting tremor, and gait disturbance. Phase III clinical trial results (XINDI study) showed that the drug reduced the Unified Parkinson's Disease Rating Scale (UPDRS III) score by 3.8 points, effectively shortened the "off" period by 1.1 hours, and prolonged the "on" period by 1.07 hours.Sulfoamide mesylate tablets were originally developed by the Italian pharmaceutical company Zambon SpA and were first approved in Europe in February 2015. In March 2017, it received FDA approval in the United States, becoming the first new chemical entity approved in the US for the treatment of Parkinson's disease in over a decade. It was successfully approved for marketing in China in December 2024, primarily for the combination treatment of adult patients with primary Parkinson's disease and fluctuating symptoms (such as end-of-dose exacerbations and on-off phenomena), and can be used in combination with levodopa or other Parkinson's disease medications.Regarding the domestic generic drug situation, on May 21, 2026, Kelun Pharmaceutical's application for salfedipine mesylate tablets was approved for marketing, becoming the first generic version in China. Qilu Pharmaceutical is now the second domestic company to receive approval for this drug. According to the latest information from the CDE (Center for Drug Evaluation), over 20 pharmaceutical companies in China, including Beijing Xinghao Pharmaceutical, Nanjing Chia Tai Tianqing Pharmaceutical , Shijiazhuang No. 4 Pharmaceutical, Sichuan Kelun Pharmaceutical, Qilu Pharmaceutical , CR Saike , and Kang Enbei , have submitted marketing applications for salfedipine mesylate tablets , all of which are currently under review, indicating extremely fierce competition.Parkinson's disease (PD) is the second leading cause of neurodegenerative disease worldwide, affecting a large number of people. With China's accelerating aging population, the number of people suffering from PD is increasing year by year. PD is a slowly progressing neurodegenerative disease characterized by high disability rates and high treatment costs.Sulfomethonium mesylate tablets have a dual mechanism of action. On the one hand, they can effectively inhibit MAO-B, reduce dopamine metabolism, and increase dopamine levels in the brain. On the other hand, they can inhibit the excessive release of glutamate and reduce neuronal overexcitation by blocking sodium ion channels and inhibiting the opening of calcium ion channels. They have a significant effect on improving both motor and non-motor symptoms in patients with Parkinson's disease.Furthermore, clinical studies have shown that salfedipine mesylate has a high safety and tolerability, with no significant difference in the incidence of adverse events compared to the placebo group. Real-world research data also indicate that this drug has good safety in special populations such as the elderly, providing strong support for its clinical application.The successful approval of Qilu Pharmaceutical's salfedipine mesylate tablets for marketing will undoubtedly provide more treatment options for patients.

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