According to the official website of NMPA, Zambon/Parexel Pharmaceuticals' Safinamide Mesylate Tablets have been approved for marketing. According to public information, Safinamide is a drug used to treat Parkinson's disease.

Parkinson's disease is the second most common neurodegenerative disease and a common activity disorder. Its main cause is a lack of dopamine. According to statistics, about 1-2% of people over 65 years old suffer from Parkinson's disease worldwide. In China, there are more than 3 million Parkinson's disease patients, and the incidence rate increases with age. It is predicted that the number of Parkinson's patients in China will exceed 5 million in 2030.

The "OFF" period is a common phenomenon in the middle and late stages of Parkinson's disease. Patients usually show severe aggravation of symptoms such as muscle stiffness, tremor and movement difficulties. According to statistics, about 75% of Parkinson's patients in the middle and late stages will have motor complications such as switching phenomenon and end-of-dose phenomenon. Among them, 40%-60% of Parkinson's patients will experience OFF events, and the frequency and severity of their attacks will continue to worsen as the disease progresses, which is a heavy burden for family members and caregivers.

Safinamide mesylate tablets are a selective inhibitor of monoamine oxidase type B (MAO-B). It selectively and reversibly inhibits monoamine oxidase B (MAO-B) and blocks voltage-dependent sodium channels through a unique mechanism of action, effectively regulating abnormal glutamate release, providing new possibilities for the treatment of patients. Safinamide was approved in Europe in February 2015 and in the United States by the FDA in 2017 for Parkinson's patients with "off-period" attacks.

It is understood that Zambon has the right to develop and commercialize Xadago worldwide (except Japan and certain key regions where Meiji Seika is responsible), and Zambon has granted the development and commercialization rights of Xadago in the United States to US worldmed.

The successful approval of safinamide mesylate tablets in China will bring new options to millions of Parkinson's patients.