Qilu Pharmaceutical's Safinamide Mesylate Tablets (Shenkening®) Approved in China as First Domestic Third-Generation MAO-B Inhibitor for Parkinson’s Disease

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Correspondence! Recently,The National Medical Products Administration Approved Qilu Pharmaceutical's Parkinson's Disease Treatment Drug—Safinamide Mesylate Tablets(Shenkening®, 50 mg and 100 mg strengths)Approved for marketing, and deemed to have passed the consistency evaluation of quality and efficacy for generic drugs.

As a major innovative drug in the global Parkinson’s disease treatment landscape over the past decade, the recent formal approval of domestically produced safinamide tablets not only marks the arrival of a high-quality Chinese-made alternative but also significantly reduces patients’ financial burden and breaks through the therapeutic impasse associated with motor fluctuations in mid-to-late stage disease.

In the treatment of Parkinson’s disease, levodopa remains the irreplaceable gold standard. However, as the disease progresses and with long-term medication use, many patients begin to suffer from “end-of-dose phenomena” (shortened duration of therapeutic effect) or “on-off phenomena” (fluctuations between sudden symptom relief and worsening).

Safinamide, a third-generation reversible and highly selective MAO-B (monoamine oxidase B) inhibitor, was specifically developed to address this clinical challenge. Leveraging its unique “dual mechanism of action,” it is internationally recognized as a leading preferred option for managing symptom fluctuations:

1. Precise Symptom Control: Prolonging "On" Time

Safinamide efficiently inhibits MAO-B enzyme in the brain, reduces dopamine degradation, and steadily elevates and maintains dopamine levels in the brain. Clinical studies have shown that it can effectively reduce patients' "off" time and significantly improve motor fluctuations.

2. Dual Mechanism: Neuroprotection and Improvement of Non-Motor Symptoms

Unlike traditional drugs in the same class, safinamide not only acts on the dopamine system but also precisely regulates glutamate release. This non-dopaminergic mechanism helps protect neuronal function and simultaneously improves non-motor symptoms commonly associated with the condition, such as depression, fatigue, and cognitive impairment, thereby comprehensively enhancing quality of life.

In the past, due to issues with target specificity, patients taking traditional first- or second-generation MAO-B inhibitors often had to strictly limit their intake of tyramine-containing foods (such as cheese, red wine, and fermented soy products) during treatment; otherwise, they risked triggering a hypertensive crisis.

As a third-generation innovative drug, safinamide mesylate tablets offer higher target specificity and safety:

Qilu Pharmaceutical R&D Personnel Conduct Formulation and Process Research

Since the launch of this project in 2022, Qilu Pharmaceutical’s R&D team has benchmarked against the highest international quality standards, overcoming technical challenges such as a high proportion of active pharmaceutical ingredients (APIs), poor powder flowability, and insufficient stability in formulation processes.

Comprehensive testing and verification demonstrate that the domestically produced Safinamide Mesylate Tablets are fully equivalent to the originator drug in terms of various in vitro quality indicators and are clinically safe and therapeutically equivalent.

The approval and market launch of Shenkening® marks another significant milestone in the pipeline of domestically produced neurological drugs. With the wider availability of high-quality, affordable domestic medications, patients with mid-to-late stage Parkinson’s disease now have a more potent weapon and a more cost-effective option in their fight against “motor fluctuations.” We also look forward to the drug’s early inclusion in centralized clinical procurement and the national medical insurance program, thereby truly benefiting the vast number of Parkinson’s patients and their families.

Disclaimer:This article is intended solely for sharing frontier medical information and does not constitute any clinical medication advice. For specific treatment and medication adjustments, patients must strictly follow their physician’s instructions.。