By Fineline Cube 
Guangdong Taienkang Pharmaceutical Co., Ltd. (SHE: 301263) announced that the National Medical Products Administration (NMPA) has accepted its marketing application for safinamide tablets, approving the drug as a Category 4 chemical product. The decision paves the way for Taienkang’s version of the Parkinson’s disease (PD) adjunctive therapy to reach Chinese patients.
About Safinamide
- Mechanism: Safinamide is a selective monoamine oxidase‑B (MAO‑B) inhibitor that enhances dopaminergic transmission and reduces motor fluctuations in PD.
- Origin: The drug was first developed by Italy’s Zambon Group under the brand name Xadago and is indicated for adults with idiopathic PD who require stable levodopa (L‑dopa) regimens, with or without other PD medications.
- Market Gap: In China, only the originator product is currently approved. Taienkang’s generic has the potential to become the first locally produced safinamide, offering a more affordable option for patients and payers.
Strategic Implications
- Competitive Advantage: The approval positions Taienkang as a key player in the growing Chinese neuro‑pharma market, which is expected to exceed US$5 billion by 2030.
- Pricing & Access: A generic entry could lower treatment costs for the ~1.5 million PD patients in China, potentially boosting market penetration and volume.
- Regulatory Momentum: The Category 4 registration streamlines post‑marketing surveillance and can accelerate the launch of subsequent generic products.
Next Steps
Taienkang plans to initiate a phase‑of‑market launch and distribution strategy in Q4 2025, coordinating with hospitals, neurology clinics, and insurance providers to facilitate reimbursement and patient access. The company also intends to explore collaborative research with academic institutions to further validate safinamide’s efficacy in the Chinese population.-Fineline Info & Tech