Tuoxin Pharmaceutical Group Co., Ltd. (301089.SZ) announced that its wholly-owned subsidiary, Xinxiang Pharmaceutical Co., Ltd., has received the"Chemical Drug API Listing Approval Notice"issued by the National Medical Products Administration for the safinamide mesylate active pharmaceutical ingredient (API).

Safinamide mesylate is a selective inhibitor of monoamine oxidase B (MAO-B), primarily used in patients with mid-to-late-stage Parkinson's disease. Its core mechanism involves inhibiting MAO-B and blocking voltage-dependent sodium channels to regulate glutamate release.

The approved indication is for the treatment of adult patients with idiopathic Parkinson's disease (PD), as an add-on therapy to a stable dose of levodopa (L-dopa), either alone or in combination with other PD treatments, specifically for patients experiencing mid-to-late-stage motor fluctuations.