SHANDONG XINHUA Receives Approval Notice for Benserazide Hydrochloride API

Stock News05-08

SHANDONG XINHUA (00719) has announced that it recently received the "Chemical Drug Substance Marketing Authorization Approval Notice" for Benserazide Hydrochloride from the National Medical Products Administration. In September 2024, SHANDONG XINHUA submitted the application dossier for the domestic production of Benserazide Hydrochloride as a chemical drug substance to the Center for Drug Evaluation of the NMPA, which was accepted. The approval notice was obtained in May 2026, with the review conclusion approving the production of this product. Benserazide Hydrochloride is a peripheral decarboxylase inhibitor. It is used in combination with Levodopa to form the compound preparation "Levodopa and Benserazide Hydrochloride". The NMPA has approved two dosage forms of this compound: Levodopa and Belserazide Hydrochloride Tablets and Levodopa and Benserazide Hydrochloride Capsules. The tablets are indicated for the treatment of Parkinson's disease and symptomatic Parkinson's syndrome, excluding drug-induced Parkinsonism. The capsules are used for Parkinson's disease and Parkinson's syndrome. The preparation containing this drug substance is classified as a Category A product in the National Reimbursement Drug List. According to relevant statistics, the sales of Levodopa and Benserazide Hydrochloride related preparations in Chinese public medical institutions in 2025 were approximately RMB 1.4 billion.

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