Xinhua Pharmaceutical Gains Regulatory Nod for Nimodipine Tablets, Bolstering Competitive Position

Bulletin Express10-19 18:20

Shandong Xinhua Pharmaceutical Company Limited (“Xinhua Pharmaceutical”) has secured approval from China’s National Medical Products Administration for its 30 mg Nimodipine Tablets, confirming that the product has passed the Consistency of Quality and Efficacy Evaluation for Generic Drugs. The supplementary drug application, filed in July 2025 under case number CYHB2550245, received formal clearance on 19 October 2026 via Notification No. 2026B07058.

Nimodipine Tablets serve as continuation therapy following nimodipine injections to prevent and treat ischemic nerve injury caused by cerebral vasospasm after aneurysmal subarachnoid hemorrhage. The product is also indicated for age-related brain dysfunction, including memory loss, disorientation, attention disorders and mood swings, provided other underlying conditions have been ruled out.

The formulation is listed as a Category A medicine in the 2025 National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance, supporting broad reimbursement coverage. According to industry data cited in the announcement, sales of Nimodipine Tablets within China’s public medical institutions reached approximately RMB130 million in 2025.

Management expects the successful generic consistency evaluation to enhance the drug’s market competitiveness. Nevertheless, the company cautions that domestic pharmaceutical policies, centralized procurement dynamics and broader market conditions may influence actual commercial outcomes, warranting investor vigilance regarding related uncertainties.

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