SHANDONG XINHUA (00719.HK): Nimodipine Tablets Pass Generic Drug Consistency Evaluation

NewTimeSpace News: On 19 October 2026, Shandong Xinhua Pharmaceutical Company Limited (the "Company") published an overseas regulatory announcement reproducing its announcement on nimodipine tablets passing the generic drug consistency evaluation, as published on CNINFO. The Company recently received the Approval Notice of Supplementary Drug Application for nimodipine tablets issued by the National Medical Products Administration, confirming that the product has passed the generic drug quality and efficacy consistency evaluation.

The announcement disclosed the basic product information: the drug name is nimodipine tablets; the dosage form is tablets; the specification is 30mg; the drug classification is prescription drug; the applicant is Shandong Xinhua Pharmaceutical Company Limited; the application matter is generic drug quality and efficacy consistency evaluation; the acceptance number is CYHB2550245; the original drug approval number is Guoyaozhunzi H10910081; the notice number is 2026B07058; and the approval conclusion is that the product has passed the generic drug quality and efficacy consistency evaluation. In July 2025 the Company submitted the consistency evaluation filing to the Center for Drug Evaluation of the NMPA, which was accepted, and in October 2026 it obtained the Approval Notice of Supplementary Drug Application.

The Company stated that the product, as continuation therapy after prior use of nimodipine injection, can prevent and treat ischaemic neurological damage caused by cerebral vasospasm following aneurysmal subarachnoid haemorrhage; it can also be used to treat senile cerebral dysfunction, such as memory impairment, disorientation, attention deficits and mood swings, with underlying diseases requiring specific treatment to be ruled out before treatment. The product is a Class A item in the National Catalogue of Medicines for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2025). According to relevant statistics, sales of nimodipine tablets at public medical institutions in China were approximately RMB 130 million in 2025. The Company said the passing of the evaluation will help enhance its market competitiveness, though pharmaceutical sales are subject to uncertainty from changes in domestic industry policy, tendering and procurement, and market conditions.