The marketing authorization application for Ivabradine Hydrochloride Tablets from Duoduo Pharmaceutical Co., Ltd., a subsidiary of Beijing Zhongguancun Science and Technology Development Holding Co., Ltd., has been accepted by the National Medical Products Administration. The product specification is 5 mg, registered as a Category 4 chemical drug, with acceptance number CYHS2601695. It is indicated for patients with chronic heart failure classified as NYHA class II to IV, with sinus rhythm and a heart rate of 75 beats per minute or higher, accompanied by systolic dysfunction. As of the announcement date, the project has accumulated research and development expenses of 3.6428 million yuan. The company stated that if approved successfully, it will enhance market competitiveness and have a positive impact on business performance, but drug sales are subject to industry policies, market conditions, and other factors, entailing significant uncertainty.
Beijing Centergate Technologies Holding Co LtdSubsidiary's drug application accepted, potential new product approval.