Two New Drug Varieties (Three Specifications) of SSY Group Obtain Approval

On June 22, two new pharmaceutical varieties with three specifications independently developed by SSY Group obtained production registration approvals issued by the National Medical Products Administration (NMPA), and were deemed to have passed the Consistency Evaluation of Quality and Efficacy of Generic Drugs. The products include Class 4 chemical drug Safinamide Mesylate Tablets (100mg, 50mg) and Class 3 chemical drug Procaterol Hydrochloride Inhalation Solution (0.3ml:30μg). Since the beginning of this year, the Group has received approval documents for a total of 48 new pharmaceutical products of various types.

Safinamide Mesylate Tablets are indicated for adjunctive treatment in adult patients with idiopathic Parkinson’s disease accompanied by motor fluctuations (including end-of-dose deterioration and on-off phenomena), to be used in combination with levodopa alone or levodopa plus other anti-Parkinson medicines. Procaterol Hydrochloride Inhalation Solution is mainly used to relieve airflow limitation-related symptoms associated with bronchial asthma, chronic bronchitis and emphysema.

Focused on addressing clinical demands and public healthcare needs, SSY Group has stepped up R&D of targeted medicines for geriatric disorders covering cardiovascular and nervous system diseases in recent years. Its product pipeline and reserve portfolio keep expanding, forming a complete series of anti-Parkinson preparations represented by Carbidopa-Levodopa Sustained-release Tablets, Rasagiline Mesylate Tablets, Entacapone Tablets, Entacapone-Levodopa-Carbidopa Tablets (II), Levodopa-Benserazide Tablets and Safinamide Mesylate Tablets. Supported by the integrated industrial advantages of APIs plus finished preparations, the Safinamide Mesylate API developed by the Group’s subsidiary Guolong Pharmaceutical has been upgraded to Registration Status A at the Center for Drug Evaluation (CDE) of NMPA, laying a solid foundation for the development and commercialization of the corresponding finished tablets.

Meanwhile, the Group continues to expand its lineup of inhalation preparations for respiratory disorders. Multiple formulations have previously secured regulatory approvals, including Terbutaline Sulfate Nebulizer Solution, Ipratropium Bromide Inhalation Solution, Formoterol Fumarate Inhalation Solution, Levosalbutamol Hydrochloride Nebulizer Solution, and Procaterol Hydrochloride Inhalation Solution (0.5ml:50μg). The diversified product portfolio offers abundant treatment options for medical markets and further consolidates the Group’s distinctive strengths in the respiratory therapeutic segment.

Up to the present, a total of 189 varieties and 253 specifications of the Group’s products have passed or been deemed to pass the Consistency Evaluation of Quality and Efficacy of Generic Drugs.