Shanghai Shyndec's Enalapril Maleate Tablets pass consistency evaluation

Shanghai Shyndec Pharmaceutical (SSE:600420) announced that its Enalapril Maleate Tablets (5mg) have passed the generic drug quality and efficacy consistency evaluation. This was confirmed by a "Drug Supplementary Application Approval Notice" from the National Medical Products Administration. The 10mg version received approval in January 2022. The 5mg tablets are indicated for primary hypertension, renovascular hypertension, and symptomatic heart failure.

The company stated that the product's original approval number is H31021937, with Shanghai Shyndec Pharmaceutical serving as both the marketing authorization holder and manufacturing enterprise. The cumulative research and development investment for this project reached approximately RMB 15,365,700.

Passing this evaluation is expected to benefit the future market expansion and sales of the product. The company noted that the drug's sales may be affected by industry policies, tender procurements, and market conditions, introducing uncertainty. According to the Minnet database, national sales of Enalapril Maleate Tablets in public medical institutions and urban pharmacies reached RMB 164m in 2024.