FUSEN PHARM (01652) announced that its wholly-owned subsidiary, Henan FUSEN PHARM, has received approval from China's National Medical Products Administration for the generic drug application of "Nicardipine Hydrochloride Injection." The injection is approved for emergency treatment of abnormal hypertension during surgery and hypertensive emergencies.

According to data from Menet, the sales of Nicardipine Hydrochloride Injection in China's public medical institutions exceeded RMB 600 million in 2024. The market has expanded rapidly in recent years, with double-digit growth rates maintained from 2022 to 2024—35.71%, 16.09%, and 14.14%, respectively.

Nicardipine Hydrochloride is a novel dihydropyridine calcium antagonist that selectively dilates arteries, enabling rapid and stable control of hypertensive emergencies. The injection is recommended as a first-line treatment in specific hypertension management scenarios by the 2020 International Society of Hypertension's Global Hypertension Practice Guidelines and is also the most widely recommended intravenous antihypertensive drug in China's Guidelines for the Diagnosis and Treatment of Hypertensive Emergencies.

The drug offers advantages such as rapid onset, stable blood pressure reduction, comprehensive organ protection, non-toxic metabolites, high vascular selectivity, minimal cardiac impact, and balanced perfusion control. FUSEN PHARM's 5ml:5mg formulation has been marketed in China for years with strong market recognition. The newly approved 2ml:2mg and 10ml:10mg specifications make FUSEN PHARM one of the few domestic companies with a complete range of formulations, catering to diverse patient needs.

The quality and efficacy of FUSEN PHARM's Nicardipine Hydrochloride Injection are consistent with the reference drug, making it a viable substitute for the original patented product. The injection demonstrates highly favorable prospects in treating acute hypertension during surgery and hypertensive emergencies.