Forson Pharmaceutical (01652): “Nicardipine hydrochloride injection” consistency evaluation application approved for listing

According to Zhitong Finance App, Fuson Pharmaceutical (01652) issued an announcement. The consistency evaluation application for the “nicardipine hydrochloride injection” developed by Henan Fuson Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the Group, has been approved by the China National Drug Administration for emergency treatment of abnormal high blood pressure during surgery and emergency cases of hypertension.

According to data from the Mi Intranet, in 2024, the terminal sales scale of nicardipine hydrochloride injections exceeded 600 million yuan in public medical institutions in China. In recent years, the sales scale of the six major markets of the three major terminals in China expanded rapidly. From 2022 to 2024, the double-digit growth rate was maintained, with year-on-year increases of 35.71%, 16.09%, and 14.14%, respectively.

Nicardipine hydrochloride is a novel dihydropyridine calcium ion antagonist. It is a highly selective arterial dilator to achieve rapid and smooth control of acute hypertension. Nicardipine hydrochloride injection is a first-line treatment recommended by the 2020 International Society of Hypertension's “Global Hypertension Practice Guidelines” for specific high blood pressure management conditions. It is also the first-line intravenous antihypertensive drug recommended by the “China Hypertension Emergency Diagnosis and Treatment Code” for the widest range of diseases, and has been recommended by many domestic and foreign guidelines.

Nicardipine hydrochloride injection has the advantages of rapid effect, stable blood pressure reduction, more thorough target organ protection, non-toxic metabolites, safe application, stronger vascular selectivity, no effect on heart rhythm, safer myocardium, and dual balance of antihypertensive infusion. The 5ml:5mg specification of nicardipine hydrochloride injection developed by the Group has been sold in the Chinese domestic market for many years and has a high degree of market recognition. The specifications approved during the same period include 2ml: 2mg and 10ml: 10mg. Fussen Pharmaceutical is currently one of the companies with the most complete specifications for this product in China, which can meet the treatment needs of different patients at the same time. The quality and efficacy of the nicardipine hydrochloride injection held by Fussen Pharmaceutical are consistent with the reference preparation, and can clinically replace the original drug. Nicardipine hydrochloride injections have shown very favorable prospects in emergency treatment of abnormal high blood pressure during surgery and emergency cases of high blood pressure.