Recently, Salubris announced that Fu Li An^® (Alisartan /Indapamide Extended-Release Tablets), China’s first ARB + thiazide-like diuretic fixed-dose combination antihypertensive drug, has obtained the drug registration certificate issued by NMPA.

Fu Li An^® is indicated for essential hypertension and represents China’s first domestically developed ARB/diuretic fixed-dose extended-release formulation (Project Code: SAL0108) ^[1]. The combination of Alisartan and Indapamide reduces adverse reactions associated with diuretics (e.g., hypokalemia and elevated uric acid). It is clinically suitable for salt-sensitive hypertension, elderly and very elderly hypertension, isolated systolic hypertension, hypertension with diabetes, obesity, or metabolic syndrome, chronic heart failure^[1-4].

Phase III clinical trial results showed that at Week 12 of the double-blind treatment period, the mean sitting systolic blood pressure (msSBP) in the combination therapy group decreased by 15.22 mmHg from baseline. At Weeks 20, 28, and 40 of the extended treatment period, the msSBP in the combination therapy group decreased by 20.42 mmHg, 21.70 mmHg, and 26.19 mmHg from baseline respectively. The further increase in blood pressure reduction suggests that long-term treatment can further optimize blood pressure control ^[2].

Following its market launch, Fu Li An^® will strategically target different segments of hypertensive patients. It will form a complementary strategy with Xin Li Tan^® (Allisartan Isoproxil Tablets), Xin Chao Tuo^® (Sacubitril and Valsartan Calcium Tablets), and Fu Li Tan^® (Allisartan Isoproxil and Amlodipine Tablets) in terms of applicable patient populations and related disease areas. This approach aims to meet more clinical needs, benefit a broader patient population, and further enhance the company's overall competitiveness in the field of cardiovascular chronic disease treatment^[1].

References:

[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement Regarding Obtaining the Drug Registration Certificate for Allisartan Isoproxil and Indapamide Sustained-release Tablets (Fuli'An^®).
[2] Phase III Clinical Trial of Allisartan Isoproxil and Indapamide Sustained-release Tablets.
[3] Indapamide Sustained-release Tablets Package Insert.
[4] Indapamide Conventional Tablets Package Insert.