In August 2026, the European Society of Cardiology Congress (ESC 2026) was held in Munich, Germany. Professor Li Jianping from Peking University First Hospital presented the results of the Phase III clinical study SALUS in the "Late-Breaking Clinical Science" session.[1] The SALUS study demonstrated that sacubitril/allisartan calcium plus amlodipine, as the world's first fixed-dose single-pill combination of an angiotensin receptor-neprilysin inhibitor (ARNI) and a calcium channel blocker (CCB), provides significant antihypertensive efficacy and a favorable safety profile. It is expected to offer a novel, mechanism-synergistic, and convenient treatment option for hypertensive patients who have long relied on multiple-drug combinations and have poor medication adherence.
The SALUS study comprised two randomized, double-blind, multicenter Phase III trials, SALUS-A and SALUS-B, enrolling over 700 hypertensive patients aged 18 to 75 years who had shown an inadequate response to amlodipine or sacubitril/allisartan calcium monotherapy. The primary endpoint was the change from baseline in mean sitting systolic blood pressure after 12 weeks of treatment.[2]
In terms of efficacy, after 12 weeks of combination therapy with sacubitril/allisartan calcium plus amlodipine, the reduction from baseline in systolic/diastolic blood pressure was 21.31/6.53 mmHg in the SALUS-A trial and 23.59/7.49 mmHg in the SALUS-B trial, both superior to the respective monotherapy groups (amlodipine or sacubitril/allisartan calcium). The response rate and control rate of blood pressure were also significantly higher in the combination groups than in the monotherapy groups. Ambulatory blood pressure monitoring showed that the antihypertensive advantage of the combination therapy was sustained throughout the day and during nighttime hours. Regarding safety, the incidence of adverse events was similar between the combination and monotherapy groups, and long-term administration did not show an increasing trend in adverse events with extended treatment duration, indicating good safety and tolerability of the fixed-dose combination.
In an interview with Cardio-Renal-Metabolic News, Professor Li Jianping noted that over 30% of hypertensive patients in clinical practice receive ARNI combined with CCB therapy. Although various fixed-dose combinations of ARBs (e.g., A+B, A+C, A+D) are available, there is currently no ARNI+CCB fixed-dose single-pill formulation internationally.[1] Sacubitril/allisartan calcium and amlodipine is a global first-in-class product, with complementary mechanisms of action between ARNI and CCB. Their combination is a recommended antihypertensive regimen in the Chinese Guidelines for the Management of Hypertension (2024 Revision).[3] As the world's first ARNI+CCB fixed-dose single-pill combination, this product has been confirmed to be bioequivalent in pharmacokinetics to the free combination of the two agents in a single-dose, two-sequence, four-period, fully replicated crossover design study. Patients need only take one tablet daily, which can effectively reduce the likelihood of missed doses and help improve long-term medication adherence.[4]
In July 2026, the new drug application for sacubitril/allisartan calcium and amlodipine tablets was formally accepted by the National Medical Products Administration for review. Upon approval and market launch, it is expected to provide a new treatment option for patients, improve adherence, address unmet clinical needs, and further enrich the company's innovative product pipeline in the cardiovascular-kidney-metabolic (CKM) syndrome therapeutic area, with a strategic focus on cardiovascular and cerebrovascular diseases.
References：
[1] Direct Coverage of ESC 2026 | Professor Li Jianping Interprets the SALUS Study: The Pathbreaking Journey of the World's First ARNI+CCB Single-Pill Fixed-Dose Combination. https://mp.weixin.qq.com/s/jFRGTKiggpQcNnUN4iiNLg
[2] Clinical Study Report on the Combination Therapy of Sacubitril/Allisartan Calcium and Amlodipine in Phase III Trials.
[3] Chinese Hypertension Prevention and Treatment Guidelines Revision Committee, et al. Chinese Guidelines for the Management of Hypertension (2024 Revision). Chinese Journal of Hypertension, 2024, 32(7):603-700.
[4] Bioequivalence Study Report of Sacubitril/Allisartan Calcium and Amlodipine Fixed-Dose Combination Tablet versus Free Combination of Sacubitril/Allisartan Calcium Tablet and Amlodipine Besylate Tablet.
|About Salubris
Salubris is an innovative,international pharmaceutical company that integrates R&D,manufacturing,and sales.We remain committed to the mission of"providing excellent pharmaceutical products for human health"and focus on the chronic disease area of cardiovascular-kidney-metabolic(CKM) syndrome,safeguarding life and health.Our marketed novel drugs include Xinlitan®(for hypertension),XinchaoTuo®(for hypertension),Fulitan®and Fuli'an®(for hypertension),Ennaluo® (for renal anemia),and Xinliting®(for type 2 diabetes mellitus).
Globally,Salubris has established five innovative drug R&D centers and three medical device R&D bases.It has also built innovation platforms covering small molecules,peptides/cyclic peptides,antibody-based biologics,siRNA oligonucleotides,in vivo gene editing,AIDD(AI-driven drug discovery),and medical devices,all aimed at addressing unmet clinical needs.
