ByFebruary 7, 2022, the enrollment of all subjects was completed according to thePhase III clinical protocol of Salubris Allisartan Isoproxil Amlodipine Tablets(Project Code: SAL0107), and the clinical follow-up would be continuedsubsequently. Salubris will carry out the clinical trial in accordance with thenational drug registration regulations and requirements, and will apply forproduction after succeeding in the clinical trial.
SAL0107is an ARB/CCB compound preparation, andthe indication is primary hypertension.
Hypertensionis a common chronic disease. The domestic and foreign practices show thathypertension is preventable and controllable, and reduction of blood pressurelevel in the patients with hypertension can significantly improve the qualityof life of patients.
Afterthe product is marketed, it will form strategic collaboration with Xinlitan(Allisartan Isoproxil Tablets), marketed Class 1.1 antihypertensive of Salubristo enrich the innovative product line of the company in the cardiovascularfield.
Thereis close causal relationship between the blood pressure level and the risk ofcardiovascular attack and death. In the meta analysis of perspectiveobservational study based on the global 61 populations (about 1 millionpersons, aged 40~89), upon average follow-up for 12 years, the clinic systolicblood pressure or diastolic blood pressure showed continuous, independent anddirect positive correlation with the risk of stroke and coronary heart diseaseevents. The risk of cardiovascular complication was doubled when the bloodpressure was increased from 115/75mmHg to 185/115 mmHg (the systolic bloodpressure was increased by 20mmHg or the diastolic blood pressure was increasedby 10 mmHg). In the Asia-Pacific cohort study (APCSC) including 13 populationsin China, the clinic blood pressure level was also closely correlated with therisk of stroke and coronary heart disease events; moreover, compared with theAustralian and New Zealand populations, the correlation between the bloodpressure elevation and the risk of stroke and coronary heart disease events wasstronger in the Asian population. With elevation of systolic blood pressure by10mmHg, the risk of stroke and fatal myocardial infarction in the Asianpopulation was increased by 53% and 31% respectively.
Thelong-term follow-up also found that the incidence of end-stage renal disease(ESRD) was significantly increase with the clinic blood pressure elevation. Theincidence of ESRD in patients with severe hypertension was more than 11 timesof that in patients with normal blood pressure, even if the blood pressure wasup to 1.9 times of the normal high level.
—— Guidelines for Prevention and Treatment ofHypertension in China
