Shenzhen Salubris Pharmaceuticals Co.,Ltd. (002294.SZ) announced that the company recently received an acceptance notice issued by the National Medical Products Administration. The clinical trial application for a new indication of the company's independently developed innovative small molecule drug SAL0140 tablets (project code: SAL0140) has been accepted for review.
SAL0140 is an aldosterone synthase inhibitor with independent intellectual property rights owned by the company. The planned indications for development include uncontrolled hypertension (including resistant hypertension), chronic kidney disease (CKD), and primary aldosteronism. Currently, SAL0140 for uncontrolled hypertension is about to commence Phase II clinical trials.
Aldosterone is the most important mineralocorticoid hormone in the human body, maintaining fluid and electrolyte balance while directly participating in target organ damage in various cardiovascular and kidney diseases. Primary aldosteronism is caused by autonomous excessive secretion of aldosterone from the zona glomerulosa of the adrenal cortex, leading to sodium retention and potassium excretion in the body, increased blood volume, and suppressed renin-angiotensin system activity. The main clinical characteristics include hypertension, cardiovascular damage, sodium retention, and frequently occurring hypokalemia, making it one of the common causes of secondary hypertension.
Primary aldosteronism accounts for 5% to 15% of the hypertensive population. Among newly diagnosed hypertensive patients, the prevalence of primary aldosteronism exceeds 4%, and the prevalence rate increases with rising blood pressure levels, accounting for approximately 20% of patients with resistant hypertension. Compared to patients with essential hypertension, those with primary aldosteronism experience more severe target organ damage and higher cardiovascular disease risk.
Aldosterone synthase inhibitors are expected to directly inhibit aldosterone synthesis, reduce aldosterone levels in patients with primary aldosteronism, thereby lowering blood pressure and organ damage, demonstrating significant development potential.
If SAL0140 can be successfully developed and approved for market launch, it is expected to provide targeted new medication options for patients in more specialized fields, meet unmet clinical needs, and further enrich the company's innovative product pipeline in the chronic disease sector.
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