Recently, Salubris announced that its novel hypertension drug Xin Chao Tuo (Sacubitril Alisartan Calcium Tablets) has obtained drug registration certification issued by NMPA.
Xin Chao Tuo (Sacubitril Alisartan Calcium Tablets) is an ARNI (Angiotensin Receptor Neprilysin Inhibitor) drug independently developed by Salubris. The approved indication is essential hypertension. As China’s first domestically developed and the world’s second approved ARNI-class drug, Xin Chao Tuo holds compound patent protection until 2037 [1].
The mechanism of ARNI drugs involves inhibiting neprilysin-mediated degradation of natriuretic peptides, thereby promoting diuresis, natriuresis, vasodilation, and antisympathetic effects. Concurrently, its angiotensin receptor blockade prevents compensatory activation of RAS following neprilysin inhibition, resulting in synergistic blood pressure reduction [2].
The Chinese Hypertension Prevention and Treatment Guidelines have classified ARNI as a new category of first-line antihypertensive drugs for both initial and maintenance therapy, distinct from the traditional five major classes of hypertension medications [2]. The Chinese Expert Consensus on Nocturnal Hypertension Management states that ARNI represents a novel class of antihypertensive agents with superior efficacy in reducing nocturnal blood pressure [3].
Following sacubitril/valsartan sodium, sacubitril alisartan calcium has overcome the technological barriers in ARNI co-crystal drug development to become the world’s second ARNI co-crystal drug. It achieves synchronous peak concentrations of LBQ657 (the primary active metabolite of sacubitril) and alisartan, while extending the half-life of the active component alisartan [4,5]. This pharmacokinetic profile demonstrates a more favorable trend in blood pressure control efficacy [6].
Phase III clinical trial results demonstrated significant antihypertensive efficacy with clear dose-dependency: After 12 weeks of once-daily treatment with Xin Chao Tuo 240 mg and 480 mg, the mean reductions in office sitting systolic blood pressure were 25.07 mmHg and 28.22 mmHg, respectively. When treatment was extended to 52 weeks, sustained and stable blood pressure control was maintained, with favorable long-term safety and tolerability [7].
With hypertension prevalence continuing to rise, control rates require urgent improvement in China, particularly regarding nocturnal blood pressure management. The successful development and market approval of Sacubitril Alisartan Calcium Tablets represents another breakthrough in China’s cardiovascular therapeutics field. This drug will provide hypertensive patients with a new treatment option, forming a strategic synergy with Salubris’s marketed products: Xin Li Tan (Alisartan Ester Tablets) and Fu Li Tan (Alisartan Ester/Amlodipine Tablets). Together, they address broader clinical needs across complementary patient populations and disease segments, delivering clinical benefits to a wide patient base.
Currently, the chronic heart failure indication for Sacubitril Alisartan Calcium Tablets (Project Code: S086) is in Phase III clinical trials, with development progressing smoothly.
References:
[1] Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement on Obtaining Drug Registration Certificate for Sacubitril Alisartan Calcium Tablets (Xin Chao Tuo).
[2] Chinese Hypertension Guidelines Revision Committee, et al. Chinese Journal of Hypertension. 2024;32(7):603-700.
[3] Chinese Expert Consensus Committee on Nocturnal Hypertension Management, China Hypertension Alliance. Chinese Journal of Hypertension. 2023;31(7):610-618.
[4] Alisartan Ester Package Insert.
[5] Sacubitril Alisartan Calcium Package Insert.
[6] Sun JC, et al. Frontiers in Cardiovascular Medicine. 2024;11:1348897.
[7] Zhang W, et al. JACC: Asia. 2024;4(9):697-707.
