By Fineline Cube 
China-based Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Xinchaotuo (sacubitril, allisartan) to treat primary hypertension. This marks the first domestically developed angiotensin receptor neprilysin inhibitor (ARNI) antihypertensive drug in China, with patent protection set to continue until 2037.
Clinical Trial Results
Xinchaotuo, the world’s second ARNI eutectic drug following Entresto (sacubitril, valsartan), demonstrated significant and dose-dependent antihypertensive effects in a Phase III study. After 12 weeks of treatment with 240mg and 480mg once daily, the average decrease in systolic blood pressure was 25.07 mmHg and 28.22 mmHg, respectively. Stable blood pressure control was maintained until 52 weeks, indicating good long-term safety and tolerability.
Ongoing Research
A Phase III study evaluating Xinchaotuo in chronic heart failure is currently underway, further exploring the drug’s potential in addressing this critical condition.-Fineline Info & Tech