Recently, Salubris announced that the new drug application (NDA) for its independently developed product, Sacubitril/Ailsartan/Amlodipine Tablets (project code: SAL0130), has been accepted for review by the NMPA ^[1].

Sacubitril/Ailsartan/Amlodipine Tablets is a proprietary fixed-dose combination product of the Company, comprising an angiotensin receptor–neprilysin inhibitor (ARNI) and a calcium channel blocker (CCB). Through the complementary synergistic effects of the ARNI and CCB components, this product is expected to achieve multi-target blood pressure reduction.

Currently, no fixed-dose combination of an ARNI plus a CCB has been approved for marketing worldwide. If successfully approved, this product is expected to offer a novel treatment option for hypertensive patients inadequately controlled on monotherapy, address the long-term medication management needs of more patients with hypertension, and further enrich the Company’s innovative product portfolio. It will also form a differentiated product mix with the Company’s already marketed products, including XinchaoTuo, Xinlitan, Fulitan^®, and Fulian^®, thereby consolidating the Company’s leading position in the hypertension therapeutic area.

References：

[1]Shenzhen Salubris Pharmaceuticals Co., Ltd. Announcement Regarding the Acceptance of the New Drug Application for Sacubitril/Ailsartan/Amlodipine Tablets.

|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.