Jiangsu Vcare Submitted an NDA for Anti- platelet Drug Vicagrel to the US

　　Recently, Jiangsu Vcare Pharmaceutical Technology Co., Ltd. (Jiangsu Vcare) submitted an NDA to the US FDA for Vicagrel capsules for the treatment of acute coronary syndrome (ACS), ischemic stroke, and confirmed peripheral arterial disease. This marks the first NDA submission from Jiangsu Vcare's innovative drug pipeline, representing a significant milestone.

　　This NDA submission is based on ongoing communication with the FDA and is strongly supported by robust non-clinical data and multiple clinical studies conducted in China and the US. Vicagrel, a next-generation oral P2Y12 receptor antagonist, is one of Jiangsu Vcare's representative achievements stemming from its "differentiated solutions for unmet clinical needs" philosophy. Its active metabolite generated in vivo effectively inhibits platelet activation and aggregation and is expected to address the issue of "clopidogrel resistance."

　　This formal NDA submission is the result of years of innovation and effort by Jiangsu Vcare. Once approved, Vicagrel is expected to provide a new treatment option for approximately 27.6 million patients in the US suffering from coronary heart disease and stroke.

　　About Vicagrel

　　Vicagrel is an industry-university-research collaboration project between Jiangsu Vcare and China Pharmaceutical University. Jiangsu Vcare holds all rights to the project. Early-stage R&D work was published in full in the JMC by the American Chemical Society and highlighted by SciBX (published by Nature).

　　As a novel anti-platelet drug based on ingenious structural design, Vicagrel offers four core advantages compared to marketed drugs:

　　1. Overcoming Clopidogrel Resistance: Vicagrel undergoes its key metabolic activation step via intestinal esterases. This breakthrough metabolic pathway avoids the hepatic enzyme CYP2C19, which is highly relied upon by clopidogrel. This overcomes "clopidogrel resistance" caused by different CYP2C19 genotypes (*1, *2, *3 mutations). Furthermore, clinical data from bridging study in ultrarapid metabolizers (*17 mutation) suggest Vicagrel may mitigate the high bleeding risk associated with excessive platelet inhibition due to clopidogrel's over-metabolism.

　　2. Favorable Safety Profile: Vicagrel's active metabolites are identical to clopidogrel's, potentially retaining clopidogrel's well-established safety profile. It avoids the high bleeding risks associated with other drugs in the same class and is also expected to alleviate bleeding concerns, particularly relevant for the elderly population.

　　3. Reduced Drug-Drug Interactions: Vicagrel's unique metabolic pathway effectively avoids the common adverse drug-drug interactions seen when clopidogrel is co-administered with drugs like repaglinide, addressing polypharmacy issues in elderly patients.

　　4. Lower Dose & Improved Tolerability: Vicagrel avoids clopidogrel's initial ineffective metabolism step, resulting in a lower effective dose (only one-twelfth of clopidogrel's dose). This implies potentially reduced dose-related side effects, making Vicagrel a novel anti-platelet drug with more stable efficacy and better-controlled safety risks.