VC004

VC004 (proposed generic name: Eratrectinib) is a Class 1 small-molecule oral anti-tumor targeted drug independently developed by Jiangsu Vcare. As a new generation of TRK inhibitor, VC004 not only demonstrates superior efficacy to first-generation drugs targeting the same molecule in clinical practice but also addresses the secondary drug resistance caused by first-generation drugs. VC004 is expected to bring longer survival benefits and better quality of life to patients. Studies have shown that VC004 has the following differentiated advantages: It features a unique second-generation anti-resistance mechanism. Based on in vitro kinase assay results, compared with first-generation drugs targeting the same molecule, VC004 not only has comparable targeted inhibitory activity against wild-type TRK but also possesses nM-level anti-resistance ability against first-generation drugs; VC004 shows significant clinical efficacy in both treatment-naive and previously treated patients. Based on the results of the single-arm pivotal Phase Ⅱ clinical study, VC004 shows a higher ORR than first-generation drugs, demonstrating significant clinical benefits in patients previously treated with TRK-TKIs; VC004 exhibits favorable clinical safety, with a significantly lower incidence of treatment-related serious adverse events (TRSAEs) than drugs targeting the same molecule, and no fatal TRSAEs reported. Currently, all first-generation drugs targeting the same molecule in the Chinese market are imported original research drugs and have not yet been fully approved for marketing, and there are no approved second-generation drugs of the same target. Clinical demand is far from being fully met. In China, VC004 has adopted a single-arm Phase Ⅱ study as its pivotal clinical trial, and its NDA has been accepted and is undergoing priority review. In the US, its IND application has been approved by FDA, and it is expected to become a world-leading new generation of TRK inhibitor.

Vicagrel

Vicagrel is an antiplatelet aggregation drug and a new generation of oral P2Y12 receptor antagonist. It is being clinically developed for the treatment and prevention of atherosclerotic thrombotic events such as acute coronary syndrome (ACS) in coronary heart disease, ischemic stroke, and peripheral arterial disease. This Class 1 small-molecule chemical innovative drug is jointly developed by Jiangsu Vcare and China Pharmaceutical University through industry-university-research cooperation. Jiangsu Vcare holds complete and independent intellectual property rights for the project. The drug design concept of Vicagrel aims to address the black box warning issue of "clopidogrel resistance" while retaining the same active metabolites as clopidogrel, with the expectation of achieving a more balanced grasp of the "double-edged sword" of therapeutic benefits and bleeding risks associated with antiplatelet drugs. The project has undergone a series of adequate clinical studies, from healthy subjects to patients, including multiple Phase Ⅰ, Phase Ⅱ, PK/PD bridging, and Phase Ⅲ studies. Compared with existing drugs, Vicagrel has the following core advantages: It improves and corrects the impact of CYP2C19 gene polymorphism on Clopidogrel, bring in more stable efficacy; It is equivalent to clopidogrel in populations with normal CYP2C19 metabolism, and has a safely controllable bleeding risk;It avoids dose loss caused by the first-step ineffective metabolism of clopidogrel, featuring a lower effective dose, faster onset of action, and no adverse drug-drug interactions (DDIs);Its metabolite profile is fully covered by that of Clopidogrel, with no drug prototype or unique metabolites detected, making its clinical application more reliable. Currently, Vicagrel is in the Phase Ⅲ clinical stage in China with patient enrollment completed, and in the preparation stage for NDA in the United States.

VC005

VC005 is a novel, potent, and highly selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. It is used clinically to treat diseases in the fields of inflammation and autoimmunity. It has been developed into two dosage forms, oral tablets and topical gel. VC005 exerts potent inhibitory activity against JAK1 while further reducing the inhibitory activity against JAK2 with high selectivity (based on in vitro kinase assay results), which is expected to alleviate safety issues caused by excessive JAK2 inhibition in clinical practice. Meanwhile, VC005 retains synergistic inhibitory effects on JAK3 and TYK2 for therapeutic efficacy. Therefore, while achieving high selectivity of JAK1 over JAK2, VC005 is expected to bring better clinical efficacy than drugs of the same class. Currently, VC005 has demonstrated significant efficacy and differentiated safety advantages in multiple clinical studies. VC005 Tablets have been developed for multiple indications, including moderate-to-severe atopic dermatitis (Phase Ⅲ clinical trial, enrollment to be completed soon), ankylosing spondylitis (Phase Ⅲ clinical trial, initiated), vitiligo (Phase Ⅱ clinical trial, initiated), rheumatoid arthritis (Phase Ⅰb clinical trial, completed), and inflammatory bowel disease (Phase Ⅰ clinical trial, completed); VC005 Topical Gel has been developed for mild-to-moderate atopic dermatitis (Phase Ⅱ clinical trial, enrollment completed). In addition, the company entered into an exclusive strategic cooperation with Huadong Medicine regarding the commercialization rights of VC005 Tablets in mainland China in August 2025. As the MAH of the project, Jiangsu Vcare grants Huadong Medicine exclusive commercialization rights in the cooperative region. This partnership has laid a solid sales foundation for the future marketing of the product.