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Introduction to innovative drug project

Vicagrel

Vicagrel is a collaborative project between Jiangsu Vcare and China Pharmaceutical University with with the company holding complete intellectual property rights to the program. It was designed to overcome the significant "clopidogrel resistance" in clinical practices, and the early related R&D breakthroughs were published in the American Chemical Society's Journal of Medicinal Chemistry (2012), and were reported as a "research highlight" in Nature-affiliated SciBX (2012), where Vicagrel was rated as "One of the most commercially promising projects in the field of new drugs". The clinical studies of vicagrel was led by Academician Han Yaling, the chairman of the Chinese Society of Cardiology and the director of the Cardiovascular Department at the General Hospital of the Northern Theater Command. As the principal investigator (PI) of the project, she has guided the clinical team in completing phase II and several other clinical studies of Vicagrel, and was excited about the previously positive results.

Vicagrel, based on its ingenious structural design, generates the active metabolite consistent with clopidogrel through a new initial metabolic pathway. Therefore, it is expected to successfully overcome the clinical challenge of clopidogrel resistance while avoiding the adverse drug interactions that occur when other drugs are co-administered with clopidogrel.Additionally, Vicagrel has a faster onset of action and a significantly lower dose, which means it has a more significant advantage in emergency medication and is expected to further reduce dose-related side effects. As a result, this product is expected to become a new type of antiplatelet drug with more stable efficacy and more controllable safety. Currently, the Vicagrel project is in Phase III clinical study in China.

VC004

VC004 is a small molecule drug targeting cancer independently developed by Jiangsu Vcare, belonging to the new- generation TRK inhibitor with a unique mechanism of overcoming drug resistance. It is expected to become a new option for the treatments of patients with NTRK fusion mutations. VC004 not only showed a higher clinical response than the first-generation drugs but also a significant advantages in overcoming resistance. Previous clinical data was impressively presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024). Currently, VC004 is in a single-arm Phase II pivotal clinical study in China (clinical trial registration number: NCT04614740). With patient enrollment now complete, we are preparing to submit a Pre-NDA application to the China’s regulatory agency. Additionally, the US IND has been approved by the FDA. At present, there are no new generation TRK inhibitors on the market domestically or internationally, and VC004 is expected to become a leading new generation TRK inhibitor globally.

VC005

VC005 is a new, highly potent, and highly selective second-generation JAK1 inhibitor independently developed by Jiangsu Vcare. The drug selectively inhibits JAK1 to reduce inflammation and the activation of immune cells, thereby achieving the effect of treating inflammatory and autoimmune diseases. Compared to the marketed drug Upadacitinib, VC005 has lower JAK2 inhibitory activity based on in vitro kinase assay results, which may help alleviate a series of safety issues caused by excessive JAK2 inhibition in the clinic. VC005 has been developed in two dosage forms: the oral tablets demonstrated positive top-line results in treating moderate to severe atopic dermatitis from the Phase II clinical study, and the related Phase III clinical study has been initiated; meanwhile, the Phase II clinical study of VC005 tablets for the treatment of ankylosing spondylitis was completed, and the subsequent Phase III clinical study is about to be initiated. The Phase I clinical study of VC005 for the treatment of mild to moderate atopic dermatitis was completed, showing good safety and efficacy, especially with excellent relief of itching.

Innovative Drug

Schedule

Vicagrel (P2Y12R) , US

Vicagrel (P2Y12R), China

VC004(TRK)

VC005 (po)(JAK1)

VC005 (us.ext)(JAK1)

VC010(ER-PROTAC)

VC013(BTK-PROTAC)

VC016(IL-17)

VC020(RIPK1)

VC022(ATM)

NEW DRUG PIPELINE

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 Table of Recent Clinical Trials

创新药临床试验统计表

Time of issue:2021-04-28 08:16:49

Project

Indications

Brief Title ( Study Phase and Progress)

Vicagrel capsules

Acute coronary syndrome

Efficacy and safety study of vicagrel in patients with ACS undergoing percutaneous coronary intervention (PCI) (Phase III ongoing)

Vicagrel capsules

Acute coronary syndrome

The efficacy, safety and pharmacokinetic of antiplatelet therapy forvicagrel (Phase II completed)

Vicagrel capsules

Acute coronary syndrome, recent stroke, peripheral arterial disease

PK/PD study ofvicagreland clopidogrel in healthy subjects with different CYP2C19 metabolizers (US pivotal bridging study completed)

VC004 capsules

NTRK gene fusion-positive solid tumor

The Phase I/Phase II clinical study of VC004 in patients with localized advanced/metastatic solid tumors. (Pivotal single-arm Phase II study ongoing)

VC005 tablets

Atopic dermatitis (moderate to severe)

Efficacy and safety clinical study of VC005 tablets in adult patients with moderate to severe atopic dermatitis. (Phase II study completed)

VC005 tablets

Ankylosing spondylitis

Efficacy and safety clinical study of VC005 tablets in subjects with active ankylosing spondylitis. (Phase II study completed)

VC005 tablets

Rheumatoid arthritis

A randomized, double-blind, dose-escalating, placebo-controlled Phase Ib clinical study ofVC005tablets in subjects with rheumatoid arthrit

VC005 gels Atopic dermatitis (mild to moderate) Safety, tolerance and pharmacokinetics clinical study of VC005 in healthy subjects (single/multiple ascending dose study) and patients (multiple ascending dose study) with mild to moderate atopic dermatitis. (Phase I study completed)

 

For more information about clinical trials of our products, please visit http://www.chinadrugtrials.org.cn/

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