New Drug Pipeline_JIANGSU VCARE PHARMATECH CO.,LTD.

Independent R&D of New Drugs

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

List of Major Clinical Trials

创新药临床试验统计表

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

Project	Subject	Brief Title
Vicagrel	Healthy subjects	The Tolerability Evaluation of Vicagrel in a Single Ascending Dose Study and the Efficacy and Tolerability of Vicagrel in a Multiple Ascending Dose Study. (Phase I completed.)
Vicagrel	Patients with coronary atherosclerotic heart disease	The Efficacy, Safety and Pharmacokinetic of Antiplatelet Therapy forVicagrel. (Phase II completed.)
Vicagrel	Healthy subjects	PK/PD Study ofVicagreland Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers. (Pivotal bridging trial in China and the US completed.)
VC004	Patients with NTRK -positive solid tumor	The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors. (Ongoing Single-arm phase II study.）
VC005(po.)	Healthy subjects	The Tolerability Evaluation of VC005 in a Single Ascending Dose Study and the Efficacy and Tolerability of VC005 in a Multiple Ascending Dose Study of VC005. (Phase I completed.)
VC005(po.)	Patients with ankylosing spondylitis	Efficacy and Safety Clinical Study of VC005 Tablets in Subjects with Active Ankylosing Spondylitis.（Ongoing phase II study.）
VC005(po.)	Patients with atopic dermatitis(moderate to severe)	Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients with Moderate to Severe Atopic Dermatitis.（Ongoing phase II study.）
VC005(us.etx.)	Healthy subjects and patients with 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. (Ongoing phase I study.）

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

Introduction to innovative drug project

Vicagrel

Vicagrel is a collaborative project between Jiangsu Vcare and China Pharmaceutical University with the rights exclusively held by Jiangsu Vcare, it was designed to overcome the significant "clopidogrel resistance" problem 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 also described as "one of the most promising commercial projects in this new drug field ". As the principal investigator, Academician Han Yaling, who is also the Chairman of the Chinese Society of Cardiology and Director of the Cardiovascular Department of the General Hospital of Northern Theater Command, has led her team to complete multiple clinical studies including the phase II study of vicagrel, and she has expressed great recognition for this project. In terms of progress, pivotal clinical trials are currently underway both in China and the US.

VC004

VC004 is a novel targeted anti-tumor drug, as well as a second-generationTRK inhibitor, independently developed by Jiangsu Vcare, which is expected toprovide a new treatment option for patients with NTRK fusion mutations andis expectedto overcome acquired resistance to first-generationdrugs, prolonging the duration of clinical benefits.Theresults of thephase I clinical studyhave demonstrated significant clinical benefits and favorable safety profiles of VC004 in patients, and the single-arm phase I clinical study is ongoing.To date, no second-generation inhibitor with an anti-drug resistance profile has been approved at home and abroad, VC004is expectedto become a leading next-generation TRK inhibitor worldwide.

VC005

VC005 is a novel, highly efficient, and selective JAK1 inhibitor, as well asa second-generation inhibitor,independently developed by JiangsuVcare.By selectively inhibiting JAK1 kinase, decreasing the inflammatory response, and reducing the activation of immune cells, VC005 displays high potential for the treatment of inflammatory and autoimmune diseases. The in vitro kinase test results indicated that VC005 exhibited a lower inhibitory activity against JAK2 kinase compared to an approved dominant JAK inhibitor, Upadacitinib, thusit is expected to alleviate many safety concerns associated with excessive JAK2 kinase inhibition. At present, two dosage forms havebeen developedsuccessfully, and two phase II clinical studiesof VC005 tablets for the treatments of Ankylosing spondylitis and moderate to severe atopic dermatitis are ongoing, respectively, and both of which have completedpatient enrolment, the data are expected to be readout by mid-2024.The phase I clinical study of VC005 gels forthe treatments ofmild to moderate atopic dermatitisis ongoing, and the enrolment of all subjects hasbeencurrentlycompleted.