Pan-Cancer Potential! Jiangsu Vcare’s Anti-Resistant TRK Inhibitor VC004 Capsule advances to NDA Preparation Phase
Published Time:
2025-01-26 18:06
Source:
In January 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced that its self-developed next-generation anti-resistant TRK inhibitor VC004 capsule has officially entered the domestic NDA preparation phase, initiating pre-NDA communications with regulatory authorities. Marking this milestone, Jiangsu Vcare has joined the top tier of domestic self-developed drugs targeting this pathway at remarkable speed.
VC004 is clinically indicated for the treatment of NTRK fusion-positive solid tumors. It features a "tumor-agnostic" mechanism and has demonstrated outstanding efficacy and favorable safety in Phase I/II clinical studies.
The Phase I data were presented at the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024):
In treatment-naïve patients, the confirmed objective response rate (ORR) in the recommended Phase II dose (RP2D) expansion cohort was 73.1% [95% CI: 52.2–88.4]. Among three patients who had progressed on prior TRK-TKI therapy, two showed tumor shrinkage, with one achieving a partial response (PR, 39.6%).
Most patients experienced rapid onset and sustained clinical benefits, with the longest-to-date duration of response exceeding 36 months. Among six patients with baseline brain metastases, two exhibited intracranial lesion reductions of 61.8% and 25%, respectively, while two others showed complete disappearance of non-target lesions after four months of treatment.
Safety-wise, treatment-related adverse events (TRAEs) were predominantly Grade 1–2, with no fatal TRAEs reported. No new safety signals were observed compared to other drugs in the same class.
About VC004
VC004 is a Class 1 targeted anti-tumor drug, independently developed by Jiangsu Vcare. As a next-generation TRK inhibitor with a unique anti-resistance mechanism, it is poised to become a new treatment option for patients with NTRK fusion mutations. In China, the project is advancing with a single-arm Phase II trial as the pivotal study, while its Investigational New Drug (IND) application has been approved by the US FDA. Currently, no second-generation NTRK inhibitor matches the efficacy of first-generation drugs on NTRK-naïve patients and possesses second-generation anti-drug resistance activity, positioning VC004 as a front-runner in this category.
Related News
18
2018
/
04
Phase II Clinical Researcher Conference of Vicagrel was Successfully Held in Shenyang
On April 14, 2018, phase II clinical researcher conference of Vicagrel capsule, the 13th five-year national science and technology major project was successfully held in Shenyang. Clinical experts, institutional leaders and data management and statistical experts from 16 hospitals attended the meeting. Shenyang military region general hospital is the responsible hospital, and Yaling Han academician is the project leader.
View Details
29
2018
/
01
Jiangsu Vcare Held 2018 Annual Company Meeting
Jiangsu Vcare’s annual company meeting was held at Pearl Spring Hotel On January 21, 2018. All employees, partners and customers participated in the grand event.
View Details
26
2017
/
09
Jiangsu Vcare Organized an Emergency Response Training
On September 22, 2017, Vcare invited the teachers of Nanjing Science Education Center to teach company employees some emergency knowledge. There were more than 40 employees participated in the training. The main training contents included prevention for accidents, treatment for emergencies, emergency techniques for CPR on-site and first aid, work fatigue, prevention and improvement of common occupational diseases. Employees learned a lot from the training.
View Details
15
2017
/
09
Jiangsu Vcare’s New R&D Center and Headquarter are being constructed
Jiangsu Vcare Pharmaceutical Technology Co., Ltd. bought a 20 mu of land in Biomedical Valley, Nanjing High-tech Industrial Development Zone, Jiangbei New District on August 15, 2017. The area is equipped with metro line 3 and the subway S8. It is about 4 kilometers away from the Nanjing High-speed Railway North Station which is under construction. The surrounding environment is very beautiful and the traffic is very convenient. It is constructed as Vcare’s headquarter and drug research and development center and the center was put into use at the end of 2019.
View Details
31
2017
/
08
Jiangsu Vcare Held “Team Building Training” Activity
Jiangsu Vcare held “Team Building Training” activity in the town of Chaxi at the end of August. The activity was divided into several parts and each task is completed within specified time. Participants need to communicate and coordinate with team awareness.
View Details
31
2017
/
08
Jiangsu Vcare Held Ten Kilometers Run Activity
87 participants arrived at the main entrance of Xuanwu Lake to participate in a ten-kilometer running activity after warm-up at 7 o'clock on August 31. Six colleagues on a business trip in Hainan and seven colleagues on a business trip in Xi'an also actively participated in the running at the local. Everyone completed the ten-kilometer running after one hour and a half and was very happy to give a test to our physical fitness through the running.
View Details
Company Address:
No. 136, Huakang Road, Jiangbei New Area, Nanjing, P. R. China
Subsidiary NJVcare Website：
Scan to see
Copyright © JIANGSU VCARE PHARMATECH CO.,LTD.
Powerby：www.300.cn nanjing.300.cn