Jiangsu Vcare's New-generation TRK Inhibitor VC004 Obtains IND Approval from the US FDA
Published Time:
2024-10-17 17:29
Source:
On October 16, 2024, Jiangsu Vcare Pharmatech Co., Ltd. (referred to as "Jiangsu Vcare")'s independently developed new-generation anti-resistant TRK inhibitor VC004 achieved a significant milestone, obtaining Investigational New Drug (IND) approval from the US FDA. This fully demonstrates Jiangsu Vcare's excellent drug research and development capabilities and successful execution of the company's strategies centered on original innovation, high-quality standards, and a global layout.
The TRK gene fusion plays a key role in various cancers and is one of the important driving factors for cancer occurrence and development. Clinically, VC004 is primarily used to treat patients with NTRK gene fusion-positive tumors and is not limited to specific cancer types. As a new-generation TRK inhibitor, VC004 has demonstrated excellent efficacy and safety in multiple previous clinical studies in China. It is currently in the subject follow-up and pre-New Drug Application (NDA) preparation stage.
VC004 not only shows a higher clinical response rate compared with first-generation drugs but also exhibits significant anti-resistance to first-generation drugs. The previous clinical data were impressively presented at the 2024 American Society of Clinical Oncology (ASCO 2024) annual meeting: among patients who have not been treated with TRK TKI previously, the confirmed objective response rate (ORR) in the recommended phase 2 dose (RP2D) expansion group is 73.1% [95% CI, 52.2-88.4]; among 3 patients who have progressed after being treated with TRK-TKIs previously, the tumors of 2 patients have shrunk, and 1 patients has achieved a partial response (PR) (39.6%); for the vast majority of patients after treatment with VC004, the drug takes effect quickly and they obtain long-term survival benefits, and the longest duration of continuous remission of patients has exceeded 36 months; among 6 patients with baseline brain metastases, the intracranial lesions of 2 patients have shrunk by 61.8% and 25% respectively, and the non-target lesions of another 2 patients have disappeared after 4 months of treatment. In terms of safety, most treatment-related adverse events (TRAEs) that patients experienced are grade 1-2, and no fatal TRAEs have occurred. Compared with other drugs of the same kind, no new safety signals have been found.
Related News
11
2025
/
08
August 8, 2025 – Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced today that it has entered into an exclusive strategic partnership with Huadong Medicine (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (000963.SZ, "Huadong Medicine"), for the commercialization rights of Jiangsu Vcare’s innovative product VC005 tablets in mainland China.
View Details
31
2025
/
07
Recently, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) announced the completion of full patient enrollment for its Phase II clinical trial of the self-developed, next-generation highly selective JAK1 inhibitor, VC005 topical gel, for the treatment of mild-to-moderate Atopic Dermatitis (AD). This marks a significant milestone in the VC005 gel development program.
View Details
03
2025
/
07
Recently, the NDA for Eratrectinib (VC004) capsules, a next-generation anti-resistance TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) has been officially accepted by China's NMPA. Previously granted priority review designation, the drug holds promise as a new treatment option for patients with advanced solid tumors.
View Details
30
2025
/
05
Recently, Eratrectinib (VC004) capsules, a self-developed next-generation anti-resistant TRK inhibitor by Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare), were included in the priority review list by the NMPA, through public notice. This milestone positions the drug within the first tier of next-generation anti-resistant products targeting the same mechanism in China.
View Details
21
2025
/
05
Recently, Jiangsu Vcare PharmaTech Co., Ltd. (Jiangsu Vcare) announced the completion of patient enrollment for its self-developed Class 1 innovative antiplatelet drug, Vicagrel Capsules, in a Phase III clinical trial conducted in China. This study evaluates the efficacy and safety of Vicagrel compared to Clopidogrel in patients with acute coronary syndrome (ACS). The milestone marks a critical step toward Vicagrel’s potential market approval.
View Details
09
2025
/
05
On May 8, 2025, Jiangsu Vcare Pharmatech Co., Ltd. (Jiangsu Vcare) achieved another major milestone in its self-developed second-generation highly selective JAK1 inhibitor, VC005 tablets. The project, intended for the oral treatment of non-segmental vitiligo received official IND approval from the NMPA (Application No.: CXHL2500200).
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