PanTRKare™ Officially Approved as the Companion Diagnostic for VELMARTO® (Eratrectinib)
Published Time:
2026-08-12 17:43
Source:
August 6，the NMPA granted approval to Geneseeq’s PanTRKare™ NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO® (Eratrectinib), a next‑generation highly selective TRK inhibitor independently developed by Vcare PharmaTech. The approval provides critical support for the precise identification and clinical medication of patients with NTRK fusion‑positive solid tumors.
As the original companion diagnostic for Eratrectinib, PanTRKare™ addresses key testing challenges including the pan‑tumor distribution, low incidence and complex fusion patterns of NTRK1/2/3 fusions, enabling accurate detection of NTRK fusion variants across diverse cancer types. Following clinical accuracy validation, bridging study results demonstrated that patients tested positive by PanTRKare™ achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment‑naïve and pre‑treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.
Eratrectinib marks Nanjing’s first innovative drug approval this year. Through innovative cyclic structural optimization, it delivers more potent and highly selective inhibition of TRK kinases, overcoming structural limitations and drug‑resistance drawbacks of first‑generation agents at the molecular‑mechanism level. The pivotal VC004‑101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long‑term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow‑up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first‑generation TRK inhibitors.
In terms of long‑term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2‑year PFS rate of 75.7% and a 2‑year DOR rate of 85.5%. These findings confirm its capacity to deliver durable disease control and sustained remission for patients. It also demonstrates prominent advantages in long‑term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long‑term survival benefits to patients.
Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long‑term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare™ obtained approval for its companion diagnostic use. This completes a key link in the diagnosis‑treatment workflow for NTRK‑fusion solid tumors, creating favorable conditions for post‑launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK‑positive patients to access Eratrectinib targeted therapy at an earlier time point. Such expedited dual approvals fully illustrate the synergistic value brought by the strong partnership between the two parties. It also underscores the industrial ecosystem strengths of Life Science & Health Industry Office of Nanjing Jiangbei New Area in connecting upstream‑downstream industrial chains and empowering collaborative innovation among resident enterprises.
Related News
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
23
2017
/
08
Jiangsu Vcare Was Honored as Jiangbei New Area Lingque Enterprise
In 2017, the list of “Lingque” enterprises in Jiangbei New District of Nanjing was announced and Jiangsu Vcare Pharmaceutical Technology Co., Ltd. was successfully selected into the list. “Lingque” enterprises project aim to select a group of innovative SMEs with high growth in Jiangbei district and provide the selected enterprises with one-stop support such as equity investment, emergency turnover, loan interest subsidy, R&D subsidies, and etc.. To be successfully selected into the “Lingque” enterprises program is an inspiration to the company. Vcare keep integrating various resources to quickly become bigger and stronger to contribute to the development of Jiangbei New Area.
View Details
15
2017
/
06
Jiangsu Vcare and Yangzhou Princechem Acquired Boya Chemical Company
The signing ceremony of Jiangsu Vcare Pharmaceutical Technology Co., Ltd. and Yangzhou Princechem Co., Ltd. acquiring Boya Chemical (Nantong) Co., Ltd. was held in the conference room of Jiangsu Vcare recently. Boya Chemical (Nantong) Co., Ltd. is located in Yangkou Chemical Industrial Park, Rudong Coastal Economic Development Zone, Jiangsu Province. The company covers an area of 70 acres and is a Hong Kong-owned enterprise. The goal of this acquisition is to build Boya Chemical into a raw material drug manufacturer that meets the standards of China, the United States and the European Union. After renovation, Boya Chemical will be a chemical raw materials production base of Yatai Group and solve the bottleneck problem of Vcare's raw material drug R&D and production. It’s believed that the acquisition will make a significant contribution to Vcare’s production and sales of intermediates and APIs.
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.
苏公网安备32011202001742号
Powerby：www.300.cn nanjing.300.cn