{"id":67011,"date":"2026-08-12T21:00:00","date_gmt":"2026-08-12T14:00:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=67011"},"modified":"2026-08-12T21:00:00","modified_gmt":"2026-08-12T14:00:00","slug":"pantrkare-officially-approved-as-the-companion-diagnostic-for-velmarto-eratrectinib","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=67011","title":{"rendered":"PanTRKare\u2122 Officially Approved as the Companion Diagnostic for VELMARTO\u00ae (Eratrectinib)"},"content":{"rendered":"

NANJING, China<\/span>, Aug. 12, 2026<\/span> \/PRNewswire\/ — August 6,\u00a0<\/span>the NMPA granted approval to Geneseeq’s PanTRKare\u2122\u00a0NTRK1\/2\/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO\u00ae <\/sup>(Eratrectinib), a next\u2011generation 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\u2011positive solid tumors.<\/p>\n

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<\/span><\/p>\n<\/div>\n

As the original companion diagnostic for Eratrectinib, PanTRKare\u2122\u00a0addresses key testing challenges including the pan\u2011tumor 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\u2122\u00a0achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment\u2011na\u00efve and pre\u2011treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.<\/p>\n

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\u2011resistance drawbacks of first\u2011generation agents at the molecular\u2011mechanism level. The pivotal VC004\u2011101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long\u2011term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow\u2011up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first\u2011generation TRK inhibitors.<\/p>\n

In terms of long\u2011term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2\u2011year PFS rate of 75.7% and a 2\u2011year 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\u2011term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long\u2011term survival benefits to patients.<\/p>\n

Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long\u2011term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare\u2122\u00a0obtained approval for its companion diagnostic use. This completes a key link in the diagnosis\u2011treatment workflow for NTRK\u2011fusion solid tumors, creating favorable conditions for post\u2011launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK\u2011positive 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\u2011downstream industrial chains and empowering collaborative innovation among resident enterprises.<\/p>\n

Commercial Cooperation:<\/b>\u00a0Strategic Development Director:\u00a0Dr. Peng\u00a0 peng_yuran@vcarepharmatech.com<\/a>
BD Director:\u00a0Liam\u00a0 xu_minghua@vcarepharmatech.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"

<\/p>\n

NANJING, China<\/span>, Aug. 12, 2026<\/span> \/PRNewswire\/ — August 6,\u00a0<\/span>the NMPA granted approval to Geneseeq’s PanTRKare\u2122\u00a0NTRK1\/2\/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO\u00ae <\/sup>(Eratrectinib), a next\u2011generation 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\u2011positive solid tumors.<\/p>\n

\n

\"\"<\/a>
<\/span><\/p>\n<\/div>\n

As the original companion diagnostic for Eratrectinib, PanTRKare\u2122\u00a0addresses key testing challenges including the pan\u2011tumor 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\u2122\u00a0achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment\u2011na\u00efve and pre\u2011treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.<\/p>\n

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\u2011resistance drawbacks of first\u2011generation agents at the molecular\u2011mechanism level. The pivotal VC004\u2011101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long\u2011term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow\u2011up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first\u2011generation TRK inhibitors.<\/p>\n

In terms of long\u2011term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2\u2011year PFS rate of 75.7% and a 2\u2011year 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\u2011term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long\u2011term survival benefits to patients.<\/p>\n

Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long\u2011term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare\u2122\u00a0obtained approval for its companion diagnostic use. This completes a key link in the diagnosis\u2011treatment workflow for NTRK\u2011fusion solid tumors, creating favorable conditions for post\u2011launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK\u2011positive 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\u2011downstream industrial chains and empowering collaborative innovation among resident enterprises.<\/p>\n

Commercial Cooperation:<\/b>\u00a0Strategic Development Director:\u00a0Dr. Peng\u00a0 peng_yuran@vcarepharmatech.com<\/a>
BD Director:\u00a0Liam\u00a0 xu_minghua@vcarepharmatech.com<\/a>\u00a0<\/p>\n

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