Recently, VELMARTO® (Eratrectinib Capsules), a new-generation drug-resistant TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co.,Ltd. (Vcare PharmaTech), has been officially approved for marketing by the NMPA. As a wholly-owned subsidiary of Vcare PharmaTech, Nanjing Vcare PharmaTech Co.,Ltd. (Nanjing Vcare) delivered in-depth full-cycle support via its full-industry-chain service capabilities. It provided efficient R&D services and end-to-end manufacturing matching, facilitating the smooth launch of the parent company’s first innovative drug and embodying the "Vcare Speed".
VELMARTO®: A New-Generation TRK Inhibitor Against Drug Resistance
VELMARTO® is a proprietary new-generation TRK inhibitor developed by Vcare PharmaTech, indicated for adult and adolescent patients aged 12 years and older with solid tumors harboring NTRK gene fusions. In pivotal registrational clinical trials enrolling patients with NTRK fusion-positive solid tumors, this tissue-agnostic broad-spectrum anti-cancer agent demonstrated outstanding efficacy and safety profiles.
Registrational clinical data showed an ORRof 68.5% and a DCRof 85.2%. Among patients followed up for more than 6 months, the ORR reached 89.7% and DCR hit 100%; the mOSwas 40.7 months, the 24-month PFSstood at 75.7%, and the 24-month DORachieved 85.5%. For patients with baseline brain metastases, the ORR was 87.5%, while patients previously treated with TRK-TKIs attained an ORR of 47.4% — both figures represent best-in-class potential among comparable agents.
As a new-generation domestically developed TRK inhibitor in China, VELMARTO® delivers durable and deep tumor regression, boasts strong blood-brain barrier permeability, and features favorable overall safety. Unlike linear molecular structures of first-generation TRK inhibitors, VELMARTO® adopts a cyclic molecular scaffold. Structural optimization reduces off-target risks and effectively circumvents drug-resistant mutations, rendering it a novel TRK inhibitor with superior efficacy for treatment-naive patients and inherent anti-resistance mechanisms.
R&D Breakthrough: IND Submission Completed Within 14 Months, Full-Cycle CMC Lays Solid Foundation
Throughout the entire R&D timeline of VELMARTO®, Nanjing Vcare delivered industry-leading R&D efficiency. Its specialized project team precisely controlled all R&D milestones and integrated premium technical resources, enabling Vcare PharmaTech to complete the full workflow from identification of PCCto domestic IND submission in merely 14 months. Such efficient progress is backed by Nanjing Vcare’s mature R&D management system, seasoned technical specialists and standardized R&D process control. The team efficiently accomplished core technical work including total synthetic route design, synthetic process optimization, polymorph screening, clinical dosage form confirmation, formulation development and manufacturing process refinement. All divisions collaborated seamlessly to cut down R&D cycles to the maximum extent while fully complying with NMPA approval standards and guaranteeing drug quality, laying a robust foundation for the rapid advancement of VELMARTO®.
Meanwhile, Nanjing Vcare’s technical team resolved critical R&D challenges one by one: synthetic routes were optimized to boost API synthesis efficiency; optimal crystal forms were screened to secure drug stability; capsule dosage forms were scientifically validated to meet clinical administration demands. The team continuously refined formulations and manufacturing processes, overcoming technical hurdles in formulation screening, process scale-up and stability testing. Finally, a clinical-suitable capsule formulation was finalized, comprehensively safeguarding the safety, efficacy and quality controllability of the drug from the source of pharmaceutical development.
Manufacturing Assurance: Affiliated Plant Delivers API and Intermediates with High Standards
Supported by a complete full-spectrum CMC service system, Nanjing Vcare provided integrated R&D and manufacturing services covering intermediates, APIs and finished dosage forms for VELMARTO®, connecting the full pipeline of drug research and material supply to achieve seamless integration of R&D and production.
For raw material supply and API manufacturing, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharma), the Group’s production base, offered full supporting capacity. As a standardized professional CDMO platform, Tianshu Pharma strictly adheres to cGMP guidelines and operates specialized production workshops complying with EU GMP, FDA requirements and ICH guidelines. Leveraging mature manufacturing workflows and comprehensive quality control systems, Tianshu Pharma ensured stable supply of high-quality intermediates and APIs, effectively mitigating material supply risks inherent in innovative drug R&D and production, and removing critical bottlenecks for industrialized drug manufacturing.
In-Depth Empowerment: End-to-End Clinical Service Support
Beyond core CMC pharmaceutical R&D and material production services, Nanjing Vcare also delivered supporting services for Phase I and Phase II clinical trials of VELMARTO®, accelerating the drug’s transition into clinical development. Its clinical team assisted the parent company in clinical trial protocol design, partner selection and subject recruitment, supported safety, tolerability and preliminary efficacy evaluation, and built a solid clinical data foundation for subsequent clinical protocol optimization and conditional marketing approval.
Since independent spin-off and operation in 2021, Nanjing Vcare has fully focused on full-industry-chain CRO/CDMO drug R&D and manufacturing services, establishing an integrated system covering research, production and clinical support. The successful approval of VELMARTO® fully validates the company’s robust comprehensive service capabilities.
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