Recently, the generic drug project of Maribavir developed by the client of Nanjing Vcare PharmaTech Co.,Ltd. (Nanjing Vcare) has obtained official approval as the first generic version in China, filling the gap in domestic generic drugs for the treatment of refractory and drug-resistant cytomegalovirus (CMV) infections after organ transplantation. Boasting one-stop full-industry chain capabilities covering starting material supply, APIdevelopment, formulation R&D, BEstudies and regulatory submission, Nanjing Vcare delivered precise support and efficient execution throughout the entire process, providing systematic technical backing and guarantees for the successful launch of this first generic product.
Maribavir is an innovative oral antiviral agent classified as a benzimidazole nucleoside. It is the world’s first antiviral drug that targets and inhibits UL97 protein kinase and its natural substrates. Featuring a distinctive molecular structure and novel mechanism of action, its R&D and production pose multiple industry challenges. Supported by a mature one-stop R&D and production service system across the full industrial chain, Nanjing Vcare has overcome core technical hurdles by streamlining key links from drug R&D to commercialization. The company has made vital contributions throughout the entire drug lifecycle, bringing more accessible medication options for patients suffering from post-transplant CMV infections in China.
Starting Material Supply: Source Control to Ensure Consistent Quality
At the initial stage of the project, Nanjing Vcare’s R&D team conducted in-depth analysis on the chemical structure of Maribavir and selected optimal suppliers for starting materials. A rigorous quality control system was established to supervise material purity, stability and batch consistency across all stages. This approach effectively prevented potential risks such as excessive impurities, batch fluctuations and material incompatibility at the source. It laid a solid and compliant foundation for subsequent API and formulation development, guaranteeing controllable quality and stable material supply from the very beginning.
API Development: Breaking Core Synthesis Barriers for Efficient and Stable Production
Given Maribavir’s complex molecular structure, lengthy synthetic routes and stringent requirements for impurity control, Nanjing Vcare’s technical team systematically optimized and upgraded the synthetic processes, and successfully established an efficient and cost-effective large-scale production route. In terms of impurity profiling, the team conducted comprehensive traceability and structural identification of process-related and degradation impurities, and formulated a complete control strategy covering known impurities, unknown impurities and genotoxic impurities. On this basis, a full-lifecycle quality management system for APIs was built, enabling efficient, stable and reproducible API production and supplying high-quality raw materials to advance formulation research.
Formulation R&D: Customized Development for Safe and Efficacious Products
As an oral solid preparation, Maribavir tablets set high standards for formula composition and process parameters. Tailored development solutions were formulated by Nanjing Vcare’s formulation R&D team, which completed systematic formula screening and optimization. The team then accelerated process scale-up studies, verified process robustness within the scope of critical process parameters, and conducted stability tests under long-term, accelerated and stress conditions. These efforts fully guaranteed the safety, efficacy and stable quality of the finished product, laying a solid scientific foundation for subsequent BE trials and regulatory submission.
Clinical Research: Scientific Design Ensures One-pass BE Trials
Leveraging rich experience in clinical research, Nanjing Vcare designed scientific, rigorous and fully compliant clinical trial protocols in line with the pharmacological characteristics of Maribavir and regulatory requirements for bioequivalence studies. The team efficiently managed the entire workflow, including coordination with clinical trial institutions, on-site trial supervision, sample collection, data compilation and analysis. Strict control over trial details and risk prevention ensured the BE trials passed smoothly on the first attempt with zero errors, clearing the key clinical hurdle for the drug’s eventual approval and launch.
Regulatory Submission & Approval: End-to-end Follow-up for the First Consistency Evaluation Approval
During the regulatory submission phase, Nanjing Vcare’s regulatory team took charge of drafting and compiling dossiers, revising and perfecting documents item by item in strict accordance with the requirements of the NMPA. In the review process, the team promptly prepared and responded to supplementary data, and coordinated seamlessly for on-site production inspections and regulatory audits. Thanks to extensive experience in generic drug registration and professional technical expertise, the team helped the client obtain approval for Maribavir tablets as the first product in China to pass the consistency evaluation.
Deepening Full-industry Chain Services to Continuously Empower Pharmaceutical Innovation
For years, Nanjing Vcare has focused on full-lifecycle R&D and production services for chemical drugs, striving to build an all-in-one CRO/CDMO service platform integrating chemistry, pharmaceutics and clinical medicine. The company owns a production base covering 225 mu in a provincial-level chemical industrial park in Hubei Province. Supported by core technology platforms including continuous flow chemistry, biocatalysis and photochemistry, alongside sound quality management and EHS systems, Nanjing Vcare delivers integrated full-industry chain services, ranging from CDMO production and supply of pharmaceutical intermediates and APIs, to CMC research and clinical CRO services as well as regulatory affairs.
To date, Nanjing Vcare has provided full-lifecycle CRO/CDMO services to over 300 renowned pharmaceutical enterprises and research institutions at home and abroad. The company has assisted clients in securing more than 80 production approvals for generic drugs and over 50 clinical trial approvals for innovative drugs, with over 120 projects currently under regulatory review. It also supplies more than 3,000 types of supporting intermediates, reference impurities and APIs.
The successful approval of the first generic Maribavir tablet further demonstrates Nanjing Vcare’s robust full-industry chain service capabilities. Going forward, the company will continue to deepen its CRO/CDMO R&D and production services across the pharmaceutical value chain, upgrade its technical systems and service models, and tackle core technical challenges in drug development. With more professional, efficient and comprehensive end-to-end services, Nanjing Vcare will empower more pharmaceutical enterprises to accelerate drug R&D, secure compliant approvals and achieve successful product launches. It will also contribute to the high-quality development of China’s pharmaceutical industry and bring more high-quality and accessible innovative medicines to patients.
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