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Avito (Shanghai) Pharmaceutical Technology Co., Ltd
QS-21CDE+DMF dual reporting
Date: 2025-07-24Read: 0
As of July 25, 2025, the QS-21 (soapberry saponin) adjuvant independently developed by Avito has successively achieved:
☑ National Medical Products Administration CDE Registration (Registration Number: F20250000075)
☑ DMF filing for excipient drugs with the US FDA (filing number: 041805)
The significance of dual authentication
Avito has become a company that has achieved QS-21 registration with the US FDA;
◆ Ranked among the few QS-21 suppliers in China with CDE registration.
◇ This marks the recognition of domestic adjuvants by the international regulatory system, providing more choices for global vaccine research and development.
QS-21 is a natural source saponin vaccine adjuvant, mainly extracted from the bark of Quillaja saponaria. It has significant immunostimulatory activity and can simultaneously activate humoral and cellular immunity, enhance antibody production and specific T cell responses, including Th1 and Th2 immune responses. It can stimulate the activation of dendritic cells, promote the production of IgG1 and IgG2a antibodies, and induce the secretion of interferon - γ (IFN - γ). In addition, QS-21 can enhance the function of cytotoxic T cells (CTLs) to combat various infectious diseases and cancers.
Traditional QS-21 is limited by the single source and purification bottleneck of soapberry trees, making it difficult to balance production capacity and purity. Avito breaks through industry bottlenecks and its independently developed QS-21 has the following four advantages:
01. Independent research and development, whole plant extraction process
Breakthrough utilization of the entire plant resources of soapberry trees, breaking through the constraints of raw materials, ensuring sufficient production capacity and controllable traceability;
02. Separation and purification technology system
Realize large-scale production of high-purity QS-21 through separation system;
03. Controllable quality, high-purity and stable supply
GMP production, purity ≥ 98%, batch stability;
04. Full range product supply, supporting customized development
Simultaneously separating scarce components such as QS-7, QS-17, and QS-18, and launching high-purity QS-ANM, providing a "QS series toolbox" for vaccine design.
In the field of biomedicine, innovation in excipients is crucial. As the core excipient in vaccine development, the quality and safety of adjuvants directly affect the efficacy and stability of vaccines. Relying on the international qualifications of both China and the United States, Avito has built a full scenario solution:
Human vaccine field → High purity QS-21 (herpes zoster/adjuvant)
Veterinary vaccine field → Customized QS-ANM (safety ≥ international standards)
Frontier research field → QS full range components (supporting the development of new adjuvant combinations)
AVT QS series product information
The dual filing of the Aiweituo QS-21 in China and the United States is an important milestone in the internationalization of domestic auxiliary materials. We will continue to optimize:
✔ Adjuvant supply system that meets international standards
✔ Customized development technical support
✔ Full lifecycle quality control service
To assist in efficient vaccine research and development with verifiable quality!