GOOD NEWS | Yeedozencom assisted Yidu Biotechnology in successfully convening the project kickoff meeting for the phase 4 clinical trial of the “Rabies Vaccine (Vero Cell)”
On July 16, 2024, the kickoff meeting for the phase 4 clinical trial of the freeze-dried human rabies vaccine, initiated by Shandong Yidu Biotechnology Co., Ltd. (hereinafter referred to as “Shandong Yidu”), was successfully convened at the Xuanhan County Center for Disease Control and Prevention, with the study titled “A Clinical Trial of the Immunogenicity Consistency and Safety of the Freeze-dried Human Rabies Vaccine (Vero Cell) in a Five-Dose Immunization Schedule in Healthy Populations (Protocol No.: YD-Vero-V-220802)”. The project kickoff meeting marks a new phase in the development of the freeze-dried human rabies vaccine independently developed by Shandong Yidu.
The opening ceremony was hosted by Chen Chunlin, Director of the Xuanhan County Center for Disease Control and Prevention.
During the meeting, the attendees once again went over the Good Clinical Practice together and received training on the details of study protocol by members of the project team.
Following the meeting, all attendees engaged in a simulation exercise of the clinical trial and then had discussions regarding various details of project conduction, generating multiple constructive suggestions to ensure the standardization and uniformity of the project details.
Rabies is an acute viral encephalitis caused by the rabies virus, with a nearly 100% fatality rate once symptoms appear. Vaccination against rabies is currently the only effective method for preventing and controlling the disease.
About Shandong Yidu
Founded in 2012, Shandong Yidu Biotechnology Co., Ltd. is a biopharmaceutical company specializing in vaccine research, production, and sales. Shandong Yidu has a GMP workshop covering more than 5,000 square meters, along with supporting facilities for the production of rabies vaccines. It has established a comprehensive quality management system to ensure that production and testing activities are controllable and traceable. The independently developed freeze-dried human rabies vaccine (Vero Cell) was approved for market in 2021. For this product, advanced bioreactor perfusion culture technology was used for large-scale, high-density cell and virus culture, a purification process was independently developed to produce high-purity rabies vaccine, and sterile, disposable multi-layer co-extrusion bags were used throughout the manufacturing process, ensuring high immunogenicity, low side effects, safety, reliability, and consistent quality, with all indicators meeting leading industry standards.
About Yeedozencom
Yeedozencom is dedicated to providing clients with an integrated, efficient, and trustworthy clinical research service. By developing core professional capabilities in specialized fields, we continuously enhance service quality and efficiency. We are not merely an “outsourcing service” provider but an extension of our clients’ teams, integrating regulations, registration, medicine, and operations into drug development to address various challenges. Since its establishment, we have assisted in the marketing approval of multiple innovative and generic drugs, becoming a trusted partner for our clients.
As of April 2024, Yeedozencom has provided services to over 400 clients, of which 45% are foreign or overseas companies.
We have undertaken more than 240 clinical projects, including over 200 clinical pharmacology-related projects (such as phase 1, PK/BE, mass balance, PK in liver or kidney impairment populations, pediatric PK, DDI) and more than 30 phase 2-4 clinical trials, with 38 generic drugs and 5 innovative drugs being approved.
We have also undertaken over 600 projects related to IND/NDA registration services and pre-IND/pre-NDA technical consultations.
Since 2019, we have assisted clients in obtaining 36 IND approvals (including 19 chemical drugs, 16 biological drugs, and 1 traditional Chinese medicine), 21 generic drug manufacturing approvals, and 5 innovative drug manufacturing approvals and 2 modified new drug manufacturing approvals via NDA registration.