不良事件/反应报告
https://www.walvax.com/public_information/?type=5&id=1
不良事件/反应报告
The virus-like particle technology is the most competitive and critical platform in Zerun Biotech. The platform technology has taken the domestic lead in the aspects of VLP purification, reassembly and disassembly, and the stability of formulation. In the aspects of advanced structure analysis and particle uniformity, Zerun Biotech has reached the international advanced standards.
Zerun Biotech has established a competitive Recombinant Protein Expression Technology Platform, including E. coli, Baculovirus-insect cell, yeast and mammalian CHO cell expression systems, to express various antigens based on the characteristics of target proteins. Moreover, we further genetically engineered each system to make it have more advantages for industrial use.
Innovative adjuvant evaluation platform is led by domestic and foreign technical talents. With advanced instruments including Analytic Ultra-centrifuge, Dynamic Lighting Scattering, Differential Scanning Calorimetry, Mass Spectrometer and Flow Cytometer, Zerun Biotech has established an evaluation system for physical-chemical properties, stability and immunogenicity enhancement of various adjuvants. Novel adjuvant has been developed into clinical trials.
To further expand the research and development technical platform of vaccine, Zerun Biotech has developed mRNA vaccine technical platform through independent research and external cooperation, and has built a professional research team.
Technology Platform
Product/Project Name
Proof of Concept
Preclinical
Phase Ⅰ
Phase Ⅱ
Phase Ⅲ
Marketing
Yeast
Human Papillomavirus Bivalent Vaccine
Human Papillomavirus 9-valent Vaccine
Other New Vaccines
CHO Cell
Recombinant SARS-CoV-2Vaccine(Prototype)
Recombinant SARS-CoV-2 Vaccine(Variant)
Varicella-Zoster Virus Vaccine
Other New Vaccines
mRNA
Other New Vaccines
Shanghai Zerun Biotechnology Co., Ltd. is dedicated to the development of novel recombinant vaccines and has a platform for Virus-Like Particle Preparation, Recombinant Protein Expression Technology and Innovative Adjuvant Research. Based on yeast expression system, we have developed bivalent and nine-valent preventive cervical cancer vaccines (HPV vaccine), etc. Among them, bivalent HPV vaccine has been approved for marketing in China on March 22, 2022, and nine-valent HPV vaccine has entered phase III clinical trial. We have developed two SARS-CoV-2 vaccines and Varicella Zoster Virus vaccines based on the CHO cell expression system, of which the SARS-CoV-2 prototype vaccine has completed Phase II clinical trials and the SARS-CoV-2 variant vaccine has completed Phase I clinical trials at home and abroad.
In addition to the above officially approved vaccines under development, Zerun Biotech is exploring other preventive vaccines based on its mature yeast and CHO cell expression systems and newly deployed mRNA vaccine technology platform to further enrich the variety of promising vaccines.
Zerun Biotech is an innovation driven company and always takes the protection of intellectual property seriously. By collaborating with well-known law firms at home and abroad, Zerun Biotech has established a complete IP protection system to manage IP portfolios, IP risk mitigation and IP licensing in/out. In 2018, Zerun Biotech was recognized as a “Pilot Enterprise for Patent Work in Shanghai” for its excellent work in intellectual property.
Up to date, Zerun Biotech has filed more than 40 patents worldwide in accordance with business strategy. Zerun Biotech’s patent portfolio protects its IP positions in China, US, Europe, South Korea, Malaysia, India, Indonesia, Russia, Mexico, Brazil and other major biomedicine markets worldwide.