GenScript ProBio, Abogen Biosciences and Walvax Biotechnology Enter into Collaboration on BLA and Commercial Manufacturing of mRNA Vaccine

GenScript ProBio, Suzhou Abogen Biosciences Technology Co. ("Abogen Biosciences") and Walvax Biotechnology Co. ("Walvax Biotechnology") announced a collaboration on commercial manufacturing of a mRNA vaccine project ("ABO-028M"). Walvax Biotechnology will submit a BLA of ABO-028M project and GenScript ProBio will provide exclusive services for the commercial manufacturing of plasmids in the project.

In June 2020, the COVID-19 mRNA vaccine project that Abogen Biosciences engaged with the Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax Biotechnology successfully obtained the NMPA clinical trial approval. It was one of the first batch of mRNA vaccine projects approved by government of China. GenScript ProBio, with the advantage of plasmid GMP manufacturing platform and rich experiences in plasmid clinical manufacturing, contributed to accelerate the pace of the mRNA vaccine project into clinical trial. The project is currently undergoing international multicenter clinical trials and has obtained Phase III clinical trial approvals from the medical products regulatory authorities of Mexico, Indonesia and Nepal. In September 2021, Walvax Biotechnology's modular facilities for COVID-19 mRNA vaccine was put into operation to accelerate the industrial manufacturing of COVID-19 vaccine.

Three parties have reached collaboration with complementary advantages to achieve mutual benefits on mRNA vaccine and drive the commercialization of the COVID-19 mRNA vaccine project of Abogen Biosciences and Walvax Biotechnology.

"It is a pleasure to collaborate with GenScript ProBio, a partner with highly professional platforms. It has a leading plasmid GMP manufacturing platform in China that provides in vitro transcription template linearized plasmids for mRNA vaccines. It's robust manufacturing process will accelerate the commercialization of our COVID-19 mRNA vaccine and help to fight the pandemic," said Dr. Ying Bo, founder and CEO of Abogen Biosciences.

"Walvax Biotechnology will work with our partners to proceed with the license application for clinical and emergency use of the COVID-19 mRNA vaccine and contribute to the containment of global pandemic and development of public health around the world. Let's look forward to further progress of the project," said Mr. Huang Zhen, Vice Chairman of Walvax Biotechnology.

"The pandemic is still raging. Abogen Biosciences had launched the project since the very beginning of the outbreak of COVID-19. It is one of the first batch of mRNA vaccine projects approved by government of China. We are very proud to provide support for such a meaningful project. We believe that with our high-quality and experienced plasmid manufacturing platform and joint efforts with our partners, we will be able to bring the COVID-19 mRNA vaccine to market sooner and thus contribute to the global fight against the pandemic," said Dr. Brian Min, CEO of GenScript ProBio.

About Abogen Biosciences

Founded at the beginning of 2019, Abogen Biosciences is an innovative clinical-stage biomedical company committed to research and development of mRNA drugs. It has an industry-leading mRNA and nano-delivery technology platform with independent intellectual property rights. The company has built extensive product pipelines, ranging from infectious disease prevention and treatment to tumor immunity. In June 2020, Abogen Biosciences was engaged with the COVID-19 mRNA vaccine project of the Academy of Military Medical Sciences (AMMS) of the PLA Academy of Military Science and Walvax Biotechnology, and succeeded to obtain the NMPA clinical trial approval by joint efforts. It was the first mRNA vaccine approved for clinical trial in China. The vaccine has gone through Phase I and Phase II clinical trials and is now undergoing Phase III clinical trials.    

About Walvax Biotechnology

Walvax Biotechnology, founded in 2001, is a modern biopharmaceutical enterprise specializing in the research and development, manufacturing and sales of biological drugs, including vaccines and blood products. The enterprise was listed on the GEM Board of Shenzhen Stock Exchange in November 2010 (Walvax Biotechnology, 300142).

About GenScript ProBio

GenScript ProBio is the biologics CDMO segment of GenScript Biotech, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.

Toward the mission of "Innovation through Collaboration", GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and building a healthier future.

Source: GenScript