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SHANGHAI, Nov. 22, 2021 /PRNewswire/ -- At the opening ceremony of the 4th China International Import Expo (CIIE) held in Shanghai on November 6, 2021, SYZJ001, a bispecific antibody drug against COVID-19 jointly developed by Shanghai ZJ Bio-Tech Co., Ltd. and Sanyou Biopharmaceuticals (Shanghai) Co., Ltd., made a brilliant appearance. It was announced that Boehringer-Ingelheim (BI), an internationally well-known pharmaceuticals company, would take charge of process optimization and manufacturing services. The appearance of SYZJ001 attracted close attention from all over the world.
In view of the changing trend of COVID-19 worldwide, Sanyou Biopharmaceuticals took full advantages of its unique R&D platforms, and built a team with ZJ Bio-Tech at the beginning of 2020 to jointly develop SYZJ001. It is an innovative drug against COVID-19 developed in China, and also a leading bispecific antibody drug worldwide.
SYZJ001 is screened from the "Ten-Trillion Innovative Antibody Discovery Platform", a platform over which Sanyou Biopharmaceuticals has independent intellectual property rights. The drug is composed of a fully-human IgG antibody and a humanized single domain antibody targeting the receptor binding domain (RBD) of SARS-CoV-2's Spike protein. The two antibodies can non-competitively bind to the antigenic epitopes of RBD proteins, block the binding between the virus and human ACE2 receptors, and efficiently neutralize SARS-CoV-2 and prevent cell infection.
To be specific, the representative data of the single domain antibody P14-F8 (CoVIC-038) have been published on top academic journal Science (p472-478, Vol.374, No. 6566). Currently no immune escape has been observed in the mainstream mutant strains or major mutation sites. The activity of the drug in neutralizing Delta and Epsilon mutant strains is stronger than that against the wild-type strain. Moreover, the combination of the fully-human IgG antibody and the single domain antibody confers "double-epitope, bispecific, and double-barrier" features. SYZJ001 presents extremely excellent activity in neutralizing SARS-CoV-2, and more appealingly offers broader-spectrum anti-infection features. It has been proved effective in neutralizing a variety of SARS-CoV-2 mutant strains and preventing virus escape. Its efficacy has been validated in vitro and in mouse models. In particular, when it comes to the Delta strain, SYZJ001 has maintained an outstanding neutralizing effect similar to the neutralizing effect observed in the case of wild-type strains. Pre-clinical toxicity studies have also demonstrated the high safety of SYZJ001.
So far, all preclinical studies on SYZJ001 have been completed. Three related patents have been applied, including two published patents and one granted patent (CN112250763B).
The project has formally entered the pre-Investigational New Drug (pre-IND) procedure for application of phase-I clinical trials in China and the US. It is expected to become a class-I innovative bispecific antibody drug against COVID-19 leading the world in terms of clinical progress.
According to Dr. Guojun Lang, CEO of Sanyou Biopharmaceuticals (Shanghai) Co., Ltd.:
"Sanyou Biopharmaceuticals is committed to building a high-quality, high-throughput, and integrated platform for R&D and value transformation of innovative antibody drugs, establishing a business ecosystem covering treatment, R&D, and diagnostic products and services, and cooperating with global biopharmaceutical, diagnostic and drug R&D companies, to usher in a new era of disease diagnosis and treatment for the patients.
The completion of all preclinical studies in this project is a milestone event that fully validating the preclinical integration capability of Sanyou Biopharmaceuticals.
All members of Sanyou Biopharmaceuticals will continue to uphold the enterprise spirit of "Excellence and innovation, pursuit of dreams, striving and evolving, for the benefit of patients", create a world-class integrated R&D platform for innovative antibody drugs, provide differentiated CRO, CPO, and core reagent solutions, and develop innovative diagnostic and therapeutic products more effectively and efficiently."
Bispecific antibody drug against COVID-19 has progressed to pre-IND
About Sanyou Biopharmaceuticals
Sanyou Biopharmaceuticals is a leading international High-tech biotechnology company focused on research, development and providing integrated solutions for innovative antibody drug developments.
Sanyou is committed to building world-leading antibody drug discovery and development platforms of high-quality, high-throughput, integrated R&D and value transformation. Sanyou is dedicated in constructing a business ecosystem for therapeutic, R&D and diagnostic products and services, and collaborating with global biopharmaceutical, diagnostic and biotech companies to open a new era for the diagnosis and treatment of human diseases.
Since Sanyou's founding six years ago, Sanyou has been growing rapidly. As of November 2021, Sanyou has a professional team of more than 230 employees, of which more than 70% hold a PhD or master degree, and this team is deeply experienced in R&D and industrialization of innovative drugs. Sanyou has established an integrated R&D laboratory of ten thousand square meters with advanced facilities in Caohejing Hi-Tech Park in Shanghai. The laboratory has 10 functional modules and more than 40 core technology platforms, led by a series of super-trillion phage display antibody libraries, and followed by a full range of essential R&D platforms for innovative antibody drug discovery, antibody engineering, in vitro and in vivo efficacy screening, pharmaceutical properties analysis, cell line construction and process development. Sanyou continues to provide new technologies, products, services and solutions of "best quality, fastest speed and lowest cost". Sanyou has established friendly business relationships with more than 300 pharmaceutical companies, biotechnology organizations and diagnostics companies around the world.
"Excellence and innovation, pursuit of dreams, striving and evolving, for the benefit of patients", holding these principles and beliefs, Sanyou looks forward to working with its clients and partners to build a long-term synergistic growth ecosystem and a healthy society.
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