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Interim Analysis Results of the Phase I clinical trial of UBIA’s COVID-19 vaccine UB-612

UBIA indicated today (Feb. 7) that in today’s principal investigator (PI) meeting for Phase II clinical trial, Huang Gaobin, the PI of the Phase I clinical trial and the vice president of China Medical University Hospital, revealed the interim analysis results of the Phase I clinical trial of the high-precision designer COVID-19 vaccine UB-612 developed by UBI/UBIA Group: the results demonstrated the safety and tolerability were good, and no serious adverse events were reported. In terms of immunogenicity, the seroconversion rate of the neutralizing antibody reached 100% 14 and 28 days after the second dose in the high-dose group, while the Geometric Mean Titer (GMT) of neutralizing antibody increased by more than 40 times. It proves that the vaccine UB-612 is good at safety and tolerability with excellent immunogenicity.

About UB-612 Vaccine
The UB-612 vaccine is the world’s first COVID-19 multitope protein/peptide-based vaccine (MPV) using its unique patented platform technology with high precision design to target the SARS-CoV-2 virus. In addition to the precisely designed viral antigen S1-RBD, UB-612 also incorporates the world’s first CTL and Th epitope peptides. These peptides are selected from the conserved sequence regions of M, S2 and N proteins that can bind to human MHC I and II and are derived from the immunodominant M, S2 and N proteins of the virus, and are not prone to mutation. These precisely designed blended Th/CTL peptides are capable of activating T cells and triggering the memory response and effector function of T cells. In animal studies, it has demonstrated that UB-612 vaccine not only elicited highly specific neutralizing antibodies with greater than 10,000-fold dilution (much higher than any current COVID-19 vaccines in the world), but also induced Th1-type T cell immune response. The carefully designed UB-612 vaccine holds the promise of generating balanced B cell activation and amplifying T cell immune response in human body and thus provides good protection. The interim report of the Phase I clinical trial showed that the UB-612 vaccine can produce a good immune response in humans, and is well tolerated without serious adverse events. Besides, UB-612 does not need to be transported and stored in an ultra-low temperature cold chain, which is more competitive than the RNA vaccines developed by companies such as Pfizer/BNT.

About UBI Group
United Biomedical, Inc. (UBI) is a private company established in Delaware in 1985 by Dr. Wang Chang Yi and her husband. UBI is energetically engaged in the research, development , and commercialization of vaccine products and immunotherapies for major chronic and infectious diseases through the mechanisms of active immunity (high-precision designer vaccines) and passive immunity (monoclonal antibody products). UBI is also the world's first biomedical company approved by the U.S. FDA to produce HIV and HCV diagnostic kits employing designed synthetic peptide antigens. In 1993, the subsidiary of UBI was established in China for the manufacture of HCV diagnostic kits with CE marking certified by the European Union; and in 2001, Shanghai Shen Lian Biomedical Corporation (Shen Lian) was formed in Shanghai, China and on October 28, 2019 it was listed on the Shanghai Science and Technology Innovation Board. Shen Lian is mainly engaged in the manufacture and sale of swine foot-and-mouth disease (FMD) synthetic peptide vaccines developed using UBI patented technology UBITh®. In the ten years since the FMD vaccine was launched in China, it has achieved sales of more than 5 billion doses.

In 1998, the Taiwan government invited UBI to forge a joint venture with the government and the United Biomedical, Inc. Asia. (UBIA), a private joint venture for non-public offering, was then created for research and development of monoclonal antibody/protein products and special generic drugs. Later, through the acquisition of Roche’s and GSK’s GMP manufacturing plants, UBIA acquired the ability to produce chemical drugs and even to offer contract manufacturing service, this further provided the resources and facilities for development of UBIA’s monoclonal antibody/protein products.

Since 2013, in order to optimize UBIA’s product lines and the values of platform technologies, UBIA has undertaken the spin-off to separate the group into various business entities each with its own distinct positioning and missions. Each business entity dedicates their own resources to support product development using specific platform technologies: United BioPharma (UBP, established in Taiwan in September 2013) specializes in the development of  monoclonal antibody drugs; UBI Pharma Inc. (UBIP, established in Taiwan in 2014) focuses on the development of long-acting protein drugs and contract manufacturing service of chemical drugs; and United Neuroscience (UNS, established in Ireland in 2014) is engaged in the development of immunotherapy and vaccine products for neurodegenerative diseases.

In addition, at the beginning of this year, UBI used special project financing to exclusively authorize COVID-19-related intellectual property to the newly formed "COVAXX Company" to raise funds to support the global development and commercialization of COVID-19 vaccines and relevant diagnostic kits. For diagnostic kits, the high-precision COVID-19 antibody diagnostic kit (UBI SARS-CoV2 ELISA) has been approved by the US FDA Emergency Use Authorization (EUA).

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Contact person: Jalon Tai, Deputy General Manager
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