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Achievement transformation

George F. Gao's team mainly focuses on the recognition and response mechanisms of pathogenic microorganisms and immunity. Building upon a series of major theoretical breakthroughs, We have engaged in innovative vaccine design and drug development. Since 2017, our team has collaborated with 18 enterprises on 27 cooperative development projects in the fields of vaccines, antibody drugs, and pathogen detection. During the COVID-19 pandemic, our team made significant contributions in areas such as virus detection, drug screening, and the rapid development of vaccines and antibodies, achieving a series of notable results.

 

1. Recombinant COVID-19 Vaccine (CHO Cell)

George F. Gao's team has developed a universal design of betacoronavirus vaccines against SARS-CoV-2, MERS and SARS, and developed a recombinant protein vaccine ZF2001 to prevent COVID-19 together with Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd,. The vaccine has been approved for emergency use (March 2021) and conditional marketing (March 2022) in China, and has been approved as a sequential booster of COVID-19 inactivated vaccine (February 2022) in China. The vaccine has also been approved for emergency use in Uzbekistan, Indonesia and Colombia, and as a sequential booster of COVID-19 inactivated vaccine in Indonesia. The related patent (202010581414.3) was awarded the Silver Prize at the 24th China Patent Award.

 

2. Therapeutic Neutralizing Antibody for COVID-19

Our team isolated several monoclonal SARS-CoV-2 neutralizing antibodies from COVID-19 convalescents. The team, together with Shanghai Junshi Biosciences Co., Ltd., has developed the antibody CB6 (JS016) to be the first SARS-CoV-2 neutralizing antibody to enter clinical trials in China, and also the first SARS-CoV-2 antibody to enter clinical trials on healthy people in the world. The antibody has been authorized to Eli Lilly for the treatment of COVID-19 with bamlanivimab. It has obtained emergency use authorization in 17 countries and regions including the United States and has sold nearly 1 million doses worldwide.

 

3. SARS-CoV-2 Antigen Test Kit

In collaboration with Jiangsu Medomics Medical Technology Co., Ltd., the team successfully developed a SARS-CoV-2 Antigen Test Kit (colloidal gold method). This product features high sensitivity and specificity, enabling rapid detection of SARS-CoV-2. The kit has obtained dozens of overseas registrations and is exported to over 40 countries and regions, making significant contributions to global pandemic prevention and control.

 

4. Anti-COVID-19 peptide nasal spray HY3000

George F. Gao's team designed a peptide fusion inhibitor against SARS-CoV-2 in the early stage of the outbreak of COVID-19. The team, together with Hybio Pharmaceutical Co., Ltd., has developed a peptide nasal spray HY3000. The product works by preventing viral infection of host cells, demonstrating good safety and tolerability, with a promising trend in preventing COVID-19 infection.

5. Bispecific Antibody Against SARS-CoV-2

Our team identified two non-competing antibodies (L4.65 and CoV56 monoclonal antibodies) from COVID-19 vaccine recipients, which exhibit potent neutralizing activity against various Omicron variants, including BA.4/BA.5 subvariants. The team licensed the use of L4.65 and CoV56 monoclonal antibodies to 3SBio, which engineered a bispecific neutralizing antibody (DIA-19) suitable for industrial production and is responsible for its subsequent development and promotion.

 

6.Monoclonal Antibody Respiratory against Syncytial Virus (RSV)

In collaboration with Beijing Children's Hospital, our team licensed the patent for a monoclonal antibody targeting respiratory syncytial virus (RSV) to ArkBio. The investigational new drug (IND) application for this drug has been approved by the National Medical Products Administration (NMPA) and is expected to prevent RSV infection in infants throughout the epidemic season.

 

7. Recombinant Chimeric Antigen Vaccine for Poxvirus

Our team developed a recombinant chimeric immunogen, JT118, composed of tandem fusion of two fragments, M1 and A35, from the monkeypox virus antigen. In specific antibody response and protective efficacy tests against vaccinia virus challenge in mice, JT118 demonstrated superior effects compared to co-immunization with M1 and A35. The monkeypox virus-specific neutralizing antibody titer induced by JT118 vaccination was 28 times higher than that induced by the vaccinia virus Tian Tan strain.

JT118 is the world's first and only monkeypox recombinant protein vaccine in preclinical development, with plans to submit a clinical trial application to the NMPA in the near future. The project has established a cell bank and production process compliant with GMP standards, conducted multiple batches of bulk and formulation production at pilot scale, and developed comprehensive quality standards for bulk and finished products. In monkeypox virus challenge models in small and large animals, JT118 immunization provided effective anti-infection protection and significantly reduced viral replication in plasma and multiple organs. This project demonstrates clear efficacy, good safety, stable and controllable processes, and strong accessibility, with promising industrial prospects.

 

8. Monkeypox Virus mRNA Vaccine

The monkeypox virus has complex virions, consisting of two morphologically distinct infectious particles: intracellular mature virus (IMV) and extracellular enveloped virus (EEV). These particles have different membrane structures, components, and infection mechanisms, with distinct surface neutralizing antigens. To achieve immune protection against both EEV and IMV, our team designed a multi-immunogen chimeric vaccine containing the EEV neutralizing antigens A35R and B6R, as well as the IMV neutralizing antigen M1R. This vaccine offers the following advantages:

1) It overcomes the safety concerns of existing live attenuated virus vaccines, with good efficacy, safety, and rapid response capabilities.

2) The C140S mutation introduced in the B6R peptide reduces the likelihood of protein multimerization, significantly improving antigen stability and immunogenicity.

3) Compared to poxvirus vaccines, this vaccine exhibits higher specificity for the monkeypox virus.

4) The vaccine removes components from the original immunogen that are ineffective or harmful to host immune responses, avoiding the inherent safety issues of attenuated vaccines. Experimental data show that the chimeric vaccine containing the three immunogens provides complete protection in mouse models.

 

Our team's achievements in technology transfer not only reflect their profound expertise in the biomedical field but also make significant contributions to global public health security. Through collaborations with multiple enterprises, the team's research outcomes have been rapidly translated into practical applications, providing strong support for pandemic prevention and disease treatment.