Genevax Files IPO Prospectus: Pioneering Innovative Vaccines for Respiratory Infectious Diseases

Unfolding the pages of history, humanity has largely eradicated smallpox, poliomyelitis, diphtheria, and other once-terrifying diseases that posed significant threats to human survival through vaccination. It can be said that the advent of vaccines has made an indelible contribution to the development of human society.

Since the advent of humanity, no medical intervention has been able to directly “eradicate” a disease as vaccines have. Since the introduction of the first vaccine (the smallpox vaccine, used to combat smallpox) in 1796, humanity has progressed from having no vaccines to developing them extensively. In the more than 200 years since the introduction of the smallpox vaccine, humans have been on a journey to explore the use of vaccination to resist diseases.

The sudden onslaught of COVID-19 has not only inflicted heavy blows and harm on people worldwide but also heightened our awareness of the importance of vaccine development. This importance is reflected not only in a deeper understanding of the virus but also in higher-level requirements for vaccine R&D capabilities—how to achieve the transition in vaccine development “from nothing to something, and from something to excellence.”

As traditional inactivated virus vaccines and live-attenuated vaccines struggle to meet our high expectations for vaccine development speed, immunogenicity, safety, and production capacity, innovative vaccines such as recombinant subunit protein vaccines, nanoparticle carrier vaccines, and RNA vaccines are poised for a period of robust growth. According to Frost & Sullivan statistics, the compound annual growth rate (CAGR) of China’s vaccine market from 2016 to 2020 reached as high as29.1%, is expected to exceed by 2030300 billionyuan, with the market share of innovative vaccines increasing year by year,Based on output value estimates, innovative vaccines surpassed traditional vaccines in 2020, accounting for 55.4% of the market. Their market share is projected to rise further from 55.4% in 2020 to over 86.6% by 2030.

The future is bright, but the path is always winding. Even though vaccine development is currently “flourishing,” there is still “a long way to go from scientific research to industrialization.”Professor Wang Xiliang, Founder & Chief Scientist of GinoVax and Renowned Anti-Infective ExpertIt was stated that the industry’s current theoretical understanding of diseases is insufficient, and there is a disconnect between basic research and industrial translation, failing to meet many current clinical needs.

In the field of infectious diseases, respiratory infectious diseases are the most predominant. In addition to the ongoing pandemic of COVID-19 since 2019, other emerging respiratory infectious diseases that have posed significant threats in recent years include SARS, MERS, and H1N1 influenza. These diseases are characterized by substantial viral structural mutations, rapid waning of antibody immunity, multiple transmission routes, and universal population susceptibility, making them highly prone to outbreaks and epidemics while posing considerable challenges to effective control. Currently, China’s capabilities in the respiratory disease sector are constrained by a limited availability of vaccines, reliance on relatively traditional technologies, and suboptimal efficacy, necessitating an urgent comprehensive upgrade.

With over 30 years of dedicated expertise in the research and development of vaccines for major respiratory infectious diseases and emergency therapeutic antibodies, Professor Wang Xiliang has a profound understanding of market pain points. His experience in developing multiple vaccine-based new drug products that have achieved industrialization has not only earned him acclaim for his scientific achievements but also endowed him with extensive expertise in translational commercialization.

Professor Wang Xiliang formerly served as the Director of the Immunology Research Division at the Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences / State Key Laboratory of Pathogen and Biosecurity. He is a Senior Research Fellow, Professor, and Doctoral Supervisor. His research focuses on anti-infective immunity. He has published over 160 research papers in domestic and international professional journals, including Science, Cell Reports, Journal of Molecular Cell Biology, Journal of Immunology, and Vaccines, and holds 13 authorized invention patents. He has received one Second Prize of the National Science and Technology Progress Award, one First Prize and two Second Prizes of Provincial Science and Technology Progress Awards, and two Second Prizes of the Military Science and Technology Progress Award. Professor Wang Xiliang has established independently owned intellectual property rights forRapid Reverse Genetics Reassortment of Vaccine Strains, Virus-Like Particle Vaccines, Non-Injectable Immunoprophylactic Vaccines, and Key Technology Platforms for Emergency Therapeutics, and as the principal investigator, he/she has successively undertaken multiple scientific research projects, including the National 863 Program, the National 973 Program, the Major Special Project on Innovative Drugs, and the Major Special Project on Infectious Diseases.One of its vaccine and new drug products has achieved industrialization, three have completed clinical trials, and four vaccine and therapeutic antibody new drug products are currently in clinical research.

Another from GenoGuardProfessor Wei Shi, Founder, currently a Researcher/Professor and Doctoral Supervisor at the National Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), and Principal Investigator (PI) of the Viral Vaccine Research Center. Professor Xi Liang introduced that Professor Wei Shi earned his Ph.D. in Immunology from the Immunology Center of the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences, and subsequently completed postdoctoral training at Loyola University Chicago's Stritch School of Medicine. Professor Wei ShiSpecializes in research on infection immunology and innovative vaccines, with extensive experience in the design and preparation of recombinant nanoparticle vaccines and viral vector vaccines, thereby establishing distinct advantages in technological translation.

Due to his outstanding contributions to the development of effective vaccines for preventing diseases such as parathyroiditis, Ebola, and COVID-19, as well as his breakthrough achievements in innovative infectious disease vaccine technologies and product research, Professor Shi Wei has repeatedly received the NIH Director’s Award in 2010, 2011, 2012, 2016, and 2021. He has published more than 200 high-quality academic papers in internationally renowned professional journals, including Nature, Science, Nat Commun, N Engl J Med, PNAS, Cell Rep, J Immunol, Vaccines, and PLoS Pathog, establishing himself as a scholar with significant academic influence in the field. From 2009 to 2019, his publications ranked within the top 1% by citation count.

Other members of Genoway’s R&D team also possess extensive experience in vaccine product development, particularly in the design and preparation of genetically engineered antigens, CHO cell modification and expression, nanoparticle vaccine design and formulation, and clinical vaccine research. Currently, Genoway has established a portfolio that includesRecombinant SARS-CoV-2 Protein Subunit Vaccine, COVID-19 and Influenza Bivalent Vaccine, Recombinant VZV Virus-Like Particle Vaccine, Recombinant RSV Nanoparticle Vaccine, Quadrivalent Hand, Foot, and Mouth Disease Nanoparticle Vaccinemultiple product pipelines. The company is headquartered in Shanghai, with a nearly 1,000-square-meter R&D center in Beijing expected to be operational by December.

The incomplete containment of the COVID-19 pandemic continues to pose ongoing threats and disruptions to the normal lives of people worldwide. Consequently, the development of more efficacious COVID-19 vaccines has naturally become Genoway’s top strategic priority. By leveraging its proprietary molecular chaperone dimer plus dual-adjuvant synergistic technology, Genoway’s innovative dual-adjuvant dimeric recombinant protein COVID-19 vaccine, compared with existing single-adjuvant recombinant COVID-19 vaccines,It can achieve a more than five-fold increase in neutralizing antibody titers using only 50% of the antigen dose, while demonstrating high protective efficacy against variant strains.The product will submit its Investigational New Drug (IND) application today, and the integrated sequential vaccination regimen is expected to be launched within 2023.

Current real-world data indicate that protection against severe disease or death persists for six months following complete COVID-19 vaccination. However, a significant proportion of vaccinated individuals lose their protection against SARS-CoV-2 infection, which can lead to new waves of transmission. “The next phase of the COVID-19 pandemic will resemble seasonal influenza; achieving herd immunity will require regular vaccination,” stated Professor Xi Liang. The development of a combined COVID-19 and influenza vaccine is intended to prepare for the recurrent and persistent nature of the epidemic.Leveraging its technical expertise accumulated from the quadrivalent split-virion influenza vaccine, GenoVax holds a leading advantage in the development of this bivalent vaccine.Plan to submit the IND application in Q1 2022.

Herpes zoster is an acute infectious skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the body. The disease causes excruciating pain upon onset, and there is currently no specific cure; vaccination is the most effective preventive measure available at present. However,Currently, two shingles vaccines are marketed globally: Zostavax (using live-attenuated vaccine technology) and Shingrix (using recombinant protein vaccine technology). In terms of protective efficacy, recombinant technology is superior to live-attenuated technology. China has currently approved only the VZV vaccine based on GSK’s recombinant protein platform.The incidence of herpes zoster in the Asia-Pacific region is approximately 1%, but it increases with age, exceeding 5% among individuals aged 40–50 and older. As China gradually transitions into an aging society, the health needs of the elderly warrant attention, making the independent research and development of varicella-zoster virus (VZV) vaccines a promising entry point. GenoImmune has currently completed confirmatory animal studies for its VZV recombinant protein vaccine and expects to submit an Investigational New Drug (IND) application in the second quarter of 2022.

Respiratory syncytial virus (RSV) is the most significant cause of seasonal lower respiratory tract infections in infants and young children, as well as the leading cause of death from viral infections in neonates. Statistics indicate that there are approximately 64 million cases and 160,000 deaths globally each year due to RSV. However, RSV vaccine development has faced repeated setbacks since the 1950s; despite more than 50 years of research efforts, no vaccine has yet been brought to market. UntilIn recent years, researchers have elucidated the mechanism by which RSV vaccines activate Th2 CD4+ T cells to secrete relevant cytokines, thereby mediating the development of pneumonia. Currently, the most promising candidates in this field are the pre-fusion conformation F protein subunit vaccines engineered via genetic technology and human adenovirus vector vaccines.GinoVax possesses a proprietary, optimally designed protein nanoparticle vaccine technology platform that enables the efficient, repetitive presentation of target antigens on virus-like particles (VLPs). Unlike virus-derived VLPs, these particles are non-immunogenic; therefore, in addition to their use in vaccine production, they can also serve as drug delivery carriers.

Certainly, the layout of numerous product pipelines is inseparable from the establishment of underlying technology platforms. The Genoway team possesses multiple key technologies ranging from vaccine R&D to industrialization, and has established, to date, includingReverse genetics-based rapid reassortment vaccine strains, recombinant nanoparticle technology, innovative vaccine adjuvants, and non-injectable immunization formulationsfour major vaccine technology platforms, including.

For vaccine development, two factors are critically important: first, a thorough understanding of the pathogen; and second, an in-depth consideration of the mechanisms underlying the body’s response to the vaccine. Professor Wang Xiliang stated that pathogens differ from single pathogenic molecules and involve highly complex mechanisms of action. Therefore, while designing antigens for vaccine development, it is essential to also account for the host’s immune response. “The limited efficacy of many previously developed vaccines against infectious diseases was partly due to inadequate consideration in this area, resulting in insufficient effectiveness and concerns about safety. By independently developing innovative adjuvants, Genovax has achieved more than an eight-fold increase in vaccine potency while using only one-third to one-half of the conventional antigen dosage,” Professor Wang explained to VCBeat.

In summary, Ginovax is currently intensively preparing for the research and development and Investigational New Drug (IND) applications of multiple products, including recombinant COVID-19 protein vaccines for respiratory infectious diseases, bivalent COVID-19 and influenza virus vaccines, recombinant VZV protein particle vaccines, and recombinant RSV nanoparticle vaccines. In addition, patent applications for two novel vaccine adjuvants are proceeding smoothly and are expected to be completed within the year. Meanwhile, the industrialization of the company’s projects has received strong government support and has achieved phased progress.

As government liaison efforts progressed step by step—from R&D filing and laboratory renovation to production preparation—Professor Wang Xiliang swiftly transitioned from a research scholar to an entrepreneurial business leader. “The innovative vaccine industry bears a heavy responsibility and has a long way to go; we look forward to welcoming more outstanding talents,” Professor Wang sincerely expressed at the conclusion of the interview. “The company has already made advance plans for incentive mechanisms aimed at attracting and retaining talent.”

A sudden stir of emotion arises. It is precisely these individual and collective groups of scientific workers, steadfastly holding their posts on the front lines of research and industry, who have exchanged the comforts of life for the busyness of work, thereby erecting a major safety barrier in the form of vaccines to protect public health. As they toil “from dawn till dusk” to develop safer and more effective vaccines, they themselves have become akin to a vaccine in the hearts of the people, subduing rampant viruses and securing well-being for the public. We look forward to GenoWise delivering more high-quality vaccine products to the public in the future.