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Monkeypox mRNA Vaccine Secures FDA Clinical Approval, Trivalent Influenza Virus Subunit Vaccine Wins First Bid in Shanxi
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- Time of issue:2026-03-04
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(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") has achieved multiple breakthroughs in the research, development, and commercialization of innovative vaccines. Its self-developed monkeypox mRNA vaccine has obtained clinical trial approval from the U.S. Food and Drug Administration (FDA), and its first and only trivalent influenza virus subunit vaccine for the entire population and all dosages in China has been approved in line with the World Health Organization's (WHO) official release of the recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026 - 2027, and has successfully won the bid in Shanxi Province. This marks that Ab&B Bio has taken a significant step forward in its internationalization journey, policy response speed, and market access capabilities.
Monkeypox mRNA Vaccine Secures FDA Clinical Approval, Trivalent Influenza Virus Subunit Vaccine Wins First Bid in Shanxi
(Summary description)Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") has achieved multiple breakthroughs in the research, development, and commercialization of innovative vaccines. Its self-developed monkeypox mRNA vaccine has obtained clinical trial approval from the U.S. Food and Drug Administration (FDA), and its first and only trivalent influenza virus subunit vaccine for the entire population and all dosages in China has been approved in line with the World Health Organization's (WHO) official release of the recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026 - 2027, and has successfully won the bid in Shanxi Province. This marks that Ab&B Bio has taken a significant step forward in its internationalization journey, policy response speed, and market access capabilities.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2026-03-04 09:13
- Views:
Recently, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") has achieved multiple breakthroughs in the research, development, and commercialization of innovative vaccines. Its self-developed monkeypox mRNA vaccine has obtained clinical trial approval from the U.S. Food and Drug Administration (FDA), and its first and only trivalent influenza virus subunit vaccine for the entire population and all dosages in China has been approved in line with the World Health Organization's (WHO) official release of the recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026 - 2027, and has successfully won the bid in Shanxi Province. This marks that Ab&B Bio has taken a significant step forward in its internationalization journey, policy response speed, and market access capabilities.
According to public information, the monkeypox mRNA vaccine developed by Ab&B Bio is the first in China and the third globally to obtain new drug clinical trial approval. Following the clinical approval of its respiratory syncytial virus (RSV) mRNA vaccine from the FDA, Ab&B Bio has once again gained international recognition for its innovative technological approach. The approval of the monkeypox mRNA vaccine for FDA clinical trials not only affirms the company's product research and development capabilities but also represents international recognition of Ab&B Bio's mRNA technology platform, signifying that the company can contribute Chinese strength to global public health prevention and control.
Currently, no monkeypox vaccine has been approved for marketing in China. The United Nations Children's Fund (UNICEF) has urgently tendered for the procurement of up to 12 million doses, and the WHO, along with its partners in the International Coordinating Group (ICG) (including Gavi and UNICEF), plan to establish a monkeypox vaccine stockpile in 2026.
At present, the vaccines urgently approved abroad for preventing monkeypox virus infection are based on attenuated vaccinia virus and replication-deficient vaccinia virus technology routes, which have room for improvement in terms of safety, immunogenicity, and production capacity. The monkeypox mRNA vaccine developed by Ab&B Bioadopts an innovative tetravalent antigen (A27, L1, A33, B5) tandem design with independent intellectual property rights, enabling the independent expression of four antigens from a single mRNA strand. This design has already been granted an invention patent by the China National Intellectual Property Administration, and the PCT international invention patent has entered the national phase. In non-clinical studies, the vaccine has demonstrated excellent immunogenicity (high levels of binding antibodies, neutralizing antibodies, and cellular immunity) and favorable safety profiles in SD rats and rhesus monkey models, and has shown good in vivo protective effects in monkeypox challenge trials. In terms of production process, this product boasts high yield (a single commercial-scale production run can yield millions of doses of the vaccine) and highly controllable quality, giving it advantages for commercial production. In the future, it is expected to provide a safer and more effective next-generation solution for global monkeypox prevention and control.
The continuous output of such innovative achievements is attributed to the mRNA technology platform established by Ab&B Bio, led by a team of domestic and overseas doctoral researchers. The core advantages of this platform lie in its research and development agility and production scalability potential. As a "digital" platform, once the target sequence is obtained, it can be rapidly designed and synthesized, enabling quick iteration. In terms of safety, mRNA does not enter the cell nucleus, eliminating the risk of genomic integration. In terms of efficacy, through sequence optimization and an advanced delivery system, it can simultaneously activate strong humoral and cellular immunity.
Currently, the company has completed the technological accumulation for developing single-pathogen mRNA vaccines in the field of infectious disease vaccines and will rapidly expand into the development of combined vaccines targeting multiple pathogens and the development of innovative cancer therapies using mRNA technology. Additionally, the company actively employs AI technology to empower its mRNA technology platform, enhancing research and development quality and efficiency.
As the WHO officially releases the recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026 - 2027, influenza vaccines may usher in the "trivalent era."
With sharp industry insights and strong ability to transform achievements, the trivalent influenza virus subunit vaccine (HRK-X® 3) independently developed by Ab&B Bio has been approved for market, becoming the first and only trivalent influenza virus subunit vaccine in China with full population and full dose. Together with the company's already listed quadrivalent influenza virus subunit vaccine, we have established a "quadrivalent+trivalent" high-end influenza vaccine product dual line of defense, achieving seamless integration with policy trends.
As a third-generation influenza vaccine, HRK-X® 3 only extracts the surface core antigen (HA/NA) of the virus, removes internal impurities of the virus, has higher purity, lower adverse reactions, better safety, and better immune efficacy. Phase III clinical data shows that local adverse reactions are lower in the split vaccine group compared to the control group. Full dose vaccination can provide stronger immune protection for infants and young children, and has good safety.
HRK-X® 3 has achieved a breakthrough by enabling a unified 0.5 ml dosage for all individuals aged 6 months and above, providing the same dosage protection for infants and adults, significantly simplifying the vaccination process and offering a more convenient and efficient operational experience for healthcare workers. In addition, HRK-X® 3 has thoughtfully incorporated a VVM label (vaccine vial monitor), allowing healthcare workers and vaccine recipients to visually determine the vaccine's effectiveness with the naked eye, establishing a final visual defense line for vaccine safety and making each vaccination more reassuring and worry-free.
On the market access side, the trivalent influenza virus subunit vaccine (HRK-X® 3) successfully won the bid for the Shanxi Province non immunization plan vaccine supplementary procurement project at a price of 298 yuan/dose! Becoming the first domestically awarded trivalent influenza virus subunit vaccine for the entire population this year! Ab&B Bio will not only provide safer and higher quality vaccine guarantees for the 2026-2027 influenza season in China, but also promote the company's sustained growth in performance; We will fully leverage the overseas market exploration experience accumulated by the quadrivalent influenza virus subunit vaccine, accelerate the "going global" process of trivalent influenza vaccine, and make every effort to create the second growth curve.
Relevant information
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Ab&B Bio-Tech Co., Ltd. collaborates with Walvax Biotechnology Co., Ltd. to seamlessly connect the third-generation subunit influenza vaccine and embark on a new journey of going globalOn March 13, 2026, Ab&B Bio-Tech Co., Ltd. (hereinafter referred to as "Ab&B Bio") and Walvax Biotechnology Co., Ltd. (hereinafter referred to as "Walvax") officially signed a strategic cooperation agreement for the overseas market of influenza virus subunit vaccines in Taizhou. Both parties announced that they will jointly promote the development of the influenza virus subunit vaccine independently developed by Ab&B Bio and set sail to the sea. This is not only a milestone moment for Chinese vaccine companies to cooperate and build a healthy industry ecosystem, but also signifies that China will bring safer and more effective solutions to the global influenza prevention and control field. - Monkeypox mRNA Vaccine Secures FDA Clinical Approval, Trivalent Influenza Virus Subunit Vaccine Wins First Bid in Shanxi 03-04
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