Recently, Yither Biotech (Shanghai) Co., Ltd. (Yither Bio) and its parent company Ab&B Bio Tech Co., Ltd. (Ab&B Bio) have achieved multiple breakthroughs in innovative vaccine research and commercialization. The independently developed monkeypox mRNA vaccine has obtained clinical trial approval from the US FDA and is the first and only domestically approved trivalent influenza virus subunit vaccine with full dose for the entire population. In response to the WHO's official release of recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026-2027, it has successfully won the bid in Shanxi Province. This marks a new milestone for Zhonghui Biotechnology in its internationalization journey, policy response speed, and market access capabilities.

▋ Obtaining FDA clinical approval again, demonstrating international strength

According to public information, the monkeypox mRNA vaccine developed by Zhonghui Biotechnology is the first in China and the third in the world to obtain clinical trial approval for new drugs. After obtaining clinical approval from the US FDA for the respiratory syncytial virus mRNA vaccine, Ab&B Bio has once again gained international recognition for its innovative technological approach. The approval of the monkeypox mRNA vaccine for clinical trials by the FDA is not only a recognition of the company's product research and development capabilities, but also an international recognition of the Ab&B BiomRNA technology platform. It also means that the company can contribute its Chinese efforts to global public health prevention and control.

There is currently no monkeypox vaccine approved for market in China. The United Nations Children's Fund (UNICEF) urgently tendered and procured up to 12 million doses, and WHO and its International Coordinating Group (ICG) partners, including Gavi and UNICEF, plan to establish a monkeypox vaccine reserve by 2026. At present, the vaccines urgently approved abroad for preventing monkeypox virus infection are attenuated smallpox virus and replication defective smallpox virus technology routes, which have room for improvement in safety, immunogenicity, production capacity, and other aspects. The monkeypox mRNA vaccine developed by Ab&B Bio adopts the innovative tetravalent antigen (A27, L1, A33, B5) tandem design with independent intellectual property rights, which can realize the independent expression of four antigens by a single mRNA. At present, the design has been authorized by the China National Intellectual Property Administration of China for invention patents, and PCT international invention patents have entered the national stage. In non clinical studies, the vaccine demonstrated excellent immunogenicity (high-level binding antibodies, neutralizing antibodies, and cellular immunity) and good safety features in SD rats and rhesus monkey models, and produced good in vivo protective effects in monkeypox challenge trials. In terms of production technology, this product has the characteristics of high yield (millions of doses of vaccines can be obtained in one commercial scale production), highly controllable quality, and has the advantage of commercial production. In the future, it is expected to provide a safer and more effective next-generation solution for global monkeypox epidemic prevention and control.

The continuous output of this innovative achievement is attributed to the mRNA technology platform built by the company's doctoral team at home and abroad. The core advantage of this platform lies in its agility in research and development and the potential for large-scale production. As a "digital" platform, once the target sequence is obtained, it can be quickly designed and synthesized, achieving rapid iteration. On a safety level, mRNA does not enter the nucleus and there is no risk of genome integration. At the efficiency level, through sequence optimization and advanced delivery systems, it can simultaneously activate strong humoral and cellular immunity.

At present, the company has completed the technological accumulation in the development of mRNA vaccines for single pathogens in the field of infectious disease vaccines, and will rapidly expand to the development of combined vaccines for multiple pathogens and innovative cancer therapies using mRNA technology. In addition, the company actively utilizes AI technology to empower the mRNA technology platform, helping to improve the quality and efficiency of research and development.

▋ Seize the opportunity and provide new market choices

With the official release of the recommended components for seasonal influenza vaccines in the Northern Hemisphere for 2026-2027 by the World Health Organization (WHO), influenza vaccines may usher in a "trivalent era".  
With sharp industry insights and strong ability to transform achievements, the trivalent influenza virus subunit vaccine (Huierkangxin 3) independently developed by Zhonghui Biotechnology 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, Huier Kangxin 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.
Huier Kangxin 3 has achieved a breakthrough in achieving unified vaccination of 0.5ml dosage form for the entire population aged 6 months and above, with infants and adults receiving the same dose of protection, greatly simplifying the vaccination process and bringing more convenient and efficient operating experience to medical staff. In addition, the Huier Kangxin 3 thoughtfully uses VVM tags (vaccine hot tags), allowing medical staff and vaccine recipients to visually judge the effectiveness of the vaccine with the naked eye, building the last visual line of defense for vaccine safety and making every vaccination more reassuring and worry free.
On the market access side, the trivalent influenza virus subunit vaccine (Huierkangxin 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! Zhonghui Biotechnology 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.

▋ About Yither Bio

Yither Bio was founded in 2020 and is a wholly-owned subsidiary of Ab&B Bio. Since its establishment, we have always adhered to the parent company's principle of not simply copying projects, and have been committed to building an innovative research and development team with an international perspective and level, dedicated to the research and industrialization of innovative vaccines for human use.
As of now, the company has established multiple technology platforms, including recombinant genetic engineering vaccine research platform, mRNA vaccine research platform, polysaccharide conjugate vaccine research platform, and innovative adjuvant research platform; And rapidly promote the research and production of multiple R&D pipelines such as multivalent pneumococcal conjugate vaccines, recombinant herpes zoster vaccines, recombinant respiratory syncytial virus vaccines, mRNA poxvirus vaccines, etc.

▋ About Ab&B Bio

Ab&B Bio Tech Co., Ltd (Ab&B Bio) is committed to the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technological methods. Aim at international standards and carry out independent innovation and research and development. As of now, multiple clinical approvals for new drugs have been obtained, and clinical trials and NDA applications are being carried out in an orderly manner.
In the future, Ab&B Bio will continue to adhere to the concept of "innovation driven, quality leading", relying on the three in one development system of "AI empowered research and development+intelligent manufacturing+precision marketing", and committed to providing the public with higher safety and more comprehensive protection of high-quality vaccine products.
Care for life and safeguard health. Zhonghui Biotechnology will continue to work hard and make China use global innovative vaccines, and the world use high-quality Chinese vaccines!