AIM Vaccine Co., Ltd. (HKG: 6660), a leading Chinese vaccine company, has taken a significant step towards global expansion by submitting its mRNA-based shingles vaccine for clinical trials to the U.S. Food and Drug Administration (FDA). This move, announced on February 23, 2025, marks a milestone for AIM as it seeks to enter the competitive U.S. market and solidify its position as a pioneer in mRNA vaccine development.
The submission of the mRNA shingles vaccine to the FDA follows promising preclinical data, which demonstrated superior efficacy compared to existing recombinant subunit control vaccines. The vaccine exhibited significantly higher specific T-cell immunity, specific IgG antibody titers, and membrane antigen fluorescent antibody (FAMA) titers in animal trials. These results highlight the vaccine's potential to address a critical gap in herpes zoster prevention and offer a more effective solution than current offerings.
AIM's mRNA shingles vaccine leverages the company's innovative mRNA technology platform, which has been validated by clinical trial data from over 10,000 mRNA vaccine product cases. The company has established a full lifecycle process for mRNA vaccine R&D and production, enabling rapid industrialization and commercialization of mRNA vaccine products upon clinical completion. This streamlined approach allows AIM to quickly bring its innovative vaccines to market, capitalizing on unmet needs and market opportunities.
The global shingles vaccine market remains underserved, with a vaccination rate of just 0.1% among the target population. AIM's mRNA vaccine could tap into this vast, unmet need, leveraging its innovative platform to deliver a more effective solution than current offerings. According to industry consultant CIC (China Insights Consultancy), the shingles vaccine market in China is expected to reach around RMB 20 billion by 2030, with the global market size projected to reach approximately USD 23.9 billion. With no mRNA shingles vaccine currently approved for marketing globally, AIM's product has the potential to capture a significant share of the market and drive substantial performance growth for the company.
In parallel with its global expansion efforts, AIM has integrated DeepSeek's large language models (LLMs) to accelerate vaccine discovery, design, and manufacturing. The partnership aims to optimize mRNA vaccine sequence design and stability using generative AI and deep learning. This strategic move underscores AIM's commitment to leveraging cutting-edge technology to drive next-generation vaccine development and maintain its competitive edge in the global market.
As AIM Vaccine continues to advance its mRNA vaccine pipeline, including the mRNA RSV vaccine and mRNA influenza vaccine, the submission of the mRNA shingles vaccine for U.S. clinical trials serves as a testament to the company's innovative spirit and global ambition. By successfully navigating the rigorous FDA approval process, AIM can unlock new markets, enhance its reputation, and solidify its position as a leader in the global vaccine market.

In conclusion, AIM Vaccine's submission of its mRNA shingles vaccine for U.S. clinical trials represents a strategic move towards global expansion and market leadership. With a strong mRNA technology platform, promising preclinical data, and a vast, underserved market, AIM is well-positioned to capture a significant share of the global shingles vaccine market and drive substantial performance growth for the company. By leveraging cutting-edge technology and maintaining a commitment to innovation, AIM Vaccine continues to solidify its position as a leader in the global vaccine market.
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