This autumn and winter, the Asia-Pacific region is experiencing an earlier and more severe flu season than usual. In Japan, the flu season arrived five weeks earlier than last year, with over 9,000 cases reported between October 6 and 12—2.65 times higher than the same period last year. Similarly, sentinel hospitals in southern China reported a 4.1% influenza-like illness rate, significantly exceeding 2022 and 2024 levels. The dominant strain, H3N2, has undergone antigenic drift, reducing vaccine efficacy and posing higher risks to vulnerable groups like children and the elderly, often leading to severe symptoms such as high fever and pneumonia.
Against this backdrop, the expanded approval of China’s first quadrivalent flu subunit vaccine, HRK-X®, for individuals aged six months and above is timely. This vaccine extends coverage to infants and the elderly, offering high-quality protection meeting adult standards.
**Safety Advantages: Filling the Gap in Pediatric Vaccines** HRK-X® employs subunit technology, emphasizing safety and purity. Compared to traditional split-virus or live-attenuated vaccines, it removes viral internal proteins and membrane impurities—requiring five doses of split-virus vaccine material to produce one subunit dose. Data from *Vaccine* journal shows HRK-X® reduces fever reactions in children aged 3–8 to 46% of the control group’s rate, with local adverse reactions in infants at 54% of split-virus vaccines. Its isotonic formula and micro-needle design further cut injection pain by 33% and bleeding by 21%, enhancing compliance.
The *Chinese Influenza Vaccination Technical Guidelines (2023–2024)* highlights subunit vaccines’ superior safety due to their purified HA/NA antigens. HRK-X® not only addresses the unmet need for premium pediatric flu vaccines but also advances China’s flu vaccine development toward greater precision.
**Market Potential: Subunit Vaccines Gain Momentum** Globally, flu causes 3–5 million severe cases annually, with China averaging 88,000 excess respiratory deaths from 2010–2015. Yet, its flu vaccination rate remains low at 3.84% (2022–2023). The global subunit vaccine market grew from $400 million in 2019 to $600 million in 2023, projected to hit $1.4 billion by 2032. In China, the segment is expected to surge from RMB 700 million in 2024 to RMB 2.9 billion by 2033, an 18.0% CAGR.
Currently, China’s flu vaccine market is dominated by second-gen split-virus products. AB&B BIO-TECH-B (02627)’s third-gen subunit vaccine stands out for safety and efficacy. Among 19 candidates in clinical development, HRK-X® is the only approved quadrivalent subunit vaccine for all ages, securing a first-mover advantage.
With winter flu peaks approaching, HRK-X® has secured approval in 26 provinces and completed first-dose administrations in cities like Shenyang, Shanghai, and Wuhan. This rapid commercialization positions AB&B BIO-TECH-B for significant near-term growth.
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