Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (referred to as "Zhonghui Bio") has achieved a significant milestone in its research and development by obtaining IND approval for its recombinant respiratory syncytial virus (RSV) vaccine from the National Medical Products Administration (NMPA) in China, marking the first dual approval for clinical trials in both China and the United States for the company [1][5] Company Developments - The RSV vaccine has also received clinical approval from the U.S. Food and Drug Administration (FDA), showcasing the company's research capabilities and marking a key breakthrough in its drug development [1] - The vaccine utilizes innovative technology with fully independent intellectual property rights and has shown promising results in preclinical studies, including the ability to stimulate high-titer neutralizing antibodies against RSV A2 and B strains [7] - The vaccine's pre-F antigen structure exhibits excellent thermal stability, allowing for long-term storage in liquid form at 2-8°C, which optimizes production processes and reduces costs, enhancing product accessibility [7] Market Potential - The global RSV drug market, including treatment and prevention, is projected to grow from $1.8 billion in 2020 to $12.8 billion by 2030, with a compound annual growth rate (CAGR) of 21.4%, indicating a significant market opportunity for Zhonghui Bio's RSV vaccine [6] - The World Health Organization (WHO) has elevated RSV to a global public health intervention priority, further stimulating interest in RSV immunization solutions [6] Financial Performance - Zhonghui Bio's recent IPO on the Hong Kong Stock Exchange received overwhelming market response, with over 190,000 subscriptions and an oversubscription rate exceeding 4,000 times, raising over HKD 200 billion [8] - The company's core product, Huiru Kangxin®, is the first and only approved quadrivalent influenza virus subunit vaccine in China, contributing to projected sales revenue of CNY 260 million in 2024 [8] - The company has a robust pipeline with 11 other vaccines under development, covering various diseases, and has received multiple new drug clinical approvals [8]
中慧生物-B(02627)重磅产品中美双获批，有望填补RSV疫苗市场空白