RSV疫苗

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中慧生物-B重磅产品中美双获批,有望填补RSV疫苗市场空白
Zhi Tong Cai Jing· 2025-08-18 06:53
Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (referred to as "Zhonghui Biotech") 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, which has also received clinical approval from the FDA in the United States, marking the first dual approval for the company [1][5]. Group 1: Company Developments - The RSV vaccine developed by Zhonghui Biotech and its subsidiary, Yihui Biotechnology (Shanghai) Co., Ltd., is designed to prevent lower respiratory tract infections caused by RSV [1][6]. - The vaccine utilizes innovative technology with fully independent intellectual property rights and employs a pre-F antigen sequence that exhibits high stability, allowing for long-term storage at 2-8°C without freeze-drying [7][8]. - The company has established a comprehensive commercial product and R&D pipeline, with its core product, a quadrivalent influenza virus subunit vaccine, already approved and used in over 30 provinces in China [8]. Group 2: 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% [6]. - The high incidence of RSV infections globally is creating a significant market opportunity, especially as there are currently no approved RSV vaccines in the domestic market [6][7]. - The successful IND approval for Zhonghui Biotech's RSV vaccine positions the company to fill a gap in the domestic RSV prevention market, potentially leading to substantial growth and market returns [7][8].