香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完整 性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部份內容所產生或因依賴該等內容而 引致的任何損失承擔任何責任。 • 相較於 AREXVY 同源重複接種，SCB‑1019 異源重複接種組的 RSV‑A 與 RSV‑B 中和抗體(nAb) 幾何平均滴度(GMT)呈現約 60–80%的上升趨勢；安慰劑組未觀察到 RSV 中和抗體出現顯著變 化; • 與三葉草生物先前針對未接種過 RSV 疫苗的老年人給予首劑 AREXVY 的臨床研究進行探索 性跨試驗比較後顯示，SCB‑1019 異源重複接種可將 RSV‑A 與 RSV‑B 的中和抗體幾何平均滴 度恢復至首劑 AREXVY 接種後峰值約 120%–135%「，而在該探索性跨試驗中的 AREXVY 同源 重複接種僅能恢復至峰值的約 75%; • AREXVY 的同源重複接種會產生增幅約 40 倍源自其自身 T4-foldon 三聚體標籤构造誘導的 "非特異性抗體"。 本公司RSV+hMPV±PIV3候選聯用疫苗，有望在這一人群中恢復RSV護效會，同時擴展對hMPV±PIV ...

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].