Ab&B Bio-Tech CO., LTD. JS (Ab&B Bio-Tech) announced that China’s Center for Drug Evaluation (CDE) has cleared the Investigational New Drug (IND) application for the Group’s self-developed messenger RNA (mRNA) respiratory syncytial virus (RSV) vaccine candidate.

The domestic approval follows the U.S. Food and Drug Administration’s IND clearance on 7 November 2025, enabling the company to initiate clinical studies for the same candidate in both the United States and China.

RSV is a widespread pathogen that can escalate into bronchiolitis or pneumonia, especially among the elderly and individuals with chronic illnesses. Current treatment in China relies on broad-spectrum antivirals and symptomatic care, underscoring the clinical need for an effective vaccine. Clinical research shows mRNA platforms can generate strong cellular and durable humoral immunity, positioning Ab&B Bio-Tech’s candidate as a potential tool to protect high-risk populations from severe lower respiratory tract infections.

Ab&B Bio-Tech focuses on innovative and premium vaccines aimed at replacing traditional and imported products in China while expanding internationally. Its pipeline also includes quadrivalent and trivalent subunit influenza vaccines and a lyophilized human rabies vaccine candidate.

Trading in the company’s H shares on The Stock Exchange of Hong Kong Limited has been suspended since 1 April 2026 and remains halted. The Board will issue further announcements on material developments.

The statement was authorized by Executive Director and Chairman Mr. An Youcai on 8 May 2026. Shareholders and potential investors are advised to exercise caution when dealing in the company’s securities.