The IND application for the recombinant respiratory syncytial virus vaccine (CHO cell) (adjuvant) has been approved in both China and the United States

IND application approved

On August 15, 2025, the IND application for a new class of drug, "Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells) (Adjuvant)", jointly submitted by Ab&B Bio-Tech Co.,Ltd（Ab&B Bio） and its subsidiary Yither biotech (Shanghai) Co., Ltd (Yither Bio), was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China. Notably, this vaccine has also obtained clinical approval from the Food and Drug Administration (FDA) of the United States, demonstrating its potential for global development. It is also the company's first product to receive clinical approval in both China and the United States, fully showcasing the company's R&D strength and internationalization capabilities!

Recombinant respiratory syncytial virus vaccine (CHO cell) (adjuvant)

Respiratory syncytial virus (RSV) is one of the primary pathogens responsible for respiratory infections in infants, children, and the elderly, potentially leading to diseases such as pneumonia and bronchitis. Its infection is most prevalent among children under 5 years old and elderly people over 60 years old. According to research statistics, a significant number of children and elderly individuals worldwide are hospitalized or even die each year due to RSV infection. However, currently, there is a lack of specific therapeutic drugs for RSV diseases, and supportive care is primarily relied upon to manage acute infections. Vaccination has emerged as the preferred clinical measure for preventing and treating RSV.

The innovative application of big data analysis in the adjuvant CHO cell technology utilizes proprietary innovative technologies and a highly stable pre-F antigen sequence. Preclinical studies have shown that this product not only stimulates the body to produce high-titer neutralizing antibodies against RSV A2 and B types, but also activates a high level of cellular immune response. In the cotton rat challenge protection study, it was able to reduce the viral load in the lungs to below the detection limit, demonstrating significant protective effects. Furthermore, no vaccine-enhanced disease (VED) phenomenon was observed, indicating high safety. At the same time, the pre-F antigen structure contained in this product exhibits excellent thermal stability, eliminating the need for lyophilization. It can be stored in a liquid state at 2~8℃ for extended periods, optimizing the formulation production process and making subsequent commercial production more convenient and efficient.