Summary by Futu AI
Sanleaf Biopharmaceutical Co., Ltd. ("Sanleaf Biopharmaceutical") announced that its bivalent RSV candidate vaccine SCB-1019 has obtained positive preliminary immunogenicity and safety data in Phase I clinical trial in elderly subjects (aged 60-85 years). The trial was conducted in Australia, with 48 elderly subjects receiving SCB-1019 or placebo saline. The results showed that on the 28th day after administration, the geometric mean titers (GMTs) of neutralizing antibodies against RSV-A and RSV-B were as high as 7,906 IU/mL and 46,674 IU/mL, respectively, significantly higher than those in the placebo group. In addition, SCB-1019 was well tolerated, and no serious adverse events were observed. These data support Sanleaf Biopharmaceutical's strategy of developing a bivalent RSV-A/B PreF vaccine, which may have differentiation advantages in safety and response immunogenicity. The complete safety and immunogenicity results are expected to be released by the end of 2024 to support further development of SCB-1019.