Kangtai Bio's trivalent flu vaccine application accepted by NMPA

Shenzhen Kangtai Biological Products Co., Ltd. (Kangtai Bio) recently announced that its marketing authorization application for the trivalent split influenza vaccine has been accepted by the National Medical Products Administration (NMPA). The application is for a vaccine designed to stimulate immunity against influenza viruses in individuals aged 3 years and above, aiming to prevent seasonal influenza.

The vaccine, if approved, will add to Kangtai Bio's comprehensive influenza vaccine portfolio, which already includes a quadrivalent split influenza vaccine, a quadrivalent split influenza vaccine for infants aged 6-35 months, and an MDCK-cell-based trivalent split influenza vaccine. This expansion is expected to enrich the company's product offerings and reinforce its market position.

While the application’s acceptance is a positive development, the company cautions that the marketing authorization process involves further technical reviews, clinical trial site inspections, and manufacturing site inspections. The company states that the outcome and timeline for product launch remain uncertain and advises investors to exercise caution, highlighting that the acceptance does not immediately impact short-term financial performance.