Medigen Vaccine Biologics Corp. (6547-TW) announced that its multivalent enterovirus vaccine development program has been selected as a Center of Excellence (IDX) project by the Center for Drug Evaluation (CDE) and has obtained special consultation and advisory qualification from the Taiwan Food and Drug Administration (TFDA). This achievement is expected to strengthen the overall development plan for its next-generation multivalent enterovirus vaccine, contributing to a positive market reaction. On Friday (20th), the company's stock opened higher and rallied, aiming to stabilize above the quarterly moving average line.
Medigen opened at NT$47.15 in early trading, reaching a peak of NT$48.30, up more than 4%. Although gains later narrowed, the stock was trading at NT$47.30 at midday, maintaining an increase of over 2%, with trading volume exceeding 1,000 shares.
The company explained that through early scientific consultation, discussions on clinical development strategy, and communication on Chemistry, Manufacturing, and Controls (CMC) issues, the selection and qualification will enhance the overall development planning for its second-generation multivalent enterovirus vaccine. Medigen also anticipates improved regulatory review efficiency and smoother communication with authorities in subsequent stages.
Furthermore, the development of the second-generation multivalent enterovirus vaccine will build upon the technological platform established from its EV1 vaccine, clinical development experience, PIC/S GMP-compliant cell-culture vaccine manufacturing facility, and CMC technical capabilities.
Regarding commercialization, Medigen's EV71 enterovirus vaccine has achieved over 95% market share in Taiwan's private vaccine market since its launch, with cumulative sales approaching 600,000 doses. Internationally, the company's EV1 vaccine received marketing authorization from Vietnam's regulatory authority in March of this year.
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- Source: PR Times
- Category: New Product