ASEAN Finance / Medigen's EV71 Vaccine Withdraws Singapore Regulatory Application to Resubmit with Additional Documents

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(CNA, Taipei, July 13) Medigen Biologics announced today that its enterovirus EV71 vaccine application in Singapore remains in the administrative pre-screening phase and has not yet entered substantive technical review. Having received a Screening Input Request for additional documentation, and considering the tight timeline, the company has decided to voluntarily withdraw the application and resubmit after supplementing the required materials.

Medigen noted that enterovirus infections are prevalent across Southeast Asia, with EV71 being a major pathogen known for its high neurotropism and virulence, potentially causing severe complications such as limb paralysis, encephalitis, meningitis, pulmonary edema, hemorrhage, or even death. Singapore is a high-incidence area for enterovirus, with an estimated 27,500 newborns in 2025, and currently no enterovirus vaccine is available on the market.

The submission of Medigen’s EV71 vaccine in Singapore is currently in the administrative pre-screening phase, not yet entering substantive technical review. Having received a Screening Input Request, and given the short processing window, Medigen has decided to proactively withdraw the application and will reapply after completing the necessary documentation.

Medigen stated that its EV71 vaccine has already obtained formal regulatory approval in Taiwan and received marketing authorization in Vietnam in March 2026. The company is actively submitting new drug applications in other Southeast Asian countries to expand its international market footprint for enterovirus vaccines.

[Announcement] Medigen's EV71 Vaccine Application in Singapore Withdrawn During Administrative Screening for Document Supplement – DBP.BULL.6547

Date: July 13, 2026

Company Name: Medigen Vaccine Biologics (6547)

Subject: Voluntary Withdrawal of EV71 Vaccine Application in Singapore During Administrative Screening for Document Supplement

Spokesperson: Lee Szu-Hsien

Details:

1. Event Date: 115/07/13

2. Name or Code of R&D Drug: MVC EV71 Vaccine

3. Indication: Active immunization for infants aged 2 months to under 6 years to prevent diseases caused by enterovirus type 71 infection.

4. Planned Development Stages: New Drug Application

5. Current Development Stage:

(1) Status (Submitted/Approved/Not Approved), Clinical Trial Results (including interim analyses), or Other Major Events Affecting Development: The EV71 vaccine application in Singapore is in the administrative pre-screening phase and has not entered substantive technical review. The company has received a Screening Input Request. Given the tight timeline, Medigen has decided to voluntarily withdraw the application and will resubmit after supplementing the required documentation.

(2) Risks and Mitigation Measures if Not Approved by Regulatory Authorities, Clinical Trial Results Not Statistically Significant, or Other Major Events: Not applicable.

(3) Future Business Direction if Approved, Statistically Significant Results, or Other Major Events: Not applicable.

(4) Cumulative R&D Expenditure: Not disclosed due to commercial strategy.

6. Next Development Stage:

(1) Expected Completion Time: To be announced according to progress.

(2) Expected Obligations: The company must bear all costs associated with the drug registration application.

7. Market Status: Enterovirus infection is a prevalent disease in Southeast Asia, with EV71 being a major pathogen exhibiting high neurotropism and virulence, potentially leading to severe complications such as limb paralysis, encephalitis, meningitis, pulmonary edema, hemorrhage, or death. Singapore is a high-incidence area for enterovirus, with approximately 27,500 newborns expected in 2025. Currently, no enterovirus vaccine is available on the market.