Shionogi & Co., Ltd.
Approval of partial amendment to manufacturing and marketing consent for the Omicron lineage JN.1-based recombinant protein vaccine ‘Cobgoes™ Injection’ for domestic use
Obtained partial approval to add the dosing and administration as a supplementary indication for the COVID-19 booster vaccine 'Cobgoes™ Injection' in domestic markets. Aims to establish a platform for rapid development and production of a vaccine aligned with the recommended strain for the 2026/2027 season. No impact expected on the fiscal year ending March 2027 as it has already been baked into guidance.
Key Figures
- Period of impact: Fiscal year ending March 2027
- Approval details: Partial amendment to add dosing as supplementary immunization in manufacturing and marketing approval
- Supply plan: No planned supply since it differs from the recommended-strain vaccine for the 2026/2027 season
AI要約
Overview of the news
Shionogi & Co., Ltd. has obtained partial approval to amend the manufacturing and marketing approval to add the indication of dosing as a supplementary immunization for the Omicron lineage JN.1-based recombinant protein vaccine 'Cobgoes™ Injection.' The approval intends to enable the rapid development and production of a recommended-strain vaccine by constructing a platform by fiscal year 2026. Domestic supply is not planned for the 2026/2027 season as it differs from the recommended-strain vaccine.
Outlook/Impact
The company is pursuing its materiality of 'liberation from infectious disease threats' by continuing to provide solutions from prevention to diagnosis and treatment. The approval aims to solidify the platform and reinforce the supply framework for vaccines aligned with the latest recommended strains. The impact on the fiscal year ending March 2027 is already baked in, and there is no additional disclosure of short-term financial effects.
Shionogi & Co., Ltd.
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