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            Taiwan approved sNDA for Xofluza (baloxavir marboxil) for the treatment and postexposure prophylaxis for influenza virus infection for paediatrics aged 5 to <12 years.

            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 16, 2024

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            Xofluza (baloxavir marboxil), a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses.

            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 12, 2023

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            Xofluza® (baloxavir marboxil) is first-in-class, single-dose oral medicine with an innovative proposed MOA that has demonstrated efficacy in influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains in non-clinical studies.

            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2022

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            Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. The sNDA allows Xofluza® (baloxavir marboxil) to be used as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza.

            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases Product Name: Xofluza

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Shionogi

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 23, 2020

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            The filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.

            Lead Product(s): Baloxavir Marboxil

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 27, 2020

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