Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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    RareStone Group
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    Room 2207, No. 233 Taicang Road, Huangpu District, Shanghai
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    +86 21 60859601
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    China NMPA Approves RareStone's Pitolisant (Wakix) for the Treatment of Narcolepsy

    Details:

    Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).


    Lead Product(s): Pitolisant Hydrochloride

    Therapeutic Area: Sleep Product Name: Wakix

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 04, 2023

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    RareStone Inc. Announces Submission of New Drug Application (NDA) of Wakix® (pitolisant) for narcolepsy with and without cataplexy in China

    Details:

    Wakix (pitolisant hydrochloride), a selective histamine H3-receptor antagonist/inverse agonist, is approved by the EMA and the FDA to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness, with or without cataplexy.


    Lead Product(s): Pitolisant Hydrochloride

    Therapeutic Area: Sleep Product Name: Wakix

    Highest Development Status: ApprovedProduct Type: Small molecule

    Partner/Sponsor/Collaborator: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 21, 2021

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