Details:
A waiver from Chinese authorities allows ALK to file for regulatory approval in China without finalising its paused local registration trial for ACARIZAX® (HDM SLIT), tablet for treatment of HDM allergic rhinitis for 12-65 year-olds and HDM allergic asthma in 18-65 year-olds.
Lead Product(s): House Dust Mite Allergen Extract
Therapeutic Area: Immunology Product Name: Acarizax
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 March 03, 2022
Details:
Jext® is expected to be the first AAI to market in China. Prior to registration in mainland China, Grandpharma plans to start selling Jext® in southern China under a special licence linked to the existing registration of Jext® in Hong Kong.
Lead Product(s): Epinephrine Bitartrate
Therapeutic Area: Immunology Product Name: Jext
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Grandpharma
Deal Size: $14.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 30, 2021
Details:
ALK has gained approval from the US Food and Drug Administration, to expand the use of ALK’s ragweed sublingual allergy immunotherapy (SLIT) tablet RAGWITEK® (RAGWIZAX® in Europe) to include paediatric patients, down to the age of 5, with ragweed-induced allergic rhinitis.
Lead Product(s): Short Ragweed Pollen Allergen Extract
Therapeutic Area: Immunology Product Name: Ragwitek
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 19, 2021