FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): Batoclimab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 01, 2020

            Details:

            National Medical Products Administration (NMPA, China) approved IND application for HBM9161, a full-human antibody targeting neonatal Fc receptor (FcRn), to conduct a Phase 2/3 clinical trial in patients with Graves‘ ophthalmopathy (GO).

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            Lead Product(s): Batoclimab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 15, 2020

            Details:

            Anti-FcRn antibody has potential to become portfolio-in-a-product; ITP trial is the first of several to study safety and efficacy in autoimmune disorders.

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            Lead Product(s): Nipocalimab

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 02, 2020

            Details:

            Company is in active communication with clinical sites to be sure patients enrolled in studies have uninterrupted access to company's investigational drugs.