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Harbour BioMed

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CAMBODIA PHAR-MED 2020

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Harbour BioMed Receives Chinese Regulatory Approval to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy

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).

Harbour BioMed

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Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Clinical Trial of HBM916

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.

Momenta Pharmaceuticals

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Momenta Provides Corporate Update Amid COVID-19 Pandemic

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.

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Harbour BioMed

Harbour BioMed Receives Chinese Regulatory Approval to Begin Seamless Phase 2/3 Clinical Trial of HBM9161 in Graves’ Ophthalmopathy

Harbour BioMed

Harbour BioMed Receives Chinese Regulatory Approval of IND Application to Begin Seamless Clinical Trial of HBM916

Momenta Pharmaceuticals

Momenta Provides Corporate Update Amid COVID-19 Pandemic