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Senhwa Biosciences

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TAIWAN Taiwan

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Senhwa Biosciences's Silmitasertib Receives Rare Pediatric Disease Designation from FDA for Treatment of Sonic Hedgehog Medulloblastoma

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Lead Product(s): Silmitasertib

Therapeutic Area: Oncology Product Name: CX 4945

Highest Development Status: Phase I/ Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

Details:

U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for company's drug Silmitasertib, a Casein Kinase 2 (CK2) inhibitor, being developed as a treatment for recurrent sonic hedgehog (SHH) medulloblastoma.

OBI Pharma

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OBI Pharma Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cance...

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Lead Product(s): OBI-999

Therapeutic Area: Oncology Product Name: Undisclosed

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

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 21, 2020

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Second Orphan Drug Designation for OBI-999, Antibody-Drug Conjugate in combination with a validated payload (MMAE) & the antibody targeting Globo H, a glycolipid antigen found on multiple tumor types.