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Q3 Interim Report November -January 2022/2023

Q3 Interim Report November -January 2022/2023
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Senhwa Biosciences Receives US FDA Study May Proceed Letter to Treat BRCA2+ or PALB2+ Solid Tumors With CX-5461

Share: TAIPEI and SAN DIEGO, Dec. 23. 2020 /PRNewswire/ Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, today announced that it has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a Phase Ib study evaluating CX-5461, a first-in-class G-quadruplex stabilizer, to treat solid tumors with BRCA2 or PALB2 mutations. The FDA s approval of our Phase Ib clinical trial application for testing CX-5461 in patients with BRCA2 or PALB2 mutations is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations, stated Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences.

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