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SH-201

A treatment for Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, MDS and Gastrointestinal tumors.

Disease state overview

  • Chronic Myeloid Leukemia (approximately 8,930 patients in the US diagnosed per year)1
  • Acute Lymphoblastic Leukemia (approximately 6,660 patients in the US diagnosed per year)2
  • Myelodysplastic/myeloproliferative diseases (approximately 20,000 patients in the US diagnosed per year)3
  • Gastrointestinal tumours (approximately 38,570 patients in the US diagnosed per year)1

Regulatory Status

U.S. FDA has granted acceptance to file for Shorla Oncology’s NDA for SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat certain forms of leukemia and other cancers. The Agency assigned a Prescription Drug User Fee Act (“PDUFA”) action date of November 30, 2024.

1American Cancer Society. Cancer Facts & Figures, 2023.

2American Cancer Society. Cancer Facts & Figures, 2022.

3Incidence and Prevalence of MDS Across Patient Populations 2022 (ajmc.com)