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HLK-1004 is an investigational formulation of the tyrosine kinase inhibitor dasatinib, developed by Shenzhen Pharmacin for the treatment of chronic myeloid leukemia (CML). Utilizing the company's proprietary SpraySol™ technology, HLK-1004 is designed as a 505(b)(2) regulatory pathway candidate to optimize the solubility and bioavailability of dasatinib. The formulation aims to address the pH-dependent absorption and significant food effects associated with the original reference drug (Sprycel), potentially providing more consistent therapeutic levels and allowing for administration regardless of gastric pH or food intake. It is currently in the IND-enabling phase of development.
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