2026.Apr.24

Corporate

OBI Announces US FDA Registration and Activation of HYProtecan™ Type II Drug Master File
Supporting Obrion Engine™ ADC Technologies and Enhancing Regulatory Efficiency

Taipei, Taiwan, April 24, 2026 — OBI Pharma (4174.TWO) today announced that it has received an acknowledgement letter from the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) confirming that the Type II Drug Master File (DMF) for HYProtecan™ is active.

HOMEWhat’s NewNewsOBI Announces US FDA Registration and Activation of HYProtecan™ Type II Drug Master File Supporting Obrion Engine™ ADC Technologies and Enhancing Regulatory Efficiency

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