Ildong Pharmaceutical to Resubmit Ensitrelvir Application with New Clinical Data
• Ildong Pharmaceutical will resubmit its application for Ensitrelvir, an oral antiviral drug for COVID-19, after strengthening clinical data.
• The resubmission will include findings from Shionogi's global clinical trial, SCORPIO-PEP, evaluating Ensitrelvir for post-exposure prophylaxis.
• Ildong's decision aligns with Shionogi's global strategy, which includes pursuing approvals from the FDA and EMA for Ensitrelvir.
• The company voluntarily withdrew its previous application to the Ministry of Food and Drug Safety to incorporate the new data.
Novel Therapies Show Promise in Idiopathic Pulmonary Fibrosis Treatment
• Bridge Biotherapeutics' BBT-877, a first-in-class autotaxin inhibitor, is undergoing Phase 2 trials with data expected in April, showing promising safety and efficacy.
• Daewoong Pharmaceutical's Versiporocin (DWN12088), targeting PRS protein action, is in Phase 2 trials and has received FDA and EMA rare drug designations, aiming for completion in 2025.
• Ildong Pharmaceutical is developing IL1512, a CXCR7-selective agent, set to enter GLP toxicity testing, while Hanmi Pharmaceutical's HM15211 shows promise in preclinical studies for IPF.
• The IPF treatment market is projected to grow from $4.6 billion to $7 billion by 2030, driven by unmet needs and the pursuit of first-in-class and best-in-class therapies.
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