• Insilico Medicine received China IND clearance from NMPA CDE for Rentosertib (ISM001-055) inhalation solution in adult idiopathic pulmonary fibrosis.
• Authorization enables a Phase I study assessing safety, tolerability, and pharmacokinetics, with about 80 subjects planned.
• Rentosertib previously received US FDA orphan drug designation for idiopathic pulmonary fibrosis in February 2023.
• China CDE added Rentosertib to its breakthrough therapy designation list in May 2025.

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