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June 2026, 2Y‑Biopharma completed FDA PAI with no Form 483 observations

2026-08-17

Recently, 2Y-Biopharma, a wholly owned subsidiary of Shanghai Haoyuan Chemexpress Co, Ltd. ("ChemExpress")  for drug product GMP manufacturing, successfully completed a Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration (FDA), with no Form 483 observations.