Baio Tai: The formulation section of the Yonghe factory does not meet EU GMP requirements, with European revenue accounting for 0.11% in 2025.

Announcement from Baiotai: the company underwent an on-site inspection by the French ANSM regarding EU GMP compliance in February 2026. Recently, the European Medicines Agency announced the inspection results: the raw material section meets EU GMP requirements and the GMP certificate has been updated; however, the formulation section does not meet EU GMP requirements, with the main deficiencies involving inadequate deviation management measures at the Yonghe factory. The company has made corrections and responses to the deficiencies, and the inspection agency has basically approved the corrective actions, with on-site verification required. The company's European revenue was 1,028,800 yuan in 2025, accounting for 0.11% of total revenue; in the first quarter of 2026, European revenue was 4,692,400 yuan, accounting for 1.87% of total revenue. This situation does not affect the company's receipt of initial payments and milestone payments in Europe, and the impact of European revenue on overall performance is relatively small. The company is in communication with ANSM and EMA to expedite the completion of the reassessment.