Baiotei: The preparation section of the Yonghe factory's EU GMP inspection does not meet the requirements.

Baiyotec announced that from February 4th to 12th, 2026, the company underwent an on-site inspection by ANSM for EU GMP compliance. Recently, the results from EMA indicated that the raw materials partially met the requirements, but the formulation part did not comply, with defects related to inadequate deviation management measures. The company has actively made corrections, and the inspection agency basically agrees, but an on-site verification is required. The European revenue for 2025 and Q1 2026 were 1,028,800 yuan and 4,692,400 yuan respectively, accounting for 0.11% and 1.87% of the total revenue. The impact on the company's European commercial cooperation receipts and overall performance was relatively small. The company has obtained FDA approval for a new drug listing and will actively communicate to strive for an early re-evaluation.