Bio-Thera Solutions Announces EU GMP Compliance Issue at Yonghe Plant, States Minimal Impact on Overall Operations

Bio-Thera Solutions, Ltd. (ASX: 688177) has announced the results of a recent inspection by the French National Agency for the Safety of Medicines and Health Products (ANSM) regarding compliance with the European Union's Good Manufacturing Practice (EU GMP) standards.

The inspection, conducted from February 4 to February 12, 2026, focused on the company's facilities. The European Medicines Agency (EMA) has communicated the following outcomes: the company's drug substance (active pharmaceutical ingredient) operations have been found compliant with EU GMP requirements, and the relevant GMP certificate has been updated.

However, the drug product (finished dosage form) manufacturing operations, specifically at the Yonghe facility, were assessed as non-compliant. The identified deficiencies primarily relate to inadequate procedures for managing deviations in the production process.

The company has actively addressed these findings with corrective actions and responses submitted to the authorities. The inspection body has largely acknowledged the company's corrective plan, and a procedural on-site verification is required. Bio-Thera Solutions, Ltd. is committed to maintaining close communication with both ANSM and the EMA to expedite the completion of the re-inspection process.

In terms of financial impact, the company's European revenue for the 2025 fiscal year was approximately 1.0288 million yuan, accounting for 0.11% of total revenue. For the first quarter of 2026, unaudited European revenue was approximately 4.6924 million yuan, representing 1.87% of total revenue.

Based on the current stage of the review and existing contractual agreements, this situation does not affect the upfront and milestone payments the company has already received for commercial collaborations in Europe. Revenue from European licensing and product supply currently has a minor effect on the company's overall operational and financial performance.

In other business developments, the company has recently obtained new drug approval from the U.S. Food and Drug Administration (FDA), and its domestic operations in China continue to run smoothly.