Bio-Thera Solutions' Yonghe Plant Fails Part of EU GMP Inspection; Shares Slip 2%

MT NewswiresJun 15 00:03 ET

The formulation process at Bio-Thera Solutions' Yonghe facility has been cited for deficiencies, subjecting its European commercialization progress to re-evaluation.

① The EU GMP inspection results for Bio-Thera Solutions' Yonghe facility have been released: the drug substance manufacturing segment has passed certification, while the drug product manufacturing segment has not yet passed due to issues related to deviation management and is currently awaiting regulatory re-evaluation; ② The company stated that this matter does not affect the upfront payment and milestone payments already received from its European collaboration, but as a critical component of the European market supply chain, the outcome of the upcoming re-evaluation remains closely watched.

cls.cnJun 14 08:32 ET

Express News | Bio-Thera Solutions Says It Has Rectified After EU Gmp Inspection Results Showed Deficiencies Involving Inadequate Deviation Management Measures

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