Huiyu Pharmaceutical (688553.SH) passed the on-site inspection by the U.S. FDA.

Huibah Pharmaceutical (688553.SH) announced that the company underwent a current Good Manufacturing Practice (cGMP) inspection and Pre-Approval Inspection (PAI) by the United States Food and Drug Administration (FDA) from October 27, 2025, to November 06, 2025. Recently, the company received the Establishment Inspection Report (EIR) issued by the FDA, which confirmed that the inspection had been completed and the company had passed the cGMP inspection and PAI. This inspection was the company's third on-site inspection by the US FDA, and it showed that the company's production lines for anti-tumor injections and raw materials meet the requirements of the FDA in terms of production management quality systems and compliance operations. This provides a solid guarantee for the company to continue expanding into the US market, positively impacting the company's future operational performance and enhancing its competitiveness in the international market, further supporting the company's sustained and healthy development.