SHANDONG XINHUA (00719) Receives Approval Notice for Artificial Calculus Bovis and Metronidazole Capsules

Stock News04-01

SHANDONG XINHUA (00719) announced that it has recently received the Drug Supplement Application Approval Notice for Artificial Calculus Bovis and Metronidazole Capsules from the National Medical Products Administration. The notice approves the supplemental application for the transfer of the drug's marketing authorization holder.

In March 2026, SHANDONG XINHUA submitted the supplemental application for the change of marketing authorization holder to the National Medical Products Administration, which was accepted for review. The recently received approval notice states that the application for the transfer of the holder complies with the relevant requirements for post-marketing change management, and the change of marketing authorization holder is approved.

This product is indicated for acute pericoronitis of wisdom teeth, local alveolar abscess, pulpitis, periapical periodontitis, and other conditions. According to relevant statistical data, the sales of Artificial Calculus Bovis and Metronidazole Capsules in China's public medical institutions reached approximately RMB 579 million in 2024.

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