Shandong Xinhua Pharmaceutical Company Limited (SHANDONG XINHUA) announced that it has received the National Medical Products Administration’s Notification of Approval of Supplementary Drug Application, officially approving the company as the new Marketing Authorization Holder (MAH) for Galculus Bovis and Metronidazole Capsules. The approval was issued under notification number 2026B02018 on 1 April 2026 in Zibo, China.

The oral prescription therapy, registered under National Medicine Zhunzi H22026771, is formulated at 0.2 g Metronidazole and 5 mg Calculus Bovis Artifactus per capsule. The product is indicated for acute wisdom-tooth pericoronitis, local alveolar abscess, pulpitis and periapical periodontitis.

The MAH transition stems from a September 2023 contract with Jilin Zhongsheng Pharmaceutical, under which Zhongsheng made a one-off transfer of formulation production approval and commercialization rights to SHANDONG XINHUA. The transaction did not require board or shareholder approval and does not constitute a related-party deal or significant asset restructuring under Shenzhen Stock Exchange regulations.

According to industry statistics, Galculus Bovis and Metronidazole Capsules generated sales of approximately RMB 579.00 million in China’s public medical institutions in 2024, underscoring the product’s commercial relevance.

Management stated that obtaining the MAH status broadens SHANDONG XINHUA’s pharmaceutical formulation portfolio and strengthens overall competitiveness. The company cautioned that pharmaceutical sales remain sensitive to policy shifts, tendering dynamics and market conditions, advising investors to monitor associated risks.