Shandong Xinhua Pharmaceutical Company Limited (Stock Code: 00719) announced that China’s National Medical Products Administration has approved the company’s supplementary drug application to transfer the Marketing Authorization Holder (MAH) status for its 10 mg Ezetimibe tablets. The approval was confirmed via Notification 2026B01495, issued in March 2026.

The MAH transition stems from a May 2023 agreement with Beijing Sunshine Nohe Pharmaceutical Research Company Limited, under which Sunshine Nohe transferred all manufacturing and commercialization rights for Ezetimibe tablets to Shandong Xinhua. The transaction did not require board or shareholder approval and is neither a related-party transaction nor a material asset restructuring under Shenzhen Stock Exchange regulations.

Ezetimibe tablets are indicated as adjunctive therapy for primary hypercholesterolemia, homozygous familial hypercholesterolemia and homozygous sitosterolemia. According to industry data cited in the announcement, China’s public medical institutions recorded Ezetimibe tablet sales of approximately RMB 810.00 million in 2024.

Management expects the newly acquired MAH to broaden Shandong Xinhua’s pharmaceutical formulation portfolio and enhance market competitiveness. The company cautions that domestic pharmaceutical policy shifts, tendering dynamics and other market factors could affect future sales performance. Investors are advised to remain aware of these uncertainties.