Shandong Xinhua Pharmaceutical Company Limited announced that it recently received a Drug Supplement Application Approval Notice from the National Medical Products Administration for Ezetimibe Tablets. The notice approves the supplemental application for the transfer of the drug's marketing authorization holder.

In May 2023, Xinhua Pharmaceutical signed a technology and holder transfer contract with Beijing Yangguang Nuobe Pharmaceutical Research Co., Ltd. Under the agreement, Yangguang Nuobe transferred all marketing authorization holder rights for Ezetimibe Tablets to Xinhua Pharmaceutical. These rights include formulation production approval and commercialization benefits, covering production, sales, and market promotion. Xinhua Pharmaceutical will make phased payments to Yangguang Nuobe according to the contract terms.

According to relevant regulations, this transaction did not require review by the company's board of directors or shareholders' meeting. The deal does not constitute a connected transaction or a major asset reorganization as defined by relevant rules.

In February 2026, Xinhua Pharmaceutical submitted the application for the marketing authorization holder change to the National Medical Products Administration, which accepted the application. The approval was granted in March 2026, with the review conclusion stating that the holder transfer application meets post-marketing change management requirements.

Ezetimibe Tablets are indicated as an adjunct to diet for treating primary hypercholesterolemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. According to relevant statistics, sales of Ezetimibe Tablets in China's public medical institutions reached approximately RMB 810 million in 2024.