山东新华制药股份：依折麦布片获得药品补充申请批准通知书

Group 1 - The company Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the transfer of the marketing authorization holder (MAH) for Ezetimibe tablets [1] - In May 2023, the company signed a contract with Beijing Sunshine Nuohua Pharmaceutical Research Co., Ltd. for the transfer of production technology and MAH rights for Ezetimibe tablets, which includes production, sales, and marketing rights [1] - The transaction does not require approval from the company's board of directors or shareholders and does not constitute a related party transaction or a major asset restructuring as per relevant regulations [1] Group 2 - Ezetimibe tablets are indicated for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, and sitosterolemia [2] - The estimated sales revenue for Ezetimibe tablets in Chinese public medical institutions is approximately RMB 810 million in 2024 [2]