SHANDONG XINHUA (00719): Notification of approval for drug supplement application obtained for Zhe Maibu

SHANDONG XINHUA (00719) announced that recently, Shandong Xinhua Limited (hereinafter referred to as "Shandong Xinhua Pharmaceutical" or "the Company") has received the Drug Supplementary Application Approval Notice issued by the National Medical Products Administration, approving the transfer of the supplementary application for the marketing authorization holder of Ezetimibe tablets (hereinafter referred to as "the Product"). In May 2023, Shandong Xinhua Pharmaceutical signed a production technology and marketing authorization holder transfer contract for the Product with Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Beijing Sun-Novo Pharmaceutical Research"). The contract stipulates that Beijing Sun-Novo Pharmaceutical Research will transfer all Marketing Authorization Holder (MAH) rights, including but not limited to product manufacturing, sales, and marketing, to Shandong Xinhua Pharmaceutical in a one-time transfer. Shandong Xinhua Pharmaceutical will make payments to Beijing Sun-Novo Pharmaceutical Research in stages according to the contract. In accordance with the Shenzhen Stock Exchange Stock Listing Rules and the Company's Articles of Association, this transaction does not require approval from the Company's Board of Directors or Shareholders' Meeting. This transaction is not considered a related party transaction and does not constitute a major asset restructuring as defined by the Measures for Administration of Major Asset Restructuring of Listed Companies. In February 2026, Shandong Xinhua Pharmaceutical submitted supplementary application materials for the change of marketing authorization holder to the National Medical Products Administration and received acceptance. In March 2026, the Drug Supplementary Application Approval Notice was granted, with the review conclusion stating that the application for the transfer of the Product holder meets the relevant requirements for post-marketing changes and approves the change of the marketing authorization holder for the Product. The Product is used for the treatment of primary hypercholesterolemia, homozygous familial hypercholesterolemia, and sitosterolemia (or plant sterolemia) as an adjunct to diet therapy. According to relevant statistics, in 2024, the sales of Ezetimibe tablets in China's public medical institutions were approximately RMB 810 million.