Shandong Xinhua Pharmaceutical Co., Ltd. (00719): Notice of Approval for the Drug Supplementary Application for Ezetimibe Tablets

Shandong Xinhua Pharmaceutical Co., Ltd. (00719) announced that recently, the company received the “Notice of Approval for the Supplementary Application of Ezetimibe Tablets” issued by the National Medical Products Administration, approving the transfer of the listing license holder for this product.

In May 2023, Xinhua Pharmaceutical signed a technology transfer and license transfer agreement with Beijing Sunshine Norvo Pharmaceutical Research Co., Ltd. (hereinafter referred to as “Sunshine Norvo”). The agreement stipulates that Sunshine Norvo will transfer all MAH rights related to the formulation production approval and commercialization of ezetimibe tablets, including but not limited to product manufacturing, sales, and marketing, to Xinhua Pharmaceutical in one lump sum. Xinhua Pharmaceutical will pay the transfer fees to Sunshine Norvo in phases according to the contract.

According to the “Shenzhen Stock Exchange Listing Rules” and relevant regulations such as the “Articles of Association,” this transaction does not require approval from the company’s board of directors or shareholders’ meeting. This transaction is not a related-party transaction and does not constitute a major asset reorganization as defined by the “Administrative Measures for Major Asset Restructuring of Listed Companies.”

In February 2026, Xinhua Pharmaceutical submitted supplementary application materials for the change of the listing license holder to the National Medical Products Administration and received acceptance. In March 2026, the company received the approval notice for the supplementary drug application, with the review conclusion stating that the transfer application of the product holder complies with the relevant requirements for post-marketing changes and approves the change of the product’s listing license holder.

This product is used as an adjunct treatment for primary hypercholesterolemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia (or phytosterolemia), outside of dietary control.

According to relevant statistics, the sales revenue of ezetimibe tablets in Chinese public medical institutions in 2024 was approximately RMB 810 million.