亚太药业：盐酸地尔硫䓬片收到药品补充申请不予批准通知书

Core Viewpoint - Recently, Asia-Pacific Pharmaceutical (002370.SZ) received a notification from the National Medical Products Administration stating that the application for the consistency evaluation of Diltiazem Hydrochloride Tablets was not approved due to the inability of the bioequivalence study to support a bioequivalence conclusion [1] Group 1 - The application for the consistency evaluation of Diltiazem Hydrochloride Tablets was submitted in November 2024 and accepted by the National Medical Products Administration [1] - The reason for the disapproval was that the bioequivalence study conducted could not support the conclusion of bioequivalence [1] - The disapproval of Diltiazem Hydrochloride Tablets will not have a significant impact on the company's current performance, and the company plans to improve the relevant experimental research before resubmitting the application [1]