尖峰集团：恩格列净获得化学原料药上市申请批准

Core Viewpoint - Jianfeng Group's subsidiary, Zhejiang Jianfeng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of the chemical raw material drug Empagliflozin, indicating a significant advancement in the company's product portfolio and potential market opportunities in diabetes treatment [1]. Group 1: Company Developments - The approval notification for Empagliflozin is identified by the document number 2025YS00624, marking a key regulatory milestone for the company [1]. - Empagliflozin is classified as a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which aids in blood sugar control for adult patients with type II diabetes when combined with exercise and diet [1]. - The drug functions by blocking the reabsorption of glucose in the kidneys, leading to the excretion of excess glucose and thereby lowering blood sugar levels, independent of β-cell function and insulin resistance [1]. Group 2: Industry Context - As of the announcement date, there are 28 companies listed on the CDE raw and auxiliary package registration information platform with an "A" status for Empagliflozin, including Jiangsu Hengrui Medicine Co., Ltd. and Zhejiang Huahai Pharmaceutical Co., Ltd. [1].