华东医药：子公司药品注射用醋酸卡泊芬净获美国FDA批准

Core Viewpoint - The approval of the abbreviated new drug application (ANDA) for injectable caspofungin by the company's wholly-owned subsidiary marks a significant step in the company's strategy for internationalization of formulations and enhances its product pipeline in the anti-infection field, although it will not have a major impact on the company's current financial status and operating results [1] Group 1 - The company's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., has received approval from the US FDA for the ANDA of injectable caspofungin [1] - Caspofungin is an echinocandin used to treat specific fungal infections in adult and pediatric patients aged three months and older [1] - The direct investment in the research and development of this project amounted to approximately 36.2 million RMB [1] Group 2 - The approval aligns with the company's strategy of "formulation internationalization" [1] - The new product enriches the company's product pipeline in the anti-infection sector [1] - The approval is not expected to significantly impact the company's current financial condition and operational performance [1]