XJZY(SZ:002332) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-10-14 05:26Core Viewpoint - Zhejiang Xianju Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of its Acetate Dexamethasone Tablets, which enhances the company's market competitiveness [1][2]. Group 1: Drug Information - The company has successfully passed the consistency evaluation for the 0.5mg specification of Acetate Dexamethasone Tablets, with the drug approval number being Guoyao Zhunzi H20258221 [2]. - The 0.75mg specification of Acetate Dexamethasone Tablets was previously approved in August 2025 [2]. - Acetate Dexamethasone Tablets are corticosteroids primarily used for allergic and autoimmune inflammatory diseases, including connective tissue diseases, severe bronchial asthma, dermatitis, ulcerative colitis, acute leukemia, and malignant lymphoma [1]. Group 2: Regulatory and Approval Process - The approval was based on the Drug Administration Law of the People's Republic of China and relevant government opinions on the reform of drug and medical device review and approval systems [1]. - The product adheres to the national drug registration standards YBH26782025 set by the National Medical Products Administration [2]. Group 3: Company Impact - The approval of the 0.5mg specification is expected to strengthen and enhance the product's market competitiveness and provide valuable experience for future drug consistency evaluations [2].