XJZY(SZ:002332) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-12-19 10:16Core Viewpoint - The company has received a drug registration acceptance notice from the National Medical Products Administration for its combined packaging of estradiol tablets and estradiol/dydrogesterone tablets, marking a significant step in the domestic production registration process [1][2]. Group 1: Drug Registration Acceptance - The acceptance notice indicates that the registration work for the combined packaging of estradiol tablets and estradiol/dydrogesterone tablets has entered the evaluation stage [2]. - The reference formulation for the combined packaging is the original imported product, Femoston?, developed by Abbott B.V., which has been approved for sale in several countries including the Netherlands, Portugal, and Germany [1]. Group 2: Product Details - The combined packaging is indicated for the treatment of perimenopausal syndrome caused by natural or surgical menopause [1]. - The specifications of the company's application for the combined packaging are consistent with those of the already approved reference product [1]. Group 3: Impact on the Company - If the approval process is successful, it will enrich the company's product line and enhance its market competitiveness [2]. - The drug registration approval process has a certain time cycle and uncertainty, which the company acknowledges [2].