Aurisco(SH:605116) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-26 04:32Core Viewpoint - Aorite Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of a combined packaging of estradiol tablets and estradiol/dydrogesterone tablets, which is expected to enhance the company's market competitiveness and positively impact its operating performance [1][5][6]. Group 1: Drug Registration Information - The drug is named estradiol tablets/estradiol/dydrogesterone tablets combined packaging, with a registration number of 2025S03486 [1]. - The formulation includes estradiol 2mg and dydrogesterone 10mg [1]. - The drug is classified as a Class 4 chemical drug and is produced by Aorite's subsidiary, Yangzhou Aorite Pharmaceutical Co., Ltd. [1][2]. Group 2: Market Situation - The drug is indicated for the treatment of menopausal syndrome caused by natural or surgical menopause [2]. - The drug was originally developed by Abbott B.V. and was approved for domestic sale in 2015 under the brand name "Fentam." [3]. - As of now, there are two companies, Abbott and Yangzhou Aorite, that have passed the consistency evaluation for this drug in China [3]. Group 3: Financial Investment - As of October 31, 2025, the company has invested approximately 12.64 million RMB in the research and development of this drug [4]. - The hospital sales revenue for "Fentam" is projected to be 564 million RMB in 2024 [4]. Group 4: Impact on Company - The approval of the drug registration is expected to enhance the company's competitiveness in the pharmaceutical market [5]. - The new product's market entry is anticipated to have a positive effect on the company's financial performance [5].