China Meheco(SH:600056) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2026-02-02 23:00Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Dabigatran Etexilate Capsules, which will enhance its product portfolio and provide valuable experience for future generic drug development [1][6]. Group 1: Drug Registration Information - The drug name is Dabigatran Etexilate Capsules, with acceptance numbers CYHS2401330 and CYHS2401331, and registration certificate numbers 2026S00242 and 2026S00243 [1]. - The drug is available in capsule form with specifications of 150mg and 110mg [1]. - The approval was granted based on compliance with the relevant requirements of the Drug Administration Law of the People's Republic of China [1]. Group 2: Drug Characteristics and Market Situation - Dabigatran Etexilate is a direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent recurrence of these conditions [2]. - The drug was developed by Boehringer Ingelheim and was first launched in Germany and the UK in March 2008, received FDA approval in October 2010, and was launched in China in February 2013 [2]. - As of the announcement date, 13 other companies, including Chengdu Better Pharmaceutical Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd., have also obtained production licenses for this drug [5]. - The sales revenue of the drug in China was approximately 571 million yuan in 2024, with about 375 million yuan in the first three quarters of 2025 [5]. Group 3: Financial Investment - The total investment in the raw material and formulation project for the drug is approximately 28 million yuan (unaudited) [4].