Core Viewpoint - The company announced that its wholly-owned subsidiary, Huaren Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (NMPA) [1][2]. Group 1: Drug Registration and Development - The drug Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, as well as for adult patients classified as WHO functional class II to IV [1][2]. - The development of this generic drug began in 2022, with the application for marketing authorization submitted on June 14, 2024, and approval granted on September 23, 2025 [2]. Group 2: Market Situation - Bosentan dispersible tablets were developed by Actelion Pharmaceuticals Ltd and were approved for sale in the EU in 2009 under the brand name "Tracleer." The drug was imported into China in September 2019 under the brand name "Quankeli" [3]. - In 2024, the global sales of Bosentan dispersible tablets reached approximately $35.9 million, with "Tracleer" accounting for about $31.3 million of that total [3]. - In the Chinese market, the total sales of Bosentan dispersible tablets were approximately 2.126 million yuan in 2024, with Johnson & Johnson holding a 100% market share [3]. Group 3: Impact on the Company - The acquisition of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].