衢州首个1类创新药批量生产

Core Viewpoint - The news highlights the successful mass production of "Aogutewei Sodium Capsules," a first-class innovative drug developed by Aisen Pharmaceutical, marking a significant milestone for the company and the local biopharmaceutical industry in Quzhou, Zhejiang Province [1][2]. Group 1: Company Developments - Aisen Pharmaceutical has commenced mass production of Aogutewei Sodium Capsules, which is the first original innovative drug in Quzhou to enter this stage [1]. - The production facility adheres to China's GMP standards, ensuring a standardized production process from raw materials to finished products [1]. - The company has established a modern R&D and production base, with centers in San Diego, California, and Hangzhou, focusing on original drug development [1]. Group 2: Product Details - Aogutewei Sodium is the world's first dual-target inhibitor for treating COVID-19, possessing global intellectual property rights [2]. - The drug is expected to produce 200,000 capsules before the Spring Festival, with prices reduced by over 60% compared to imported alternatives [2]. - The dual-action mechanism of the drug targets both 3CL protease and L-protease, significantly reducing potential drug interaction risks, making it suitable for patients with multiple underlying conditions [2]. Group 3: Government Support - Local government support has been crucial in the rapid approval and production of the new drug, with a comprehensive service system established to assist the company [2]. - The market regulatory department has facilitated over 30 meetings with national and provincial drug supervision departments to provide targeted assistance [2]. Group 4: Future Plans - The company plans to expand the application of Aogutewei Sodium Capsules to treat chronic obstructive pulmonary disease and osteoporosis, with related clinical studies set to begin [3]. - Aisen Pharmaceutical has multiple new drugs at various clinical stages, including a next-generation BTK inhibitor and a first-in-class CD38-targeted ADC drug undergoing clinical trials in both China and the U.S. [3].