SC Pharmaceuticals(SZ:002693)2025-05-09 09:20Group 1: Development Direction and Progress - The company focuses on high-end complex formulations, particularly in markets with large scale, high technical difficulty, and few competitors, to establish a unique competitive advantage [2][3] - Currently, the company has three peptide injection products (including APIs) approved for market in the U.S., with four more under FDA review [2] - The company aims to accelerate the registration process in Europe and expand into other global markets, leveraging approvals obtained in the U.S. [2] Group 2: Internationalization Efforts - The company has consistently pursued an internationalization strategy, successfully passing GMP inspections from the U.S. FDA, EU EMA, Philippines FDA, and Saudi Arabia SFDA [3] - Products such as thymosin alpha-1 and other injections have received FDA approval and have been exported to the U.S. [3] - The company plans to continue submitting DMF and ANDA applications in the U.S. and EU to further its internationalization efforts [3] Group 3: Raw Material Development - The company's thymosin alpha-1 has passed technical review by the Italian Medicines Agency (AIFA), and its somatostatin API has obtained a CEP certificate [3] - Other raw material businesses are being developed as a key focus for future growth [3] Group 4: Quality Management and CMO Cooperation - The subsidiary Ningbo Shuangcheng has passed the U.S. FDA CGMP inspection, ensuring compliance with quality management standards [3] - The company is actively pursuing CMO collaborations, particularly with major clients, while ensuring the production of its proprietary products [3]