太美智研医药2025年终回顾：高光闪耀，笃行致远

Core Insights - The company has rebranded from "圣方医药研发" to "太美智研医药," positioning itself as an "AI-driven pharmaceutical research solution provider" to contribute to the innovation in the pharmaceutical industry [2] Group 1: Strategic Developments - The company is actively involved in the TALENTop Phase III study for hepatocellular carcinoma, led by Professor Fan Jia from Fudan University, with results set to be globally unveiled at the 2025 ESMO conference [4] - The company has established a clinical endpoint evaluation alliance, CMAC, which received the "Best Annual Project Award" from CMAC Club, enhancing its industry influence [17] Group 2: Professional Support and Safety Management - The company provided independent and professional adjudication support for a key Phase III registration project of a well-known pharmaceutical company [5] - It offered drug safety risk management services for Tian Shili's clinical trial of a drug for cerebral infarction, aiding in the approval of the core indication [5] Group 3: Data Science and Innovation - The company provided Data Monitoring Committee (DMC) services for the global Phase III clinical trial of a pioneering dual-antibody ADC drug, accelerating the development of innovative therapies [11] - Collaboration with Stanford University resulted in a publication in the New England Journal of Statistics, focusing on considerations for single-arm trials to support accelerated approval of oncology drugs [11] Group 4: Publications and Knowledge Sharing - The company organized the translation and publication of "Cardiovascular Safety Assessment of Drugs: Innovative Methods and Regulatory Trends," introducing authoritative international findings [13] - It contributed to the writing of "Real-World Evidence in Drug Development: From RWD to RWE," providing industry-standard references [22] Group 5: Patient Recruitment and Market Expansion - The intelligent subject recruitment system developed for Nocare received the "2025 IDC Digital Native Enterprise Special Award" [19] - The company assisted Lepu Biopharma in obtaining approval for the world's first EGFR ADC drug, MRG003 [21] Group 6: Future Outlook - The company is set to embark on a new journey in pharmaceutical innovation in 2026, aiming to build a new brilliance in the health industry [30]