Core Insights - The breast cancer treatment field is experiencing significant advancements in 2025, characterized by the launch of numerous new drugs and clinical breakthroughs [2][18] Group 1: Milestone Breakthroughs - In January 2025, AstraZeneca and Daiichi Sankyo's HER2 ADC, Enhertu (T-DXd), received FDA approval for HR+/HER2 low-expressing advanced breast cancer as a second-line treatment, extending treatment lines [3] - Enhertu also gained FDA approval in December for use with pertuzumab in first-line treatment of unresectable or metastatic HER2-positive breast cancer, achieving a median PFS of over 40 months and reducing the risk of disease progression or death by 44% [3] - AstraZeneca's Capivasertib became the first AKT inhibitor approved in China for breast cancer patients with PIK3CA/AKT1/PTEN alterations, providing new treatment options [3][4] Group 2: New Drug Approvals - In May, Rongchang Bio's RC48 was approved as the first ADC for HER2-positive breast cancer with liver metastasis, addressing a gap in standardized treatment [7] - In September, Eli Lilly's oral SERD, Inluriyo (imlunestrant), was approved for ER+/HER2-negative breast cancer patients previously treated with endocrine therapy, marking it as the second oral SERD on the market [7] - In December, Zhenhua Tianqing's Kumosili capsules were approved for use with fulvestrant in HR+/HER2- locally advanced or metastatic breast cancer, becoming the first CDK2/4/6 inhibitor [8] Group 3: Breakthrough Research Outcomes - Roche's Giredestrant demonstrated significant clinical results in the evERA BC and lidERA BC studies, filling a gap in oral SERD treatment for HR+/HER2- early breast cancer and showing a 3-year IDFS rate of 92.4% [9][10] - Giredestrant is designed to cover all treatment stages of ER+ breast cancer, aiming to replace existing endocrine therapies and serve as a backbone for combination therapies [10] - AstraZeneca's T-DXd showed promising results in the DESTINY-Breast studies, with a 3-year IDFS of 92.4%, outperforming existing standard treatments [13][14] Group 4: New Targets and Mechanisms - The exploration of new targets and mechanisms in breast cancer treatment is gaining momentum, with PROTAC technology emerging as a promising approach for targeting undruggable proteins [14] - Vepdegestrant, a PROTAC drug, is under FDA review for ESR1 mutation-positive ER+/HER2- breast cancer, potentially becoming the first PROTAC drug approved [15] - The PD-L1/VEGF dual antibody Pumitamig showed a 68% cORR in a global study for locally advanced or metastatic triple-negative breast cancer [16][17]