Core Viewpoint - Enhertu (DS-8201) has evolved into a "complete entity" with the recent approval for first-line therapy in HER2+ breast cancer, marking significant progress from its initial approval as a third-line therapy in December 2019 to its current status [1][2] Group 1: Enhertu's Progression - Enhertu's journey includes approvals for HER2+ breast cancer in third-line therapy (December 2019), second-line therapy (January 2021), and now first-line therapy [2] - The first-line therapy approval is in combination with pertuzumab, with expectations for single-agent approval in the future [2] Group 2: Competitive Landscape - The HER2 ADC breast cancer market is approaching a critical phase, with companies like Rongchang Biopharma, Kelun-Biotech, and BaiLi Tianheng adopting various strategies to compete [3][6] - Rongchang Biopharma has focused on differentiated strategies, avoiding direct competition in breast cancer and targeting unmet clinical needs in other indications like gastric cancer [4][6] - Kelun-Biotech has actively pursued HER2+ breast cancer, achieving approval for its product A166 as the first domestic ADC for second-line therapy, leveraging a strategy of gradual advancement [7][9] Group 3: Strategic Approaches - BaiLi Tianheng aims to create a competitive product against Enhertu, with its T-Bren ADC targeting both HER2+ breast cancer and non-small cell lung cancer (NSCLC) [11][14] - HengRui Medicine adopts a multi-cancer strategy, focusing on various indications beyond breast cancer, with its SHR-A1811 ADC already approved for HER2-mutated NSCLC [16][17] Group 4: Differentiated Strategies - Lepu Biopharma's strategy centers on combining its ADC with PD-1 therapies, positioning its products as complementary rather than direct competitors [18][20] - In contrast, YingEn Biopharma has established a global strategy, securing a partnership with BioNTech for its DB-1303 ADC, focusing on unmet needs in endometrial cancer [22][24] Group 5: Future Outlook - The competitive landscape in the HER2 ADC market is intensifying, with companies employing diverse strategies to carve out their niches [26] - The future success in this sector may hinge on the depth of differentiated strategies and the ability to commercialize effectively, rather than solely on product efficacy [26]