China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2 positive advanced colorectal cancer, marking a significant step forward in the company’s pipeline.
SHR-A1811’s Clinical Studies and Indications
SHR-A1811 is currently undergoing multiple Phase I-III clinical studies, with indications that include advanced solid tumors and advanced breast cancer with HER2 expression or mutation. The drug’s development is part of a broader effort to address the needs of patients with HER2 positive cancers, offering a potential alternative to existing treatments.
Market Competition and Import Approvals
SHR-A1811’s potential market entry comes amidst competition from similar products. Roche’s Kadcyla and AstraZeneca/Daiichi Sankyo’s Enhertu have been approved for import into China in 2019 and 2023, respectively. These approvals set a precedent for the import of HER2 targeted therapies, highlighting the growing importance of this class of drugs in the Chinese market.-Fineline Info & Tech
