China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low HER2 expression, marking a significant step in the development of innovative cancer therapies.
Market Context and Competitive Landscape
Similar products from Roche (Kadcyla) and AstraZeneca/Daiichi Sankyo (Enhertu) have already established a strong market presence. Kadcyla was approved for import into China in 2019, and together with Enhertu, generated USD 2.752 billion in global sales in 2021. This highlights the significant market potential for HER2-targeted ADCs.
Clinical Development Pipeline
In addition to SHR-A1811, several other HER2-targeted ADCs are in clinical development in China and beyond. These include ARX788, DP303c, A166, RC48, SYD985, and BAT8001, among others. The clinical development of these drugs indicates a growing interest and investment in the HER2-targeted therapy space, driven by the high unmet need for effective treatments for HER2-positive cancers.-Fineline Info & Tech
