Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has announced that its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate (ADC), is on course to receive Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is for the treatment of HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Competition from Established Players
Similar products in the market include Roche’s Kadcyla and AstraZeneca/Daiichi Sankyo’s Enhertu, which were approved for import into China in 2019 and 2023, respectively. Additionally, RemeGen’s disitamab vedotin received conditional approval in China in June 2021. These approvals highlight the competitive landscape for HER2-targeted therapies in the country.
Trastuzumab Rezetecan’s Regulatory Progress in China
Trastuzumab rezetecan is also awaiting regulatory decisions in China for the treatment of locally advanced or metastatic HER2 mutant adult non-small cell lung cancer (NSCLC) patients who have previously been treated with at least one systemic therapy. The indication approval filing was accepted for review by the CDE in September this year with priority review status, indicating the potential urgency and significance of the drug’s approval.-Fineline Info & Tech
