Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult patients with locally advanced or metastatic HER2 mutant non-small cell lung cancer (NSCLC) who have previously received at least one systemic therapy.
The market for HER2-targeted ADCs in China has seen the approval of similar products from global pharmaceutical giants Roche (Kadcyla) in 2019 and AstraZeneca/Daiichi Sankyo (Enhertu) in 2023. Additionally, RemeGen, a local Chinese firm, received conditional approval for its disitamab vedotin in June 2021.
The filing for SHR-A1811 is supported by the positive results of the Phase II SHR-A1811-I-103 study, which met its primary endpoint. The data demonstrated that SHR-A1811 monotherapy achieved significant improvements over preset historical data in treating HER2 mutant NSCLC patients, notably increasing the objective response rate (ORR) among the subjects. – Flcube.com
