Hengrui’s SHR-A1904 granted breakthrough therapy designation in China

Jiangsu Hengrui Medicine Co., Ltd. announced that its injectable SHR-A1904, a novel Claudin18.2-targeted antibody-drug conjugate (ADC), has been granted breakthrough therapy designation by China's Center for Drug Evaluation (CDE). This designation is for the treatment of CLDN18.2-positive advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that has progressed after at least one prior systemic therapy. Globally, no similar products have yet been approved.

In a related development, Jiangsu Hengrui Medicine's subsidiary, Suzhou Sinovent Pharmaceuticals Co., Ltd., received approval from the National Medical Products Administration (NMPA) to commence clinical trials for injectable SHR-A2102. This Nectin-4-targeted ADC will be investigated in combination with other therapies for advanced solid tumors and locally advanced or metastatic esophageal cancer.

SHR-A1904 has incurred development costs of approximately 174 million yuan, while SHR-A2102 has development costs of about 248.22 million yuan. The company emphasizes the inherent risks associated with drug development, including technical, approval, and policy uncertainties, and commits to transparent disclosure of further progress.