Jiangsu Hengrui Pharmaceuticals Co.,Ltd. (600276.SH) has announced that its subsidiary, Suzhou Sundia Biopharmaceuticals Co., Ltd., received approval from the National Medical Products Administration for the third indication of its injection, Ruikang Trastuzumab. This makes it the first anti-HER2 product approved in China for colorectal cancer.

The newly approved indication is for adult patients with HER2-positive colorectal cancer who have failed treatment with oxaliplatin, fluorouracil, and irinotecan. The injection, Ruikang Trastuzumab, had previously received approval in China for two other indications: the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy, and the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapies.