Jiangsu Hengrui Medicine gets trial approval for breast cancer drug

Jiangsu Hengrui Medicine Co., Ltd. announced its subsidiary, Suzhou Suncadia Biopharmaceuticals Co., Ltd., received approval from the National Medical Products Administration for a clinical trial of injectable rekarstuzumab. The trial will evaluate rekarstuzumab (SHR-A1811) as a monotherapy compared to a combination regimen for the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer. The drug, which targets HER2-expressing tumor cells, had total R&D expenditures of approximately RMB 141,475 million.

Separately, Jiangsu Hengrui Medicine reported a share repurchase on October 23, 2025. The company bought back 97,500 A-shares on the Shanghai Stock Exchange at prices ranging from RMB 64.23 to RMB 64.57 per share, totaling RMB 6,280,825. These shares are intended for the A-share employee stock ownership plan.

The injectable rekarstuzumab previously received market approval in May 2025 for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy. Global sales of similar products exceeded $65.57 billion in 2024.