HENGRUI PHARMA (01276.HK): ADC filing accepted for priority review

NewTimeSpace News: On 29 October 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) said its subsidiary Suzhou Suncadia Biopharmaceuticals Co., Ltd. received acceptance from the National Medical Products Administration for the marketing application of trastuzumab rezetecan for injection (acceptance number CXSS2600174), which was granted priority review. The proposed indication is first-line treatment of locally advanced or metastatic HER2-positive breast cancer, with or without pertuzumab.

The filing is based on the Phase III trial SHR-A1811-307 at 75 sites in China, with blinded independent central review of PFS by RECIST v1.1 as the primary endpoint; the drug, with or without pertuzumab, significantly prolonged PFS and lowered the risk of progression or death versus the THP regimen. The HER2-targeted ADC has three approved indications in China, and cumulative R&D investment reached about RMB 2,360.70 million (unaudited).