Jiangsu Hengrui Pharmaceuticals (01276): Marketing authorization application for trastuzumab rezetecan for injection accepted and included in priority review process

Jiangsu Hengrui Pharmaceuticals (01276) announced that recently, the company's subsidiary Suzhou Suncadia Biopharmaceuticals Co., Ltd. received the Notice of Acceptance issued by the National Medical Products Administration. The marketing authorization application for the company's trastuzumab rezetecan for injection has been accepted and has been included in the priority review process. The company's trastuzumab rezetecan for injection has been approved for three indications in China, namely: for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy; for the treatment of adult patients with locally advanced or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies; and for the treatment of adult patients with HER2-positive colorectal cancer who have failed treatment with oxaliplatin, fluorouracil, and irinotecan. The application for this new indication is based on a multicenter, randomized, open-label, active-controlled Phase III clinical trial (SHR-A1811-307), which was designed to evaluate the efficacy and safety of trastuzumab rezetecan with or without pertuzumab versus docetaxel combined with trastuzumab and pertuzumab (THP) in HER2-positive breast cancer patients who have not received prior systemic anti-tumor therapy in the recurrent/metastatic setting. The study was co-led by Professor Jiang Zefei of the Fifth Medical Center of the Chinese People's Liberation Army General Hospital and Professor Yin Yongmei of Jiangsu Province Hospital, and was conducted collaboratively at 75 research centers nationwide. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR) based on RECIST v1.1. The study results showed that, compared with the control group, trastuzumab rezetecan with or without pertuzumab significantly prolonged PFS and reduced the risk of disease progression or death in HER2-positive breast cancer patients who had not received prior systemic anti-tumor therapy in the recurrent/metastatic setting.