On May 10, 2025, Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced the publication of pivotal Phase 3 clinical trial results for cetuximab β Injection (trade name: Enlituo) in collaboration with MabPharma. The findings were published online in Signal Transduction and Targeted Therapy (Impact Factor: 40.8), a prestigious journal under Nature.
This open-label, multicenter, randomized, parallel-group Phase 3 trial was led by Professor Yuankai Shi from the Cancer Hospital, Chinese Academy of Medical Sciences, and Professor Yi Ba from Peking Union Medical College Hospital. The study demonstrated the excellent efficacy and safety profile of cetuximab β in patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC), providing strong clinical evidence supporting its application in medical practice.
Between January 4, 2018, and September 2, 2021, a total of 520 eligible patients were enrolled, with 505 receiving study treatment—either cetuximab β plus FOLFIRI or FOLFIRI alone.
Key Clinical Findings
Compared to FOLFIRI alone, cetuximab β plus FOLFIRI significantly improved:
Median progression-free survival (PFS): 13.1 vs. 9.6 months (hazard ratio [HR]: 0.639; 95% CI: 0.468–0.872; P = 0.004).
Median overall survival (OS): 28.3 vs. 23.1 months (HR: 0.729; 95% CI: 0.551–0.965; P = 0.024).
Objective response rate (ORR): 69.1% vs. 42.3% (odds ratio: 3.090; 95% CI: 2.280–4.189; P < 0.001).
Notably, cetuximab β plus FOLFIRI exhibited manageable toxicity without new safety concerns. Only 0.4% of patients in the cetuximab β combination group experienced Grade 3 or higher infusion reactions, with no reported cases of Grade 3 or higher hypersensitivity reactions.
Advancing Colorectal Cancer Treatment
Colorectal cancer is the second most prevalent malignancy in China, with over 510,000 new cases annually. Approximately 45% of these cases involve RAS/BRAF wild-type patients, for whom epidermal growth factor receptor (EGFR)-targeted therapies significantly enhance treatment efficacy.
Cetuximab β, a recombinant EGFR monoclonal antibody independently developed in China, is classified as a 2.4-class modified biological drug. Using a proprietary protein expression technique, cetuximab β effectively avoids glycosylation modifications that could trigger hypersensitivity to EGFR antibodies.
The China National Medical Products Administration approved cetuximab β for market release in June 2024. The same year, it was included in the National Medical Insurance Catalogue, offering patients a new, effective, safe, and accessible treatment option.