Qilu Pharmaceutical's Patuoju Monoclonal Antibody (Ankeze®) Becomes China's First Fully Human Anti-EGFR mAb Approved for RAS Wild-Type mCRC

In a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial, Ankeze® combined with the mFOLFOX6 regimen was compared to placebo combined with the mFOLFOX6 regimen to evaluate the efficacy and safety of first-line treatment for RAS wild-type advanced metastatic colorectal cancer. A total of 641 patients were enrolled in the study and randomly assigned to the experimental group (426 cases) and the control group (215 cases) at a ratio of 2:1. The primary endpoint of the study was progression-free survival (PFS) assessed by the Blinded Independent Review Committee (BIRC).

As of March 22, 2025, the BIRC assessment results showed that the median PFS in the experimental group and the control group were 11.2 months (95% confidence interval [CI]: 9.9–13.0) and 8.3 months (95% CI: 7.3–8.5), respectively. The difference was statistically significant (stratified Log-Rank P <0.001; hazard ratio [HR] 0.61 [95% CI: 0.49–0.76]). The primary endpoint of the study met the pre-specified superiority target.

Clinical trials have shown that Encorafenib® combined with the mFOLFOX6 regimen has good efficacy and acceptable safety as a first-line treatment for RAS wild-type metastatic colorectal cancer patients.

As a long-term partner, Taimei Medical Technology has repeatedly undertaken the independent imaging assessment work for key clinical studies of Qilu Pharmaceutical's critical products. Relying on AI + digital systems and a professional team, it has efficiently and qualitatively completed a series of tasks from image uploads to reviews, strongly supporting the smooth progress of the research and product approval.

Taimei Medical Technology sincerely congratulates its partners on their achievements and looks forward to continuing the sincere cooperation with partners in the future, helping more innovative and effective drugs reach the market and benefiting patients worldwide!

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