Qilu Pharmaceutical's Panitumumab Biosimilar Ankeze® Approved in China as First Fully Human Anti-EGFR Monoclonal Antibody for mCRC

Note:This article does not constitute any investment opinions or suggestions; please refer to official/company announcements for accuracy.This article only introduces drugs related to medical health, not a recommendation of treatment options (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.

On December 9, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's Pertuzumab N01 Injection (Ankeze) was announced.^®) has been approved for marketing, becomingChina's First Fully HumanAnti-EGFR Monoclonal AntibodyIts approved indication is: in combination with FOLFOX for the first-line treatment of patients with RAS wild-type (both KRAS and NRAS wild-type) metastatic colorectal cancer (mCRC). Pertuzumab N01 Injection is about to enter clinical application, offering a new treatment option for colorectal cancer patients.

Pertuzumab is aRecombinantFully Human IgG2 Monoclonal Antibody Targeting Epidermal Growth Factor Receptor (EGFR). Its mechanism of action involves specifically binding to EGFR expressed on the surface of tumor cells, inhibiting ligand-induced receptor autophosphorylation and receptor-associated kinase activation, thereby blocking downstream signal transduction, suppressing tumor cell proliferation, and inducing apoptosis. Additionally, Pertuzumab reduces the production of pro-inflammatory cytokines and vascular growth factors, decreases EGFR internalization, and its longer half-life ensures prolonged and stable efficacy in vivo.

Qilu Pharmaceutical actively laid out plans, initiating research on Pertuzumab in 2012, and conducted pharmaceutical comparative studies with the international counterpart Panitumumab to meet unmet clinical treatment needs and improve drug accessibility. In pharmaceutical research, the researchers scientifically and systematically developed the manufacturing process of this product and conducted comprehensive quality studies on its structural physicochemical properties, biological activity, and immunological characteristics. The results demonstrated that Qilu Pharmaceutical's Ankeze...^®The quality attributes are highly similar to Panitumumab, and the overall quality is comparable.

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.

In terms of safety, this study did not identify any new safety signals. The incidence rates of treatment-emergent adverse events (TEAEs) graded ≥3 were 81.6% and 65.7% in the two groups of subjects, respectively. Regarding Ankose,^®In the group, the incidence of infusion reactions related to the drug was only 1.2%, all of which were grade 1-2. Clinical trials have shown that Ankeze^®Combination mFOLFOX6 Regimen Shows Good Efficacy and Acceptable Safety as First-Line Treatment for RAS Wild-Type Metastatic Colorectal Cancer Patients.

Currently, Qilu Pharmaceutical has 15 biologics approved for marketing in China, covering key therapeutic areas such as solid tumors, supportive cancer care, rheumatology and immunology, ophthalmology, and more. The company also has multiple innovative biologics and biosimilars under development.

References:

Qilu Pharmaceutical