Recently, Qilu Pharmaceutical's pertumumab N01 injection (QL1203) was approved for marketing, for use in combination with FOLFOX as first-line treatment for patients with RAS wild-type (KRAS and NRAS are both wild-type) metastatic colorectal cancer (mCRC) , under the brand name Ankeze.

This drug is classified as a Class 3.4 new drug. The original panitumumab (trade name Vectibix) is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), developed by Takeda in collaboration with Amgen, and has not yet been approved for marketing in China.

Epidermal growth factor receptor (EGFR) is currently the most representative targeted therapy target for colorectal cancer treatment. In colorectal cancer, EGFR is often overexpressed, and its high expression is closely related to poor prognosis. EGFR activation can inhibit apoptosis, promote invasion and angiogenesis, ultimately leading to tumor growth.

Panitumab has a high affinity for the extracellular portion of the EFGR protein and can competitively bind to EGFR, thereby blocking EGFR and downstream signaling pathways, promoting apoptosis, and preventing angiogenesis, thus exerting an anti-tumor effect.

In September 2006, panitumumab was first approved for marketing by the U.S. FDA. It has since been approved for multiple cancer indications worldwide, including monotherapy for patients with metastatic colorectal cancer (mCRC) whose tumors express EGFR, first-line treatment in combination with FOLFOX chemotherapy regimen for patients with KRAS exon 2 wild-type mCRC, and second-line treatment for patients with RAS wild-type mCRC.

In 2012, Qilu Pharmaceutical initiated a research project on pertuzumab and conducted a pharmaceutical comparative study with Amgen's panitumumab. The results demonstrated that the quality attributes of Qilu Pharmaceutical's Ankerzeb were highly similar to those of panitumumab , and their overall quality was comparable.

In a multicenter, randomized, double-blind, parallel-controlled phase III clinical trial, Ancozeb in combination with mFOLFOX6 was compared with placebo in combination with mFOLFOX6 to evaluate the efficacy and safety of first-line treatment for RAS wild-type advanced metastatic colorectal cancer. The study enrolled 641 patients, who were randomly assigned in a 2:1 ratio to the experimental group (426 patients) and the control group (215 patients). The primary endpoint was progression-free survival (PFS) as assessed by a blinded independent review center (BIRC).

As of March 22, 2025, 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, with a statistically significant difference (stratified Log-Rank P < 0.001; hazard ratio 0.61 [95% CI: 0.49–0.76]). The primary endpoint of the study met the pre-specified superiority objective.

Regarding safety, no new safety signals were identified. The incidence of ≥3 grade treatment-emergent adverse events (TEAEs) was 81.6% and 65.7% in the two groups, respectively.

Colorectal cancer is the third leading cause of cancer incidence and the second leading cause of cancer death worldwide. In 2022, there were over 1.9 million new cases of colorectal cancer globally, with 904,000 deaths. In recent years, the incidence and mortality rates of colorectal cancer in my country have shown a rapid upward trend. In 2022, there were approximately 517,100 new cases of colorectal cancer, ranking second among malignant tumors.

The approval of pertumumab N01 injection has brought new treatment options to patients in China.

Currently, Qilu Pharmaceutical has obtained approval for 15 biological drugs in China , covering multiple important areas such as solid tumors, supportive care for tumors, rheumatology and immunology, and ophthalmology. It also has several innovative biological drugs and biosimilars under development.