Innovent Biologics Receives Approval for Ipilimumab Injection in Colon Cancer Treatment
Monday, February 24, 2025
Innovent Biologics has announced that the New Drug Application (NDA) for its ipilimumab injection, an anti-CTLA-4 monoclonal antibody (R&D Code: IBI310), has been accepted by the Centre for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).
Colon cancer is a malignancy that develops in the large intestine (colon), often beginning as benign polyps that become cancerous over time. Risk factors include age, diet, genetics, and inflammatory conditions.
Symptoms may include changes in bowel habits, blood in stool, and weight loss. Early detection improves treatment outcomes and survival rates.
Ipilimumab (R&D Code: IBI310) is a fully human monoclonal antibody injection developed by Innovent. This mechanism promotes T-cell activation and proliferation, enhancing tumour immune response and exerting anti-tumour effects.
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. It binds to PD-1 molecules on T-cells, blocking the PD-1/PD-L1 pathway and restoring T-cell activity to target cancer cells.
It has also been granted Priority Review designation in combination with sintilimab for the neoadjuvant treatment of resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.
This marks the first NDA submission for a domestically developed CTLA-4 inhibitor in China, reinforcing sintilimab’s role in cancer immunotherapy. Immune checkpoint blockade therapy targeting PD-1 and CTLA-4 has significantly advanced cancer treatment.
The combination of ipilimumab and sintilimab as a neoadjuvant therapy aims to improve the R0 resection rate, achieve a complete pathological response, and reduce the need for adjuvant chemotherapy.
The treatment is also expected to lower recurrence rates and enhance long-term prognosis for MSI-H/dMMR colon cancer patients.
Innovent has highlighted the urgent need for effective neoadjuvant therapies for resectable MSI-H/dMMR colon cancer. The interim findings confirm that the NeoShot trial has achieved its primary objective, positioning ipilimumab as the first domestic CTLA-4 inhibitor to reach the NDA submission stage in China.
The company is working closely with regulatory authorities to expedite approval and make this treatment available to patients as soon as possible.
Source: innoventbio.com
