Innovent Biologics’ Ipilimumab Injection Receives Priority Review Designation in China for Neoadjuvant Treatment of Colon Cancer
On February 23, 2025, Innovent Biologics, Inc., a leading biopharmaceutical company based in both San Francisco, USA, and Suzhou, China, made a significant announcement regarding the acceptance of their New Drug Application (NDA) for ipilimumab injection by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This application was granted Priority Review designation in conjunction with sintilimab for the treatment of resectable microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colon cancer.
First Domestic CTLA-4 Inhibitor in China
This marks a significant milestone for Innovent Biologics, as it is China’s first NDA for a domestic CTLA-4 inhibitor. CTLA-4 is a protein found on the surface of T cells that plays a crucial role in regulating the immune response. By blocking CTLA-4, ipilimumab can enhance the immune system’s ability to fight cancer cells. The combination of ipilimumab and sintilimab, an anti-PD-1 monoclonal antibody, has shown promising results in clinical trials, particularly in the treatment of advanced solid tumors.
Strengthening Sintilimab’s Leadership Position
The acceptance of this NDA further strengthens sintilimab’s position as a leader in cancer immunotherapy in China. Sintilimab has already been approved for the treatment of multiple indications, including relapsed or refractory classical Hodgkin’s lymphoma and relapsed or refractory urothelial carcinoma. The combination of ipilimumab and sintilimab has the potential to expand the therapeutic options for patients with colon cancer, particularly those with MSI-H or dMMR tumors, which are characterized by a high degree of genetic instability and an increased likelihood of responding to immunotherapy.
Impact on Patients
For patients with MSI-H or dMMR colon cancer, the acceptance of this NDA could mean access to a new and potentially effective treatment option. Colon cancer is one of the most common types of cancer worldwide, and the prognosis for patients with advanced or metastatic disease is often poor. Immunotherapies like ipilimumab and sintilimab offer the potential for long-term remission and improved quality of life. With the acceptance of this NDA, patients in China may soon have access to this innovative treatment.
Impact on the World
The acceptance of this NDA is not only significant for China but for the global cancer community as well. The combination of ipilimumab and sintilimab has the potential to revolutionize the treatment of colon cancer, particularly in countries where access to advanced cancer therapies is limited. As more countries follow China’s lead in approving these innovative treatments, the global cancer landscape is likely to change, with a greater focus on personalized and targeted therapies that can improve outcomes and save lives.
Conclusion
The acceptance of Innovent Biologics’ NDA for ipilimumab injection in combination with sintilimab marks a major milestone in the fight against colon cancer. This is China’s first NDA for a domestic CTLA-4 inhibitor and further strengthens sintilimab’s position as a leader in cancer immunotherapy. For patients with MSI-H or dMMR colon cancer, this could mean access to a new and potentially effective treatment option. The global impact of this development is significant, as it has the potential to revolutionize the treatment landscape for colon cancer and inspire similar advancements in other countries.
- Innovent Biologics announces acceptance of NDA for ipilimumab injection in combination with sintilimab for neoadjuvant treatment of resectable MSI-H or dMMR colon cancer.
- This is China’s first NDA for a domestic CTLA-4 inhibitor and further strengthens sintilimab’s position as a leader in cancer immunotherapy.
- For patients with MSI-H or dMMR colon cancer, this could mean access to a new and potentially effective treatment option.
- The global impact of this development is significant, as it has the potential to revolutionize the treatment landscape for colon cancer and inspire similar advancements in other countries.
