China’s top drug regulator has approved Innovent Biologics’ cancer drug Daboxin® for use in combination with another monoclonal antibody as a preoperative immunotherapy for colon cancer, marking the world’s first approved dual-immunotherapy neoadjuvant regimen for patients with resectable stage IIB to III MSI-H/dMMR disease.

The approval allows Daboxin® (Ipilimumab N01 Injection), an anti-CTLA-4 monoclonal antibody developed by Suzhou-based Innovent, to be used in combination with Tyvyt® (Sintilimab Injection), a PD-1 inhibitor co-developed by Innovent and Eli Lilly, as a short course of treatment before surgery, the company said on Tuesday.

Innovent said the combination significantly improves the pathological complete response rate — a measure of whether any viable tumour cells remain in the tissue removed during surgery — allowing most patients to avoid follow-up chemotherapy.

Daboxin® is the first domestically developed anti-CTLA-4 antibody to be approved in China, the company said.

The indication applies to patients with microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) colon cancer at stage IIB to III whose tumours are considered resectable.

Neoadjuvant immunotherapy is designed to shrink or eliminate tumours before surgery and has become a growing area of cancer research, but most such treatments have until now been used primarily in advanced or metastatic disease.

Innovent said the approval reflects China’s accelerating push to develop innovative biologic drugs and expand access to advanced cancer therapies, particularly in precision medicine and immuno-oncology.

Colon cancer is among the most common malignancies in China, and the company said the new regimen could improve outcomes while reducing the physical and financial burden associated with chemotherapy.