On 25 December 2025, Innovent announced that its Tabosun® (ipilimumab N01 injection), referencing BMS’ Yervoy®, in combination with Tyvyt® (sintilimab, co-developed by Innovent and Eli Lilly), has been approved by China’s National Medical Products Administration as a neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient (MSI-H/dMMR) colon cancer.
According to Innovent, the combination therapy is “the first and only dual-IO regimen approved globally for neoadjuvant treatment of colon cancer”. Innovent also claims in its announcement that Tabosun® is “the world’s first approved CTLA-4 mAb for neoadjuvant treatment of colon cancer”.
BMS’ Yervoy® (ipilimumab) has been approved in combination with Opdivo® (nivolumab) for treatment of colorectal cancer in the EU (December 2024), US (April 2025), Australia (June 2025), Japan (August 2025) and Canada (August 2025).
Tyvyt® has previously been approved in China in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (June 2022); and in combination with Byvasda® (biosimilar bevacizumab), as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (June 2021).
Other ipilimumab biosimilars are in development, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.