On May 18, 2026, according to the CDE website, Akeso Biopharma's clinical trial application for cantulimab injection, submitted under registration category 2.2, was implicitly approved. The proposed indication is: neoadjuvant/adjuvant therapy with AK104 monotherapy for resectable, highly microsatellite unstable (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This signifies that this world's first PD-1/CTLA-4 bispecific antibody drug is officially launching its assault on the perioperative treatment of colorectal cancer.
Cartunib is Akeso Biopharma's first independently developed bispecific antibody drug. It simultaneously blocks the interaction between PD-1 and its ligands PD-L1/PD-L2, and CTLA-4 and its ligands B7.1/B7.2, relieving immunosuppression in both signaling pathways and efficiently activating tumor-specific T cells, thereby exerting a synergistic anti-tumor effect. This "one drug, two targets" design achieves synergistic anti-tumor effects while significantly reducing toxic side effects compared to traditional immunotherapy combinations, achieving an optimized balance between efficacy and safety. Since its initial approval in June 2022, the indications for cartunib have continued to expand, with the intravenous formulation already securing three indications in China:
• In June 2022, it was approved for the treatment of recurrent or metastatic cervical cancer that has failed previous platinum-based chemotherapy, filling the gap in immunotherapy for advanced cervical cancer in China.
• In September 2024, it was approved for first-line treatment with combination chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
• In May 2025, it was approved for first-line treatment of persistent, recurrent or metastatic cervical cancer with or without platinum-based chemotherapy.

Thanks to its excellent clinical value, cantulimumab has been included in more than 20 domestic and international clinical treatment guidelines and expert consensus recommendations. Its market performance is equally impressive: in 2025, sales of this drug in Chinese hospitals and retail pharmacies exceeded 2.1 billion yuan, a year-on-year increase of 28.65%, making it a leader among domestically produced bispecific antibody drugs. Currently, Akeso Biopharma has initiated more than 30 clinical studies on cantulimumab in multiple tumor types, including gastric cancer, lung cancer, and liver cancer, covering more than 20 indications.
The approval of canducimab for colorectal cancer in clinical trials marks another significant step forward for Akeso Biopharma in the field of gastrointestinal oncology. From late-stage treatment to first-line therapy, and now to perioperative neoadjuvant/adjuvant therapy, canducimab is continuously expanding the boundaries of tumor immunotherapy. We look forward to this world's first-in-class PD-1/CTLA-4 bispecific antibody achieving breakthroughs in colorectal cancer treatment, providing more and better treatment options for patients as soon as possible, and allowing more cancer patients worldwide to benefit from innovative Chinese drugs.

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