Innovent Biologics said on October 26, 2026, that China’s National Medical Products Administration had accepted its sintilimab melanoma application for review. The proposed use combines sintilimab with Nolgileucel injection for patients with advanced melanoma whose disease has progressed after multiple prior treatments.
Key Takeaways
- The application has been accepted for review; the proposed indication has not been approved.
- A Phase II trial reported median progression-free survival of 4.3 months for the experimental treatment, versus 1.6 months for chemotherapy.
- Sintilimab is co-developed and commercialized in China by Innovent and Eli Lilly; Nolgileucel was developed by Juncell Therapeutics.
Who the sintilimab melanoma application would cover
The proposed indication is for patients with unresectable or metastatic melanoma whose disease has progressed after at least two lines of systemic therapy, including PD-1 antibody treatment. Innovent said it would be the 11th indication for sintilimab if approved.
Acceptance for review is a regulatory step, not authorization to use the combination for this indication. Innovent did not provide a decision date.
What the Phase II study found
The application is primarily based on MIZAR-003, a multicenter, randomized, open-label Phase II study. It evaluated Nolgileucel, also known as GC101, with sintilimab support in melanoma patients who had failed or were intolerant to anti-PD-1 antibody therapy.
At the May 12, 2026, data cutoff, the trial had met its primary endpoint. Among patients whose prior anti-PD-1 treatment had failed and who had received a median of two prior systemic treatment lines, median progression-free survival was 4.3 months in the experimental arm and 1.6 months in the chemotherapy control arm. Innovent reported a 57% reduction in the risk of progression or death.
Innovent said adverse reactions in the experimental arm were manageable. Severe reactions were mainly blood-related toxicities caused by preconditioning treatment.
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