Innovent Seeks Chinese Approval for Sintilimab Combination in Advanced Melanoma

Innovent Biologics, a Chinese biopharmaceutical company developing and manufacturing innovative medicines, has announced that China's National Medical Products Administration has accepted an application to expand the approved uses of sintilimab, marketed as Tyvyt, in combination with nolgileucel injection (GC101).

The proposed indication covers patients with unresectable or metastatic melanoma whose disease has progressed after at least two systemic treatments, including PD-1 antibody therapy.

The application is supported by the randomized Phase II MIZAR-003 trial, which compared the combination with chemotherapy.

According to Innovent, median progression-free survival reached 4.3 months with the experimental treatment, compared with 1.6 months for chemotherapy. The company reported a 57% reduction in the risk of disease progression or death.

GC101 is a tumor-infiltrating lymphocyte therapy developed by Juncell Therapeutics using its DeepTIL cell expansion platform.

The combination pairs cell-based immunotherapy with sintilimab, a PD-1 inhibitor co-developed by Innovent and Eli Lilly.

For biotechnology research teams, the application illustrates continued development of combination immunotherapies for treatment-resistant cancers.

Regulatory acceptance begins the review process; it does not constitute approval for the proposed indication.

Posted by MedCloudInsider Editors on 10/26/2026