NMPA 受理信达生物信迪利单抗联合 GC101 治疗晚期黑色素瘤的上市申请

The submission seeks approval for patients with unresectable or metastatic melanoma following at least two previous systemic treatments.

Innovent Biologics has received acceptance from China’s National Medical Products Administration (NMPA) to review its sintilimab and Nolgileucel injection (GC101) combination for advanced melanoma.

The submission seeks approval for patients diagnosed with unresectable or metastatic melanoma whose condition has progressed following at least two previous systemic treatments, including anti- programmed death-1 (PD-1) therapy.

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If cleared, this regimen will mark the 11th approved indication for sintilimab.

The regulatory filing relies on findings from MIZAR-003, a randomised, multi-centre, open-label, parallel-controlled Phase II trial assessing GC101 with sintilimab against standard chemotherapy in individuals with prior anti-PD-1 exposure.

As of the 12 May 2026 data cut-off date, the study achieved its primary endpoint. Participants receiving the experimental therapy achieved a median progression-free survival of 4.3 months, compared with 1.6 months for those receiving chemotherapy.

This demonstrated a 57% reduction in the risk of disease progression or death, reflecting a hazard ratio of 0.43.

Adverse events in the study were manageable, with Grade 3 or higher reactions consisting predominantly of haematological toxicities associated with preconditioning.

The median duration of adverse events was shorter in the combination cohort at eight days compared with 13 days in the control arm, with most individuals resolving without further therapeutic intervention.

Initial data from the trial was presented orally at the ASCO Annual Meeting in June 2026.

Innovents oncology chief research and development officer Dr Hui Zhou said: “We are pleased that the 11th indication application for sintilimab has been accepted for review by the NMPA, with the potential to offer a more effective treatment option for patients with advanced melanoma in China.

“This acceptance further consolidates the position of sintilimab as a cornerstone therapy in immuno-oncology. It also marks another milestone for us in advancing the full life-cycle management of this product and continuously maximising its clinical value.”

Co-developed by Eli Lilly and Company and Innovent, sintilimab, marketed in China as TYVYT, is an immunoglobulin G4 monoclonal antibody directed at PD-1.

Its partner therapy, GC101, is a tumour-infiltrating lymphocyte product developed by Juncell Therapeutics via its DeepTIL platform.

GC101 does not require high-intensity lymphodepletion or interleukin-2 and is listed in the 2026 CSCO melanoma guidelines, with additional Phase II evaluations underway in non-small cell lung cancer and planned for glioma.

Innovent was established in 2011 and has commercialised 20 products to date.

The biopharmaceutical developer maintains one application under regulatory review, five candidates across Phase III or pivotal studies, and 20 investigational molecules in early-stage assessment.

It also holds more than 30 strategic alliances valued at more than 350bn yuan ($52.4bn) with global partners, including Eli Lilly, Incyte, MD Anderson Cancer Center, Pfizer, Roche, Sanofi, and Takeda.

In August, Innovent Biologics and Daiichi Sankyo signed an exclusive agreement to commercialise Vanflyta (quizartinib), an oral type II FLT3 inhibitor, in China.