Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that a New Indication Application for sintilimab in combination with Nolgileucel injection (GC101) has been accepted for review by the China National Medical Products Administration (NMPA). The application is proposed to be sintilimab in combination with Nolgileucel Injection (GC101) for the treatment of patients with unresectable or metastatic melanoma whose disease has progressed following at least two lines of prior systemic therapy, including PD-1 antibody therapy. This would be the 11th indication for sintilimab, further consolidating its position as a cornerstone therapy in immuno-oncology (IO).

The new indication application is primarily based on the results of the pivotal Phase II clinical study MIZAR-003. MIZAR-003 (NCT04943913) is a pivotal Phase II, multicenter, randomized, open-label, parallel-controlled study designed to evaluate the efficacy and safety of GC101 TIL cell injection with sintilimab support in melanoma patients who have failed or are intolerant to anti-PD-1 antibody therapy. The study results were first presented as an oral Late-Breaking Abstract (LBA 9509) at the 2026 ASCO Annual Meeting in June 2026. As of the data cutoff date of May 12, 2026, the primary endpoint was met. In patients with advanced melanoma who had failed prior anti-PD-1 antibody therapy and had received a median of 2 prior lines of systemic therapy, the median progression-free survival (mPFS) in the experimental arm reached 4.3 months, significantly superior to 1.6 months in the chemotherapy control arm, with a 57% reduction in the risk of disease progression or death (HR=0.43, 95% CI: 0.26–0.68; P=0.0002). Meanwhile, adverse reactions in the experimental arm were manageable. Grade ≥3 adverse reactions were mainly preconditioning-induced hematologic toxicity, and the median AE duration was comparable and rapidly reversible in experimental arm (8 days vs 13 days); most patients recovered without additional intervention. 

"Treatment options are very limited for patients with advanced, treatment-resistant melanoma," said Professor Guo Jun, Vice President of Peking University Cancer Hospital, Director of the Department of Melanoma and Sarcoma Medical Oncology, and Director of the Department of Urologic Oncology. "For patients whose disease continues to progress after prior PD-1 antibody therapy and multiple lines of systemic treatment, subsequent treatment presents significant challenges, and there is an urgent clinical need for more effective treatment options. The MIZAR-003 study demonstrated positive antitumor activity and a favorable safety profile in this patient population, offering a new treatment option for patients with unresectable or metastatic melanoma who have experienced disease progression following at least two prior systemic therapies, including an anti-PD-1 antibody. We look forward to sintilimab and Nolgileucel bringing further benefits to patients."

"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," said Dr. Hui Zhou, Chief R&D Officer of Oncology at Innovent. "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 maximizing its clinical value."