#China #Suzhou #Innovent #Sintilimab #Nolgileucel

Innovent's Groundbreaking Announcement in Advanced Melanoma Treatment

Recently, Innovent Biologics, Inc., a biopharmaceutical firm based in Suzhou, announced that the China National Medical Products Administration (NMPA) has accepted its New Indication Application for Sintilimab. This innovative treatment combines Sintilimab with Nolgileucel injection (GC101) and targets patients suffering from unresectable or metastatic melanoma after they have failed at least two prior systemic therapies, including PD-1 antibody treatments.

## Context of the New Indication
This will mark the 11th indication for Sintilimab, reinforcing its vital role in the realm of immuno-oncology. The information supporting this application primarily stems from the pivotal Phase II clinical study MIZAR-003. This study was a multicenter, randomized trial designed to analyze the efficacy and safety of the GC101 TIL cell injection alongside Sintilimab in melanoma patients who either did not respond to or were intolerant of anti-PD-1 antibody therapy.

## Study Findings
The findings of the MIZAR-003 study were first shared at the 2026 ASCO Annual Meeting, revealing promising outcomes. The study showed that those with advanced melanoma who had previously failed anti-PD-1 therapy and underwent a median of two prior treatments exhibited a median progression-free survival (mPFS) of 4.3 months, in stark contrast to just 1.6 months in the control group receiving chemotherapy. Significantly, patients in the experimental arm faced a 57% reduction in the risk of disease progression or death (HR=0.43).

It’s also noteworthy that adverse reactions in the experimental group were manageable. The most prominent were hematologic toxicities from preconditioning, but they were reversible. The duration of adverse effects was comparable across both treatment groups, highlighting the tolerability of the new combination therapy.

## Expert Opinions
According to Professor Guo Jun, Vice President at Peking University Cancer Hospital, treatment options for individuals with advanced, treatment-resistant melanoma are limited. The acceptance of this application presents a pivotal moment, as it addresses the urgent need for more efficacious treatment alternatives for patients whose disease progresses after PD-1 antibody therapy.

Dr. Hui Zhou, Innovent's Chief RD Officer of Oncology, expressed satisfaction regarding the NMPA’s acceptance, which embodies a significant advancement in the full life-cycle management of Sintilimab. His optimism underscores the potential for this combination therapy to significantly aid patients battling advanced melanoma in China.

## About Sintilimab and Nolgileucel
Sintilimab, known as TYVYT® in China, is a novel PD-1 inhibitor developed in collaboration with Eli Lilly. This monoclonal antibody binds to PD-1 molecules on T cells, inhibiting the tumor's evasion of immune surveillance and facilitating anti-tumor responses. The addition of Nolgileucel (GC101), which utilizes the DeepTIL™ cell enrichment platform developed by Juncell Therapeutics, represents a cutting-edge therapeutic approach that eliminates the need for intense lymphodepletion chemotherapy.

## Innovent Biologics Overview
Founded in 2011, Innovent Biologics strives to empower patients by offering high-quality, affordable biopharmaceutical therapies. With a portfolio that includes treatments for cancer, cardiovascular diseases, and more, Innovent leads the charge in innovative medicine development. The company has achieved significant milestones, including partnerships valued over RMB 350 billion, solidifying its position as a frontrunner in China's biopharmaceutical industry.

For those interested in the future of melanoma treatment, Innovent's latest advancement represents a beacon of hope, illustrating not only innovation in drug development but also a commitment to improving patient outcomes in significant medical areas.