On March 24, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on developing oncology drugs, reported that it has submitted a new indication application (NDA) for sugemalimab to the European Medicines Agency (EMA) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed after concurrent or sequential chemoradiotherapy (CRT) (Press release, CStone Pharmaceauticals, MAR 24, 2025, View Source [SID1234656219]). This is the second indication CStone has advanced in the European market, following its initial EMA approval in 2024 for the first-line treatment of metastatic squamous and non-squamous NSCLC. If approved, sugemalimab will address a critical unmet need in Stage III NSCLC, becoming the second PD-(L)1 antibody approved for this indication in Europe . Furthermore, sugemalimab’s dual application in both Stage III and Stage IV NSCLC will further solidify its position as a core immunotherapy for lung cancer.

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This application is based on a multicenter, randomized, double-blind Phase III clinical study called GEMSTONE-301 , which aims to evaluate the efficacy and safety of sugemalimab as consolidation therapy for patients with unresectable Stage III NSCLC after CRT. The results of the GEMSTONE-301 study have been published in The Lancet Oncology, and the results show that:

Sugemalimab can significantly prolong patients’ progression-free survival (PFS) and reduce the risk of disease progression or death by 36%;
A clear trend toward overall survival (OS) benefit, with a 56% reduction in the risk of death ;
Consistent clinical benefits were observed regardless of whether patients received concurrent or sequential chemoradiotherapy;
The safety profile was good and no new risk signals were found.
Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "Following the successful approval of sugemalimab for the treatment of Stage IV NSCLC in Europe, we have been working closely with the EMA to actively expand its indication for earlier-stage lung cancer and other tumor types. Based on its outstanding efficacy and favorable safety profile, sugemalimab has the potential to address the unmet clinical needs of patients with Stage III NSCLC. Furthermore, we will continue to deepen our international strategic collaborations and work closely with regulatory agencies to increase global access to sugemalimab and ensure that this innovative therapy can benefit patients worldwide as soon as possible."

About Sugemalimab

Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform licensed from US-based Ligand Corporation . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab closely resembles the natural G-type immunoglobulin 4 (IgG4) response in humans, minimizing the potential risk of immunogenicity and related toxicities in patients. This offers unique advantages over similar drugs.

The European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have sensitizing EGFR mutations or genomic tumor alterations in ALK, ROS1, or RET.

Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (Zegemet ) :

First-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC and metastatic squamous NSCLC without EGFR or ALK gene mutations;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 CPS ≥ 5.