CStone Secures Historic MHRA Approval for Sugemalimab Treatment in Stage III NSCLC
On February 22, 2026, CStone Pharmaceuticals, a leading biopharmaceutical firm, announced a significant milestone in oncology care with the UK Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for sugemalimab, an innovative cancer immunotherapy. This approval marks the second indication for sugemalimab in the UK, reinforcing its position as a pivotal treatment option for patients suffering from stage III non-small cell lung cancer (NSCLC).
The approval follows the endorsement by the European Commission in July 2024, allowing sugemalimab's use in Europe. This latest indication is targeted specifically at adult patients with unresectable stage III NSCLC who exhibit PD-L1 expression in 1% or more of their tumor cells, and who do not have sensitizing EGFR mutations or genomic aberrations related to ALK or ROS1. Additionally, patients must have demonstrated no disease progression after undergoing platinum-based chemoradiotherapy (CRT).
The approval is primarily based on promising results from the GEMSTONE-301 study, which is a multicenter, randomized, double-blind Phase III clinical trial. The study results indicated that treatment with sugemalimab significantly improved progression-free survival (PFS) and delivered a clinically meaningful extension of overall survival (OS) for patients with this aggressive form of lung cancer.
Dr. Jason Yang, CEO and President of R&D at CStone, expressed his enthusiasm regarding this critical development, stating that sugemalimab is now one of only two PD-(L)1 targeted therapies approved for stage III NSCLC in Europe. This dual approval not only enhances treatment options for patients battling advanced lung cancer but also symbolizes CStone's commitment to expanding its commercial footprint, which now spans over 60 countries and regions worldwide.
The MHRA's approval is seen as a major boost for CStone, as it provides further validation and wide-ranging commercial potential for sugemalimab. The acceptance of sugemalimab into multiple national reimbursement systems across countries highlights the recognized clinical value and pharmacoeconomic advantages it offers over existing treatments.
Furthermore, the inclusion of sugemalimab in the European Society for Medical Oncology (ESMO) guidelines for treating stage IV NSCLC exemplifies the treatment’s solid clinical standing. The drug was given the highest level of recommendation for use in first-line settings for both squamous and non-squamous NSCLC, thereby enhancing its significance in clinical practice.
Apart from its success in NSCLC, CStone is also pursuing additional regulatory submissions for sugemalimab, targeting other malignancies such as gastric cancer and esophageal squamous cell carcinoma (ESCC). The innovative efforts surrounding sugemalimab reflect a broader ambition held by CStone to address a range of unmet medical needs in oncology.
Sugemalimab is a fully human monoclonal antibody developed using a unique OmniRat® transgenic platform, which promotes reduced immunogenicity and toxicity risks compared to other similar therapeutic antibodies. With its robust development history and increased market presence, sugemalimab stands poised to become a cornerstone treatment option for patients with advanced lung cancer and beyond.
CStone Pharmaceuticals was founded in 2015 and has rapidly evolved into an innovation-driven enterprise focusing on oncology and other significant disease areas. Since its inception, the company has launched four groundbreaking drugs and has submitted 20 new drug applications that cover nine distinct indications.
As CStone continues its advancement in the biopharmaceutical landscape, the company seeks to make substantive contributions to oncology treatment, ensuring that patients receive the most effective therapies available. With the recent MHRA approval, sugemalimab’s future looks promising, providing hope to those facing the challenges of stage III non-small cell lung cancer.
The approval follows the endorsement by the European Commission in July 2024, allowing sugemalimab's use in Europe. This latest indication is targeted specifically at adult patients with unresectable stage III NSCLC who exhibit PD-L1 expression in 1% or more of their tumor cells, and who do not have sensitizing EGFR mutations or genomic aberrations related to ALK or ROS1. Additionally, patients must have demonstrated no disease progression after undergoing platinum-based chemoradiotherapy (CRT).
The approval is primarily based on promising results from the GEMSTONE-301 study, which is a multicenter, randomized, double-blind Phase III clinical trial. The study results indicated that treatment with sugemalimab significantly improved progression-free survival (PFS) and delivered a clinically meaningful extension of overall survival (OS) for patients with this aggressive form of lung cancer.
Dr. Jason Yang, CEO and President of R&D at CStone, expressed his enthusiasm regarding this critical development, stating that sugemalimab is now one of only two PD-(L)1 targeted therapies approved for stage III NSCLC in Europe. This dual approval not only enhances treatment options for patients battling advanced lung cancer but also symbolizes CStone's commitment to expanding its commercial footprint, which now spans over 60 countries and regions worldwide.
The MHRA's approval is seen as a major boost for CStone, as it provides further validation and wide-ranging commercial potential for sugemalimab. The acceptance of sugemalimab into multiple national reimbursement systems across countries highlights the recognized clinical value and pharmacoeconomic advantages it offers over existing treatments.
Furthermore, the inclusion of sugemalimab in the European Society for Medical Oncology (ESMO) guidelines for treating stage IV NSCLC exemplifies the treatment’s solid clinical standing. The drug was given the highest level of recommendation for use in first-line settings for both squamous and non-squamous NSCLC, thereby enhancing its significance in clinical practice.
Apart from its success in NSCLC, CStone is also pursuing additional regulatory submissions for sugemalimab, targeting other malignancies such as gastric cancer and esophageal squamous cell carcinoma (ESCC). The innovative efforts surrounding sugemalimab reflect a broader ambition held by CStone to address a range of unmet medical needs in oncology.
Sugemalimab is a fully human monoclonal antibody developed using a unique OmniRat® transgenic platform, which promotes reduced immunogenicity and toxicity risks compared to other similar therapeutic antibodies. With its robust development history and increased market presence, sugemalimab stands poised to become a cornerstone treatment option for patients with advanced lung cancer and beyond.
CStone Pharmaceuticals was founded in 2015 and has rapidly evolved into an innovation-driven enterprise focusing on oncology and other significant disease areas. Since its inception, the company has launched four groundbreaking drugs and has submitted 20 new drug applications that cover nine distinct indications.
As CStone continues its advancement in the biopharmaceutical landscape, the company seeks to make substantive contributions to oncology treatment, ensuring that patients receive the most effective therapies available. With the recent MHRA approval, sugemalimab’s future looks promising, providing hope to those facing the challenges of stage III non-small cell lung cancer.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.