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  • CStone Announces Receipt of GCP Inspection Notification from the European Medicines Agency (EMA) for Sugemalimab Marketing Authorization Application

    Times:2023.07.11   Author:CStone

    Suzhou, China, July 11, 2023, CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced receipt of a Good Clinical Practice (GCP) inspection notification from the European Medicines Agency (EMA) regarding the marketing authorization application (MAA) for sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC).

    The EMA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom have both accepted applications for sugemalimab combinational therapy as a first-line treatment for metastatic NSCLC, and the two MAAs are currently under review. The receipt of the GCP inspection notification, as anticipated, indicates that the sugemalimab registration process is progressing steadily at the EMA. CStone has been maintaining smooth communications with the EMA since the MAA acceptance and will continue to work closely with the Agency and investigators to ensure successful inspections.

    To date, sugemalimab has achieved success in five registrational clinical trials, covering indications of stage III NSCLC, stage IV NSCLC, lymphoma, gastric cancer, and esophageal cancer. The clinical data of sugemalimab have been presented at multiple international academic conferences and published in top-tier journals such as The Lancet Oncology, Journal of Clinical Oncology, Nature Cancer, etc.

    Given its outstanding clinical results from multiple pivotal trials, sugemalimab holds great potential for the global market. CStone will continue to engage health authorities, such as the EMA, the U.K. MHRA and the U.S. FDA. Meanwhile, CStone is actively exploring partnership for the development and commercialization of sugemalimab outside of Greater China.


    About Lung cancer

    In 2020, lung cancer was the third most diagnosed cancer in Europe and the leading cause of cancer-related mortality, accounting for one fifth of cancer deaths.[1] Approximately fifty to seventy percent of lung cancer cases in Europe are diagnosed in Stage IV.[2] This contributes to a poor prognosis, with a 5-year survival rate of 13 percent in the region.2 Globally, it is estimated that NSCLC accounts for approximately 85% of all lung cancers.[3]


    About Sugemalimab

    The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using the OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

    Sugemalimab is approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC.

    The supplemental biologics license applications for sugemalimab for the treatment of patients with relapsed/refractory extranodal NK/T-cell lymphoma, as well as in combination with chemotherapy for first-line treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, and in combination with chemotherapy for first-line treatment of unresectable locally advanced, recurrent, or metastatic ESCC have been accepted by the NMPA of China and are currently under review.


    About CStone

    CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received eleven NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone’s vision is to bring innovative oncology therapies to cancer patients worldwide.

    For more information about CStone, please visit


    Forward-looking statements

    The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.


    1. Dyba T, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.

    2. van Meerbeeck, J. et al. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res,2021;10(5) 2407-2417.

    3. Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.

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