Press Release
  • Press Release
  • Contact Us
  • CStone announces acceptance of marketing authorization application by UK MHRA for sugemalimab in metastatic non-small cell lung cancer

    Times:2022.12.19   Author:CStone

    • This is the first marketing authorization application of sugemalimab outside of China.
    • Application is based on data from the phase 3 GEMSTONE-302 trial evaluating sugemalimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment of metastatic non-small cell lung cancer, which has met its primary and secondary endpoint of progression-free survival and overall survival, respectively.
    • In 2021, the National Medical Products Administration of China approved sugemalimab in combination with chemotherapy as first-line treatment of patients with metastatic squamous or non-squamous non-small cell lung cancer.

     

    Suzhou, China, December 19, 2022- CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application (MAA) submitted by its partner EQRx for sugemalimab in combination with chemotherapy as first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC).

    “The acceptance of the first international marketing authorization application for sugemalimab is an important milestone for our global strategy under the collaboration with EQRx that we believe reflects the potential relevance of an innovative drug developed in China in a global market,” said Dr. Jason Yang, CEO of CStone. “We look forward to supporting our partner, with the goal of making sugemalimab available to patients in the UK.”

    In 2021, sugemalimab was granted Innovation Passport designation in the U.K. through the Innovative Licensing and Access Pathway (ILAP) from the ILAP partner organizations including the MHRA. The ILAP was established in early 2021 to accelerate the development of and access to medicines in the U.K.

    This MAA for sugemalimab is supported by clinical data from the CStone-sponsored GEMSTONE-302 study, a multicenter, randomized, double-blind phase 3 study to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy in first-line treatment-naïve patients with stage IV NSCLC as compared to placebo in combination with chemotherapy. The GEMSTONE-302 study met its primary and secondary endpoints, demonstrating statistically significant and clinical meaningful improvement in progression-free survival (PFS) and overall survival (OS), respectively. The data has been published in the Lancet Oncology and presented in several international conferences (2022 ASCO, 2021 WCLC, 2020 ESMO Asia).

     

    About Sugemalimab

    The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using 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 allow a reduced the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

    Currently, sugemalimab is approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable Stage III NSCLC 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. Sugemalimab is the first anti-PD-(L)1 monoclonal antibody approved for both stage III and stage IV NSCLC.

    In addition, the NMPA of China has accepted and granted priority review to the supplemental new drug application (sNDA) for sugemalimab in the treatment of patients with R/R ENKTL. A registrational study of sugemalimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric adenocarcinoma (GC)/gastro-esophageal junction (GEJ) adenocarcinoma has met its primary endpoint. The other registrational study designed to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) has completed patient enrollment.

    CStone has a strategic collaboration agreement with EQRx, under which EQRx holds the exclusive rights for development and commercialization of sugemalimab outside of Greater China.

     

    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 world-class 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 nine NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

    For more information about CStone, please visit www.cstonepharma.com.

     

    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.

    Your privacy is important for us. We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies or select “Reject all” for using only strictly necessary cookies.