Suzhou, China, February 23, 2023 - 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 Marketing Authorization Application (MAA) for sugemalimab in combination with chemotherapy as first-line treatment for metastatic non-small cell lung cancer (NSCLC) has been accepted by the European Medicines Agency (EMA). This marks the second MAA for sugemalimab outside of Greater China.
“We are delighted that sugemalimab’s second MAA outside of Greater China has been accepted, following MAA acceptance in the United Kingdom.” said Dr. Jason Yang, CEO of CStone. “This marks a significant milestone in our global strategy. We look forward to supporting our partner with the goal of making this immunotherapy treatment available to patients around the globe as soon as possible.”
This MAA for sugemalimab, submitted by CStone’s partner EQRx, is supported by clinical data from the GEMSTONE-302 study, which is sponsored by CStone. The study is 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 endpoint and secondary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) and overall survival (OS), respectively. The data has been published in The Lancet Oncology and presented at several international conferences, including the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, the 2021 World Conference on Lung Cancer (WCLC), and the 2020 European Society for Medical Oncology Asia Congress (ESMO ASIA).
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 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.
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. Sugemalimab has received “Innovation Passport” recognition from the ILAP (Innovative Licensing and Access Pathway) partnering organizations, including the MHRA, through the ILAP program. Launched in early 2021, the ILAP aims to accelerate the development and market launch of drugs in the UK.
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 relapsed or refractory extranodal natural killer/T cell lymphoma (R/R ENKTL). Two registrational studies evaluating the efficacy and safety of sugemalimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric adenocarcinoma (GC)/gastro-esophageal junction (GEJ) adenocarcinoma and sugemalimab in combination with chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), respectively, have met their primary endpoints.
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 ten 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.
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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