SUZHOU, China, Feb. 9, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that its key product, Cejemly® (sugemalimab), has been included in the European Society for Medical Oncology (ESMO) Non-Oncogene-Addicted Metastatic Non-Small-Cell Lung Cancer (NSCLC) Living Guideline. Sugemalimab is recommended as a first-line combination therapy for both squamous and non-squamous NSCLC, with substantial clinical benefits. This is a significant milestone in sugemalimab's global journey and provides critical support for our efforts to expand market access, enter the markets, and reach patients.
According to the ESMO Guideline:
For patients with squamous NSCLC, performance status (PS) 0-1, regardless of tumour PD-L1 status and without contraindications for immune checkpoint inhibitors (ICI), sugemalimab-platinum-doublet chemotherapy is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of 4, indicating substantial clinical benefit. Link to guideline: PS 0-1 & any expression of PD-L1 | ESMO
For patients with non-squamous NSCLC, PS 0-1, regardless of tumour PD-L1 status and without contraindications for ICI, sugemalimab-platinum-based chemotherapy is recommended as a Level [I, A] first-line combination therapy, with an ESMO-MCBS v1.1 score of 4, also indicating substantial clinical benefit. Link to guideline: PS 0-1 & any expression of PD-L1 | ESMO
These recommendations are supported by robust clinical data from the Phase III GEMSTONE-302 trial, which demonstrated significant benefits in progression-free survival (PFS) and overall survival (OS) with sugemalimab plus platinum-based chemotherapy, compared to placebo plus platinum-based chemotherapy. Notably, sustained and consistent benefits were observed across various histological subtypes and PD-L1 expression levels. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 ESMO Annual Meeting.
Currently, sugemalimab has been approved in China, the EU, and the UK for first-line treatment of advanced NSCLC. After successfully establishing commercial partnerships in dozens of countries in Switzerland, Central and Eastern Europe, the Middle East, Africa, and Latin America, CStone is actively pursuing strategic commercial partnerships in Western Europe, Southeast Asia, and Canada. This effort is in parallel with the overseas registration and launch process for other indications of sugemalimab.
About Cejemly® (sugemalimab)
The anti-PD-L1 monoclonal antibody Cejemly® (sugemalimab) was developed 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.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5).
The European Commission (EC) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
About CStone
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 17 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit www.cstonepharma.com.
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