Suzhou, China, October 28, 2024--CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the population pharmacokinetics (PopPK) modelling results of its internally developed anti-PD-L1 antibody, sugemalimab (brand name: Cejemly®), have been published in the renowned British Journal of Clinical Pharmacology.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, “The PopPK modelling results have characterized the pharmacokinetic profile of sugemalimab and provided robust scientific evidence supporting the rationale behind applying a standard dosing regimen across diverse patient populations. We remain committed to advancing the global development and commercialization of sugemalimab, to provide innovative treatment options to more patients.”
This study employed PopPK modeling and integrated data from 1,628 patients across nine Phase I-III clinical trials, involving various types of cancers including non-small cell lung cancer (NSCLC), NK/T-cell lymphoma, and esophageal squamous cell carcinoma (ESCC). The PopPK model adequately described the pharmacokinetic properties of sugemalimab in patients. While factors such as weight, albumin levels, sex, anti-drug antibodies, tumor burden, and tumor type slightly influenced drug clearance (less than 20%), none of these variables had a clinically significant impact.
The analyses further supported the use of the approved standard dosage of sugemalimab (1200 mg administered every three weeks) across different patient groups. The results demonstrated that patients, including the elderly, those of different ethnicities, and those with mild to moderate hepatic or renal impairment, achieve adequate drug exposure at the prescribed dosage, without the need for dose adjustment, highlighting the convenience of sugemalimab treatment and its potential to improve patient compliance. In addition, the model could also be used to guide the dosage in certain extreme cases (e.g., patients weighing over 115 kg).
About Sugemalimab
The anti-PD-L1 monoclonal antibody 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. Sugemalimab’s unique molecular design enables a dual mechanism of action that not only blocks PD-1/PD-L1 interaction, but also induces antibody dependent cellular phagocytosis (ADCP) by cross-linking PD-L1 expressing tumor cells with tumor associated macrophages (TAMs) without harming Effector T-cells. This differentiation has resulted in potentially best-in-class efficacy/safety across a variety of tumor types.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
The European Commission (EC) has approved sugemalimab (brand name: Cejemly®) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has accepted the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitising EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The application is currently under review.
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 15 new drug applications (NDAs) covering 9 indications. The company’s pipeline is balanced by 16 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.
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
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