Recently, the clinical trial applications for two Class 1 innovative drugs independently developed by CGeneTech have successively received implied consent for clinical trials from the National Medical Products Administration. CGT-1881, a CXCR4 antagonist, is applicable for hematopoietic stem cell mobilization in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM); CGT-9475, as a next-generation ALK inhibitor, is expected to be used for subsequent treatment after resistance to existing ALK inhibitors.
CGT-1881: Efficient, Highly Selective "Stem Cell Mobilization"
CXCR4 not only plays a key role in tumors but is also closely related to some immune diseases, genetic disorders, and viral diseases. Currently, the clinical indications of CXCR4 antagonists under research globally include various directions such as acute lymphoblastic leukemia, acute myeloid leukemia, breast cancer, glioblastoma, hepatocellular carcinoma, and stem cell mobilization.
As we all know, stem cells are present in the human bone marrow. Therefore, the traditional collection of stem cells is a dangerous and complex process. The person being collected often needs to undergo a puncture operation in a sterile operating room. Although anesthesia can alleviate some of the pain, anesthesia itself also carries a high risk. CXCR4 antagonists can block the interaction and signal transmission of SDF-1/CXCR4, causing the highly expressed SDF-1 in the bone marrow microenvironment to lose its chemotaxis on hematopoietic stem/progenitor cells, preventing them from transendothelial migration and homing to the bone marrow niche, thereby mobilizing bone marrow hematopoietic stem/progenitor cells into the peripheral blood circulation.
CGT-1881, a highly efficient and selective next-generation CXCR4 antagonist currently under development by the company, is applicable for mobilizing hematopoietic stem cells into peripheral blood in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM), facilitating the collection and autologous transplantation of hematopoietic stem cells. Compared to existing injectable drugs on the market, CGT-1881 is administered orally, offering greater convenience and accessibility.
CGT-9475: Premium and Differentiated Development
Lung cancer is the leading cause of cancer-related deaths globally and the primary cause of cancer mortality in China. Lung cancer is divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) based on biological characteristics, treatment, and prognosis, with NSCLC accounting for 80%-85%. Among NSCLC patients, approximately 3%-7% have ALK gene mutations. The average age of ALK-positive advanced NSCLC patients is 52 years, and some patients are already diagnosed with brain metastases at initial diagnosis, with the incidence increasing over time, posing a severe challenge to patient survival.
ALK inhibitors have shown significant advantages in clinical applications, but their use inevitably leads to secondary resistance and brain metastasis issues. CGT-9475, an ALK inhibitor under development by the company, aims to overcome resistance and address the challenge of central nervous system metastasis, with a focus on high-quality and differentiated development.
CGT-9475 Demonstrates Significant Inhibition Against L1196M, RET, and Other Resistance Mutations in Non-Small Cell Lung Cancer Cell Lines in Preclinical Studies, for Which There Are Currently No Solutions Available. Meanwhile, the Drug Exhibits Favorable Blood-Brain Barrier Penetration in Preclinical Studies, Offering New Hope for NSCLC Patients with Brain Metastases. Therefore, CGT-9475 Has the Potential to Become a Next-Generation ALK Inhibitor for Subsequent Treatment After Resistance to Existing ALK Inhibitors.
Dr. Tong Wang, Chief Scientific Officer of CGeneTech, stated: "We are very pleased that CGT-1881 and CGT-9475 have been successively approved for clinical trials. Currently, there is no oral drug targeting CXCR4 antagonists approved globally, presenting a broad market prospect; the mechanism of action of this target is clear and has been clinically proven to be effective, with application potential in multiple indications such as solid tumors and blood cancers. CGT-9475 effectively addresses two major clinical pain points in NSCLC treatment—drug resistance and brain metastasis—and is expected to become a new generation of ALK inhibitor. We hope that both drugs can advance quickly through clinical trials to benefit patients worldwide as soon as possible."
CGeneTech was founded in 2010 in Suzhou Industrial Park. The core team has decades of international experience in the entire lifecycle of pharmaceuticals and is committed to the research and industrialization of small molecule innovative drugs for breakthrough therapies. With an integrated drug development technology platform and diverse commercial perspectives, the company has established a rich pipeline of innovative drugs, covering multiple disease areas such as diabetes treatment, cancer, and rare diseases.
Typesetting | Qiao Weijun
