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New medicine is coming!
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With the development of diagnosis and treatment technology, the survival of patients with cancer diseases has been improved, but there is still a large unmet treatment need, and it is necessary to actively explore new treatment drugs and new treatment options. According to the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China, in April this year, about 60 Category 1 new drugs were approved for clinical trials in China for the first time. According to the classification of new registrations, "Class 1 new drugs" refer to drugs that have not yet been approved for marketing in any country or region in the world, and they often represent the frontier direction in the field of drug research and development.
From the perspective of disease fields, there are more than 30 anti-tumor drugs among the Class 1 new drugs approved for clinical use in China for the first time in April, accounting for more than 60%, involving unresectable or metastatic advanced solid tumors and hematologic malignancies. In terms of drug types, the first Category 1 new drugs approved for clinical trials in China in April include cell and gene therapy (CGT), antibody drug conjugates (ADCs), monoclonal antibodies, bispecific antibodies, targeted therapies and other different types.
In this article, we have selected key drugs for the benefit of readers.
Table 1 Category 1 new drugs approved for clinical trials in China in April 2024
ADC drugs
Including IBI133, a HER3-targeted ADC drug, which is primarily aimed at unresectable locally advanced or metastatic solid tumors. With the continuous study of the epidermal growth factor receptor (EGFR/HER) family, HER3 has been found to be able to participate in the pathological process of tumors by activating downstream signaling pathways through heterodimerization with HER2 or EGFR.
In addition, it includes GQ1010 injection, an ADC drug targeting TROP2, for adult patients with advanced solid tumors; HB0052 targeting CD73 for injection in advanced solid tumors; SGN-B6A, targeting integrin β6, is intended for the treatment of adult patients with advanced solid tumors.
Monoclonal antibodies
Monoclonal antibodies are one of the main means of biotargeted therapy, and the function of these monoclonal antibodies is mainly to activate innate immune effector function and complement activity through contact with Fc receptors. As the core of molecular targeted therapy, targeted therapy antibodies have gone through the stages of murine monoclonal antibodies, chimeric monoclonal antibodies, humanized antibodies and fully human antibodies, and have become a hot spot in clinical research and an important tool for clinical treatment of tumors.
The monoclonal antibody drugs approved this time, such as LNF2008 monoclonal antibody injection for advanced solid tumors; Monoclonal antibody BGB-A3055 injection targeting CCR8 is used in advanced or metastatic solid tumors, among others.
Bispecific antibodies
PT217, a DLL3/CD47 bispecific antibody for advanced solid tumors, is a bispecific antibody with natural IgG structure, targeting DLL3 and CD47, which can be used for the treatment of small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NECs).
In addition, there is SCTB14 injection, a bispecific antibody for immunotherapy of multi-tumor solid tumors for advanced malignant solid tumors.
Small molecule targeted therapy
Including humanized monoclonal antibody DM919 injection targeting MICA/B protein, which can be used in advanced solid tumors. DM919 is a humanized monoclonal antibody targeting MICA/B protein, which is expressed at low levels in normal tissues but significantly upregulated in cancerous cells.
Cell & Gene Therapy (CGT)
There are 10 CGT products, including tumor-infiltrating lymphocyte (TIL) therapy, γδT cell drugs, CAR-T cell drugs, TCR-T cell drugs, CAR-raNK cell therapy, etc.
■GC203
GC203 is a new tumor infiltrating lymphocyte (TIL) drug and the world's first new TIL drug based on non-viral vectors. GC203 is based on natural TIL cells, and through non-viral vector-mediated genetic engineering technology, TIL cells can stably express the membrane-bound and spontaneously aggregated cytokine IL-7, which can improve the in vivo expansion potential of TIL cells and the ability to modify the tumor microenvironment, enhance the local immunity of tumors, avoid the systematic destruction of immune balance, and reduce toxic side effects.
■γδT cell injection
γδT cell injection is an innovative immune cell drug. γδ T cells are a type of T cell that has been found to play an important role in the development of tumors, infections, and autoimmune diseases.
■CAR-T cell drugs
Approved CAR-T cell agents include GPC3-targeted chimeric antigen receptor autologous T cell injection C-CAR031 for GPC3+ advanced/relapsed hepatocellular carcinoma, and BRD-03, a CD99-targeted chimeric antigen receptor gene-modified autologous T cell injection for relapsed/refractory CD99+ bone or soft tissue sarcoma ≥ 18 years of age.
GPC3 is highly expressed in a variety of malignant solid tumors (such as hepatocellular carcinoma, squamous non-small cell lung cancer, esophageal squamous cell carcinoma, etc.), but is almost not expressed in healthy adults, so it is an ideal target with potential for a variety of malignant solid tumors.
BRD-03 is an anti-CD99 CAR-T cell drug, which specifically targets CD99-positive tumor cells with surface-specific receptors, recognizes and binds to CD99 antigens on the surface of tumor cells without MHC restrictions, activates T cells through signal transduction pathways, releases granzyme, perforin and a variety of cytokines, triggers apoptosis of CD99-positive tumor cells, and exhibits specific recognition and direct killing activity against CD99-positive tumor cells, so as to achieve the purpose of treating CD99-positive tumors.
■KSH01
KSH01 is a new TCR-T cell drug targeting large cancers of the digestive tract and urinary tract, targeting MAGE-A4 antigen. The core sequence of the drug is a naturally derived TCR sequence with potent anti-tumor activity that was rapidly screened from patients, and MAGE-A4 is an antigen that is ubiquitous in a variety of solid tumors.
■IBR822
IBR822 is a non-viral, non-genetically modified NK cell (CAR-raNK) drug that specifically targets the TROP2 antigen and has the ability to kill tumor cells. The drug is chemically covalently conjugated to NK cells through linkers by TROP2, a specific antibody targeting tumor antigens, and has a high safety and ability to kill tumor cells.
Exciting information is waiting for you
Editor in charge: Sheep
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