Eight CGT Therapies Receive IND Approval or Acceptance in China, Highlighting Innovations in CAR-T, TCR-T, Oncolytic Virus, and AAV Gene Therapy

According to the Center for Drug Evaluation of China's National Medical Products Administration（CDE）According to incomplete statistics from the official website and publicly available information, last week(December 22 - December 28)Approximately 30 Class 1 innovative drugs are proposed to be included in the breakthrough therapy designation/priority review/IND approved for clinical trial by default/IND application accepted, covering fields such as CAR-T/TCR-T, gene therapy, XDC, and bi-/tri-specific antibodies.

The following will introduce representative Class 1 innovative drugs that have been approved or declared for clinical trials.

Chineo's IND Application for 610 Cell Injection Accepted; Based on Public Information, the Product May Be Its SCART610 Under Research. Chineo isChina TIL/NeoantigenRepresentative companies of innovative immune cell therapies, such as Chineo, are advancing the clinical research of SCART610 for treating CD19-positive relapsed or refractory non-Hodgkin lymphoma patients.

SCART610: Chineo's "Super-Enhanced Genetically Modified Peripheral Blood TIL-like Cell Technology"（ScTIL）Application in B-cell lymphoma. Its core design highlights are significant: embedding the CAR target into TIL-like cells sorted from peripheral blood.（cTILs）On the surface, these cells carry both natural TCRs that can recognize various mutated neoantigens of cancer cells andKilling CD19-negative escape cancer cells; while adopting the "signal reversal" enhancement strategy to significantly improve the independent killing ability of cells in the tumor microenvironment. In addition, this product adopts2 DaysRapid preparation process, without the need for large-scale cell expansion, effectively simplifies the production process.

Recently, the research on ScTIL for the treatment of highly malignant biliary tract tumors was published inCell Reports Medicine。Compared with the control group, ScTIL significantlyExtended the survival period of advanced patients who were ineffective after multiple lines of treatment.（OS）, Extension RangeUp to 5 times，Overall survival is even better than the standard first-line treatment.。

GuangDong XIANGXUE LIFE SCIENCES LTD's XLS-103 Injection IND Application Approved for Genotype HLA-A*11:01, KRAS G12V Mutation-Positive Advanced Pancreatic Cancer/Advanced Non-Small Cell Lung Cancer.

XLS-103 is the third high-affinity TCR-T product developed by Xiangxue Life Sciences' TAEST core technology platform, following the previous two products, TAEST16001.(A*02:01/NY-ESO-1 Soft Tissue Sarcoma, Esophageal Cancer, Non-Small Cell Lung Cancer)and TAEST1901(A*02:01/AFP Liver Cancer, Stomach Cancer)。

The TCR-T target is A*11:01/KRAS G12V, offering a new approach for the development of drugs targeting the difficult-to-drug KRAS mutation. Unlike traditional targeted drug development strategies, TCR-T therapy does not rely on the structure of the KRAS protein itself, and factors such as its strong binding to GTP or the lack of a druggable pocket in the protein structure need not be considered. The mutated KRAS protein can be normally metabolized and enzymatically cleaved within tumor cells, generating short peptides carrying the mutation. These peptides can be presented on the tumor cell surface by HLA and recognized by TCR-T cells, leading to their destruction.

IND Application for VRT106 Injection by Weirongte Pharmaceutical Accepted. It is the world’s first oncolytic virus product based on the M1 alphavirus backbone, which can be administered through multiple methods including intratumoral injection and intravenous injection. It features clear therapeutic-related biomarkers, complementary companion diagnostic technology, and a convenient lyophilized powder formulation for ease of use, transportation, and storage. Its Phase I/II clinical trial for the treatment of recurrent glioblastoma was launched in July this year.

JWK001 Injection from JinkoBio Gets IND Application Accepted. It is the first AAV gene therapy new drug using the "two-plasmid packaging system," which achieves the treatment purpose in a single administration by continuously and efficiently expressing anti-VEGF protein in retinal cells through an AAV vector carrying a newly self-designed anti-VEGF protein expression cassette. Notably, JWK001 targets the wet age-related macular degeneration pipeline.The effective dose is much lower than that of similar products abroad.，Avoid high-dose risks from the source.

CG-Bio's CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection IND Application Accepted. As the first domestically produced bone marrow mesenchymal stem cell injection independently developed by CG-Bio, it has obtained three clinical trial approvals in China for indications including acute-on-chronic liver failure, ischemic stroke, and moderate to severe adult acute respiratory distress syndrome caused by infection. Among these, the CG-BM1 treatment pipelines for acute-on-chronic liver failure and chronic ischemic stroke have both entered Phase II clinical trials.

For more information on the IND progress of new drugs, please refer to the table.

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