Multiple CGT Therapies Receive IND Approval in China: Abogen, NeoOrigin, Senlang, and Exegenesis Advance Clinical Pipeline

Abogen Biosciences independently developedABO2102 Injection is a novel mRNA tumor vaccine capable of simultaneously covering multiple KRAS mutations., intended for use as a single agent or in combination with sintilimab to treat KRAS-mutated locally advanced or metastatic solid tumors. This candidate product achieves broad coverage of HLA subtypes through multidimensional technological breakthroughs.

Moreover, the ABO2102 injectable simultaneously encodes5 TypesmRNA molecules of common KRAS mutant antigens are translated into antigens within cells, and then presented via MHC-I/II molecules, activating dual immune responses from CD8⁺ cytotoxic T cells and CD4⁺ helper T cells to achieve precise recognition and attack on KRAS mutant antigens.The First in ChinaTherapeutic tumor vaccine targeting multiple KRAS mutations.

In May this year, ABO2102 injection has received clinical trial approval from the U.S. FDA. This CDE approval marks an important milestone for ABO2102 in achieving dual submissions and approvals in both China and the U.S., showcasing Abogen's globally leading innovation capabilities and international layout in the field of tumor immunotherapy.

Neowise BiotechnologyNW-101C Injection is a TCR-T cell therapy targeting PRAME., intended for HLA typing containing the HLA-A*02:01 subtype and PRAME-positive tumor expression, with advanced malignant solid tumors that are recurrent or metastatic and cannot be radically resected by surgery.

Neowise Biotechnology is an innovative enterprise focused on the development of TCR-T immunotherapy drugs for solid tumors. It has independently developed a high-throughput, high-sensitivity target antigen-natural TCR discovery platform and established multiple R&D pipelines.

In June this year, Neowise Biotechnology reached a non-exclusive licensing agreement with BeiGene to authorize the rights of a self-developed antigen-specific TCR molecule to BeiGene for the development of next-generation universal cell therapy drugs based on the iPSC platform.

SENL103 Autologous T Cell Injection isA CAR-T candidate therapy targeting BCMA, The indication for which clinical implication permission was obtained this time is refractory generalized myasthenia gravis.（rgMG）In March this year, the candidate product was also approved for clinical trials, aiming to treat relapsed or refractory multiple myeloma.（RRMM）The research. This shows that the recent approval for clinical trials has expanded the indications from cancer to autoimmune diseases.

Jiyin Bio's EXG202 Injection Intended for the Treatment of Wet Age-Related Macular Degeneration（wAMD）The patient, currently disclosed information is relatively limited.

Jiyin Bio is a gene and cell therapy enterprise with industry-leading R&D and manufacturing capabilities. The design of its innovative gene therapy products is based on three major platforms assisted by artificial intelligence: viral capsid, promoter, and unique protein engineering. In February this year, Jiyin Bio completed the initiation of the first clinical research center for EXG001-307 Injection, its gene therapy for SMA; in December last year, the IND for Jiyin Bio’s EXG110 Injection was approved for clinical trials targeting Fabry disease.

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