KSH01 TCR-T Injection Receives IND Approval in China for Advanced Solid Tumors

Apr 26, 2024 10:47 CST Updated 10:48

TCRX

Developer of T-Cell Therapies for Solid Tumors

KSH01 TCR T-cell New Drug for Solid Tumors Developed by Keshihua (Nanjing) Biotechnology Co., Ltd. Approved for Clinical Trials by China's National Medical Products Administration, Targeting Indications Such as Esophageal Cancer, Gastric Cancer, and Urothelial Cancer, with Over 1 Million New Patients Annually in China.

KSH01 TCR-T Injection is the first TCR-T cell new drug variety in China targeting gastrointestinal and genitourinary major cancers, and it is also the first TCR-T cell drug in China targeting the MAGE-A4 antigen.

About Keshihua Bio

Keshihua Bio (TCRx Therapeutics) by MD Anderson Cancer Center2018Nobel Prize Winner Team Returnee Scientist Yu2020Yearly ReturnFounded in China, it is a company that integratesTCRInnovative Sequence Discovery,Anti-tumorTCellA technology-based enterprise integrating new drug research and development with clinical sample production.The company has established an efficientTCRSequence Screening PlatformTCRX-Finder^TM, throughTCell Big DataAccumulation, Led by artificial intelligence algorithms and cutting-edge sequencing technology,Established an efficientTCRDrug PCC POCScreening system, one of the few worldwide capable of simultaneously conducting both personalized and fixed-targetTCR TPharmaceutical development companies.

2023Year3Month, BeautifulCountryFDAOfficially Granted to KeshihuaKSH01 HD-TCR TOrphan Drug Designation, also the first drug developed by a local Chinese company to receive approval in the United States.FDAOrphan Drug DesignationTCR TCellular Medicine. In April 2024, this variety hasApproved by the Center for Drug Evaluation of the National Medical Products Administration for clinical trials, with indications including advanced solid tumors such as esophageal cancer, gastric cancer, and urothelial carcinoma. This is China's first TCR-T cell new drug product targeting major cancers of the digestive tract and urinary system.Large clinical demand, wide impact, and an innovative force filling the gaps in global cell-based drug competition.。

At present, Keshihua personalized and fixed targetsTCR TMedicineThe pipelines have obtained Phase I clinical trial data on human safety and efficacy at the National Cancer Center./Cancer Hospital of Chinese Academy of Medical Sciences, Second Affiliated Hospital of Zhejiang University, and First Affiliated Hospital of Guangxi Medical University are continuously recruiting patients.

E.N.D

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