CARsgen Receives CTA Authorization from Health Canada for CLDN18.2-targeted CAR T-cell Product CT041

SHANGHAI,Nov. 22,2021 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK),a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors,today announced that the Company has received a No Objection Letter from Health Canada in response to the Clinical Trial Application (CTA) of CT041,an autologous CAR T-cell product candidate against the claudin18.2 protein,"CLDN18.2".

As of this announcement,CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND clearance from both the FDA and the NMPA,and CTA authorization from Health Canada.

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first in its class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CARsgen believes that CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide.

In addition to the investigator-initiated trials in China,CARsgen has initiated a Phase Ib/II clinical trial for advanced GC/GEJ or PC in China and a Phase 1b clinical trial for advanced GC/GEJ or PC in North America. CT041 was granted PRIME Eligibility by the EMA for the treatment of advanced GC. CT041 received Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020 and Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021. CARsgen has applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. The company also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company with operations in China and the U.S. mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The company has built an integrated cell therapy platform with in-house capabilities that span target discovery,antibody development,clinical trials,and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies,such as improving the safety profile,enhancing the efficacy in treating solid tumors,and reducing treatment costs. Our vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

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