CARsgen Therapeutics Holdings Limited announced that the Company has received a No Objection Letter from Health Canada in response to the Clinical Trial Application of CT041, an autologous CAR T-cell product candidate against the claudin18.2 protein, "CLDN18.2". As of the date 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 approvals from the FDA, the NMPA and Health Canada. CT041 is a potential global first-in-class, autologous CAR T-cell product candidate against the protein CLDN18.2. CT041 targets the treatment of CLDN18.2 positive solid tumours with a primary focus on gastric/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favourable safety in ongoing clinical trials. The Company 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, the company have initiated a Phase Ib/II clinical trial for advanced GC/GEJ and PC in China and a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America. CT041 was granted PRIME Eligibility for the treatment of advanced gastric cancer from the EMA in 2021, Orphan Medicinal Product designation for the treatment of gastric cancer from the EMA in 2021, and Orphan Drug designation for the treatment of GC/GEJ from the U.S. FDA in 2020. The company have applied to the NMPA for the required regulatory approval for initiating the pivotal Phase II clinical trial in China. The company also intend to conduct a pivotal Phase 2 clinical trial in North America in 2022.