CARsgen Announces CAR T-cell Product Candidate CT041 Granted PRIME Eligibility by the EMA

SHANGHAI,Nov. 15,2021 -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK),a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors,today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to CT041,an autologous CAR T-cell product candidate against the claudin18.2 protein (CLDN18.2) for the treatment of gastric/gastroesophageal junction cancer (GC/GEJ).

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 approvals from both the FDA and the NMPA. Also,CT041 is the first solid tumor CAR T-cell product to be granted PRIME eligibility. CARsgen is currently the only company with two CAR T-cell products active in the PRIME scheme.

"Access to PRIME support and enhanced interaction with EMA is an important milestone in accelerating the development and commercialization of CT041 CAR T cells," said Dr. Zonghai Li,Founder,Chairman of the Board,Chief Executive Officer,and Chief Scientific Officer of CARsgen. "We believe that CT041 has the potential to become a backbone therapy for gastric/gastroesophageal junction cancer and pancreatic cancer in the future. With the mission of 'making cancer curable,' we will continue our efforts to develop more innovative technologies and products for cancer patients worldwide."

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 GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials.

In addition to the investigator-initiated trials in China,CARsgen has 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 the United States. 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. CARsgen also intends to conduct a pivotal Phase 2 clinical trial in North America in 2022.

About PRIME

PRIME is a scheme operated by the EMA to support the development of medicines that target an unmet medical need. Through PRIME,EMA offers early and proactive support to medicine developers to optimize the generation of robust data and enable accelerated assessment of medicine applications.

The PRIME scheme helps patients to benefit as early as possible from treatments that may significantly improve their quality of life. To be accepted for PRIME,a medicine must show its potential to offer a major therapeutic advantage over existing treatments,or to benefit patients without treatment options.

About CARsgen Therapeutics Holdings Limited

CARsgen Therapeutics Holdings Limited is a biopharmaceutical company with operations in China and the U.S. 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. The vision of CARsgen 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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