CARsgen’s Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA

科济药业 Holdings Limited, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel (“satri-cel”, CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy.

Strategic Impact of Breakthrough Therapy Designation

This designation underscores the potential of satri-cel as an innovative treatment for advanced gastric and gastroesophageal junction cancer, a condition with high unmet medical need. The Breakthrough Therapy Designation is expected to expedite the regulatory review process, allowing for a faster path to approval and ultimately providing patients with access to this promising therapy sooner.

“We are fully committed to advancing the preparation work for the NDA submission of satri-cel. We are delighted that satri-cel has received Breakthrough Therapy Designation, which is expected to expedite its approval process and bring this therapy to patients as soon as possible,” said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate that targets Claudin18.2, a protein expressed in various solid tumors, including gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). It has the potential to be the first-in-class CAR T-cell therapy targeting Claudin18.2 globally.

The ongoing clinical trials include:

Phase II trial for advanced gastric/gastroesophageal junction cancer in China (CT041-ST-01, NCT04581473)

Phase I trial for pancreatic cancer adjuvant therapy in China (CT041-ST-05, NCT05911217)

Phase 1b/2 trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595)

Satri-cel has already garnered recognition, receiving Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for Claudin18.2-positive advanced GC/GEJ in January 2022, as well as Orphan Drug designation from the U.S. FDA for the treatment of GC/GEJ in September 2020.

About CARsgen Therapeutics Holdings Limited

CARsgen Therapeutics is a biopharmaceutical company with operations in China and the U.S., focusing on the development of innovative CAR T-cell therapies for both hematologic malignancies and solid tumors. CARsgen has established a comprehensive platform covering target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. The company aims to address significant challenges in current CAR T-cell therapies, including improving safety profiles, enhancing efficacy in solid tumors, and reducing treatment costs.

CARsgen's mission is to become a global leader in biopharmaceuticals by providing innovative and differentiated cell therapies to cancer patients worldwide, ultimately striving to make cancer curable.

This breakthrough designation propels Satri-cel closer to offering a potential life-changing treatment for patients with Claudin18.2-positive advanced gastric cancer and beyond.