#China #Shanghai #Satri-cel #CARsgen Therapeutics #NMPA

CARsgen Therapeutics Marks a Major Milestone for Satri-cel

CARsgen Therapeutics Holdings Limited, a pioneering biopharmaceutical company focused on CAR T-cell therapies, proudly announces that the National Medical Products Administration (NMPA) of China has accepted its New Drug Application (NDA) for satricabtagene autoleucel (referred to as Satri-cel). This innovative therapy targets Claudin18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJA) patients who have experienced failure with at least two prior lines of treatment.

This landmark NDA acceptance represents a significant progression for CARsgen, particularly as Satri-cel is deemed to be the world's first CAR T-cell therapy product aimed at solid tumors, thus marking a major step forward in the CAR T-cell field. The submission of the NDA was bolstered by robust data emerging from a multicenter, randomized controlled Phase II clinical trial (CT041-ST-01) conducted in China. The trial's results, recently published in The Lancet and presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, underscore the potential of Satri-cel in offering improved outcomes compared to standard therapies.

Clinical Need and Development of Satri-cel

Gastric cancer poses a severe burden globally with intricate treatment challenges. Professor Lin Shen, a leading investigator from the Beijing Cancer Hospital involved in the clinical trial, emphasized the limited efficacy of existing treatment options, particularly for advanced stages of gastric cancer. Many patients have increasingly encountered failures with both immunotherapy and anti-angiogenic therapies, leaving a substantial gap in effective treatment.

The Phase II trial of Satri-cel has demonstrated substantial benefits, particularly in extending both progression-free survival (PFS) and overall survival (OS) when compared to current treatment standards. The results have not only attracted attention but have also provided robust evidence supporting the NDA submission, paving the way for a potentially pivotal new option for patients who have very few choices left after conventional treatments.

Future Prospects for Satri-cel

Encouraged by the NDA’s acceptance, CARsgen is also planning to explore Satri-cel’s applications in early-line and perioperative cancer treatments. Currently, ongoing trials include a Phase Ib registrational trial focusing on adjuvant treatment for pancreatic cancer and innovative therapeutic strategies for patients recovering after resection of G/GEJA.

Dr. Zonghai Li, the founder and CEO of CARsgen, expressed his enthusiasm regarding the milestone achievement, highlighting the collaborative efforts of clinical investigators, trial coordinators, and the courageous patients involved in the trials. He anticipates that the upcoming approval will signify a new chapter in treatment possibilities for gastric cancer patients, offering them renewed hope.

Satri-cel: A Potential Game-Changer

Satri-cel functions as an autologous CAR T-cell therapy designed specifically against the Claudin18.2 protein, making a substantial impact as it targets solid tumors primarily focusing on G/GEJA and pancreatic cancer. In addition to the confirmatory Phase II study, the therapy's development pipeline includes multiple trials aimed at addressing the pressing needs of patients dealing with difficult-to-treat solid tumors. It’s noteworthy that Satri-cel has already received Priority Review and Breakthrough Therapy Designation from the NMPA in China, alongside Orphan Drug Designation from the U.S. FDA, signaling its significant potential within the biopharmaceutical landscape.

As CARsgen Therapeutics continues to make strides in CAR T-cell therapy, Satri-cel remains at the forefront, potentially revolutionizing treatment for patients suffering from one of the world’s deadliest cancers. With regulatory progress underway and clinical trials ongoing, the future appears promising for this groundbreaking treatment approach.

In conclusion, the NDA acceptance of Satri-cel signifies not only a milestone for CARsgen but heralds hope to a patient population that has been in dire need of effective interventions. As they move towards securing market approval, the anticipation mounts for what could become a transformative therapy in the realm of oncology.