CARsgen's CAR-T Product Satri-cel Included in China's Commercial Health Insurance Innovative Drug List

SHANGHAI, Nov. 14, 2026 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that satricabtagene autoleucel ("satri-cel", product code: CT041), an autologous CAR T-cell therapy product targeting Claudin18.2, has been included in the Commercial Health Insurance Innovative Drug List (2026) (the "CHIIDL") issued by the National Healthcare Security Administration ("NHSA") and the Ministry of Human Resources and Social Security ("MOHRSS"), for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. The new list was published today by the NHSA at a press conference held in Suzhou, and will officially take effect on January 1, 2027.

The CHIIDL primarily covers innovative drugs that go beyond the "basic coverage" mandate of the national basic medical insurance scheme and therefore cannot yet be included in the basic reimbursement list, but which are highly innovative, of significant clinical value, deliver substantial patient benefit, and are well suited to insurance coverage. It provides a payment basis for China's multi-tiered healthcare security system, including commercial health insurance and mutual medical aid. Satri-cel is the first CAR T-cell therapy product for solid tumors to be included in the CHIIDL since the list was established, marking an extension of the multi-tiered healthcare security system's support for CAR T-cell therapy from hematologic malignancies into solid tumors, which affect a considerably larger patient population.

Taking this inclusion as an opportunity, CARsgen will, on the premise of doing its utmost to ensure product quality and a stable supply, actively support the design and implementation of commercial insurance products and accelerate market access at healthcare institutions and standardized clinical use, so as to bring this first-in-class cell therapy product to more patients as soon as possible.

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, stated, "Satri-cel was approved in China this June and has been included in the national CHIIDL within the same year. This is recognition at the national level of the clinical value and the innovation of the world's first CAR T-cell therapy for solid tumors. The CHIIDL establishes an institutionalized payment channel for high-value innovative therapies outside basic medical insurance, and brings us one step closer to truly bringing this first-in-class achievement to patients. The Company will continue to build the payment and service ecosystem together with insurers and healthcare institutions, so as to make diversified payment a workable and ever-broadening pathway."

About Satri-cel

Satri-cel is an autologous CAR T-cell therapy product against the protein Claudin18.2 that is the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in June 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy, making it the world's first approved CAR T-cell therapy product for solid tumors.

The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase I clinical trial for pancreatic cancer adjuvant therapy in China (NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (NCT07179484).

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

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SOURCE CARsgen Therapeutics