Company Announcements

SHANGHAI , Dec. 7, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced today announced with great pleasure that its independently developed fully human BCMA-targeted CAR-T product, zevorcabtagene autoleucel (zevor-cel, R&D code: CT053), has been included in China's Commercial Health Insurance Innovative Drug Catalogue (2025) (referred to as the "Innovative Drug Catalogue") for the treatment of relapsed/refractory multiple myeloma. The Innovative Drug Catalogue was released today at a press conference held by the National Healthcare Security Administration (NHSA) in Guangzhou. Dr. Huamao Wang, Co-founder and Chief Operating Officer of CARsgen, attended the conference.

This year, the NHSA took the landmark step of establishing the Innovative Drug Catalogue, operating alongside the Basic Medical Insurance Catalogue. This Innovative Drug Catalogue specifically targets drugs that are highly innovative, of significant clinical value, and deliver substantial patient benefits. It is designed to empower the innovative drug industry chain with unprecedented support and enhance drug accessibility.

Zevor-cel is a Category 1 innovative biological product with its Marketing Authorization (MA) held by CARsgen Life Sciences Co., Ltd., a subsidiary of CARsgen Therapeutics. It is manufactured by CARsgen Pharmaceuticals Co., Ltd. Zevor-cel was approved for marketing by the National Medical Products Administration (NMPA) on February 23, 2024, for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent).

CARsgen has granted exclusive commercialization rights for zevor-cel in mainland China to Huadong Medicine Co., Ltd. (Stock Code: 000963.SZ). Huadong Medicine has established a dedicated, professional, and comprehensive commercial team to promote the use of zevor-cel and has been utilizing China's multi-layered insurance system to improve patient accessibility. Currently, certification and regulatory filings for zevor-cel have been completed in more than 20 provinces and municipalities across China. From January to September 2025, CARsgen received 170 confirmed orders from Huadong Medicine, exceeding the total number of orders for the full year of 2024.

Five-year follow-up results from the Phase I clinical trial of zevor-cel, presented at the 2025 IMS Annual Meeting, demonstrated a manageable safety profile and deep, durable efficacy in patients with relapsed/refractory multiple myeloma. No grade 3 or higher cytokine release syndrome (CRS) was observed. No immune effector cell-associated neurotoxicity syndrome (ICANS), delayed neurotoxicities, second primary malignancy, or other delayed adverse events was observed. The overall response rate was 100% (95% CI: 76.8, 100.0) with 11 (78.6%) patients achieving complete response (CR) or stringent complete response (sCR). All patients who achieved CR or better were minimal residual disease (MRD) negative at 10⁻⁵ threshold. The median progression-free survival (mPFS) and the median duration of response (mDoR) were 44.1 months and 43.2 months in CR/sCR patients, respectively. The median overall survival (mOS) was not reached. The patient survival rate at 60 months post-infusion was 76.9%.

Dr. Huamao Wang, Co-founder and Chief Operating Officer of CARsgen, said: "We are very pleased to see zevor-cel included in the first batch of the Innovative Drug Catalogue. This reflects the nation's high recognition of and policy support for innovative drugs. This inclusion will help further alleviate the financial burden on patients and enhance the accessibility of advanced cell therapies, allowing more patients to benefit from innovative treatments. CARsgen remains committed to addressing unmet clinical needs, developing more innovative and differentiated CAR T-cell products, bringing them to patients as quickly as possible, and contributing to the 'Healthy China' initiative."

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.

Contact CARsgen

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