#China #Guangzhou #CAR-T therapy #CARsgen Therapeutics #Zevor-cel

CARsgen's Zevor-Cel Included in China's Health Insurance Drug Catalogue

In a significant development for the biotech industry, CARsgen Therapeutics Holdings Limited has announced that its CAR-T cell therapy, Zevorcabtagene autoleucel (commonly known as Zevor-Cel), has been included in the Innovative Drug Catalogue by the National Healthcare Security Administration (NHSA) of China. This inclusion marks a critical step toward increasing patient access to innovative treatments for relapsed and refractory multiple myeloma. The announcement was made during a press conference held in Guangzhou on December 7, 2025, attended by Dr. Huamao Wang, the Co-founder and Chief Operating Officer of CARsgen.

Innovative Drug Catalogue Overview

The Innovative Drug Catalogue is a groundbreaking initiative that aims to promote drugs that exhibit high levels of innovation and clinical value. The NHSA's move to establish this catalogue is designed to empower the landscape of innovative medications, significantly benefiting patients and their families. By doing so, the NHSA is not only endorsing cutting-edge therapies but is also enhancing overall drug accessibility throughout the country.

Zevor-Cel is recognized as a Category 1 innovative biological product and has received marketing authorization from the National Medical Products Administration (NMPA) in February 2024. The therapy specifically targets adult patients suffering from relapsed or refractory multiple myeloma who have experienced disease progression after at least three prior treatment regimens, which must include a proteasome inhibitor and an immunomodulatory agent.

Impact on Patients and the Healthcare System

CARsgen has granted exclusive commercial rights for Zevor-Cel within mainland China to Huadong Medicine Co., Ltd. The latter has developed a comprehensive commercial strategy to market Zevor-Cel effectively. The collaboration focuses on enhancing accessibility for patients via China’s multi-layered insurance system. This strategy has already shown promising results, with CARsgen reporting 170 confirmed orders from Huadong Medicine between January and September 2025, surpassing the total number for the entirety of 2024.

Recent data from a five-year follow-up of a Phase I clinical trial presented at the 2025 IMS Annual Meeting highlighted Zevor-Cel's impressive performance. It showcased a manageable safety profile without severe adverse events or noteworthy delayed reactions. Among the patients investigated, 100% responded to the treatment, with 78.6% achieving complete response or stringent complete response. Notably, all patients who attained complete responses were minimal residual disease negative at a threshold of 10^-5.

Expert Insights

Dr. Huamao Wang expressed enthusiasm regarding the inclusion of Zevor-Cel in the Innovative Drug Catalogue. He remarked, "This recognition by the state reflects a significant commitment to the development and support of innovative medical solutions, which aim to alleviate the financial burdens on patients." His vision for CARsgen is to continue tackling unmet clinical needs by developing more innovative CAR T-cell products that can be rapidly delivered to patients. This is a vital step forward in supporting the wider initiative for a healthier China.

About CARsgen Therapeutics

CARsgen is dedicated to developing advanced CAR T-cell therapies targeting significant unmet clinical needs, especially within hematologic malignancies and solid tumors. By establishing end-to-end capabilities in CAR T-cell development, the company aims to tackle challenges posed by traditional therapies. These include enhancing safety, efficacy in solid tumors, and reducing associated treatment costs. CARsgen strives to position itself as a global leader in biopharmaceuticals, committed to making cancer and other diseases manageable or curable for patients around the world.

The future of CAR T-cell therapy looks promising under the auspices of CARsgen. With the official endorsement of Zevor-Cel by the NHSA, the potential for broader patient access and enhanced treatment options is on the horizon, marking a commendable advance for the field of oncology.

For more information about CARsgen Therapeutics and their innovative therapies, visit CARsgen's website.