#China #Shanghai #CARsgen #Satri-cel #Zevor-cel

CARsgen Therapeutics 2025 Interim Results

CARsgen Therapeutics Holdings Limited, identified by its stock code 2171.HK, recently published its interim results for 2025, indicating a period of significant progress in the development of CAR T-cell therapies. The announcement details both financial and operational advancements, emphasizing the company's innovative approach in tackling unmet clinical needs, particularly in the fields of hematologic malignancies, solid tumors, and autoimmune diseases.

Business Highlights

As of June 30, 2025, CARsgen's cash and bank balances stood at approximately RMB 1,261 million, with expectations to maintain at least RMB 1,100 million through to the end of the year. This financial buffer positions the company favorably for future developments and commitments until 2028, excluding further cash inflows. In the first half of the year, the company completed regulatory filings for its flagship product, zevor-cel, across over 20 regions in China, receiving 111 confirmed orders from its commercialization partner, Huadong Medicine.

Moreover, the New Drug Application (NDA) for satri-cel has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This drug has garnered considerable attention as it targets solid tumors, making it a groundbreaking innovation within CAR T-cell therapy. The findings from the confirmatory Phase II trial for satri-cel have been published in the reputable journal, The Lancet, and were presented at the 2025 ASCO Annual Meeting, showcasing its efficacy and safety profile compared to traditional treatments.

Financial Overview

The revenue reported for the first half of 2025 reached RMB 51 million, primarily driven by the sales of zevor-cel. The company's gross profit for the same period was estimated at around RMB 29 million. These figures exemplify CARsgen's strong market positions as they navigate the complexities associated with CAR T-cell manufacturing, particularly the discrepancy between received orders and actual deliveries.

Cash reserves experienced a slight decline from RMB 1,479 million reported at the end of 2024, mainly due to substantial investments in research and development along with administrative expenses. Despite this decrease, CARsgen is poised for sustained financial health and innovation-driven growth.

Zevor-cel: Rapid Sales Growth

Zevor-cabtagene autoleucel, commonly referred to as zervor-cel, represents CARsgen’s clinical innovation for treating adult patients suffering from relapsed or refractory multiple myeloma. Approved by the NMPA in China, this product has been incorporated into Huadong Medicine's commercial plans, which includes a dedicated team focused on facilitating patient access through China's intricate insurance system. The completion of regulatory certification enhances the momentum for zevor-cel sales, ensuring CARsgen's competitive edge in the CAR T-cell landscape.

Satri-cel: Leading the Charge against Solid Tumors

Satricabtagene autoleucel, known as satri-cel, is recognized as the premier CAR T-cell therapy targeting Claudin18.2, addressing a critical gap in treatment for Claudin18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma patients. Its NDA acceptance marks a significant milestone not only for CARsgen but also for the broader domain of cancer therapies, signaling substantial potential for positive clinical outcomes.

Satri-cel has been granted both Priority Review and Breakthrough Therapy Designation by the CDE, underscoring its transformative potential. The efficacy showcased in clinical trials illustrates notable improvements in progression-free survival, paving the way for its role in addressingsolid tumor challenges.

Future Prospects in Allogeneic CAR-T Products

CARsgen is diversifying its research with allogeneic CAR T-cell products utilizing its proprietary platforms, including the latest THANK-u Plus™. Among the promising candidates under development, CT0596 targets BCMA for multiple myeloma and is currently in Investigator Initiated Trials (IITs) in China.

Innovative candidate products such as KJ-C2219 and KJ-C2320 are also in the pipeline, targeting B-cell malignancies and acute myeloid leukemia, respectively. This robust development pipeline positions CARsgen at the forefront of CAR-T innovation.

In summary, CARsgen Therapeutics has demonstrated substantial innovation and financial performance in its 2025 interim report, amidst soaring demand for advanced CAR T-cell therapies. With its commitment to improving patient outcomes and expanding treatment accessibility, CARsgen aims to solidify its status as a leader in the biopharmaceutical industry.

Company Overview: CARsgen Therapeutics Holdings Limited is committed to developing advanced CAR T-cell therapies that meet critical clinical needs, fortifying its position as a major player in the biopharmaceutical landscape focusing on both hematologic malignancies and solid tumors.