CARsgen Books RMB62 Million in First-Half Revenue in Its First Period With Satri-cel on the Market

Sixty-two million renminbi, almost all of it myeloma

The half-year revenue came mainly from zevorcabtagene autoleucel, the autologous BCMA CAR-T the NMPA approved in 2024 for adults with relapsed or refractory multiple myeloma who have progressed after at least three prior lines including a proteasome inhibitor and an immunomodulatory agent. CARsgen recognizes that revenue on completion of ex-works delivery and at the ex-works price, so the reported figure sits below end-market spending on the product. Gross profit of about RMB42 million reflects in-house production of plasmids and vectors, the company said. Commercialization partner Huadong Medicine booked 110 confirmed orders during the period, and because CAR-T manufacturing runs on its own clock, orders and ex-works deliveries do not line up inside a single reporting window.

Zevor-cel entered China's Commercial Health Insurance Innovative Drug Catalogue in December 2025. Founder, chairman and chief executive Zonghai Li tied the balance sheet to the next phase of spending: "The Company maintains a sound financial position, and our ample cash reserves provide a solid foundation for our ongoing global expansion, advancement into earlier lines of treatment, and development of next-generation allogeneic/ in vivo CAR-T technologies."

Approved on CT041-ST-01, with no companion assay named

Satricabtagene autoleucel is an autologous humanized CAR-T directed at Claudin18.2, approved in June for patients with Claudin18.2-positive, HER2-negative advanced G/GEJA who have failed at least two prior lines. CARsgen calls it the first CAR-T therapy anywhere approved to treat a solid tumor. The registration package rests on CT041-ST-01, an open-label randomized Phase 2 run at Chinese centers in which 156 patients were allocated 2:1 to satri-cel or treatment of physician's choice, drawn from nivolumab, paclitaxel, docetaxel, irinotecan or apatinib. Median progression-free survival by independent review reached 3.25 months (95% CI 2.86 to 4.53) against 1.77 months (1.61 to 2.04), a hazard ratio of 0.37 (95% CI 0.24 to 0.56). Toxicity was heavy: grade 3 or worse treatment-emergent adverse events occurred in 87 of 88 treated patients, and cytokine release syndrome in 84 of 88. Dosing ran up to three infusions of 250 million cells.

Laboratories asked to screen for this therapy get their criterion from the trial itself. CT041-ST-01 defined Claudin18.2 positivity as immunohistochemistry intensity of 2+ or greater in at least 40% of tumor cells, a looser threshold than the 75% of viable tumor cells required by the Ventana CLDN18 (43-14A) RxDx assay, the companion diagnostic FDA approved for zolbetuximab in October 2024. CARsgen's release names no companion assay for the Chinese approval.

For patients with advanced G/GEJA who have failed multiple lines of prior therapy, previous treatment options were extremely limited and the prognosis was very poor. The approval of satri-cel provides us with a novel and effective therapeutic weapon.

That assessment came from Lin Shen of Peking University Cancer Hospital, whose team led the satri-cel clinical program, in CARsgen's June 22 approval announcement.

Two allogeneic candidates cleared for registrational trials this month

In August the NMPA cleared INDs for CT0596, a BCMA-directed allogeneic CAR-T for relapsed or refractory myeloma, and for CT1190B, a CD19/CD20 allogeneic candidate for relapsed or refractory large B-cell lymphoma after at least two prior lines of standard therapy. Both come from the THANK-u Plus platform, both had investigator-initiated results presented at the EHA 2026 congress in June, and both now move into Phase 1 registrational studies. Separately, CARsgen has started an investigator-initiated trial of KJ-C2529, a CD19/CD20 candidate built on its CARvivo in vivo platform, in relapsed or refractory B-cell non-Hodgkin lymphoma. Satri-cel itself is being pushed earlier, with a Phase 1 adjuvant pancreatic cancer study (NCT05911217) and investigator-initiated trials in resected G/GEJA (NCT06857786) and after first-line therapy (NCT07179484).

Why This Matters to the APO|APE Reader

Satri-cel passed preliminary formal review for China's 2026 National Commercial Insurance Innovative Drug Catalogue and appears in this year's CSCO gastric cancer guidelines and in the China Anti-Cancer Association's guidance on commercial insurance for innovative oncology technology, the listings that decide whether a cell therapy gets used beyond a handful of top-tier hospitals. Outside China the product has no approval and no filing date, and the company describes its plan only as authorization filings in selected regional hub markets. The longest human follow-up in print remains a three-patient case report published in the Journal of Hematology and Oncology in July 2026, with a maximum of 48 months of observation in gastric cancer with peritoneal metastasis.