Ever Supreme Bio Technology reported that its continued growth in proprietary cell therapy preparation and storage services helped drive consolidated revenue of NT$90.54 million in August, a 3% year-on-year increase and a 10% month-on-month rise, marking a record high for the same period historically. Cumulative revenue from January to August reached NT$570 million, up 14.3% year-on-year.
For the first half of the year, the company reported earnings per share (EPS) of NT$2.02, an 18.1% increase compared with the same period last year. With current orders already scheduled through next year, analysts expect Ever Supreme Bio Technology’s second-half operations to perform even stronger, supporting continued profit growth for the year.
Globally, existing CAR-T therapies are autologous (patient-derived) and primarily target hematologic cancers, which account for roughly 10% of all cancers. The remaining 90% are solid tumors—such as colorectal, lung, and breast cancers—which create highly immunosuppressive tumor microenvironments that act as a formidable barrier, preventing traditional CAR-T therapies from effectively penetrating and exerting their effects. To date, no clinically successful CAR-T therapy exists for these tumors.
Ever Supreme Bio Technology’s CAR001 represents the world’s first allogeneic γδT cell therapy combining an HLA-G nanobody chimeric antigen receptor (CAR) with a PD-L1 bispecific antibody (BiTE), specifically targeting microsatellite stable (MSS) colorectal cancer. MSS patients make up approximately 85% of colorectal cancer cases, yet current immune checkpoint inhibitors covered by Taiwan’s National Health Insurance are effective only in microsatellite instability-high (MSI-High) patients, roughly 15% of cases, leaving MSS patients with almost no treatment options—indicating substantial market potential.
CAR001 is currently in clinical trials, enrolling 10 patients with relapsed or refractory solid tumors. Only 2 patients experienced grade 1 mild cytokine release syndrome (CRS), demonstrating a favorable safety profile. Notably, one MSS metastatic colorectal cancer patient receiving two low-dose CAR001 treatments showed a tumor reduction of 42.86% on day 40 per iRECIST (immune therapy response criteria), achieving a partial response (PR). By day 96, tumor shrinkage increased to 72.89%, maintaining PR status. The tumor marker CA199 also dropped from 48.2 U/ml pre-treatment to 13.1 U/ml, signaling a potential breakthrough for MSS colorectal cancer patients.
CAR001 uses γδT cells from healthy donors, enabling large-scale production and off-the-shelf availability, bypassing the lengthy cell processing required in autologous CAR-T therapies. The therapy also employs non-viral mRNA modification, enhancing safety and shortening tracking time. Combined with Ever Supreme Bio Technology’s integrated, one-stop cell manufacturing capability, this ensures stable product quality compliant with regulatory standards. Preclinical animal studies have demonstrated tumor elimination rates exceeding 90%, with results published in the international journal Advanced Science.
CAR001 is patent-protected in major markets including the United States, Europe, Japan, China, and Taiwan. With the recent announcement of Taiwan’s Regenerative Medicinal Products Act, if CAR001 completes Phase II trials demonstrating safety and preliminary efficacy, the therapy may apply for a five-year conditional drug license, enabling early market entry and providing more cancer patients with access to this innovative treatment.
Resource: 長聖8月營收創同期新高 前八月營收年增14.3％
