Ever Supreme Bio Technology presented at an earnings conference hosted by the Taipei Exchange on the 7th. Chairperson Judy Liu stated that the company’s CDMO orders are growing steadily, with visibility now extending into the first quarter of 2026. Looking ahead, the company plans to expand into international cell therapy contract manufacturing collaborations. As for its pipeline, three therapies are expected to complete Phase I clinical trials this year: the CAR-T therapy CAR001 for solid tumors, and the allogeneic umbilical cord mesenchymal stem cell therapy UMSC01 for acute ischemic stroke and multiple sclerosis (MS).
Liu noted that Ever Supreme achieved strong results in 2024, with annual revenue reaching NT$933 million, a 23.6% increase compared to 2023. Earnings per share (EPS) stood at NT$4.55. The board of directors has approved a dividend payout of NT$6 per share, comprising NT$1 in stock dividends and NT$5 in cash dividends. Looking ahead, operations in 2025 are expected to outperform 2024. The company is currently in active licensing discussions with several global pharmaceutical firms for its four major development platforms. Future growth will be driven by a dual-engine strategy: new drug licensing and CDMO cash flow to support global expansion.
Ever Supreme has long been engaged in the cell therapy CDMO business and now collaborates with 19 medical institutions across Taiwan. With the advancement of the dual legislation on regenerative medicine and growing acceptance of cell therapies in the market, CDMO orders have seen steady growth, with visibility into early 2026. The company is now preparing to expand its services to international partners.
CAR001 is the world’s first allogeneic, mRNA-engineered, multi-target CAR.BiTE-γδT cell therapy. Featuring both “off-the-shelf” availability and built-in immune synergy, the therapy has been approved by both the U.S. FDA and Taiwan FDA to proceed with Phase I/IIa clinical trials. The current trial targets solid tumors including colorectal cancer, glioblastoma, triple-negative breast cancer, and non-small cell lung cancer. Recruitment for Cohorts 1 and 2 has been completed, and the trial has now advanced to Cohort 3, demonstrating a favorable safety profile. The study is expected to proceed to Cohort 5 to determine the maximum tolerated dose (MTD) and identify initial efficacy signals, with completion of the Phase I trial anticipated this year. A Phase IIa trial is planned to begin next year.
The allogeneic umbilical cord mesenchymal stem cell therapy UMSC01 is undergoing clinical trials for multiple major diseases. For acute myocardial infarction, the trial has entered Phase IIa, with 11 patients treated to date. Most patients have shown significant cardiopulmonary function improvement 6 to 12 months post-treatment, as measured by cardiopulmonary exercise testing (CPET), and have been discharged without any serious adverse events. UMSC01 offers a novel option for cardiac repair following acute myocardial infarction and is expected to complete Phase IIa by next year.
The acute ischemic stroke trial has enrolled 10 patients. Before treatment, most had NIHSS scores between 16 and 20, indicating total dependence. After one year of treatment, NIHSS scores had decreased to 0–4, allowing patients to regain independent living abilities, indicating meaningful neurological recovery. The Phase I trial is expected to complete this year.
UMSC01 is also being evaluated for the treatment of multiple sclerosis (MS), with three patients enrolled so far. The first long-term follow-up patient has shown more than 50% improvement in neurological function, significantly enhancing their daily living capabilities. With a total target enrollment of six patients, the Phase I trial is expected to complete this year.
The company’s nanoparticle drug delivery platform is currently focused on developing a new formulation, INSP003, which uses carrier technology to encapsulate European paclitaxel for solid tumor treatment. A pre-IND meeting has been completed, and an IND submission to the U.S. FDA is expected in early 2026 to initiate Phase I/IIa clinical trials.
In addition, the targeted exosome platform has entered the acute myocardial infarction drug development field. This product delivers specific microRNAs to regulate myocardial cell proliferation and inhibit apoptosis-related gene expression, facilitating cardiac repair and regeneration. A pre-IND meeting with the U.S. FDA is planned for this year, marking another milestone in the company’s drug development pipeline.
With the dual regenerative medicine legislation expected to take effect in 2025, Ever Supreme plans to activate an expedited drug approval pathway. Should CAR001 and UMSC01 demonstrate early safety and efficacy in Phase IIa trials, the company may apply for conditional drug approval, potentially bringing the therapies to market 5 to 7 years ahead of the standard timeline, achieving both commercialization and licensing milestones.
Resource: 長聖CDMO將拓跨國細胞委託製造合作，三項一期臨床試驗拚今年完成
