Longtech's Dual Engine of CDMO and New Drug Development Drives Record July Revenue of NT$99.25 Million

Longtech (6712-TW) announced July revenue of NT$99.25 million, representing a 5.72% increase from the previous month and a 20.72% increase year-over-year. Cumulative revenue for the first seven months of the year reached NT$559 million, up 16.31% compared to the same period last year.

Longtech stated that rising demand in regenerative medicine and cell therapy markets has driven steady volume growth in its CDMO business, with the 'CDMO + new drug development' dual-engine strategy continuing to gain traction.

The company's proprietary allogeneic, off-the-shelf CAR-T cell therapy candidate, CA002, has completed the approved Phase 1 dose-escalation trials in both the United States and Taiwan. The trials demonstrated favorable safety profiles with no dose-limiting toxicities (DLT) observed, successfully passed review by the Safety Monitoring Committee (SMC), and have officially advanced into the Phase 2a efficacy verification stage, including enrollment of the first patient.

Given that glioblastoma (GBM) is a common and highly aggressive primary malignant tumor in adults with poor clinical prognosis, Longtech has initiated planning for an Orphan Drug Designation (ODD) application with the U.S. FDA for CAR001 targeting GBM indications. Successful designation would provide regulatory review acceleration, tax incentives, and market exclusivity, strengthening competitiveness in international clinical development, global licensing collaborations, and multi-center trials.

Looking ahead, Chairman Liu Zhuqi will continue to advance CAR001's clinical development, international regulatory strategy, and global licensing partnerships, while integrating with the CDMO business to strengthen the 'CDMO + innovative cell therapy' dual-engine growth strategy.