On November 14, 2025 Jecho (Tianjin) Biopharmaceutical Co., Ltd. ("Jecho Bio"), a global, clinical stage biopharmaceutical company advancing medicines focusing in oncology, reported a major regulatory milestone. Jecho’s independently developed innovative drug, JL19001, an IL-15/human serum albumin fusion protein, has been approved by the U.S. Food and Drug Administration (FDA) to begin clinical trials for non–muscle-invasive bladder cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This achievement further advances the international clinical development for JL19001, as it was approved to begin clinical trials by China’s National Medical Products Administration (NMPA) in September 2025.

Notably, this approval is the tenth IND clearance and second U.S. FDA IND clearance Jecho Bio has obtained, validating Jecho Bio’s strong capabilities in innovative drug development.

About JL19001 Injection

JL19001 is a recombinant fusion protein composed of human serum albumin (HSA) and IL-15Rα/IL-15. It activates NK cells and CD8+ T cells, enhancing both innate and adaptive immune responses. When used in combination with Bacillus Calmette–Guérin (BCG) therapy for patients with non–muscle-invasive bladder cancer (NMIBC), it may help patients avoid radical cystectomy and improve both survival rates and quality of life.

(Press release, Jecho Laboratories, NOV 14, 2025, View Source [SID1234660001])