April 27, 2026
Frederick, MD – Jecho Laboratories, Inc. (“Jecho”), a clinical-stage biotechnology company focused on developing innovative therapeutics, announces that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for JLM019.
JLM019 is a CD80/PD-1 dual-target Fc fusion protein with a unique bidirectional synergistic mechanism. With its precise targeting design, the drug is expected to overcome the limitations of existing immunotherapies, improve immunotherapy response rates, and delay the development of tumor cell resistance. As a result, it has the potential to significantly enhance immunotherapy and provide new treatment options and hope for survival for patients with advanced solid tumors and lymphomas.
JLM019 is currently in a Phase 1 study for advanced malignant tumors in Peking Union Medical College Hospital, as it was approved to commence clinical trials by China’s National Medical Products Administration (NMPA) in September 2025. The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of JLM019 injection in patients with advanced malignancies.
This achievement marks the third U.S. FDA IND clearance Jecho has obtained and the 11th overall IND clearance.