JY BioMed Receives FDA Orphan Drug Designation for Anti-CEACAM6 ADC Targeting Pancreatic Cancer

Taipei, Taiwan — July 24, 2025 — JY BioMed (Ji Yan Biomedical Co., Ltd.), a biotechnology company focused on next-generation immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational therapy, an anti-CEACAM6 humanized heavy chain antibody-drug conjugate (HCAb-ADC), for the treatment of pancreatic cancer.

Pancreatic cancer remains one of the most lethal malignancies worldwide, with limited treatment options and a five-year survival rate below 10%. The FDA’s Orphan Drug Designation is granted to therapies intended to treat rare diseases or conditions affecting fewer than 200,000 patients in the United States, and highlights the urgent need for innovative treatments in this area.

Advancing a Novel ADC Platform

JY BioMed’s HCAb-ADC platform represents a next-generation approach to targeted cancer therapy. By combining a humanized heavy chain antibody (HCAb) with a potent cytotoxic payload, the therapy is designed to selectively target CEACAM6, a tumor-associated antigen highly expressed in pancreatic cancer and multiple solid tumors.

This precision-targeting strategy aims to:

• Enhance tumor-specific delivery of cytotoxic agents

• Minimize off-target toxicity

• Improve therapeutic efficacy in difficult-to-treat cancers

Significance of Orphan Drug Designation

The FDA’s Orphan Drug Designation provides several development incentives, including:

• Tax credits for qualified clinical trials

• Exemption from certain FDA fees

• Potential eligibility for seven years of market exclusivity upon approval

“This designation represents an important milestone for JY BioMed and validates the therapeutic potential of our ADC platform,” said a spokesperson from JY BioMed. “We are committed to accelerating the clinical development of this program to bring new hope to patients with pancreatic cancer.”

Development Status

The anti-CEACAM6 HCAb-ADC program is currently in the preclinical stage, with promising efficacy observed in multiple tumor models. JY BioMed is actively advancing IND-enabling studies and preparing for future clinical trials.

About JY BioMed

JY BioMed is a Taiwan-based biotechnology company dedicated to developing innovative therapies across oncology and regenerative medicine. The company’s core platforms include:

• Antibody-drug conjugates (ADC)

• Gamma delta (γδ) T cell therapies

• Exosome-based therapeutics

With a strong focus on translational science and global regulatory strategy, JY BioMed aims to deliver breakthrough treatments for patients with high unmet medical needs.