Huadong Medicine announced that HDM2012 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for two indications: gastric cancer or gastroesophageal junction cancer and pancreatic cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

15 December 2025: Huadong Medicine announced that HDM2012 has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for two indications: gastric cancer or gastroesophageal junction cancer and pancreatic cancer

Huadong Medicine announced that its independently developed ADC, injectable HDM2012, has been granted Orphan Drug Designation by the U.S. FDA for two indications, gastric and gastroesophageal junction cancer, and pancreatic cancer, highlighting growing international recognition of the company’s innovation in ADC research and development
The dual Orphan Drug Designations represent an important milestone in Huadong Medicine’s global drug development strategy, reinforcing its progress in internationalisation and its focus on advancing novel targets in oncology
HDM2012 is the first ADC globally to target MUC-17 and the only known ADC against this target to have entered clinical development, positioning it at the forefront of innovation for cancers where MUC-17 is highly expressed and therapeutic options remain limited
Preclinical data have demonstrated favourable safety and efficacy, with findings presented at the 2025 AACR Congress supporting HDM2012’s potential across MUC-17 positive gastric, colorectal, and pancreatic cancers, while clinical trials have already been approved in both China and the US for advanced malignant tumors
With Orphan Drug Designation in place, HDM2012 may now benefit from key US regulatory incentives, including tax credits, reduced regulatory fees, and seven years of market exclusivity upon approval, strengthening Huadong Medicine’s competitive position in the ADC oncology landscape