2Y-Biopharma, a wholly owned subsidiary of 2Y-Chem, was established in 2017 as a high-quality CDMO platform serving clients in China and around the world. We support drug product programs throughout the entire development lifecycle—from pre-IND and Phase I–III clinical studies to NDA/ANDA submissions and commercial manufacturing—in compliance with Chinese, U.S., and EU regulatory requirements.

Our GMP manufacturing facility includes eight independent Class D manufacturing suites and warehouse areas with a total area of approximately 14,000 square meters, designed in accordance with international cGMP standards. Manufacturing capabilities include oral solid dosage forms (including OEB 3/4 anti-cancer drugs) and semi-solid topical and transdermal dosage forms. Comprehensive quality management systems and fully equipped QC laboratories have been established on site. DMS, TMS, WMS, and EMS systems have been implemented to support efficient operations.

2Y-Biopharma's specialized technology platforms include solubility enhancement, controlled-release technologies, orally disintegrating tablets (ODTs), sublingual tablet technologies, and semi-solid formulation development.