2Y-Biopharma clears FDA pre-approval inspection with no 483 observations

ChemExpress subsidiary 2Y-Biopharma completed a U.S. FDA pre-approval inspection from June 22-26, 2026, with no Form 483 observations and received its Establishment Inspection Report. The outcome strengthens the company’s regulatory position as it expands U.S. drug product manufacturing capabilities.

Why it matters: - The FDA outcome gives 2Y-Biopharma a cleaner regulatory record as it pushes deeper into the U.S. market. - The inspection result also supports ChemExpress’s broader effort to build a global quality and compliance platform across drug substance and drug product services. - The milestone may help strengthen customer confidence in the company’s drug product manufacturing and commercialization capabilities.

What happened: - 2Y-Biopharma, a wholly owned subsidiary of Shanghai Haoyuan ChemExpress Co., Ltd. (SSE: 688131), completed a U.S. FDA Pre-Approval Inspection with no Form 483 observations. - The FDA inspection took place from June 22 to 26, 2026. - Following the inspection, 2Y-Biopharma received its Establishment Inspection Report, or EIR. - Mr. Wensheng Tang, co-founder and general manager of 2Y-Biopharma, said the EIR followed a successful inspection outcome and strengthens the compliance foundation for the drug product business as it expands into the U.S. market.

The details: - 2Y-Biopharma operates as ChemExpress’s drug product GMP manufacturing site. - The company said the inspection result is an important milestone for ChemExpress’s drug product business. - ChemExpress said the result strengthens its integrated CDMO capabilities across regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs, biologics and drug products. - ChemExpress supports clients from process development through commercialization across the drug development and manufacturing chain. - 2Y-Biopharma supports drug product development and manufacturing from registration and clinical supply to commercial production. - The formulation platform includes spray drying, hot-melt extrusion, lyophilization and fluidized-bed amorphous solid dispersion for poorly soluble drugs. - 2Y-Biopharma also has capabilities in modified-release formulations and topical semi-solid formulations. - Those capabilities are designed to support formulation development, scale-up, GMP manufacturing and commercialization. - ChemExpress was founded in 2006 and provides CRO and CDMO services for pharmaceutical and biotechnology companies. - ChemExpress focuses on small molecules, biologics and newer modalities including ADCs/XDCs, peptides and PROTACs. - The company says its platform supports research, development, manufacturing and supply across multiple product categories. - 2Y-Chem was founded in 2003 and provides pharmaceutical development and cGMP manufacturing services for regulatory applications in the U.S., Europe and China. - 2Y-Biopharma was established in 2017 as a wholly owned cGMP drug product manufacturing plant. - Over the past five years, 2Y-Chem and 2Y-Biopharma have supported 14+ MAH clients in obtaining marketing approval for innovative or generic drugs and have handled commercial production for those clients. - 2Y-Chem says it has served more than 200 NME projects worldwide across preclinical, clinical and commercial stages. - ChemExpress says it has more than 20 years of dedicated chemistry experience through 2Y-Chem.

Between the lines: - A no-483 FDA inspection outcome is a strong signal, because Form 483 observations can flag conditions that may need correction before approval or broader commercial activity. - The inspection result positions 2Y-Biopharma to look more credible to global customers that need U.S.-aligned manufacturing and regulatory readiness. - The announcement also shows ChemExpress is trying to present itself as an end-to-end CDMO rather than a single-service supplier.

What's next: - ChemExpress is expected to keep expanding its drug product services for the global pharmaceutical market. - The company will likely use the inspection result to support future U.S. market growth and new client business. - 2Y-Biopharma’s manufacturing and formulation platform is positioned for additional development, scale-up and commercial projects.

The bottom line: - The FDA inspection clears a key regulatory hurdle for 2Y-Biopharma and strengthens ChemExpress’s case as a broader integrated CDMO.