First FDA inspection
Asymchem has completed its first U.S. Food and Drug Administration pre-approval inspection of the TIDES development and manufacturing facility run by Asymchem Life Science (Tianjin) Co., Ltd., known as TJ4, the company said. The inspection took place between June 29 and July 2, 2026.
The company said it was the first inspection of the Tianjin 4 site by a western regulatory agency.
What was reviewed
The pre-approval inspection concerned a small molecule entity and covered the site's quality systems, data integrity measures and manufacturing operations, the company said. TJ4 houses peptides, oligonucleotides, drug product, payload linkers, excipients and small molecule API manufacturing.
The facility
The site covers 41 acres and brings together automated production for solid- and liquid-phase synthesis of oligonucleotides and peptides, enzymatic ligation, preparative HPLC and tangential flow filtration. It also has isolation capacity including lyophilization, precipitation and spray drying for injectable and oral indications, and is designed to comply with NDA and BLA requirements.
Audit record and comment
Asymchem said it handles roughly 200 customer audits a year worldwide and has undergone more than 100 regulatory inspections. Dr. Hao Hong, chairman and chief executive of Asymchem Group, said the inspection reflected the standards the company applies daily and that its systems, people and culture were set up to carry partners through to commercialization.