- Asymchem has successfully completed its first U.S. Food and Drug Administration (USFDA) Pre-Approval Inspection (PAI) at its TJ4 TIDES development and manufacturing facility in Tianjin, China. The inspection took place from June 29 to July 2, 2026.
- The 41-acre facility supports multiple manufacturing modalities, including peptides, oligonucleotides, drug products, payload linkers, excipients and small-molecule APIs.
Asymchem has completed its first U.S. Food and Drug Administration (USFDA) Pre-Approval Inspection (PAI) at its Asymchem Life Science (Tianjin) Co., Ltd. TIDES development and manufacturing facility, known as TJ4. The inspection took place from June 29 to July 2, 2026, marking the first inspection by a Western regulatory agency at the Tianjin 4 site. The PAI involved a small-molecule entity and included a review of the facility’s quality systems, data integrity measures and manufacturing operations.
Located in Tianjin, China, the 41-acre facility houses manufacturing capabilities across peptides, oligonucleotides, drug products, payload linkers, excipients and small-molecule active pharmaceutical ingredients (APIs). Its infrastructure includes automated solid- and liquid-phase synthesis for peptides and oligonucleotides, enzymatic ligation, preparative high-performance liquid chromatography (prep-HPLC) and tangential flow filtration (TFF).
The facility also includes isolation capabilities such as lyophilization, precipitation and spray drying for injectable and oral indications. Its design is intended to meet the requirements for both New Drug Applications (NDAs) and Biologics License Applications (BLAs).
“This milestone reflects the standards we hold ourselves to every day. Our systems, people and culture are built to deliver at the highest level, putting us in a position to successfully bring our valued partners through to commercialization.”
Dr. Hao Hong, Chairman and CEO of Asymchem Group
Asymchem said the inspection outcome reinforces its regulatory performance, supported by approximately 200 annual global customer audits and more than 100 regulatory inspections.
