#China #Tianjin #Asymchem #TIDES #USFDA

Asymchem Achieves a Major Regulatory Milestone

Asymchem Life Science, a prominent player in integrated pharmaceutical solutions, celebrated a significant achievement by successfully passing its inaugural U.S. Food and Drug Administration (USFDA) Pre-Approval Inspection (PAI) for its Tianjin-based TIDES development and manufacturing facility, known as TJ4. This inspection, which took place from June 29 to July 2, 2026, marked the first evaluation by a western regulatory agency of the Tianjin 4 site.

The TJ4 facility, which spans 41 acres, is equipped with advanced capabilities for the development and manufacturing of various pharmaceutical modalities, including peptides, oligonucleotides, drug products, payload linkers, excipients, and small molecule Active Pharmaceutical Ingredients (APIs). The inspection included a thorough examination of the facility’s quality systems, data integrity procedures, and manufacturing operations, affirming the high standards that Asymchem adheres to in its operations.

Dr. Hao Hong, Chairman and CEO of Asymchem Group, expressed his pride over this milestone, stating, "This accomplishment reflects the standards we maintain daily. Our systems, workforce, and culture are geared towards delivering exceptional quality, positioning us to effectively guide our partners through the commercialization phase."

The TJ4 facility features state-of-the-art automation for solid and liquid phase synthesis, enzymatic ligation, and several other advanced processes. Additionally, it is designed with compliance in mind, ensuring it meets the requirements of both New Drug Applications (NDA) and Biologics License Applications (BLA).

This FDA milestone not only enhances Asymchem's standing in the industry but also reinforces the company's proven track record of regulatory success, having undergone approximately 200 global customer audits annually and over 100 regulatory inspections throughout its history.

Founded in 1995, Asymchem has grown into a leading global Contract Development and Manufacturing Organization (CDMO), offering comprehensive solutions to the pharmaceutical and biotech industries. The company operates cutting-edge R&D and manufacturing sites across China, the U.S., and Europe and employs over 10,000 professionals worldwide. Asymchem provides an extensive range of services, including small molecules, TIDES, biologics, and synthetic biology, among others.

As part of its commitment to innovation and sustainability, Asymchem makes continuous investments in research and development, aiming to create significant value for its expanding global clientele. The company's determination to uphold the highest quality standards is evident in its operational philosophy and is crucial for maintaining its leadership position in the market.

For further information on Asymchem’s capabilities and services, please visit www.asymchem.com.