BRIEF—WuXi AppTec peptide facility receives PMDA approval

With peptides, oligos and peptide conjugates continuing to attract drug developer interest and industry capacity in short supply, China’s WuXi AppTec says its Changzhou site has been approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The three-day inspection was passed without any major findings and follows on from the continuing expansion plans announced late last month.

The new investments cover several large sites, including the 169-acre active pharmaceutical ingredient (API) manufacturing facility in Taixing, alongside existing drug-product manufacturing facilities in Wuxi City, China, and Couvet, Switzerland, and forthcoming sites in Middletown, Delaware, and Tuas, Singapore.

Phase 1 of the Taixing site – which spans an initial 81 acres with nine manufacturing plants, three of which are now in use – has been operational since January 2024.

Including the new site, the company’s total reactor volume for active pharmaceutical ingredient (API) production will increase to 3,773 m3 by the year’s end (2024).

WuXi AppTec is one of the companies identified specifically in the USA’s BIOSECURE Act0, which aims to prevent contracts with Chinese biotech companies.